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 .
Status of Claims
This office action is responsive to the Response to Election filed 9 January 2026.
Claims 1-6, 8-14, and 16-22 were elected in a provisional election described below.
Claims 7, 15, and 16 are withdrawn.
Claims 1-6, 8-14, and 16-22 are presently pending in this application.
Election/Restrictions
Claims 7 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9 January 2026.
Claim 16 is also withdrawn as it depends from withdrawn claim 15.
Applicant's election with traverse of species 1 in the reply filed on 9 January 2026 is acknowledged. The traversal is on the ground(s) that all claims of the present invention can be examined without serious search burden. This is not found persuasive because :
Each of the inventions are separately classifiable.
Each of the claimed inventions must be found separately and would not naturally overlap during examination. As such, each of the inventions would require different search queries:
Species 2 includes a main body and a main-body-side attachment sheet directly fixed without interposing of an intermediate member. Species I requires an intermediate member and, therefore, species 2 requires a different structure to be searched that would completely contrast with species 1.
Species 3 includes a one-end extension part projecting further than the one-end extension part in species 1, which is an additional structure that was not required in species 1.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 17 is objected to because of the following informalities:
“not stuck” - line 13 and 14. Inconsistent with the language of the rest of the claim. Interpreted as --not adhered—
“having positioned” – line 3. Interpreted as –positioned--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 12, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “the boundary adjacent part” in lines 7-9 of the claim. It is unclear if “the boundary adjacent part” in each instance of claim 4 is the same boundary adjacent part of the first lateral extension or the second lateral extension. For the purposes of examination, examiner interprets “the boundary adjacent part” to mean –the boundary adjacent part of the first lateral extension--.
Claim 12 recites the limitation “dividing the attachment member into three equal parts” in line 7 of the claim. It is unclear what the term “equal” means as it relates to the “three equal parts”. Furthermore, it is unclear what the term “dividing” means in relation to the limitation, as it could refer to either a physical division/separation or an abstract partitioning of parts.
Claim 20 recites the limitation “the second section including a periphery that surrounds the first section”. It is unclear if the periphery of the second section is the same periphery of the first section, as the first section periphery also surrounds the first section. For the purposes of examination, examiner interprets “the second section including a periphery that surrounds the first section” to mean --the second section including a periphery that surrounds the second section--.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 8, 9, 11, 14, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nishimura et al. (US Patent Publication No. 20180280609 A1), hereinafter Nishimura.
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Regarding claim 1, Nishimura teaches a self-retaining device (Nishimura: Fig. 4, instrument 10a) comprising: a sheet-shaped attachment member (Fig. 4, application member 30); a main body (Fig. 4, device 20a) positioned in overlapping relation to the sheet-shaped attachment member (Fig. 4, device 20a is placed over member 30) so that a back surface of the main body (20) faces the sheet-shaped attachment member (Fig. 1, back surface of device 20 faces member 30, which is the case for all embodiments); the sheet-shaped attachment member (30) including: a first section (Fig. 4 shown above, first section A) fixed to the back surface of the main body (Fig. 4 above and 5, first section A is fixed to the back of device 20a via 30a; para. 0039), the first section (A) of the sheet-shaped attachment member (30) including a first surface (Fig. 1 and 4 above, part of surface 30b that is part of section A) that faces away from the main body (Fig. 1 and 4 above, surface 30b faces away from device 20a), an entirety of the first surface (part of 30b of A) of the first section (A) being provided with an adhesive (para. 0042) configured to adhere to a body surface of a living body to retain the first section (A) of the sheet-shaped attachment member (30) on the body surface of the living body (para. 0041), the first section (A) including a periphery (Fig. 4 above, peripheral edge of section A); a second section (Fig. 