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 Objections
Claim 1 is objected to because of the following informalities:
In Claim 1, “An applicator for attaching, to skin of a user, a medical device...” should read “An applicator for attaching, to the skin of a user, a medical device....”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1 and 11 recite “a medical device comprising a sensor unit having a sensor of which at least a portion is to be inserted into the skin of the user and a base unit attached to the skin of the user to be coupled to the sensor unit”. By claiming “a base unit attached to the skin of the user”, the applicant is also claiming the skin of the user, which is directed to a human organism.
Claims 2-10 are rejected by virtue of dependence on Claim 1.
Claim Rejections - 35 USC § 102
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 1-7 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac et al (US 20170188910 A1, cited in applicant’s IDS, hereinafter Halac).
Regarding Claim 1, Halac discloses an applicator (Element 104, Fig. 1) for attaching, to skin of a user, a medical device (Element 600, Fig. 4; “FIG. 2 illustrates a perspective view of an applicator system 104 for applying at least portions of an on-skin sensor assembly 600 (shown in FIG. 4) to skin of a host (e.g., a person)”, [0259]) comprising a sensor unit (Element 134, Fig. 4) having a sensor (Element 138, Fig. 4; Element 156, Figs. 7-11) of which at least a portion is to be inserted into the skin of the user (“The needle 156 can guide the sensor 138 into the skin of the host”, [0287]) and a base unit (Element 128, Figs. 18-19) attached to the skin of the user to be coupled to the sensor unit (“FIG. 4 illustrates a perspective view of the on-skin sensor assembly 600, which includes the base 128. An adhesive 126 can couple the base 128 to the skin 130 of the host”, [0272]; “The system 104 can also secure (e.g., couple via mechanical interlocks such as snap fits and/or interference features) the glucose sensor module 134 to the base 128 to ensure the glucose sensor 138 is coupled to the base 128”, [0273]), the applicator comprising:
an applicator body (Element 152, Figs. 7-11) to which the base unit is separably coupled (“As shown in FIGS. 7-11, several embodiments hold the base 128 in a stationary position relative to the second portion 152 of the telescoping assembly 132 as the sensor module 134 moves towards the base 128”, [0348]);
a locking hook (Element 220, Fig. 18; Element 232, Fig. 19; “The second flex arm 220 comprises a first horizontal protrusion (e.g., the locking feature 232)”, [0358]) disposed to the applicator body to engage with the base unit (“the base 128 comprises a first radial protrusion 230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion 232 (e.g., a locking feature) of the second portion 152 of the telescoping assembly 132 (shown in FIG. 7)”, [0354]);
an insertion unit (Element 150, Figs. 7-8; “FIG. 7 illustrates a telescoping assembly 132 having a first portion 150 (e.g., a “pusher”)...”, [0280]) disposed to the applicator body (See Figs. 7-11) for moving the sensor unit from a first position spaced apart from the base unit (“As illustrated in FIGS. 7 and 14, the sensor module 134 (and the glucose sensor 138) can be located remotely from the base 128”, [0316]) to a second position for being coupled to the base unit (“The sensor module 138 is coupled to a distal portion of the first portion 150 such that moving the first portion 150 to the distal position (as described above) couples the sensor module 134 to the base 128”, [0284]; “The system is configured such that moving the first portion 150 to the distal position couples the sensor module 134 to the base 128 (as shown in FIG. 11)”, [0318]; see all of [0280]); and
an operation part (Element 222, Fig. 18 and Element 220, Fig. 18; the examiner notes element 220 of the locking hook can be considered an operation part under broadest reasonable interpretation) disposed to the applicator body (“The second portion 152 of the telescoping assembly 132 comprises a second flex arm 220 that protrudes distally”, [0355]) to be moved by control by the user (“A user can actuate an applicator to insert the analyte sensor into its functional location”, [0006]) from a third position to a fourth position for operating the insertion unit ("The system is configured such that moving the first portion 150 from the proximal starting position to the distal position along the path 154 (shown in FIG. 7) causes the first arm 222 to deflect the second flex arm 220, and thereby detach the second flex arm 220 from the base 128 to enable the base 128 to decouple from the telescoping assembly 132 (shown in FIG. 7)”, [0355]),
wherein the locking hook is maintained to be in a fixed mode of engaging with the base unit, in a state in which the operation part is positioned at the third position (“the base 128 comprises a first radial protrusion 230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion 232 (e.g., a locking feature) of the second portion 152 of the telescoping assembly 132 (shown in FIG. 7”, [0354]), and the fixed mode is releasable by an operation of the operation part moving to the fourth position (“The system is configured such that moving the first portion 150 to the distal position moves the second radial protrusion 232 relative to the first radial protrusion 230 to detach the base 128 from the telescoping assembly 132”, [0354]).
