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 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 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.
Claim(s) 1, 4, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde et al. (US Patent Pub. 20060184119 hereinafter “Remde”) in view of Yang (US Patent Pub. 20160158436).
Regarding Claim 1, Remde teaches (Figs 1-2) A skin patch drug infusion device (See Fig 1; [0029] teaching device of Fig 1 may be directly placed on skin by an adhesive pad), comprising:
an infusion mechanism module (M1), wherein the infusion mechanism module includes:
a reservoir (3), used for accommodating a drug to be infused, a screw (10; see [0030] teaching 10 is a threaded rod) and a piston (11) connected with the screw (10), wherein the screw (10) and the piston (11) are arranged inside the reservoir (3; see Fig 1);
a driving unit (M, 9), provided with a driving wheel (9) and a driving end (part of 9 that is connected to 10), wherein the driving wheel is connected with the screw, and the driving end pushes the driving wheel to make the screw advance in the reservoir (See [0030]);
a power unit (24), connected with the driving unit, used for offering power for the driving unit (See [0033]);
a control mechanism module (M2), electrically connected with the infusion mechanism module to regulate drug infusion (See [0032] teaching how M2 includes the pump, the pump regulates drug infusion);
a blockage detection module (12,15, 23, 25, 26), operably connected to the control mechanism module, including a detection circuit (22) used to sense and measure physical parameters during a drug filling process or a drug infusion process to confirm whether a blockage has occurred (see [0033]); and
an adhesive patch (see [0029] and [0045] teaching an adhesive pad), for attaching the infusion mechanism module (M1) and the control mechanism module (M2) to a skin surface (See [0029] and [0045];
wherein the infusion mechanism module and the control mechanism module are detachable with each other (see [0029] teaching how the device is mechanically coupled such that they can be easily quickly released and connected to one another again),
Remde does not specify the device wherein the control mechanism module is reusable, wherein the infusion mechanism module comprises an outward extending portion, a block is provided outside the outward extending portion, the outward extending portion and the block form an engaging position, when the control mechanism module is pressed to the engaging position, the control mechanism module is limited by the block to prevent from detaching, wherein the outward extending portion is provided with a pressing portion for releasing the block.
Yang teaches (Figs 1-3) a device with an infusion mechanism module (12) and a control mechanism module (11) that are detachable with each other (See Fig 1 where 11 and 12 are detached, and see Fig 2 when they are attached; also see [0085] teaching how there is disengagement when 123 is pressed). Yang further teaches the control mechanism module is reusable (See [0106] teaching how the controller notifies user to attach a new pump; it is interpreted that the controller is reusable since it notifies user to change the pump), wherein the infusion mechanism (12) module comprises an outward extending portion (121), a block (hook of 121) is provided outside the outward extending portion (121), the outward extending portion and the block (entire hook 121) form an engaging position (position of hook 121 in Fig 3), when the control mechanism module (11) is pressed to the engaging position (se Fig 3), the control mechanism module (11) is limited by the block to prevent from detaching (see Fig 3, 111 and 121 are attached to keep 11 and 12 together), wherein the outward extending portion (121) is provided with a pressing portion (123) for releasing the block (hook portion of 121; see [0085 teaching how pressing 123 could detach the components).
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 Remde such that the control mechanism module is reusable, wherein the infusion mechanism module comprises an outward extending portion, a block is provided outside the outward extending portion, the outward extending portion and the block form an engaging position, when the control mechanism module is pressed to the engaging position, the control mechanism module is limited by the block to prevent from detaching, wherein the outward extending portion is provided with a pressing portion for releasing the block as taught by Yang. One of ordinary skill in the art would have been motivated to do so in order to provide the device with an easy connection and detachment mechanism between the infusion mechanism and controlling mechanism (See Yang [0006]).
Regarding Claim 4, the combination of Remde and Yang teaches all elements of claim 1 as described above. Remde further teaches the skin patch drug infusion device wherein the blockage detection module (12,15, 23, 25, 26) comprises at least one detection element (12, 15, 23, 25, 26) electrically connected to the detection circuit, the at least one detection element is at least one of a force sensor (See [0036] teaching 15 measures force), an acceleration sensor, and a position detection element (See [0033] teaching position sensors 12).