4 shown above, second section B) facing the back surface of the main body (20a) and positioned adjacent the first section (A) so that the first (A) and second (B) sections are positioned adjacent one another (Fig. 4 above, section B is adjacent to section A) in an arrangement direction (Fig. 4 above, arrangement direction AD) with a linear boundary (Fig. 4 above, linear boundary LB) between the first section (A) and the second section (B); the second section (B) of the sheet-shaped attachment member (30) including a first surface that faces away from the main body (Fig. 1 and 4 above, part of surface 30b that is part of section B) an entirety of the first surface (part of 30b of B) of the second section (B) being provided with an adhesive (para. 0042) configured to adhere to the body surface of the living body to retain the second section (B) of the sheet- shaped attachment member (30) on the body surface of the living body (para. 0041), the second section (B) including a periphery (Fig. 4 above, peripheral edge of section B);
the second section (B) not being fixed to the back surface of the main body (20a) so that the second section (B) is movable relative to the main body (Fig. 4 above, section B is shown not attached to the device 20a); a peripheral section (Fig. 4, second region 32) extending outwardly from the periphery of the first section (A) and outwardly from the periphery of the second section (B), the peripheral section (32) including a first surface (Fig. 1, part of surface 30b part of second region 32) provided with an adhesive (para. 0042) configured to adhere to the body surface of the living body to retain the peripheral section (32) of the sheet-shaped attachment member (30) on the body surface of the living body (para. 0041); the peripheral section (32) including a lateral extension part (Fig. 4 above, lateral extension part LEP 1) that extends parallel to the arrangement direction (Fig. 4 above, LEP 1 is shown extending parallel to AD); the lateral extension part (LEP 1) including: a boundary adjacent part (Fig. 4 above, BAP) through which passes an imaginary extension of the linear boundary (LB); a first section adjacent part (Fig. 4 above, first section adjacent part C) adjacent to the boundary adjacent part (BAP1) and the first section (Fig. 4 above, part C is adjacent to both section A and BAP1); and a second section adjacent part (Fig. 4 above, second section adjacent part D) adjacent to the boundary adjacent part (BAP1) and the second section (Fig. 4 above, part D is adjacent to both section B and BAP1); and the boundary adjacent part (BAP1) possessing a width (Fig. 4 above, width W1) measured transverse to the arrangement direction (AD) that is equal to or greater than a maximum width of the first section adjacent part (Fig. 4 above, W1 is shown to have an equal width to section C) and greater than a maximum width (Fig. 4 above, W2) of the second section adjacent part (Fig. 4 above, W1 is shown to be larger than W2).
Regarding claim 2, Nishimura teaches the device above, further comprising an adhesive part (Fig. 1, attachment surface 30a; para. 0042) located between the main body (20a) and the first section (A) of the sheet-shaped attachment member (para. 0042).
Regarding claim 4, Nishimura teaches the device above, wherein the lateral extension part (LEP1 and LEP2) is a first lateral extension part (Fig. 4 shown above, LEP1) located on one side of the sheet-shaped attachment member (Fig. 4 above, LEP1 is located on one side of the member 30), and further comprising: a second lateral extension part (Fig. 4 above, LEP2) that extends parallel to the arrangement direction (AD), the second lateral extension part (LEP2) including: a boundary adjacent part (Fig. 4 above, BAP2) overlapping an imaginary extension of the linear boundary (LB); a first section adjacent part (Fig. 4 above, first section adjacent part E) adjacent to the boundary adjacent part (BAP2) and the first section (Fig. 4 above, part E is adjacent to both section A and BAP2); and a second section adjacent part (Fig. 4 above, second section adjacent part F) adjacent to the boundary adjacent part (BAP2) and the second section (Fig. 4 above, part F is adjacent to section B and BAP2); the boundary adjacent part (BAP2) of the second lateral extension part (LEP2) possessing a width (Fig. 4 above, width W3) measured transverse to the arrangement direction (AD) that is equal to or greater than a maximum width of the first section adjacent part (Fig. 4 above, W3 is shown to be equal to the width of part E) of the second lateral extension part (LEP2) and greater than a maximum width (Fig. 4 above, width W4) of the second section adjacent part (Fig. 4 above, W3 is shown to be greater than W4) of the second lateral extension part (LEP2).