Regarding Claim 2, Halac discloses the applicator of claim 1, wherein the locking hook is tiltably (See arrow 228, Fig. 18) coupled to the applicator body (See Figs. 18-19; element 232 is attached to element 220; “The first arm 222 and the second flex arm 220 can be oriented within 25 degrees of each other (as measured between their central axes). The system is configured such that moving the first portion 150 from the proximal starting position to the distal position along the path 154 (shown in FIG. 7) causes the first arm 222 to deflect the second flex arm 220, and thereby detach the second flex arm 220 from the base 128 to enable the base 128 to decouple from the telescoping assembly 132 (shown in FIG. 7)”, [0355]; “the unlocking movement (of the arm 220 bending as shown by arrow 228) is perpendicular (within plus or minus 20 degrees) to the input force (e.g., as represented by arrow 226)”, [0350]).
Regarding Claim 3, Halac discloses the applicator of claim 2, wherein the locking hook (Element 220, Fig. 18; Element 232, Fig. 19; “The second flex arm 220 comprises a first horizontal protrusion (e.g., the locking feature 232)”, [0358]) comprises:
a shaft (Element 220, Fig. 18) rotatably coupled to the applicator body (See Fig. 18; “Referring now to FIG. 18, once the sensor module 134 is attached to the base 128, the system can release the base 128 by bending flex arms 220 that couple the base 128 to the second portion 152”, [0348]);
a hook part (Element 232, Fig. 19) protruded from the shaft to engage with the base unit (“the base 128 comprises a first radial protrusion 230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion 232 (e.g., a locking feature) of the second portion 152 of the telescoping assembly 132 (shown in FIG. 7)”, [0354]); and
an extension part protruded from the shaft to engage with the operation part (See Figs. 18-19; “The second flex arm 220 comprises a first horizontal protrusion (e.g., the locking feature 232)”, [0358]; the connection between element 220 and element 232 can be considered an extension part).
Regarding Claim 4, Halac discloses the applicator of claim 1, wherein the locking hook is movable from a locking position at which the fixed mode is maintained to a release position at which the fixed mode is released (“The system is configured such that moving the first portion 150 to the distal position moves the second radial protrusion 232 relative to the first radial protrusion 230 to detach the base 128 from the telescoping assembly 132”, [0354]), and
the operation part is configured to move the locking hook to the release position while moving to the fourth position (“The distal protrusions 222 bend the flex arms 220 to detach the base 128 from the telescoping assembly 132 (shown in FIG. 7)”, [0349]).
Regarding Claim 5, Halac discloses the applicator of claim 4, comprising a return member (Element 224, Fig. 18) disposed to the applicator body (“The flex arms 220 can include a ramp 224”, [0349]) and configured to provide a moving force for moving, by returning the operation part toward the third position, the operation part which has moved to the fourth position to a return position for disengaging from the locking hook (“A distal end of the distal protrusions 222 can contact the ramp 224 and then can continue moving distally to bend the flex arm 220 as shown by arrow 228 in FIG. 18”, [0349]; by providing the force for moving the operation part 220 elastically from the third engaged position to the fourth releasing position, element 224 also provides an equal and opposite return moving force for moving, by returning the operation part toward the third position, the operation part which has moved to the fourth position to a return position for disengaging from the locking hook).
Regarding Claim 6, Halac discloses the applicator of claim 5, wherein the return member is configured to be elastically deformed with movement of the operation part to apply an elastic force to the operation part (“A distal end of the distal protrusions 222 can contact the ramp 224 and then can continue moving distally to bend the flex arm 220 as shown by arrow 228 in FIG. 18”, [0349]).
