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 .
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 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.
Response to Amendment
The Response filed February 2, 2026 has been entered. Claims 1-60 are pending in the application. The previous objections to the claims and rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
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 1-60 are rejected under 35 U.S.C. 103 as being unpatentable over
Chae et al. (U.S. Patent Application Publication No. 2020018899; hereinafter “Chae”) in view of Cole et al. (U.S. Patent Application Publication No. 20150018643; hereinafter “Cole”) and Moore et al. (U.S. Patent Application Publication No. 20110237967; hereinafter “Moore”).
Regarding claim 1, Chae discloses an applicator (10; Fig. 4) for applying a medical instrument to a host (annotated Fig. 4 below), wherein:
the applicator comprises a housing (100), an auxiliary mechanism (300), a first drive mechanism (S1), and a second drive mechanism (S2);
the housing comprises a first holding portion (combination of internal container (102) and container cover (103)), a proximal end close to the host, and a distal end remote from the host in operation;
the auxiliary mechanism comprises a moving body (300) releasably held by the first holding portion (para. [097]) and configured to be relatively movable to the housing when released (para. [0098]);
a receiving portion (510) is provided to the moving body and configured to receive and accommodate the medical instrument (520; Fig. 10);
PNG
media_image1.png
1085
748
media_image1.png
Greyscale
a second holding portion (340) is provided to the moving body (Fig. 6; para. [0124]-[0126]);
a puncture member (550) is releasably held by the second holding portion and configured to be relatively movable to the receiving portion when released (para. [0085]-[0087]);
the first drive mechanism is configured to act on the moving body in a manner toward the proximal end (para. [0098]);
the second drive mechanism is configured to act on the puncture member in a manner toward the distal end (para. [0123]);
when released, the moving body is driven by the first drive mechanism toward the proximal end to place the medical instrument received in the receiving portion at least partially subcutaneously in the host through the puncture member (Fig. 22A; para. [0133]); and
the puncture member is driven toward the distal end by the second drive mechanism to move the puncture member away from the host (Fig. 23; para. [0135]).
Chae discloses the invention substantially as claimed except for the applicator including a magnet.
However, Chae discloses the medical instrument being a glucose monitor (para. [0053]).
Cole, a reference in the medical device applicator field of endeavor, teaches that it was known in the prior art to include a magnetic switch to a glucose sensor device to activate the sensor device (paras. [0099]-[0101]).
Moore, a reference in the medical device applicator field of endeavor, teaches providing an applicator with magnet (210) configured to control an off state and an on state of a switch module (220) of a medical instrument by moving between a proximate position and a remote position (Figs. 5c-5d; paras. [0084]-[0086]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the applicator of Chae with a magnet configured to control an off state and an on state of a switch module of the medical instrument by moving between a proximate position and a remote position, in view of Cole and Moore, to facilitate activating the glucose sensor once applied to a user.
Regarding claim 2, Chae discloses wherein the moving body comprises a first locking portion (310; Fig. 4) configured to releasably interlock with the first holding portion (para. [0097]).
Regarding claim 3, Chae discloses wherein the first holding portion and the first locking portion are releasably interlocked by at least one structure of a buckle, a hook (para. [0097), a latch, or a pin.
Regarding claim 4, Chae discloses the applicator further comprising a first trigger mechanism (110; Fig. 4) configured to enable the first holding portion (102) to be separated from the first locking portion (310) for releasing the moving body (para. [0093]).
Regarding claim 5, Chae discloses wherein:
the first trigger mechanism comprises an actuation portion (1112) extending substantially in a direction of a central axis of the applicator (Figs. 14-15); and
the first trigger mechanism is configured to be movable in the direction of the central axis of the applicator (e.g., hinge rods (1112) move with external container (101) in the direction of the central axis of the applicator (i.e., distal-to-proximal direction) when applicator is moved into contact with a user’s skin).
Regarding claim 6, Chae discloses wherein, when projected in the direction of the central axis of the applicator,
a projection of the actuation portion (e.g., body of hinge rod (1112); Fig. 15) of a first trigger portion at least partially coincides with a projection (1021) of the first holding portion (Fig. 5; para. [0097]), and
the first holding portion is actuated to move away from the first locking portion when a first trigger portion moves in the direction of the central axis of the applicator (internal container (102) is capable of actuated movement away from hook (310) under the force of elastic spring (S1) if the internal container is fixed in place when button (110) is pressed).
Regarding claim 7, Chae discloses wherein, when projected in the direction of the central axis of the applicator,
a projection of the actuation portion (e.g., body of hinge rod (1112); Fig. 15) of the first trigger portion at least partially coincides with a projection (1021) of the first locking portion (Fig. 5; para. [0097]), and
the first locking portion is actuated to move away from the first holding portion as the first trigger portion moves in the direction of the central axis of the applicator para. [0098]).