Regarding Claim 9, the combination of Remde and Yang teaches all elements of claim 1 as described above. Remde further teaches the skin patch drug infusion device wherein a comparator that compares the sensed related physical parameters which is sensed by the detection element (12, 15) with preset thresholds which is provided in the detection circuit, when the sensed related physical parameters are greater than or less than the corresponding preset thresholds, the detection circuit sends out an alarm signal (see [0034] teaching a comparison being done based on the measured parameters).
Regarding Claim 10, , the combination of Remde and Yang teaches all elements of claim 9 as described above. Remde further teaches the skin patch drug infusion device wherein the form of the alarm signal is at least one or more combinations of luminous signal, vibration signal, and sound signal (see [0037] teaching a vibratory alarm).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436) as applied to claim 1 above, and further in view of Kamen et al. (US Patent Pub. 20130336814 hereinafter “Kamen”).
Regarding Claim 3, the combination of Remde and Yang teaches all elements of claim 1 as described above. Remde does not specify a timer is provided in the detection circuit to record a time it takes for the power unit to push the piston forward by one step.
Kamen teaches an infusion device with a dedicated timer to count/time the outputs of the sensor (See [1260]).
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 detection circuit of Remde such that it includes a timer as taught by Kamen. One of ordinary skill in the art would have been motivated to do so to record the sensed data consistently (Kamen [1260]). Recording the data consistently would allow a user to analyze any differences in the sensed elements, further enabling the device/user to determine changes in position or blockage in the device.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436) as applied to claim 4 above, and further in view of Sundar et al. (US Patent 8147448 hereinafter “Sundar”)
Regarding Claim 5, the combination of Remde and Yang teaches all elements of claim 4 as described above. Remde does not specify a skin patch drug infusion device of claim 4, wherein the position detection element detects a position by a non-contact detection, the position detection element is a magnetic element.
Sundar teaches (Fig 5) a position detection element (506) that detects a position (Position of plunger 502) by a non-contact detection (see Col 11 lines 9-47 teaching how the detection element 506 detects position of plunger through the magnetic elements 505 in the plunger 502), the position detection element is a magnetic element (see Col 11 lines 9-47 teaching how the detection element 506 detects position of plunger through the magnetic elements 505 in the plunger 502).
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 position sensor of Remde such that the position detection element detects a position by a non-contact detection, the position detection element is a magnetic element as taught by Sundar. One of ordinary skill in the art would have been motivated to do so as this would provide a measure of the position of the plunger relative to the barrel of the syringe, along with the volume delivered and the rate of delivery (Sundar Col 6 lines 14-17).
Regarding Claim 6, the combination of Remde and Yang teaches all elements of claim 4 as described above. Remde does not specify a skin patch drug infusion device wherein the at least one detection element is provided in the piston, the screw, or a connection point of the screw and the piston.
Sundar teaches (Fig 5) at least one detection element (505) that is provided in the piston (502).
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 detection element of Remde such that wherein the at least one detection element is provided in the piston as taught by Sundar. One of ordinary skill in the art would have been motivated to do so as this would provide a measure of the position of the plunger relative to the barrel of the syringe, along with the volume delivered and the rate of delivery (Sundar Col 6 lines 14-17).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436) and Sundar (US Patent 8147448) as applied to claim 6 above, and further in view of Ramey (US Patent 7025226)
Regarding Claims 7-8, the combination of Remde, Yang and Sundar teaches all elements of claim 6 as described above. The combination does not specify wherein the at least one detection element is provided in the piston, the piston is provided with at least one recess for accommodating the at least one detection element; wherein the recess is provided with a plurality of projects, for fixing the detection element.
Ramey teaches (Fig 6-7) a piston (26) with a recess (30) where a detection element (170) is accommodated. Ramey further teaches the recess is provided with a plurality of projects (rim 172, and rim 124), for fixing the detection element (170).
