DETAILED ACTION
Response to Amendment
The 112 rejection of claim 3 is withdrawn in light of the amendment to claim 3 filed on 8/13/2026.
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.
Claim(s) 16-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 3,170,485 B2 to SOOIL DEV CO LTD (hereinafter 'SOOIL').
As per claim 16, SOOIL discloses an inserter in a device for delivering fluid (an injection needle unit comprising an injection needle section 3-11 for injecting a solution into the body; figures 27, 30; page 7, paragraph [0047]), the inserter comprising: a cannula configured to deliver the fluid (injection needle section 3-11 for injecting solution into the body; figures 27, 30; page 7, paragraph [0047]); and a glucose monitoring sensor disposed coaxially to and surrounding an external diameter of the cannula (307 or enzyme member 302 is shown disposed coaxially and surrounding the injection needle section 3-11, wherein the enzyme member 302 is used to detect glucose levels; figures 27, 30; page 7, paragraph [0047]; page 8, third paragraph); wherein the glucose monitoring sensor includes a biosensor layer that monitors glucose in the fluid and provides feedback to the device (enzyme member 302 is a biosensor layer surrounding the injection needle section 3-11, wherein the enzyme member 302 is used to detect glucose levels and generates an electric charge (feedback) according to the blood glucose level; figures 27, 30; page 7, paragraph [0047]; page 8, third paragraph).
As per claim 17, SOOIL discloses the inserter of claim 16. SOOIL further discloses wherein the device is an injection port (an injection needle unit comprising an injection needle section 3-11 for injecting a solution into the body; figures 27, 30; page 7, paragraph [0047]).
As per claim 19, SOOIL discloses, wherein the glucose monitoring sensor (307) includes a substrate stiffener layer (303) surrounded by the biosensor layer.
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.
Claim(s) 1, 8, 10-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over SOOIL in view of PACIFIC Diabetes Technologies (WO 2020/252324; hereafter Pacific).
As per claims 1 and 15, SOOIL discloses a device for delivering fluid (an injection needle unit comprising an injection needle section 3-11 for injecting a solution into the body; figures 27, 30; page 7, paragraph [0047]), the device comprising: an inserter for expelling the fluid (an injection needle unit comprising an injection needle section 3-11 for injecting a solution into the body; figures 27, 30; page 7, paragraph [0047]); wherein the inserter includes a glucose monitoring sensor disposed coaxially with the inserter (enzyme member 302 is shown disposed coaxially and surrounding the injection needle section 3-11, wherein the enzyme member 302 is used to detect glucose levels; figures 27, 30; page 7, paragraph [0047]; page 8, third paragraph), wherein: the inserter includes a cannula (needle section 3-11 for injecting a solution into the body; figures 27, 30; page 7, paragraph [0047]); and the glucose monitoring sensor surrounds an external diameter of the cannula (enzyme member 302 is shown disposed coaxially and surrounding the injection needle section 3-11, wherein the enzyme member 302 is used to detect glucose levels; figures 27, 30; page 7, paragraph [0047]; page 8, third paragraph).
SOOIL does not disclose the device comprising: an annular guide configured to engage a pen or a syringe injection needle; a main body enclosed by a base and a cover.
PACIFIC discloses an annular guide configured to engage a pen or a syringe injection needle (housing 740 is shown comprising an annular guide for insertion of pen tip 756; paragraph [0081]; figures 10A, 10C); a main body enclosed by a base and a cover (the area around signal processing module 741 and PC board 747 is shown comprising a main body, wherein the main body is enclosed by base 714 and housing 740 (cover); paragraph [0081]; figures 10A-B).
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 delivery device of SOOIL, with an annular guide configured to engage a pen or a syringe injection needle and a main body enclosed by a base and a cover, as taught by PACIFIC, for the advantage of using the delivery device with an injection pen, which is widely used for delivering insulin to patients, and for housing and easily accessing the components within the delivery device for repair or replacement.
As per claim 8, SOOIL does not disclose wherein the main body includes a frame having a sensor contact pad electrically connected to the glucose monitoring sensor to receive sensor feedback.
PACIFIC further discloses wherein the main body includes a frame (as shown; figure 10B) having a sensor contact pad electrically connected to the glucose monitoring sensor to receive sensor feedback (a set of electrical connections to the sensing cannula 720 from the signal processing electronics 741 are provided via a set of electrical contacts 722 and 724 on the sensor surface contacting a socket having a set of contacts 743 and 745; paragraph [0081]; figure 10D).
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 device of SOOIL, with the frame, as taught by in the embodiment of figure 10B of PACIFIC, for the advantage of providing means for receiving sensor feedback.
As per claim 10, SOOIL does not disclose wherein the main body includes a frame having retention features configured to secure and release a reusable electronic module. However, PACIFIC discloses in the embodiment of figure 7A includes a frame having retention features configured to secure and release a reusable electronic module (base 414 also has a set of retention arms 418 for holding the electronic signal processing module 440, wherein the electronic signal processing module 440 is reusable; paragraphs [0076], [0077]).
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 CGM infusion device taught in SOOIL, with the frame having retention features configured to secure and release a reusable electronic module, as taught by in the embodiment of figure 7A of PACIFIC, for the advantage of removing the signal processing module so that it can be reused repeatedly, thereby reducing the recurring cost of the system (PACIFIC; paragraph [0076]).