Regarding claim 8, Chae discloses wherein:
the first holding portion comprises a surface facing the distal end (i.e., surface of stepped portion (1021) facing hook (310); Fig. 5);
the first locking portion comprises a surface facing the proximal end (i.e., surface of hook (310) facing stepped portion (1021); Fig. 5);
the surface facing the distal end of the first holding portion is engaged with the surface facing the proximal end of the first locking portion when the moving body is held (Fig. 5; para. [0097]); and
the surface facing the distal end of the first holding portion is separated from the surface facing the proximal end of the first locking portion when the moving body is released (para. [0098]).
Regarding claim 9, Chae discloses wherein at least a portion (1021) of the first holding portion is “L”-shaped or hook-shaped (Fig. 5).
Regarding claim 10, Chae discloses wherein the first holding portion (combination of internal container (102) and container cover (103)) comprises an arm (1041; Fig. 20) extending substantially in a direction of a central axis of the applicator and a protrusion (1042; Fig. 20) cooperating with the arm and projecting substantially in a direction orthogonal to the central axis of the applicator (Fig 20; paras. [0118]-[0121]).
Regarding claim 11, Chae discloses wherein the arm of the first holding portion is resilient in the direction substantially orthogonal to the central axis of the applicator (para. [0118]).
Regarding claim 12, Chae discloses wherein:
the arm of the first holding portion converges toward the central axis of the applicator in a direction from the distal end to the proximal end (Fig. 22B; para. [0119]); and
the protrusion of the first holding portion projects toward the central axis of the applicator (Fig. 20).
Regarding claim 13, Chae discloses wherein:
the arm of the first holding portion back-faces away from the central axis of the applicator in a direction from the distal end to the proximal end (annotated Fig. 5 below); and
the protrusion of the first holding portion back-faces and projects away from the central axis of the applicator (annotated Fig. 5).
PNG
media_image2.png
946
811
media_image2.png
Greyscale
Regarding claim 14, Chae discloses wherein the first locking portion (310) is substantially parallel to or away from a central axis of the applicator in a direction from the proximal end to the distal end (hook (310) extends substantially parallel to a central axis when button (110) is pressed, as shown in phantom in Fig. 5).
Regarding claim 15, Chae discloses wherein the first locking portion (310) is substantially parallel to or converges toward a central axis of the applicator in a direction from the proximal end to the distal end (hook (310) converges toward a central axis; Fig. 5).
Regarding claim 16, Chae discloses wherein the puncture member comprises a second locking portion (410) configured to releasably interlock with the second holding portion (Fig. 6; para. [0124]-[0126]).
Regarding claim 17, Chae discloses wherein the second holding portion and the second locking portion are releasably interlocked by at least one structure of a buckle, a hook (para. [0124]), a latch, or a pin.
Regarding claim 18, Chae discloses the applicator further comprising a second trigger mechanism (130) configured to enable the second holding portion to be separated from the second locking portion for releasing the puncture member (Fig. 22A; para. [0126]).
Regarding claim 19, Chae disclose wherein the second holding portion is releasably interlocked with the second locking portion by at least one of a buckle, a hook (para. [0124]), a latch, and a pin when the puncture member is held.
Regarding claim 20, Chae discloses wherein:
the housing comprises a first housing (combination of internal container (102) and container cover (103)) having the first holding portion and a second housing (101) mountable to the first housing (Fig. 4);
the second housing comprises a first limiting mechanism (110) and a second limiting mechanism (120) communicating with each other;
the second limiting mechanism is configured to define an attachment position of the medical instrument (e.g., an attachment position of sensor (20) to applicator (10); Fig. 5); and
the auxiliary mechanism (300) is mounted to the first limiting mechanism (by interaction between button (110) and hooks (310); Fig. 5) and movable along the first limiting mechanism when the moving body is released by the first holding portion (para. 0098]).
Regarding claim 21, Chae discloses wherein:
the moving body (300; annotated Fig. 17 below) comprises a first bottom portion close to the distal end, a second bottom portion close to the proximal end, a side wall connecting the first bottom portion and the second bottom portion, and a hollow portion formed between the first bottom portion, the second bottom portion, and the side wall (e.g., hollow portion housing pod (510); Figs. 5-6); and
the receiving portion (510) is provided at the second bottom portion and movable along the hollow portion when the puncture member is released (Figs. 18A-18B; para. [0114]).