Regarding Claim 7, Halac discloses the applicator of claim 4, wherein the locking hook is tiltably (See arrow 228, Fig. 18) coupled to the applicator body (See Figs. 18-19; element 232 is attached to element 220; “The first arm 222 and the second flex arm 220 can be oriented within 25 degrees of each other (as measured between their central axes). The system is configured such that moving the first portion 150 from the proximal starting position to the distal position along the path 154 (shown in FIG. 7) causes the first arm 222 to deflect the second flex arm 220, and thereby detach the second flex arm 220 from the base 128 to enable the base 128 to decouple from the telescoping assembly 132 (shown in FIG. 7)”, [0355]; “the unlocking movement (of the arm 220 bending as shown by arrow 228) is perpendicular (within plus or minus 20 degrees) to the input force (e.g., as represented by arrow 226)”, [0350]), and
the operation part comprises a stopper comprising a stopper contact part (Element 222, Fig. 18) configured to be in contact with the locking hook to restrict tilting motion of the locking hook (“A distal end of the distal protrusions 222 can contact the ramp 224 and then can continue moving distally to bend the flex arm 220 as shown by arrow 228 in FIG. 18”, [0349]; under broadest reasonable interpretation this tilting motion from element 222 is restricted to a certain distance) and a stopper detent (The distal end of element 222, Fig. 18) configured to be in contact with the locking hook to push the locking hook toward the release position (“A distal end of the distal protrusions 222 can contact the ramp 224 and then can continue moving distally to bend the flex arm 220 as shown by arrow 228 in FIG. 18”, [0349]).
Regarding Claim 10, Halac discloses the applicator of claim 4, comprising a retention protrusion (Element 222, Fig. 18) provided to the applicator body to be in contact with the locking hook for preventing the locking hook which has moved to the release position from moving toward the locking position (“distal protrusions 222 of the first portion 150 aligned with the flex arms 220 such that the distal protrusions 222 are configured to bend the flex arms 220 (via the distal protrusions 222 contacting the flex arms 220)”, [0348]; when elements 222 are actively bending the flex arms 220 away from the locking position, they are also preventing the flex arms from returning to the locking position).
Regarding Claim 11, Halac discloses an applicator assembly (Element 104, Fig. 2) comprising:
a medical device (Element 600, Fig. 4; “FIG. 2 illustrates a perspective view of an applicator system 104 for applying at least portions of an on-skin sensor assembly 600 (shown in FIG. 4) to skin of a host (e.g., a person)”, [0259]) comprising a sensor unit (Element 134, Fig. 4) having a sensor (Element 138, Fig. 4; Element 156, Figs. 7-11) of which at least a portion is to be inserted into skin of a user (“The needle 156 can guide the sensor 138 into the skin of the host”, [0287]) and a base unit (Element 128, Figs. 18-19) attached to the skin of the user to be coupled to the sensor unit (“FIG. 4 illustrates a perspective view of the on-skin sensor assembly 600, which includes the base 128. An adhesive 126 can couple the base 128 to the skin 130 of the host”, [0272]; “The system 104 can also secure (e.g., couple via mechanical interlocks such as snap fits and/or interference features) the glucose sensor module 134 to the base 128 to ensure the glucose sensor 138 is coupled to the base 128”, [0273]);
an applicator body (Element 152, Figs. 7-11) to which the base unit is separably coupled (“As shown in FIGS. 7-11, several embodiments hold the base 128 in a stationary position relative to the second portion 152 of the telescoping assembly 132 as the sensor module 134 moves towards the base 128”, [0348]);
a locking hook (Element 220, Fig. 18; Element 232, Fig. 19; “The second flex arm 220 comprises a first horizontal protrusion (e.g., the locking feature 232)”, [0358]) disposed to the applicator body to engage with the base unit (“the base 128 comprises a first radial protrusion 230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion 232 (e.g., a locking feature) of the second portion 152 of the telescoping assembly 132 (shown in FIG. 7)”, [0354]);
an insertion unit (Element 150, Figs. 7-8; “FIG. 7 illustrates a telescoping assembly 132 having a first portion 150 (e.g., a “pusher”)...”, [0280]) disposed to the applicator body (See Figs. 7-11) for moving the sensor unit from a first position spaced apart from the base unit (“As illustrated in FIGS. 7 and 14, the sensor module 134 (and the glucose sensor 138) can be located remotely from the base 128”, [0316]) to a second position for being coupled to the base unit (“The sensor module 138 is coupled to a distal portion of the first portion 150 such that moving the first portion 150 to the distal position (as described above) couples the sensor module 134 to the base 128”, [0284]; “The system is configured such that moving the first portion 150 to the distal position couples the sensor module 134 to the base 128 (as shown in FIG. 11)”, [0318]; see all of [0280]); and