As per claim 11, PACIFIC further discloses wherein the reusable electronic module includes a connector that is configured to engage a printed circuit board in the main body (a set of electrical connections to the sensing cannula 720 from the signal processing electronics 741 are provided via a set of electrical contacts 722 and 724 on the sensor surface contacting a socket having a set of contacts 743 and 745. This socket conveys signal currents onto PC board 747 containing the electronic signal processing electronic module; paragraph [0081]).
In regard to claim 13, the combination teaches wherein the device delivers the fluid by injecting into or through a patient's skin (functional limitation).
In regard to claim 14, the combination teaches wherein the base is configured to be attached on a patient's skin (via 3-14).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over SOOIL in view of PACIFIC and in further view of US 2004/0024433 A1 to Roy et al. (hereinafter 'ROY').
As per claim 3, the combination of SOOIL and PACIFIC discloses the device of claim 2. SOOIL discloses the glucose monitoring sensor surrounding the cannula (enzyme member 302 is shown disposed coaxially and surrounding the injection needle section 3-11, wherein the enzyme member 302 is used to detect glucose levels; figures 27, 30; page 7, paragraph [0047]; page 8, third paragraph), but does not disclose wherein the glucose monitoring sensor includes a substrate stiffener layer comprising a polytetrafluoroethylene fluoropolymer surrounding the cannula.
ROY discloses a substrate stiffener layer comprising a polytetrafluoroethylene fluoropolymer surrounding the cannula (a needle coated with PTFE; paragraph [0077]). Since the needle with the surrounding sensor of SOOIL is used to contact the skin, 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 glucose monitoring sensor of SOOIL such that a layer of polytetrafluoroethylene fluoropolymer surrounds the cannula, as taught by ROY, for the advantage of reducing friction between the needle and the tissue to thereby reduce or prevent tenting, which happens when insertion of the needle causes a surface of the tissue around the needle to "tent" and such that the tenting region loses contact with the needle (ROY; paragraphs [0009], [0077]). Furthermore, coating the needle with PTFE to reduce friction between the needle and the tissue would decrease the pain caused by inserting the needle into the patient.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over SOOIL in view of PACIFIC in view of WO 2019/239258 A1 to ASCENSIA DIABETES CARE HOLDINGS AG (hereinafter 'ASCENSIA').
As per claim 7, the combination does not disclose an insertion trocar cover to shield the insertion trocar when not in use.
ASCENSIA discloses an insertion trocar cover to shield the insertion trocar when not in use (capsule shaped central body 216 to contain the sensor holder 210 and the introducer 212; paragraphs [0052]-[0053]; figures 2A-B, 3A).
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 device of the combination, with an insertion trocar cover to shield the insertion trocar when not in use, as taught by ASCENSIA, for the advantage of maintaining the device under sterile conditions (ASCENSIA; paragraph [0052]).
Claim(s) 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over SOOIL in view of PACIFIC in view ASCENSIA.
As per claim 9, the combination does not disclose one or more batteries disposed in the main body that are electrically connected to the glucose monitoring sensor.
ASCENSIA discloses one or more batteries disposed in the main body that are electrically connected to the glucose monitoring sensor (battery 142 is supported on the flexible circuit board layer 114 and is connected to the glucose sensor 150; paragraphs [0043]-[0044]).
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 glucose monitor of the combination, with one or more batteries disposed in the main body that are electrically connected to the glucose monitoring sensor, as taught by ASCENSIA, for the advantage of powering the electronic components of the device (ASCENSIA; paragraph [0044]).
As per clam 12, the combination not disclose wherein the reusable electronic module includes a control panel having one or more of a microprocessor, a real-time clock, a Bluetooth, a near field communicator and a power management controller.
ASCENSIA discloses wherein the reusable electronic module includes a control panel having one or more of a microprocessor, a real-time clock, a Bluetooth (electronic components mounted on the flexible circuit board layer 324 (control panel). One set of such components includes a transmitter module 340 in including a Bluetooth; paragraph [0060]), a near field communicator and a power management controller.
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 glucose monitor of the combination, wherein the reusable electronic module includes a control panel having Bluetooth, as taught by ASCENSIA, for the advantage of sending out the data to an external device used by patients and/or healthcare providers to, among other things, track the patient's blood glucose level over time (ASCENSIA; paragraphs [0071]-[0072]).
Allowable Subject Matter
Claims 4-6, 18, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 8/13/2026 have been fully considered but they are not persuasive.
The applicant did not provide arguments for the 103 combination of SOOIL in view of Pacific.
In response to the applicant’s argument that SOOIL does not disclose “a glucose monitoring sensor disposed coaxially to and surrounding an external diameter of the cannula; wherein the glucose monitoring sensor includes a biosensor layer that monitors glucose in the fluid and provide feedback to the device”, the examiner respectfully disagrees. The applicant argues that the enzyme body 302 is provided at the distal tip of the injection needle portion 3-11 and therefore SOOIL does not disclose a layer surrounding an external diameter of the cannula along its length. This is not persuasive because enzyme body 302 still surrounds the needle 3-11 along at least a portion of the needle and therefore the scope of the claim is anticipated.
In response to the applicant’s argument that SOOIL does not disclose a unified biosensor layer, the examiner respectfully disagrees. The examiner first notes that “unified” is not a limitation in the claim and therefore not a requirement of the prior art. Furthermore, elements 302 or 307 are unified elements and do not need to be considered in combination.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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