DETAILED ACTION
Claims 1-18 are pending and hereby under examination.
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 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.
Claims 1-18 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.
Regarding claims 1-18, the claims are directed towards a needle aid device; however, the claims recite method steps. As a few examples, claim 1 recites “the trigger module drives the emitter mechanism”; claim 2 recites “when moving downward to the thin-walled portion, the elastic clamping jaws release the emitter mechanism”; and claim 9 recites “the adjusting knob is rotated to drive a guide needle to stretch or retreat”. Examiner suggests reciting the structure of the needle followed by “configured to …” and the action that structure performs. For examination purposes, the claims will be interpreted such that they are directed towards a needle aid device configured to perform the actions recited in the claims.
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 1-4, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chae (US 12402814).
Regarding claim 1, Chae teaches a needle aid device, comprising:
an outer shell (Fig. 3, outer case 101);
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an inner shell located in the outer shell (Fig. 3, inner case 102 located in outer case 101) and comprising an upper portion and a lower portion (Fig. 3 above), a trigger shell passage penetrating through the upper portion (Fig. 3 above, wherein the upper and lower portion comprise a passage) and the lower portion being formed in the inner shell, and an inner diameter of the lower portion being greater than that of the upper portion (see Fig. 3 above); and
a trigger module (Fig. 3, plunger body 300) capable of moving in the trigger shell passage (Col, 10, lines 63-65, “an inner case (102) coupled at the inside of the outer case (101) and configured to guide a linear movement path of the plunger body (300)”; Thus, the path the plunger body takes within inner case 102 reads on the trigger shell passage) and used for clamping or releasing (Col 9, lines 38-47, “plunger body (300) can linearly move from the first location and the second location, and the body attachable unit (20) is coupled with one side of the plunger body (300) and the body attachable unit (20) is configured to be moved together with the plunger body (300) from the first location to the second location”) an emitter mechanism (Fig. 3, body attachable unit 20 with housing 510 and sensor unit 520);
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in an initial state, the trigger module being locked on the upper portion (see Fig. 15 above, wherein the plunger body 300 is at a first location; Col 13, lines 10-13, “the plunger body 300 being positioned at the first location within the upper portion of inner case 102; Col 9, lines 32-35, “a plunger body (300) coupled to a first location of the inside of the main case (100) and configured to be decoupled from the first location by the operation of the pressure button (110)”; Examiner interprets the plunger body being coupled to the first location as being “locked”); and
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when unlocked, the trigger module drives the emitter mechanism to move downward until the emitter mechanism is separated from the trigger module (see Fig. 16 above, wherein the plunger body 300 is in a second location; Col 9, lines 32-35, “a plunger body (300) coupled to a first location of the inside of the main case (100) and configured to be decoupled from the first location by the operation of the pressure button (110) and linearly move from the first location to a second location in an outward discharge direction”; The Examiner interprets the plunger body being decoupled from the first location by operation of the button as being “unlocked”).
Regarding claim 2, Chae further teaches wherein elastic clamping jaws are formed on the trigger module and are used for clamping the emitter mechanism (Fig. 3, sensor fixing hook 330 on plunger body 300, wherein the hook 330 fixedly couples to the body attachable unit 20; see Fig. 5 for two sensor fixing hooks 330), a thin-walled portion is formed on the lower portion of the inner shell, and when moving downward to the thin-walled portion, the elastic clamping jaws release the emitter mechanism (Col 13, lines 27-43, “Although not illustrated, a hook guide unit (not shown) is formed on the inner surface of the inner case (102) and the hook guide unit pressurizes the sensor fixing hook (330) in an inward direction to be interlocked with the body attachable unit (20) and has a cross-sectional shape having a structure that the sensor fixing hook (330) is released from the pressurization in the state of the plunger body (300) moved to the second location. Therefore, the hook guide unit may have a structure with convex and concave surfaces on the inner surface of the inner case (102), the convex surface applies pressure to the sensor fixing hook (330) and the concave surface releases the sensor fixing hook (330) from the pressure application, and the concave is formed to release the sensor fixing hook (330) from the pressure application in a state that the sensor fixing hook (330) is moved together with the plunger body (300) to the second location”; The Examiner interprets the “concave surface” that releases the sensor fixing hook to read on the claim limitation of a “thin-walled portion”).
