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 .
Response to Amendment
This office action is responsive to the amendment filed on 04/30/2026. As directed by the amendment: claims 1-20 have been amended; no claims have been canceled; and no new claims have been added. Thus, claims 1-20 are presently pending in this application.
Applicant’s amendments to claims have overcome the objections and 112(b) rejections previously set forth in the office action mailed 02/06/2026.
Response to Arguments
Applicant’s argument pages 10-11 of the remarks filed 04/30/2026 that Cabiri fails to disclose the feature “the security base … provided with an infusion needle accommodating part, for accommodating the infusion needle when the drug infusion device is priming”. Applicant’s argument has been fully considered and are not persuasive. As shown in figs. 4A-4D, the infusion needle accommodating part 404 is placed on the security base 402 and is connected to the security base 402 such that 402 is a base of 404. Therefore, 402 and 404 read on the limitation “the security base provided with an infusion needle accommodating part”. And as shown in figs. 4A-4D, 404 is used to accommodating needle 410. Therefore, 402 and 404 read on the limitation “for accommodating the infusion needle when the drug infusion device is priming”.
Applicant’s argument pages 11-12 of the remarks filed 04/30/2026 that Cabiri fails to disclose the feature “the security base arranged on a bottom of the adhesive patch”. Applicant’s argument has been fully considered and are not persuasive. Cabiri discloses in par. 0122 that the adhesive patch 413 retaining base 402 in the collapsed state; and after base 402 is attached to the injection site and/or collapses into 404, 413 contacts and/or attaches to the skin such that the attachment of 413 to the skin holds base 402 collapsed together with 404. Therefore, 402 is arranged on 413 as well as a bottom of 413 so that 413 contacts and attaches to the skin to hold 402 together with 404.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-2, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri et al. (US 2019/0030240) in view of CN111939371 (Examiner notes: see attached NPL for its translation).
Regarding claim 1, Cabiri discloses
A drug infusion device (device shown in figs. 4A-4D and pars. 0114-0137) with security base (402, fig. 4A), comprising:
a reservoir (422, fig. 4A and par. 0123), used for accommodating a drug to be infused (see fig. 4A and also fig. 1B for the device with a reservoir configured to discharge a drug after inserting a needle through a skin of a subject);
an infusion needle unit (410/424, fig. 4A and par. 0123), including an infusion needle (410) and an infusion needle holder (424), wherein the infusion needle holder (424) is used to fixedly place the infusion needle (410, see fig. 4A), when the infusion needle unit (410/424) is at a non-initial position (figs. 4A-4B), the infusion needle (410) is communicated with the reservoir (422, see figs. 4A-4B);
an adhesive patch (413 with adhesive disclosed in par. 0122), for attaching the drug infusion device (see figs. 4A-4D) module to a skin surface (see par. 0122); and
a security base (402), arranged on a bottom of the adhesive patch (413, see figs. 4A-4D), provided with an infusion needle accommodating part (404), for accommodating the infusion needle (410) when the drug infusion device is priming (see fig. 4B and pars. 0126-0127).
Cabiri only discloses the device comprising a plunger driver assembly 426 (see fig. 4A and par. 0125), but is silent about the plunger drive assembly comprising a piston, a screw, and a driving wheel connected with the screw, driving the screw to push the piston forward by rotation.
However, CN111939371 teaches drug infusion device comprising a reservoir (100, fig. 2 and lines 221-223, 225-227 of the translation) provided with a piston (120) and a screw (130), and a driving wheel (140) connected with the screw (130), driving the screw to push the piston (120) forward by rotation (see fig. 2 and lines 221-234 of the translation).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri such that the plunger driver assembly comprising a piston, a screw, and a driving wheel, as taught by CN111939371, for the purpose of infusing the medicine/drug (lines 221-234 of CN111939371).
Regarding claim 2, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 1,
Cabiri further discloses wherein a thickness of the security base (402) is gradually decreased from an end (left end of 402, see annotated fig. 4A below) close to an end of the adhesive patch (left end of 413, see annotated fig. 4A below) to a middle part of the adhesive patch (see fig. 4A), and forms a plane with an other end of the adhesive patch (see fig. 4B for 402 forming a plane with 413).
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Regarding claim 17, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 1,
Cabiri further discloses wherein the drug infusion device includes an infusion mechanism module (426/422) and a control mechanism module (control interface disclosed in par. 0090, trigger and/or locking/triggering mechanism disclosed in fig. 3 and par. 0105), the reservoir (422), the drive unit (426), and the infusion needle unit (424/410) are arranged on the infusion mechanism module (426/422).
CN111939371 further teaches the drive wheel (140, fig. 2)
Regarding claim 18, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 17, as set forth above, except for wherein the infusion mechanism module and the control mechanism module are detachable to each other, and the control mechanism module is reusable.
