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 05/04/2026. As directed by the amendment: claims 1-5, 7, 10, 12-13, 15-21 have been amended; claims 6, 8-9, 11, 14 have been canceled; and no new claims have been added. Thus, claims 1-5, 7, 10, 12-13, 15-21 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 02/20/2026.
Response to Arguments
Applicant’s argument pages 12-14 of the remarks filed 05/04/2026 that JP2019-165835 fails to disclose the feature “a stopper and a conductive platform positioning post are provided on the frame to fix the at least one conductive platform”. Applicant’s argument has been fully considered and are not persuasive. JP2019-165835 discloses a stopper and a conductive platform positioning post provided on the frame (see annotated fig. 5 below) to fix the conductive platform 34. As disclosed in par. 0050 (see the translation mailed with the Office Action 02/20/2026), 34 is disposed on the first storage surface unit 31; and as shown in figs. 5 and 9-10, the stopper and the conductive platform positioning post are provided and disposed on unit 31a to fix 34 to the frame/case 31 so that the battery unit 12 is fixed to the frame/case 31 when main body 7 and main body 8 are coupled. Fig. 10 shows 34 is coupled and being fixed to the frame, ready for use.
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Applicant’s argument page 14 of the remarks filed 05/04/2026 that JP2019-165835 fails to disclose the feature “the circuit module includes a circuit board, …; a power unit, …” since the substrate 35 and the battery 19 are disposed in the different modules and connected by the element 34. Applicant’s argument has been fully considered and are not persuasive. Fig. 10 shows that the substrate 35 and the battery 19 are elements of the skin patch drug infusion device, therefore, 35 and 19 read on the circuit board and the power unit limitations required in claim 1.
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) 1-3, 7, 10, 12-13, 16-17, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2019-165835 in view of CN111939371 (Examiner notes: JP2019-165835 is cited in the IDS 06/29/2023. See attached NPL files for JP2019-165835 and CN111939371 translations).
Regarding claim 1, JP2019-165835 discloses
A skin patch drug infusion device (1, figs. 1-10 and pars. 0011-0094 of the translation), comprising:
an infusion mechanism module (2, fig. 1), wherein the infusion mechanism module (2) includes an infusion module (7 without battery 19, see fig. 2 and pars. 0019-0045 of the translation) and a circuit module (8 with battery 19, fig. 5 and pars. 0046-0071 of the translation) (see also figs. 8-10 and pars. 0072-0086 of the translation), the circuit module (8/19) includes:
a circuit board or a three-dimensional circuit, for supplying power (see fig. 5 and for pars. 0050-0051 of the translation for element 35. Examiner notes: when 7 and 8 are coupled, power is supplied from the battery 19 to the drive motor 42 via the substrate 35. Therefore, 35 reads on the limitation of being a three-dimensional circuit for supplying power from the battery to the drive motor. Examiner also notes that since claim 1 uses the language “or”, only one limitation of the “or” statement is positively claimed and required);
a power unit (19), for providing power to pull a driving wheel (17a, fig. 2 and par. 0030 of the translation) of the infusion mechanism module (7 without 19) to implement drug infusion (see pars. 0029-0032, 0051-0052, and 0086 of the translation for power is supplied to 42 of 32, the drive force of 32 is transmitted to 17 causing movement of 17a/17b moving 14a along the axial direction X to implement drug infusion);
at least one conductive platform (34, fig. 5 and pars. 0053-0055 of the translation), the at least one conductive platform (34) provided with a conductive platform protrusion (free end portion of 64 of 61, see fig. 7), the conductive platform protrusion (free end portion of 64 of 61, see fig. 7) is connected to a connection end on the circuit board or on the three- dimensional circuit (35, see par. 0062 of the translation for 61 connected to 35 and 61 connected to 19), causing the power unit electrically connecting the circuit board or the three-dimensional circuit (see fig. 7 and par. 0062);
an adhesive patch (71), configured to attach the infusion mechanism module and the control mechanism module to a skin surface (see par. 0016 of the translation),
wherein the infusion mechanism module (2) further includes a frame (see fig. 1, see also fig. 2 for casing 11 and see fig. 5 for case 31),
wherein a stopper and a conductive platform positioning post are provided on the frame to fix the at least one conductive platform (see annotated fig. 5 below for the stopper and the conductive platform positioning post provided and positioned on frame 31 to fix 34 to the frame 31 when 7 and 8 are coupled – see also fig. 10).