Regarding claim 3, Chae further teaches wherein the trigger module is provided with a trigger buckle (Figs. 13-14, shooting plate 150); when the trigger module is locked, the trigger buckle is clamped at an opening of the trigger shell passage (Col 10, lines 55-60, “The plunger body (300) may be configured to be coupled and interlocked with the shooting plate (150) and fixed at the first location”, wherein shooting plate 150 is held in place by elastic structure 163 at the opening of the trigger shell passage where the plunger body 300 meets the shooting plate via interlock hook 310); and when an external force is applied to the trigger button to push the trigger buckle away from a top surface of the inner shell, the trigger module is unlocked (Fig. 14, wherein when the button is pressed, the shooting plate 150 translates from being aligned with the top surface of the inner shell in a direction towards one side of the surface. Under the broadest reasonable interpretation of the trigger buckle being pushed away from the top surface, Chae meets this limitation. The initial state of the shooting plate sits directly on the inner surface, and once the shooting plate is pushed, it is pushed away towards one side of the top surface; Col 10, lines 55-60, “The plunger body may … be released from the interlock with the shooting plate (150) according to the movement of the shooting plate (150) and be moved to the second location by the elastic force of the plunger elastic spring (S1)).
Regarding claim 4, Chae further teaches wherein a trigger button and a trigger button connecting terminal are connected to the outer shell (Fig. 9, button 110 connected to main case 100 placed on hanging raised part 1012 of button guide groove 1011), the trigger button is movably connected to the trigger button connecting terminal, and an external force is applied to the trigger button to unlock the trigger module (Col 9, lines 32-36, “a plunger body (300) coupled to a first location of the inside of the main case (100) and configured to be decoupled from the first location by the operation of the pressure button (110) and linearly move from the first location to a second location in an outward discharge direction”; As the button operates via pressure, Examiner interprets the button to be movably connected to the button guide groove 1011).
Regarding claim 8, Chae further teaches wherein the needle aid device further comprises a guide needle passage formed in the inner shell (see Fig. 3 above, the guide needle passage being formed in the “upper portion” of inner case 102) and a needle withdrawing member (Fig. 3, needle extracting body 400) for clamping or releasing a guide needle mechanism (see Fig. 3 and Col 14, lines 50-58, “a needle extracting body (400) coupled with the needle head (551) of the needle unit (550) and linearly move along the inner case (102) from the first location to the second location together with the plunger body (300) by being interlocked with the plunger body (300), the needle extracting body (400) is coupled with the needle head (551) of the needle unit (550) through an end of a needle head coupling unit (420)”), and a cavity allowing a sensor of the emitter mechanism to stretch therein is formed in a guide needle (Col 9, lines 13-17, “the needle unit (550) is inserted into the human body first before the sensor unit (520) is inserted into the human body and the needle unit (550) may support the sensor unit (520) such that the sensor unit (520) can be stably inserted in the skin”; see Figs. 2B and 22).
Regarding claim 10, Chae further teaches wherein a sliding slope is formed on the needle withdrawing member (Figs. 3-4, elastic hook 410), the trigger module is provided with a needle withdrawing shell clamping buckle, which is matched with the sliding slope to limit the needle withdrawing member when the trigger module is locked (Col 14, lines 59-65, “The needle extracting body (400) is interlockedly coupled to the plunger body (300), and for this purpose, a separate elastic hook (410) configured to be elastically transformable is provided at the needle discharge body (400), and the elastic hook (410) is elastically biased in a direction interlockedly coupled to the hook interlocking unit (350) of the plunger body (300)”; wherein the elastic hook is the sliding slope on the needle extracting body 400 and the clamping buckle is the hook interlocking unit 350 of the plunger body 300).