However, CN111939371 teaches an infusion unit (102, fig. 1a) and a program unit (101, fig. 1a) wherein these units are detachable to each other and the program unit is reusable (lines 197-199 of the translation).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri such that the control mechanism and the infusion mechanism are detachable so that the control mechanism is reusable, as taught by CN111939371, for the purpose of allowing the control mechanism be reused and the infusion mechanism be discarded after one-time use (lines 197-199 of CN111939371).
Regarding claim 19, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 18,
Cabiri further discloses wherein the infusion mechanism module (426/422) and the control mechanism module (control interface disclosed in par. 0090, trigger and/or locking/triggering mechanism disclosed in fig. 3 and par. 0105) are electrically connected to each other by an electrical contact (par. 0090, fig. 3 and par. 0105).
CN111939371 further teaches wherein the infusion mechanism module (102) and the control mechanism module (101) are electrically connected to each other by an electrical contact (see lines 189-192 of the translation).
Regarding claim 20, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 17,
Cabiri further discloses wherein the infusion mechanism module and the control mechanism module are disposed in one housing (see figs. 4A-4D), discarded together after a single-use (Examiner notes: the device can be disposed after one-time use).
Claim(s) 4-7, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri et al. (US 2019/0030240) in view of CN111939371 in further view of Helm et al. (IS 2019/0247623).
Regarding claim 4, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 1, as set forth above, except for wherein the adhesive patch includes at least one layer of tape and a protective film, the protective film is fixed around an outer contour of the at least one tape.
However, Helm teaches a drug infusion device comprising an adhesive patch (220), for attaching the drug infusion device to a skin surface (see fig. 2R), wherein the adhesive patch (220) includes at least one layer of tape (220) and a protective film (210) (see figs. 2A-2M and par. 0070), the protective film (210) is fixed around an outer contour of the at least one tape (before being used, as shown in fig. 2B).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri by adding a protective film, as taught by Helm, for the purpose of covering the adhesive layer being use (par. 0070 of Helm).
Regarding claim 5, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 1, as set forth above, except for wherein the adhesive patch includes at least two tapes.
However, Helm teaches a drug infusion device comprising an adhesive patch (220) for attaching the drug infusion device to a skin surface (see fig. 2W), wherein the adhesive patch includes at least two tapes (220 and 270).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri by adding a dressing with additional adhesive layer, as taught by Helm, for the purpose of further securing the device on the skin.
Regarding claim 6, Cabiri in view of CN111939371 and Helm discloses the drug infusion device with security base of claim 5,
Helm further teaches wherein the adhesive patch (220) further includes at least one layer of protective film (210, see figs. 2A-2M and par. 0070).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri by adding a protective film, as taught by Helm, for the purpose of covering the adhesive layer being use (par. 0070 of Helm).
Regarding claim 7, Cabiri in view of CN111939371 and Helm discloses the drug infusion device with security base of claim 5, as set forth above, except for wherein a rockwell hardness of the protective film is greater than a rockwell hardness of the tape.
However, there is no evidence of record that establishes that changing the rockwell hardness of the protective film and the rockwell hardness of the tape would result in difference in function of the device. Further, a person having ordinary skill in the art, being faced with modifying the rockwell hardness of Cabiri in view of CN111939371 and Helm, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed rockwell hardness. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the rockwell hardness of the protective film greater than the rockwell hardness of the tape as an obvious matter of design choice within the skill of the art.
Regarding claim 9, Cabiri in view of CN111939371 and Helm discloses the drug infusion device with security base of claim 5,
Helm further teaches wherein the at least two tapes (220 and 270) comprise an outer tape (270) and an inner tape (220), the outer tape completely covers the inner tape (see figs. 2A-2M).
Regarding claim 10, Cabiri in view of CN111939371 and Helm discloses the drug infusion device with security base of claim 5,
Helm further teaches wherein the at least two tapes (220 and 270) comprise an outer tape (270) and an inner tape (220), the outer tape at least partially covers the inner tape (see figs. 2A-2M).
Regarding claim 11, Cabiri in view of CN111939371 and Helm discloses the drug infusion device with security base of claim 4,
Helm further teaches wherein the protective film is provided with at least one tearing portion (see fig. 2U for the cut-out portions of 210).
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Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabiri et al. (US 2019/0030240) in view of CN111939371 in further view of Yang (US 2019/0175819).
Regarding claim 16, Cabiri in view of CN111939371 discloses the drug infusion device with security base of claim 1, as set forth above, except for wherein the infusion needle is a U-shaped steel needle.
However, Yang teaches a drug infusion device with an infusion needle wherein the infusion needle is a U-shaped needle (see fig. 8).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Cabiri’s infusion needle to be U-shape needle and adding a refilled reservoir, as taught by Yang, for the purpose of allowing the needle to further connect to a refilled reservoir to refill the drug as needed (pars. 0048-0049 of Yang).
Allowable Subject Matter
Claim(s) 3, 8, 12-15 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
THIS ACTION IS MADE FINAL. 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 DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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