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JP2019-165835 is silent about a control mechanism module, electrically connected with the infusion mechanism module.
However, CN111939371 teaches a control mechanism module (101, see figs. 1a-1b and lines 186-192 of the translation), electrically connected with the infusion mechanism module (102, see figs. 1a-1b and lines 197-201).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify JP2019-165835 by adding a control mechanism module, as taught by CN111939371, for the purpose of controlling drug infusion, controlling the power output of the power unit, and establishing wireless communication with remote devices (lines 189-192 of CN111939371).
Regarding claim 2, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein each of the at least one conductive platform (34) includes a conductive platform body (65 of 61, see fig. 7) and a conductive arm (64 of 61), the conductive platform protrusion (free end portion of 64) is provided on the conductive arm (64, see fig. 7).
Regarding claim 3, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 2,
JP2019-165835 further discloses wherein the conductive platform body (65) includes a conductive platform body end portion (end portion of 65 that is connected to 64, see fig. 7).
Regarding claim 7, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 2,
JP2019-165835 further discloses wherein the conductive platform protrusion (free end portion of 64 of 61, see fig. 7) is a linear protrusion or a dot protrusion (see fig. 7 for the linear free end portion of 64. Examiner notes: since claim 7 uses the language “or”, only one limitation of the “or” statement is positively claimed and required).
Regarding claim 10, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein a conductive platform boss is provided on the frame, located near the conductive platform positioning post (see annotated fig. 5 above).
Regarding claim 12, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein the circuit board is flexible (Examiner notes: since claim 1 uses the “or” language, only one limitation of the “or” statement is positively claimed and required in claim 1. Examiner interpreted that the limitation “three-dimensional circuit” is positively required and claimed, and the limitation “circuit board” is not positively required and claimed. Therefore, the limitation of claim 12 for the circuit board is also not positively required and claimed).
Regarding claim 13, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein the infusion mechanism module (2) further includes a battery (19, fig. 4. Examiner notes: see par. 0043 for two batteries 19 are used in the module. One battery 19 is read for the limitation “a power unit” in claim 1 and the other batter 19 is read for the limitation “a battery” in claim 13) and an elastic conductor (62, fig. 7) with protrusions (one end on 64 and the other end on 66, see fig. 7), the protrusions are connected to the battery and the connection end on the circuit board or on the three-dimensional circuit (see pars. 0062 of the translation for 61 connected to 35 and 61 connected to 19).
Regarding claim 16, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
CN111939371 further teaches wherein the infusion mechanism module (102) and the control mechanism module (101) are detachable with each other, and the control mechanism module is reusable (see fig. 1a and lines 197-199 of 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 JP2019-165835 by adding a control mechanism module such that the control mechanism module is detachable with the infusion mechanism module, as taught by CN111939371, for the purpose of allowing the control mechanism module to be reused while the infusion mechanism module to be discarded after one-time use (lines 197-199 of CN111939371).
Regarding claim 17, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
CN111939371 further teaches wherein the infusion mechanism module (102) and the control mechanism module (101) are disposed in one housing (10), discarded together after a single-use (see fig. 1b and lines 199-201 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 JP2019-165835 by adding a control mechanism module such that the control mechanism module and the infusion mechanism module are disposed in one housing, as taught by CN111939371, for the purpose of allowing the control mechanism module and the infusion mechanism module to be discarded as a whole after one-time use (lines 199-201 of CN111939371).
Regarding claim 20, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein the infusion mechanism module (2) further includes a case (31, fig. 5), the case (31) is provided with an outward extending portion (see annotated fig. 5 below), and a block is provided on an outside of the outward extending portion (see annotated fig. 5 below).