Regarding claim 5, Nishimura teaches the device above, wherein the width (W1) of the boundary adjacent part (BAP1) of the first lateral extension (LEP1) is 1.4 times to 3.5 times the width (W2) of the second section adjacent part (Fig. 4 above, W1 is shown to be 1.4 – 3.5 times the width of W2).
Regarding claim 8, Nishimura teaches a self-retaining device (10a) comprising: a main body (20a); an attachment member that is sheet-shaped (30) and configured to be attached to a body surface of a living body (para. 0042) to retain the main body (20a) on the body surface of the living body (para. 0042); the attachment member (30) including: a first section (A) fixed to a back surface of the main body (20a); a second section (B) that faces the back surface of the main body (20a) at a position adjacent to the first section (B is adjacent to A) and is separable from the main body (Fig. 4 above, section B is shown not attached to main body 20a); a periphery section (32) that is adjacent to an outside of the first section (A) and an outside of the second section (B) and is configured to be attached to the body surface of the living body (para. 0041-0042); the periphery section (32) includes a lateral extension part (LEP1) that extends parallel to a direction (AD) in which the first section (A) and the second section (B) are arranged; the lateral extension part (LEP1) including: a boundary adjacent part (Fig. 4 above, comprising BAP1 and 2) overlapping an extension line of a linear boundary (LB) between the first section (A) and the second section (B); a first section adjacent part (C) adjacent to the boundary adjacent part (BAP1 and 2) and the first section (C is adjacent to A and BAP1); and a second section adjacent part (D) adjacent to the boundary adjacent part (BAP1 and 2) and the second section (D is adjacent to B and BAP1); and a width (W1 and 3) of the boundary adjacent part (BAP1 and 2) is equal to or wider than a maximum width of the first section adjacent part (W1 and 3 are both the same width as parts C and E) and is wider than a maximum width (W2 and 4) of the second section adjacent part (W1 and 3 are both wider than W2 and 4).
Regarding claim 9, Nishimura teaches the device above, wherein the width (W1 and 3) of the boundary adjacent part (BAP 1 and 2) is 1.4 times to 3.5 times the width (W2 and 4) of the second section adjacent part (Fig. 4 above, W1 is shown to be 1.4 – 3.5 times the width of W2).
Regarding claim 11, Nishimura teaches the device above, further comprising an adhesive part (Fig. 1, attachment surface 30a; para. 0042) positioned between the main body (20a) and the attachment member (para. 0042).
Regarding claim 14, Nishimura teaches the device above, wherein the periphery section (32) has, in the attachment member (30), a one-end extension part (Fig. 4 above, one-end extension part G) that is opposite to the second section (Fig. 4 above, part G is shown to be opposite of section B) with respect to the first section (A), is adjacent to the first section (Fig. 4 above, part G is adjacent to section A), and is continuous with the first section adjacent part (Fig. 4 above, part G is continuous with part C), and a width of the first section adjacent part (C) and a width of the one-end extension part (G) equal the width of the boundary adjacent part (Fig. 4 above, the width of parts C and G are shown to be the same).