PNG
media_image3.png
1045
848
media_image3.png
Greyscale
Regarding claim 22, Chae discloses wherein a protrusion back-facing away from a central axis of the applicator in a direction generally orthogonal to the central axis of the applicator is provided on an end, near the distal end, of the moving body (annotated Fig. 17 above).
Regarding claim 23, Chae discloses wherein the moving body comprises at least one of a groove and a ridge provided on an outer wall of a side wall substantially in a direction of a central axis of the applicator (annotated Fig. 17 above).
Regarding claim 24, Chae discloses wherein the moving body comprises a cut (formed about hook (310); annotated Fig. 17 above) substantially in a direction of a central axis of the applicator.
Regarding claim 25, Chae discloses wherein a protrusion (111; Fig. 5), protruding toward the central axis of the applicator via the cut, is provided on an inner wall of the first limiting mechanism.
Regarding claim 26, Chae disclose wherein the moving body is configured to inhibit a rotation of the puncture member (e.g., via interactions between hook (410) and hook engaging portion (340); Fig. 6; para. [0124]).
Regarding claim 27, Chae discloses wherein the moving body comprises at least one of a groove (groove receiving hook (410); Fig. 6) and a ridge provided on an inner wall of a side wall substantially in a direction of a central axis of the applicator.
Regarding claim 28, Chae discloses wherein:
the puncture member (550) comprises a sharp object having a groove (groove receiving sensor probe (521); Fig. 2A) and a bearing (400) for supporting the sharp object (Fig. 4; paras. [0123]-[0128]);
the medical instrument is configured to be wholly or partially placed in the groove of the sharp object (para. [0085]); and
the second drive mechanism (S2) is configured to apply an action on the bearing (para. [0123]).
Regarding claim 29, Chae discloses wherein the sharp object is integrally formed with the bearing (Fig. 5; para. [0127]).
Regarding claim 30, Chae discloses wherein the sharp object is configured for removable engagement with the bearing (e.g., as no structure of needle (550) would prevent removal of the needle from needle head coupling portion (420); Fig. 5; para. [0127]).
Regarding claim 31, Chae discloses wherein:
the sharp object comprises a needle shape portion (550) and a cover portion in (551) fixed connection with the needle shape portion (Fig. 5);
the bearing comprises a plurality of finger shape portions (forming needle head coupling portion (420); Fig. 5; para. [0127]) converging toward one another; and
the cover portion is releasably clamped by the plurality of finger shape portions (e.g., as no structure of needle head (551) would prevent release from needle head coupling portion (420); Fig. 5; para. [0127]).
Regarding claim 32, Chae discloses wherein:
the puncture member comprises a second locking portion (510) configured to releasably interlock with the second holding portion and provided on the bearing (Fig. 6; para. [0124]-[0126]);
the second locking portion comprises an arm extending substantially in a direction of a central axis of the applicator (annotated Fig. 6 below); and
a protrusion cooperating with the arm and back-facing away from the central axis of the applicator substantially in a direction orthogonal to the central axis of the applicator (annotated Fig. 6).
PNG
media_image4.png
915
828
media_image4.png
Greyscale
Regarding claim 33, Chae discloses wherein the arm of the second locking portion is resilient in the direction substantially orthogonal to the central axis of the applicator (paras. [0124]-[0126]).
Regarding claim 34, Chae discloses wherein:
the moving body comprises a cut substantially in the direction of the central axis of the applicator; and
the protrusion of the second locking portion passes through the cut when the puncture member is held (annotated Fig. 6 above).
Regarding claim 35, Chae discloses wherein, when the puncture member is released, the arm of the second locking portion is pressed toward the central axis of the applicator (Fig. 22A; para. [0134]).
Regarding claim 36, Chae discloses wherein the bearing comprises at least one of a groove and a ridge (410) provided on an outer wall substantially in a direction of a central axis of the applicator (Fig. 6).
Regarding claim 37, Chae discloses wherein:
the bearing (400) of the puncture member is provided in the hollow portion;
the receiving portion (510) is provided at the second bottom portion;
the second bottom portion comprises a through hole (e.g., opening allowing exit of sensor (20) from sensor receptacle (301)); and
the sharp object passes through the through hole of the second bottom portion (Figs. 22A-22B).
Regarding claim 38, Chae discloses wherein, when the puncture member is held, a distance between the bearing (400) and the first bottom portion is not less than a length of the sharp object protruding from the receiving portion (Fig. 22A).
Regarding claim 39, Chae discloses wherein the second drive mechanism (S2) is disposed between the bearing (400) and the second bottom portion (Fig. 6).
Regarding claim 40, Chae discloses wherein:
the first housing (102) comprises a hollow cylindrical peripheral portion and an end portion provided at one end of the peripheral portion near the distal end; and
the first holding portion is provided at the end portion (annotated Fig. 4 below).