Regarding claim 12, Chae further teaches wherein the needle withdrawing shell clamping buckle is used for clamping or releasing the needle withdrawing member, and when moving from the upper portion to the lower portion of the inner shell, the needle withdrawing shell clamping buckle releases the needle withdrawing member (Col 15, lines 4-10, “a needle extracting pressurizing unit (130) configured to pressurize the elastic hook (410) in an inward direction so that the elastic hook (410) is released from the interlock with the hook interlocking unit (350) of the plunger body (300) according to the movement of the needle extracting body (400) to the second location is included in the inner case (102)”; The needle extracting body 400 with elastic hook 410 is released from the hook interlocking unit 350 when pressed into the second position and is separated from the hook interlocking unit 350, see Fig. 20).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chae (US 12402814) as applied to claim 1 above, and further in view of Li (US 20230181217).
Regarding claim 5, Chae discloses a safe mode for the pressure button so that the pressurizing operation cannot be performed. However, the safe mode is activated by pushing down on the button such that it is coupled to a hanging raised part to block the its movement (Col 11, lines 34-42). Chae fails to disclose a clamp and collet lock bracket that clamps to the trigger button to prevent its movement.
Li teaches an analogous glucose monitor applicator, wherein the button comprises an error prevention mechanism with a clamp and a collet (see Fig. 7C below), and the clamp clamps the trigger button to prevent the trigger button from moving with respect to the outer shell (Paragraph 0249, wherein the error prevention mechanism 520 may be disposed between the pressing portion 502 of the trigger mechanism 50 and first housing 100 to prevent undesired movement of the trigger mechanism).
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As Chae is concerned with preventing the button from being pressed prematurely by creating a safe mode for the button to be placed in, Li teaches an alternate structure and method of preventing the button from being pressed prematurely through an error prevention mechanism. A substitution of one locking mechanism for another yields predictable results of preventing a misfire of the button to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the button of Chae to incorporate the error prevention mechanism taught by Li, and the combination would yield the predictable result of preventing a premature firing.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chae (US 12402814) as applied to claim 1 above, and further in view of Li (CN 212015601 – cited by Applicant, English translation provided), hereinafter ‘Li 601’.
Regarding claim 6, Chae discloses wherein when the button is activated by a user, the plunger body moves linearly within the inner case 102 (Col 9, lines 28 - 43). However, Chae fails to disclose wherein the trigger shell has guide ribs arranged in the trigger shell passage, the trigger module has grooves, the trigger shell guide ribs are clamped in the guide grooves and allowed to move in the guide grooves for vertical movement of the trigger module.
However, Li 601 teaches a booster for an implantable medical device with an outer shell (Fig. 1, shell 2), an inner shell (Fig. 1, fixing bracket 4), and a trigger module (Fig. 1, movement bracket 5) for moving within the inner shell to clamp or release an emitter mechanism (Fig. 1, movement bracket 5 with claw 51; Fig. 2, the claw 53 used for grasping/releasing booster fitting such as puncture needle assembly 9 and thus sensor assembly 10). The fixing bracket 5 contains guide ribs 49 which matches to and is located within guide groove 55 of the moving bracket 5 (Figs. 1 and 6) to guide movement of movement bracket 5 (Page 7, paragraph 8). As Chae discloses the plunger body moving in a linear direction, Li 601 teaches guide ribs and grooves to guide the movement bracket in a linear motion which would be useful to prevent twisting or turning within the inner housing/shell. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner shell and plunger body disclosed by Chae to incorporate the guide ribs and grooves taught by Li 601 to guide the plunger body and needle linearly and to prevent lateral movement.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chae (US 12402814) as applied to claim 1 above, and further in view of Li (CN 113456066), hereinafter ‘Li 066’.
Regarding claim 7, Chae discloses wherein when the button is activated by a user, the plunger body moves linearly within the inner case 102 (Col 9, lines 28 - 43). However, Chae fails to disclose wherein trigger shell guide grooves are formed in the inner wall of the inner shell, the trigger module has bottom guide grooves matched with the trigger shell guide grooves and allowed to move with respect to the guide grooves to realize vertical movement of the trigger module.