Regarding claim 20, Nishimura teaches a method comprising: positioning a self-retaining device (10a) adjacent a body surface of a living body (para. 0042), the self-retaining device (10a) comprising: a sheet-shaped attachment member (Fig. 4, application member 30); a main body (Fig. 4, device 20a) positioned in overlapping relation to the sheet-shaped attachment member (Fig. 4, device 20a is placed over member 30) so that a back surface of the main body (20) faces the sheet-shaped attachment member (Fig. 1, back surface of device 20 faces member 30, which is the case for all embodiments); the sheet-shaped attachment member (30) including: a first section (Fig. 4 shown above, first section A) fixed to the back surface of the main body (Fig. 4 above and 5, first section A is fixed to the back of device 20a via 30a; para. 0039), the first section (A) of the sheet-shaped attachment member (30) including a first surface (Fig. 1 and 4 above, part of surface 30b that is part of section A) facing away from the main body (Fig. 1 and 4 above, surface 30b faces away from device 20a) and provided with an adhesive (para. 0042), the first section (A) including a periphery (Fig. 4 above, peripheral edge of section A) that surrounds the first section (A); a second section (Fig. 4 shown above, second section B) facing the back surface of the main body (20a) and positioned adjacent the first section (A) so that the first (A) and second (B) sections are positioned adjacent one another (Fig. 4 above, section B is adjacent to section A) in an arrangement direction (Fig. 4 above, arrangement direction AD) with a linear boundary (Fig. 4 above, linear boundary LB) between the first section (A) and the second section (B); the second section (B) of the sheet-shaped attachment member (30) including a first surface facing away from the main body (Fig. 1 and 4 above, part of surface 30b that is part of section B) and provided with an adhesive (para. 0042), the second section (B) including a periphery (Fig. 4 above, peripheral edge of section B) that surrounds the second section (B); the second section (B) not being fixed to the back surface of the main body (20a) so that the second section (B) is movable relative to the main body (Fig. 4 above, section B is shown not attached to the device 20a); a peripheral section (Fig. 4, second region 32) extending outwardly from the periphery of the first section (A) and outwardly from the periphery of the second section (B), the peripheral section (32) including a first surface (Fig. 1, part of surface 30b part of second region 32) provided with an adhesive (para. 0042); the peripheral section (32) including a lateral extension part (Fig. 4 above, lateral extension part LEP 1) that extends parallel to the arrangement direction (Fig. 4 above, LEP 1 is shown extending parallel to AD); the lateral extension part (LEP 1) including: a boundary adjacent part (Fig. 4 above, BAP) overlapping an imaginary extension of the linear boundary (LB); a first section adjacent part (Fig. 4 above, first section adjacent part C) adjacent to the boundary adjacent part (BAP1) and the first section (Fig. 4 above, part C is adjacent to both section A and BAP1); and a second section adjacent part (Fig. 4 above, second section adjacent part D) adjacent to the boundary adjacent part (BAP1) and the second section (Fig. 4 above, part D is adjacent to both section B and BAP1); and the boundary adjacent part (BAP1) possessing a width (Fig. 4 above, width W1) measured transverse to the arrangement direction (AD) that is equal to or greater than a maximum width of the first section adjacent part (Fig. 4 above, W1 is shown to have an equal width to section C) and greater than a maximum width (Fig. 4 above, W2) of the second section adjacent part (Fig. 4 above, W1 is shown to be larger than W2); and pressing the adhesive (para. 0042) on the first surface (30b of section A) of the first section (A), the adhesive (para. 0042) on the first surface (30b of section B) of the second section (B) and the adhesive (para. 0042) on the first surface (30b of region 32) of the peripheral section (32) against the body surface of the living body to retain the main body (20a) on the body surface of the living body (para. 0042) while also allowing a portion of the main body (20a) that faces the second section (B) to move relative to the body surface of the living body (Fig. 4 above, section B is shown not attached to device 20a, therefore, allowing device 20a to move relative to the subject). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Cabiri et al. (US Patent Publication No. 20140128815 A1), hereinafter Cabiri.
Regarding claim 3, Nishimura teaches the device above.
Nishimura does not expressly disclose an intermediate member positioned between the main body and the sheet-shaped attachment member, a first adhesive part adhering the sheet-shaped attachment member and the intermediate member to one another, and a second adhesive part that adheres the main body and the intermediate member to one another.