PNG
media_image5.png
1084
736
media_image5.png
Greyscale
Regarding claim 41, Chae discloses wherein:
one or a plurality of rib shape protrusions (104) are provided on an inner wall of the first housing (annotated Fig. 4 below);
one or a plurality of rib shape grooves are provided on an outer wall of the second housing (101); and
the one or plurality of rib shape protrusions are respectively embedded into the one or plurality of rib shape grooves when the second housing is mounted to the first housing.
PNG
media_image6.png
1083
696
media_image6.png
Greyscale
Regarding claim 42, Chae discloses wherein:
the first limiting mechanism (110) and the second limiting mechanism (120) are in hollow cylindrical shape (button (110) and locking device (120) are in the hollow cylindrical shape of container (101); Fig. 4); and
an inner diameter of the first limiting mechanism (diameter of button (110)) is not greater than an inner diameter of the second limiting mechanism (space between rods (121); Fig. 14).
Regarding claim 43, Chae discloses wherein when the moving body is released, the moving body is movable along the first limiting mechanism and the receiving portion is movable along the second limiting mechanism (Figs. 21-23; paras. [0130]-[0136]).
Regarding claim 44, Chae discloses wherein the first limiting mechanism limits a travel of the moving body in a direction of a central axis of the applicator (para [0093]).
Regarding claim 45, Chae discloses wherein, when projected in the direction of the central axis of the applicator,
a projection (310) of the receiving portion coincides at least partially with a projection (111) of a wall of the first limiting mechanism (Fig. 5), and
the end, near the distal end, of the moving body coincides at least partially with the wall of the first limiting mechanism (e.g., when button (110) is pressed; shown in phantom in Fig. 5).
Regarding claim 46, Chae discloses wherein the first limiting mechanism inhibits rotation of the moving body (e.g., as protrusion (111) abuts hook (310; Fig. 4).
Regarding claim 47, Chae discloses wherein the first limiting mechanism comprises at least one of a groove and a ridge provided continuously or discontinuously on an inner wall substantially in a direction of a central axis of the applicator (e.g., the indented groove of button (110) extends in a direction of a central axis of the applicator; Fig. 5).
Examiner note: Claims 48-58 depend from claim 1 and recite features of the “medical instrument” which is only functionally recited in claim 1 (i.e., “an applicator for applying a medical instrument” (emphasis added)). Thus, the features of the medical instrument recited in claims 48-58 are also merely functionally recited.
Regarding claim 48, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the medical instrument comprises a sensor configured to be placed subcutaneously in the host and an attachment portion that is connected to the sensor and configured to be attached to a body surface of the host (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor and an attachment portion; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 49, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the sensor is configured to react with an analyte in body fluid and generate analyte information (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 50, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the analyte comprises at least one item selected from the group consisting of acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormone, hormone, ketone body, lactate, oxygen, peroxide, prostate specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 51, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the sensor comprises an implant portion configured to be positioned subcutaneously in the host, and a connection portion connecting the implant portion to the attachment portion (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor having an implant portion and a connection portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 52, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the sensor is detachably mounted to the attachment portion (e.g., no structure prevents applicator (10) from applying a medical instrument with a detachable sensor as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 53, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the attachment portion is configured to supply power to the sensor and receive information generated by the sensor (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor and an attachment portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 54, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein: the attachment portion comprises a hole penetrating from an upper surface to a lower surface; and an axis of the sensor passes through the hole when the sensor is mounted to the attachment portion (e.g., no structure prevents applicator (10) from applying a medical instrument with a sensor and an attachment portion with a hole as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 55, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the attachment portion is configured to adhere to a body surface of the host (e.g., no structure prevents applicator (10) from applying a medical instrument with an attachment portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 56, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the attachment portion comprises an initial state configured to be an open circuit and an operation state configured to be a closed circuit (e.g., no structure prevents applicator (10) from applying a medical instrument with an attachment portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 57, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the attachment portion is configured to communicate with an external device through a wireless communication or a wired communication (e.g., no structure prevents applicator (10) from applying a medical instrument with an attachment portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 58, Chae discloses the applicator (10) being capable of applying a medical instrument, wherein the attachment portion is configured to be excited from an initial state to an operation state by a magnetic action or a light action (e.g., no structure prevents applicator (10) from applying a medical instrument with an attachment portion as claimed; Figs. 10-13; paras. [0079]-[0093]).
Regarding claim 59, Chae discloses wherein the second drive mechanism is a spring (S2; Fig. 4; para. [0123]).
Regarding clam 60, Chae discloses wherein the first drive mechanism is a spring (S1; Fig. 4; para. [0093]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771