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Regarding claim 21, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1,
JP2019-165835 further discloses wherein the adhesive patch (71) comprises a tape (71) and a protective film (72), a first side of the tape (71) is fixedly connected with the skin patch drug infusion device (see par. 0016 of the translation for 71 is used to attach the device to the patient’s skin. Therefore, the upper-facing side of 71 is fixedly connected with 2 and 3 when 2 is attached to 3), and a second side opposite the first side of the tape is coated with a paste material (adhesive material of 71 to attaching the device to the patient’s skin), the protective film (72) is fixed around an outer edge of the first side of the tape (see fig. 1), an outer edge of the protective film (72) contour corresponds to the outer edge of the tape (see fig. 1 for 72 fully covering 71 prior to use).
JP2019-165835 is silent about a rockwell hardness of the protective film is higher than a rockwell hardness of the tape.
There is no evidence of record that establishes that changing the rockwell hardness of the protective film would result in a difference in function of JP2019-165835 device. Further, a person having ordinary skill in the art, being faced with modifying the rockwell hardness of the protective film, 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 to be higher than the rockwell hardness of the tape, as an obvious matter of design choice within the skill of the art.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2019-165835 in view of CN111939371 in further view of Holmqvist et al. (US 2019/0015597).
Regarding claim 4, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 3, as set forth above, except for wherein the at least one conductive platform is a sheet metal.
However, Holmqvist teaches a spring element made of a sheet metal (par. 0037).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify JP2019-165835 spring element 61 to be made of a sheet metal, for the purpose of providing conductivity and elasticity to the spring element.
Claim(s) 15, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2019-165835 in view of CN111939371 in further view of Hanson et al. (US 9,421,321).
Regarding claim 15, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1, as set forth above, except for wherein the infusion mechanism module further includes a symmetrical conductive tower- spring with a small diameter in a central part and a large diameter at both ends.
However, Hanson teaches a first housing portion (901, figs. 27A-27B) and a second housing portion (902, figs. 27A-27B) wherein the first housing portion and the second housing portion comprises electrical contacts (910/920), and wherein the first housing portion comprises a symmetrical conductive tower- spring (919, figs. 27A-27B).
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 control mechanism module and the infusion mechanism module by adding electrical contacts, as taught by Hanson, for the purpose of providing a signal to the user that the control mechanism module and the infusion mechanism module are properly connected (col. 31 lines 45-61 of Hanson).
Hanson is silent about the spring having a small diameter in the middle and a large diameter at both ends. Handson only teaches member 919 (figs. 27A-27B) being a bias member, such as a spring, or the like (col. 33 lines 9-11).
There is no evidence of record that establishes that changing the shape of the spring would result in a difference in function of Hanson spring. Further, a person having ordinary skill in the art, being faced with modifying the shape of the spring, 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 shape.
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 shape of the spring to have a small diameter in the middle and a large diameter at both ends, as an obvious matter of design choice within the skill of the art.
Regarding claim 18, JP2019-165835 in view of CN111939371 discloses the skin patch drug infusion device of claim 1, as set forth above, except for wherein the control mechanism module is provided with a plurality of first electrical contacts exposed on a surface of the control mechanism module and the infusion mechanism module is provided with a plurality of second electrical contacts electrically connected with the first electrical contacts.
However, Hanson teaches a first housing portion (901, figs. 27A-27B) and a second housing portion (902, figs. 27A-27B) wherein the first housing portion (901) is provided with a plurality of first electrical contacts (910) exposed on a surface of the first housing portion (see figs. 27A-27B) and the second housing portion (902) is provided with a plurality of second electrical contacts (922/924) electrically connected with the first electrical contacts (see fig. 27B).
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 control mechanism module and the infusion mechanism module by adding electrical contacts, as taught by Hanson, for the purpose of providing a signal to the user that the control mechanism module and the infusion mechanism module are properly connected (col. 31 lines 45-61 of Hanson).
Regarding claim 19, JP2019-165835 in view of CN111939371 and Hanson discloses the skin patch drug infusion device of claim 18,
Hanson further teaches wherein the first electrical contacts are rigid metal pins or elastic conductive members, or the second electrical contacts are rigid metal pins or elastic conductive members (Examiner notes: since claim 19 uses the “or” language, only one limitation of the “or” statement is positively claimed and required in claim 19. See figs. 27A-27B for the first electrical contacts being elastic conductive members. See also col. 31 lines 15-17 for the first electrical contacts made of metal, or rubber conductive pad).
Allowable Subject Matter
Claim 5 is 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.
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 DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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