an operation part (Element 222, Fig. 18 and Element 220, Fig. 18; the examiner notes element 220 of the locking hook can be considered an operation part under broadest reasonable interpretation) disposed to the applicator body (“The second portion 152 of the telescoping assembly 132 comprises a second flex arm 220 that protrudes distally”, [0355]) to be moved by control by the user (“A user can actuate an applicator to insert the analyte sensor into its functional location”, [0006]) from a third position to a fourth position for operating the insertion unit ("The system is configured such that moving the first portion 150 from the proximal starting position to the distal position along the path 154 (shown in FIG. 7) causes the first arm 222 to deflect the second flex arm 220, and thereby detach the second flex arm 220 from the base 128 to enable the base 128 to decouple from the telescoping assembly 132 (shown in FIG. 7)”, [0355]),
wherein the locking hook is maintained to be in a fixed mode of engaging with the base unit, in a state in which the operation part is positioned at the third position (“the base 128 comprises a first radial protrusion 230 (e.g., a locking feature) releasably coupled with a first vertical holding strength to a second radial protrusion 232 (e.g., a locking feature) of the second portion 152 of the telescoping assembly 132 (shown in FIG. 7”, [0354]), and the fixed mode is releasable by an operation of the operation part moving to the fourth position (“The system is configured such that moving the first portion 150 to the distal position moves the second radial protrusion 232 relative to the first radial protrusion 230 to detach the base 128 from the telescoping assembly 132”, [0354]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Chae et al (KR 20180132552 A, cited in applicant’s IDS, hereinafter Chae; an attached machine translation was relied upon for this rejection).
Regarding Claim 8, Halac discloses the applicator of claim 7. Halac discloses the claimed invention except for expressly disclosing wherein the insertion unit comprises a plunger disposed to be movable together with the sensor unit from the first position to the second position,
the operation part comprises a movement member configured to restrict movement of the plunger at the third position and move to the fourth position to release restriction of the plunger, and the stopper is coupled to the movement member.
However, Chae, which also teaches an applicator (See Abstract; Element 10, Fig. 1), teaches wherein the insertion unit comprises a plunger (Element 300, Fig. 4) disposed to be movable together with the sensor unit from the first position to the second position (“The applicator (10) is configured to include a main case (100) on one side which is equipped with a pressure button (110) to be operated by a user, a plunger body (300) which is coupled and fixed at a first position inside the main case (100) and is released from the first position and moves linearly to a second position in the external discharge direction according to the operation of the pressure button (110)”, [0074]),
the operation part comprises a movement member (“one side of the inner case (102”, [0080]) configured to restrict movement of the plunger at the third position and move to the fourth position to release restriction of the plunger, and the stopper is coupled to the movement member (“Additionally, a stopper projection (320) may be formed on the plunger body (300) to limit the range of movement to a second position, and the stopper projection (320) may limit the movement of the plunger body (300) by engaging with one side of the inner case (102) as the plunger body (300) moves to the second position”, [0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Halac with Chae, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 9, modified Halac discloses the applicator of claim 8, wherein the operation part is movable in a direction (See arrow 228, Fig. 18; “A distal end of the distal protrusions 222 can contact the ramp 224 and then can continue moving distally to bend the flex arm 220 as shown by arrow 228 in FIG. 18”, [0349]) crossing a movement direction of the sensor unit (“The user places the applicator (e.g., the telescoping assembly 132) against the skin surface and applies a force distally on the applicator (e.g., by pushing down on the proximal end of the applicator). When the user-generated force exceeds a threshold, the applicator collapses (e.g., telescopes distally) and the user drives the sensor into the body”, [0397]; the side path of element 220 and the downward path of the sensor cross movement directions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Halac et al (US 20170188912 A1).
See Huang et al (EP 3771427 A1).
See Pushpala et al (US 20170251958 A1).
See Chae et al (US 20210259595 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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