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 piston of Remde such that it includes a recess where the detect element is inserted, a plurality of projects to secure the detection element as taught by Ramey. One of ordinary skill in the art would have been motivated to do so as this is an alternative method of placing a sensor in the piston that provides the same result of the sensor detecting pressure/force as the piston is moved distally (see Ramey Col 7 lines 4-34).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436) as applied to claims 1 above, and further in view of Mounce et al. (US Patent Pub. 20080077081 hereinafter “Mounce”).
Regarding Claim 13, the combination of Remde and Yang teaches all elements of claim 1 as described above. Remde does not specify a skin patch drug infusion device wherein the control mechanism module is provided with a first physical component and the infusion mechanism module is provided with an in-position detection module, wherein the in-position detection module includes a second physical component, the first physical component and the second physical component are operatively electrically connected to each other to generate an in-position detection signal.
Mounce teaches (Fig 42) a first physical component (516a) and the infusion mechanism module is provided with an in-position detection module (516), wherein the in-position detection module includes a second physical component (516n), the first physical component and the second physical component are operatively electrically connected to each other to generate an in-position detection signal (see [0216] teaching that the elements 516a-516n are used to detect proper connection between components of the device, this is considered ‘in-position’ detection).
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 Remde such that the control mechanism module is provided with a first physical component and the infusion mechanism module is provided with an in-position detection module, wherein the in-position detection module includes a second physical component, the first physical component and the second physical component are operatively electrically connected to each other to generate an in-position detection signal as taught by Mounce. One of ordinary skill in the art would have been motivated to do so in order to ensure proper connection of other components in the infusion device (Mounce [0216]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436) as applied to claim 1 above, and further in view of Nelson (CN 110604545).
Regarding Claim 14, the combination of Remde and Yang teaches all elements of claim 1 as described above. Remde does not specify a skin patch drug infusion device wherein the adhesive patch comprises a tape and a protective film, a first side of the tape is fixedly connected with the skin patch drug infusion device, and a second side opposite the first side of the tape is coated with a paste material, the protective film is fixed around an outer edge of the first side of the tape, an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape, and a rockwell hardness of the protective film is higher than a rockwell hardness of the tape.
Nelson teaches (Fig 1) a device (100) with an adhesive patch (20) comprising a tape (30) and a protective film (50), a first side of the tape (side 30 facing 20) is fixedly connected with the skin patch drug infusion device and a second side opposite the first side of the tape is coated with a paste material (Pg 4 line 2 teaches 30 is a foaming adhesive layer, as such it is interpreted that the foaming adhesive meets the limitation of a tape coated with paste material), the protective film (50) is fixed around an outer edge of the first side of the tape (30), an outer edge of the protective film (50) contour corresponds to the outer edge of the first side of the tape (30; see Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the adhesive patch of Remde with an adhesive patch that comprises a tape and a protective film, a first side of the tape is fixedly connected with the skin patch drug infusion device, and a second side opposite the first side of the tape is coated with a paste material, the protective film is fixed around an outer edge of the first side of the tape, an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape as taught by Nelson. One of ordinary skill in the art would have been motivated to do so as this is an alternative design of an adhesive patch that would provide similar results of adhering the device to the user’s skin.
The combination does not specify a rockwell hardness of the protective film is higher than a rockwell hardness of the tape. It would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Remde to include a rockwell hardness of the protective film is higher than a rockwell hardness of the tape since applicant has not disclosed that having a rockwell hardness of the protective film is higher than a rockwell hardness of the tape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a rockwell hardness of the protective film is higher than a rockwell hardness of the tape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. Furthermore, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Response to Arguments
Applicant’s arguments, see Pg. 9-12, filed 3/10/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Remde (US Patent Pub. 20060184119) in view of Yang (US Patent Pub. 20160158436).
The 112 rejections of 1/2/2026 are withdrawn.
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783 /WESLEY G HARRIS/Examiner, Art Unit 3783