However, Li 066 teaches an analogous percutaneous analyte sensor insertion device (Abstract) comprising a framework 7 inside of shell 8 (Fig. 1), wherein the framework 7 comprises a bracket 1/base 2 system with guide groove 16 (Fig. 2a),
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that corresponds to the guiding ribs 76 of the inside of the framework 7 (Fig. 4a). The “ribs” adjacent to the guiding rib 76 are interpreted as a “groove” that matches with the guide groove 16 of bracket 1 / base 2 system.
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Li 066 discusses this system “ensure the driving device moving process is stable; smooth, so as to ensure the guide needle inserting and pulling process movement track and the axis of the frame parallel, reducing the moving amount of the needle tip” (page 5, paragraph 3). As Chae is concerned with guiding a needle in a linear motion, Li 066 teaches a system to ensure the movement of the needle tip is parallel to the frame. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner shell and plunger body of Chae to incorporate the guide grooves and ribs of Li 066 to ensure parallel movement of the needle tip to the frame.
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chae (US 12402814) and Li 601 (CN 212015601) as applied to claim 6 above, and further in view of Li 066 (CN 113456066).
Regarding claim 17, Chae in combination with Li 601 discloses wherein when the button is activated by a user, the plunger body moves linearly within the inner case 102 (Col 9, lines 28 - 43). However, Chae fails to disclose wherein trigger shell guide grooves are formed in the inner wall of the inner shell, the trigger module has bottom guide grooves matched with the trigger shell guide grooves and allowed to move with respect to the guide grooves to realize vertical movement of the trigger module.
However, Li 066 teaches an analogous percutaneous analyte sensor insertion device (Abstract) comprising a framework 7 inside of shell 8 (Fig. 1), wherein the framework 7 comprises a bracket 1/base 2 system with guide groove 16 (Fig. 2a),
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that corresponds to the guiding ribs 76 of the inside of the framework 7 (Fig. 4a). The “ribs” adjacent to the guiding rib 76 are interpreted as a “groove” that matches with the guide groove 16 of bracket 1 / base 2 system.
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Li 066 discusses this system “ensure the driving device moving process is stable; smooth, so as to ensure the guide needle inserting and pulling process movement track and the axis of the frame parallel, reducing the moving amount of the needle tip” (page 5, paragraph 3). As Chae is concerned with guiding a needle in a linear motion, Li 066 teaches a system to ensure the movement of the needle tip is parallel to the frame. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner shell and plunger body of Chae in combination with Li 601 to incorporate the guide grooves and ribs of Li 066 to ensure parallel movement of the needle tip to the frame.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record of Chae, Li, Li 601, and Li 606 fail to teach or suggest the claim limitations of claim 9, including an adjustable guide needle mechanism, an adjusting knob, an adjusting knob connecting terminal, an adjusting knob passage, and a needle withdrawing member. The prior art of record fails to teach or suggest adjusting the needle to a specific depth.
Chae (US 20240197209) teaches an continuous glucose monitoring sensor applicator (Abstract) wherein the insertion depth may be adjusted based on the user’s needs (Paragraph 0097). A needle extracting means (N) withdraws or removes the guide needle from the skin (Paragraph 0091 and Figs. 10A-C). The needle extracting means is not an adjusting knob nor is it rotated to remove the needle. Additionally, the insertion depth is not controlled by driving a guide needle to stretch or retreat. Rather, the insertion depth is controlled and set prior to implantation (Paragraph 0094).
Brister (US 20210186381) teaches an applicator for a glucose measuring system (Abstract). Brister suggests that the applicator can be designed with a variety of adjustable settings to control the distance of the needle (Paragraph 0438). However, Brister does not teach or suggest any of the limitations of claim 9 to adjust the needle.
Thus, the prior art of record, alone or in combination, fails to teach or provide an obviousness rationale to combine the prior art to read on dependent claim 9. As claims 11, 13-16, and 18 depend on claim 9, the prior art of record above also fails to teach or provide an obviousness rationale to combine the prior art to read on the claims.
Claims 9, 11, 13-16, and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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