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 § 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, 2, 6-7, 11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde (US Patent Pub. 20060184119) in view of Nelson (CN 110604545) and Vaillancourt et al. (US Patent Pub. 20160243338 hereinafter “Vaillancourt”).
Regarding Claim 1, Remde teaches (fig 1) a skin patch drug infusion device, comprising:
an infusion mechanism module (8), wherein the infusion mechanism module includes an upper case (1) and a lower case (2, 20);
a control mechanism module (Msub2), arranged on the lower case (2, 20), and electrically connected with the infusion mechanism module (6); and
an adhesive patch (see [0029] and [0045] teaching an adhesive pad).
Remde does not specify the adhesive patch comprising a tape and a protective film, wherein a first side of the tape is fixedly connected with the lower case of the infusion mechanism module, 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”.
The combination does not specify wherein the protective film is constantly fixed to the first side of the tape.
Vaillancourt teaches (Figs 6-7) a device with an adhesive patch comprising a tape (23) with a first side (side we see in Fig 6-7) and a second side (opposite side we see in Fig 6-7); the first side of the tape comprises a protective film (22) that is fixed to the first side of the tape (23) and the protective film (22) is constantly fixed to the first side of the tape (See Fig 7 showing how 22 may remain on the first side of the tape, while release liner 24 may be removed).
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 protective film of the modified Vaillancourt such that the protective film is constantly fixed to the first side of the tape as taught by Vaillancourt. One of ordinary skill in the art would have been motivated to do so in order to allow the protective film to cover portions of the device while still allowing the tape to adhere the device to the patient (See Vaillancourt [0050]).
Regarding Claim 2, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device of wherein the rockwell hardness of the protective film is 80HRM~100HRM.
However, 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 and Nelson to include the rockwell hardness of the protective film is 80HRM~100HRM since applicant has not disclosed that having the rockwell hardness of the protective film is 80HRM~100HRM 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 the rockwell hardness of the protective film is 80HRM~100HRM, 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.
Regarding Claim 6, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device wherein the protective film is annular.
Nelson teaches (Fig 1) a protective film (50) which is annular (see Fig 1, 50 is circular).
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 shape of the protective film of the modified Remde such that the protective film is annular as taught by Nelson. It would have been an obvious matter of design choice to modify the protective film to be annular since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claim 7, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. Remde further teaches a skin patch drug infusion device wherein the infusion mechanism module (8) includes an infusion needle (6), a drug (See [0030] teaches drug in reservoir 3) to be infused is infused subcutaneously through the infusion needle (see [0031] teaches subcutaneous delivery).
Regarding Claim 11, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. Remde further teaches a skin patch drug infusion device of claim 1, wherein the infusion mechanism module (8) and the control mechanism module (Msub 2) are detachable to each other, and the control mechanism module is reusable (see [0029] teaching how the device is mechanically coupled such that they can be easily quickly released and connected to one another again).
Regarding Claim 15, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. Remde further teaches a skin patch drug infusion device wherein the lower case (20, 2) is provided with an outward extending portion (See Fig 2, portion where 2 extends), and a block (2) is provided on an outside of the outward extending portion (See Fig 2).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde in view of Nelson and Vaillancourt as applied to claim 1 above, and further in view of オネイル et al. (JP 2005505360 hereinafter “JP ‘360”).
Regarding Claim 3, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device wherein the tape comprises polyethylene, polypropylene, non-woven cloth or pure cotton.
JP ‘360 teaches [0017] an adhesive patch comprising a layer that is made of the material polyethylene.
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 tape of the modified Remde such that it is made of the material polyethylene as taught by JP ‘360. One of ordinary skill in the art would recognize this as a known material used for medical device adhesives (JP ‘360 [0017]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 5, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device of claim 1, wherein the protective film comprises is one of polycarbonate, polyamide, polyformaldehyde, polyphenyl ether, polyester, polyphenylene sulfide or polyaryl ester.
JP ‘360 teaches [0018] an adhesive patch comprising a layer that is made of the material polyester.
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 film of the modified Remde such that the film is made of a polyester material as taught by JP ‘360. One of ordinary skill in the art would recognize this as a known material used for medical device adhesives (JP ‘360 [0017]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde in view of Nelson and Vaillancourt as applied to claim 1 above, and further in view of オネイル et al. (JP 2005505360 hereinafter “JP ‘360”) and Kinning, (NPL 12 - Rheology for adhesion science and technology, Adhesion Science and Engineering, hereinafter “Kinning”).
Regarding Claim 4, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device wherein a thickness of the tape is 0.001 – 1 um and a thickness of the protective film is 0.01 um – 100 um.
JP ‘360 teaches [0018] an adhesive patch comprising a layer that is 0.001 inch thick (0.001 inch is approximately 24.5 um).
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 thickness of the film of the modified Remde such that it is 24.5 um as taught by JP ‘360. One of ordinary skill in the art would recognize this is a known thickness for a layer of an adhesive medical device (JP ‘360 [0018]). Additionally, it would have been an obvious matter of design choice to have modified the thickness of the film of the modified Remde since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
The combination does not specify wherein a thickness of the tape is 0.001 – 1 um.
Kinning teaches (Chap 12 Pg. 1) a known thickness for a tape is less than 1 um.