Cabiri teaches an intermediate member (Cabiri: Fig. 4A, stiffener 216) positioned between a main body (adjacent surface of infuser; para. 0109) and a sheet-shaped attachment member (Fig. 4A, adhesive substrate 218), a first adhesive part (Fig. 4A, underside surface of start location 234) adhering the sheet-shaped attachment member (218) and the intermediate member (216) to one another (underside of start location 234 is attached to substrate 218; para. 0109), and a second adhesive part (Fig. 4A, extension 438) that adheres the main body (infuser; para. 0109) and the intermediate member (216) to one another (Fig. 4A, extension 438 adheres rib 328c to infuser; para. 0109 and 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Nishimura such that it comprised an intermediate member positioned between the main body and the sheet-shaped attachment member, a first adhesive part adhering the sheet-shaped attachment member and the intermediate member to one another, and a second adhesive part that adheres the main body and the intermediate member to one another as taught by Cabiri in order to enable the adhesive substrate improved conforming to the skin of the user (Cabiri: para. 0109).
Claims 6, 10, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Goldstein et al. (US Patent Publication No. 20210038805 A1), hereinafter Goldstein.
Regarding claim 6, Nishimura teaches the device above.
Nishimura does not expressly disclose a difference between the width of the second section adjacent part and the width of the boundary adjacent part is 2.5 mm to 10 mm.
Goldstein teaches a medicament reservoir (Goldstein: Fig. 1, reservoir 4) with a second section adjacent part (Fig. 2, removal handle 14) and a boundary adjacent part (Fig. 2, shoulders layer 6 leading to removal handle 14). A length of the reservoir is 45-90 mm, while a width of the reservoir is 30-80 mm (para. 0137). The width of the second section adjacent part appears to be half of the width of the reservoir (Fig. 1). The width of the boundary adjacent part appears to be slightly larger than the width of the second section adjacent part.
It would have been an obvious matter of design choice to make the width of the second section adjacent part and the width of the boundary adjacent part of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that a difference between the width of the second section adjacent part and the width of the boundary adjacent part is 2.5 mm to 10 mm, 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 10, Nishimura teaches the device above.
Nishimura does not expressly disclose a difference obtained by subtracting the width of the second section adjacent part from the width of the boundary adjacent part is 2.5 mm to 10 mm.
Goldstein teaches a medicament reservoir (Goldstein: Fig. 1, reservoir 4) with a second section adjacent part (Fig. 2, removal handle 14) and a boundary adjacent part (Fig. 2, shoulders layer 6 leading to removal handle 14). A length of the reservoir is 45-90 mm, while a width of the reservoir is 30-80 mm. The width of the second section adjacent part appears to be half of the width of the reservoir (Fig. 1). The width of the boundary adjacent part appears to be slightly larger than the width of the second section adjacent part.
It would have been an obvious matter of design choice to make the width of the second section adjacent part and the width of the boundary adjacent part of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that a difference between the width of the second section adjacent part and the width of the boundary adjacent part is 2.5 mm to 10 mm, 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 19, Nishimura teaches the device above.
Nishimura does not expressly disclose the second section adjacent part has a straight part parallel to a direction in which the first section and the second section are arranged, and a length of the straight part is 1 mm to 15 mm.
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Goldstein teaches a second section adjacent part (Goldstein: Fig. 2, handle 14) has a straight part (Fig. 2, straight part A) parallel to a direction in which a first section (Fig. 2, top half of layer 6) and a second section (Fig. 2, bottom half of layer 6) are arranged, and a length of the straight part is 1 mm to 15 mm. A length of the reservoir is 45-90 mm, while a width of the reservoir is 30-80 mm (para. 0137). The straight part A appears to be less than 1/12 the length of the entire device.
It would have been an obvious matter of design choice to make the straight part of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that a length of the straight part is 1 mm to 15 mm, 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.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Moga et al. (US Patent Publication No. 20110172645 A1), hereinafter Moga.
Regarding claim 13, Nishimura teaches the device above, wherein the main body includes an operation unit operable by a user.