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 thickness of the tape of modified Remde such that it is less than 1 um. One of ordinary skill in the art would recognize that this is a known thickness for layers of adhesives (Kinning Chap 12 Pg. 1). Additionally, it would have been an obvious matter of design choice to have modified the thickness of the tape of the modified Remde since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde in view of Nelson and Vaillancourt as applied to claims 1 and 7 above, and further in view of Searle (CN 204910157).
Regarding Claim 8, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 7 as described above. The combination does not specify a skin patch drug infusion wherein the tape is provided with a first through hole, and the infusion needle passes through the first through hole.
Searle teaches (Fig 30a-30c) a tape (796) with a first through hole (aperture where 791 is inserted) and the infusion needle (791) passes through the first hole (See Figs 30a-30c).
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 tape of the modified Remde such that the tape is provided with a first through hole, and the infusion needle passes through the first through hole as taught by Searle. One of ordinary skill in the art would have been motivated to do so in order to insert the needle while also keeping the device adhered to the skin, and allow the drug to flow through the hole (Searle PG. 20 lines 15-17).
Regarding Claim 12, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 1 as described above. The combination does not specify a skin patch drug infusion device wherein the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single-use.
Searle teaches (Fig 9; Pg. 8 second full paragraph) a disposable patch device (200) with an infusion mechanism (230) and control mechanism (235) disposed in one housing (220).
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 modified Remde such that the infusion mechanism module and the control mechanism module are disposed in one housing, discarded together after a single-use as taught by Searle. One of ordinary skill in the art would have been motivated to do so in order to allow the user to dispose of the device after one use or reuse the device as desired (Searle Pg. 8 fourth full paragraph).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde, Nelson, Vaillancourt and Searle as applied to claim 8 above, and further in view of Fabo (CN 101896145).
Regarding Claims 9-10, the combination of Remde, Nelson, Vaillancourt and Searle teaches all elements of claim 8 as described above. The combination does not specify a skin patch drug infusion device wherein before the adhesive patch is pasted to a skin surface, the second side of the tape is covered with at least one layer of release paper; wherein the release paper is provided with a second through hole, and a position of the second through hole corresponds to a position of the first through hole, so that the infusion needle passes through the second through hole
Fabo teaches (Fig 2 and [0032]) an adhesive skin patch including a tape (3) covered with at least one layer of release paper (7), wherein the release paper (7) includes a through hole (See where 8 points to). And the position of the second through hole corresponds to a position of the first through hole such that the infusion needle passes through the second through hole (see Fig 2).
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 adhesive patch of the modified Remde such that before the adhesive patch is pasted to a skin surface, the second side of the tape is covered with at least one layer of release paper; wherein the release paper is provided with a second through hole, and a position of the second through hole corresponds to a position of the first through hole such that the infusion needle passes through the second through hole as taught by Fabo. One of ordinary skill in the art would have been motivated to do so in order to protective the adhesive layer in the storing and transporting process of the device (Fabo [0032]), and to protect the surrounding skin from the piercing object (Fabo [0034]).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Remde in view of Nelson and Vaillancourt as applied to claim 11 above, and further in view of Cargill et al. (US Patent Pub. 20220265210 hereinafter “Cargill”).
Regarding Claim 13, the combination of Remde, Nelson and Vaillancourt teaches all elements of claim 11 as described above. Remde further teaches a skin patch drug infusion device wherein the control mechanism module (Msub2) is provided with a plurality of first electrical contacts (see 23, 26, these interrupters are considered to broadly meet the limitation of ‘electrical contacts’) exposed on a surface of the control mechanism module (Msub2) and the infusion mechanism module (8) is provided with a plurality of second electrical contacts (13, 14,15) electrically connected with the first electrical contacts (indirectly connected with interrupters 23, 26; see [0032-0033]).
In the event that the applicant believes Remde does not teach the first electrical contacts and second electrical contacts as claimed, the examiner is providing a secondary reference Cargill.
Cargill teaches (Fig 13A-14B) a skin patch drug infusion device wherein the control mechanism module (926) is provided with a plurality of first electrical contacts (927, 928) exposed on a surface of the control mechanism module (926; see Fig 13A) and the infusion mechanism module (940, 932, 970) is provided with a plurality of second electrical contacts (942, 944) electrically connected with the first electrical contacts (see [0087] “A compressible material 948 is placed behind the set of contacts 927 and 928 to accommodate compression by the set of contact pins 942 and 944 on the sensor electronic module 940.”).
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 modified Remde such that 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 as taught by Cargill. One of ordinary skill in the art would have been motivated to do so in order to co-locate electrical and fluid connections to a sensing cannula in an infusion device (See Cargill [0087]).
Regarding Claim 14, the combination of Remde, Nelson, Vaillancourt and Cargill teaches all elements of claim 13 as described above. The combination further teaches a skin patch drug infusion device wherein the first electrical contacts (Cargill 927, 928) are elastic conductive members (see Cargill [0086] teaching “set of elastomeric electrical contacts”), or the second electrical contacts (Cargill 942, 944) are rigid metal pins (See Cargill [0087] teaching 942 and 944 are pins).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection takes into consideration the amendment filed 3/13/2026.
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.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783