Nishimura does not expressly disclose the attachment member includes an attachment-member-side exposure hole that exposes the operation unit from a body-surface attachment surface of the attachment member, and the attachment-member-side exposure hole is provided in the second section.
Moga teaches an attachment member (Moga: Fig. 3, adhesive layer 22) includes an attachment-member-side exposure hole (Fig. 3, holes 28) that exposes an operation unit (Fig. 4, delivery assembly 36) from a body-surface attachment surface (Fig. 4, bottom wall 61) of the attachment member (22), and the attachment-member-side exposure hole (28) is provided in a second section (Fig. 3, holes 28 are shown provided on the front half of the layer 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Nishimura such that the attachment member includes an attachment-member-side exposure hole that exposes the operation unit from a body-surface attachment surface of the attachment member, and the attachment-member-side exposure hole is provided in the second section as taught by Moga in order to accommodate the needle to penetrate the skin and deliver a substance (Moga: para. 0026 and 0036).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Fiechter et al. (US Patent Publication No. 20230211075 A1), hereinafter Fiechter.
Regarding claim 18, Nishimura teaches the device above, wherein a portion of the attachment member (30) that includes the first section (A) and a part of the periphery section (32) surrounding the first section (A) is defined as a first region (Fig. 4 above, comprising section A and parts C, E, and G) and a portion of the attachment member (30) that includes the second section (B) and a part of the periphery section (32) surrounding the second section (B) is defined as a second region (Fig. 4 above, comprising section B, parts D and F).
Nishimura does not expressly disclose that an area of the second region is 1/4 or more of an area of the first region.
Fiechter teaches an area of a second region (Fiechter: Fig. 6, region outside of first surface area 8) is 1/4 or more of an area of a first region (Fig. 6, first surface area 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Nishimura such that an area of the second region is 1/4 or more of an area of the first region as taught by Fiechter in order to allow a user to grip the device, allowing for peeling off of a layer (Fiechter: para. 0073). Additionally, it would have been an obvious matter of design choice to make the area of the second region of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that an area of the second region is 1/4 or more of an area of the first region, 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Caspers (US Patent Publication No. 20170252509 A1).
Regarding claim 21, Nishimura discloses a method for treating a patient comprising: providing a medicine supply source (Fig. 4, instrument 10a) containing medicine and comprising a sheet-shaped attachment member (Fig. 4, application member 30) and a main body (Fig. 4, device 20a) positioned in overlapping relation to the sheet-shaped attachment member (Fig. 4, device 20a is placed over member 30) so that a back surface of the main body (20) faces the sheet-shaped attachment member (Fig. 1, back surface of device 20 faces member 30, which is the case for all embodiments); the sheet-shaped attachment member (30) including: a first section (Fig. 4 shown above, first section A) fixed to the back surface of the main body (Fig. 4 above and 5, first section A is fixed to the back of device 20a via 30a; para. 0039), the first section (A) of the sheet-shaped attachment member (30) including a first surface (Fig. 1 and 4 above, part of surface 30b that is part of section A), an entirety of the first surface (part of 30b of A) of the first section (A) being adhered to the body surface of the living body (para. 0042); a second section (Fig. 4 shown above, second section B) facing the back surface of the main body (20a) and positioned adjacent the first section (A) so that the first (A) and second (B) sections are positioned adjacent one another (Fig. 4 above, section B is adjacent to section A) in an arrangement direction (Fig. 4 above, arrangement direction AD) with a linear boundary (Fig. 4 above, linear boundary LB) between the first section (A) and the second section (B); the second section (B) of the sheet-shaped attachment member (30) including a first surface (Fig. 1 and 4 above, part of surface 30b that is part of section B), an entirety of the first surface (part of 30b of B) of the second section (B) being adhered to the body surface of the living body (para. 0042); the second section (B) not being fixed to the back surface of the main body (20a) so that the second section (B) is movable relative to the main body (Fig. 4 above, section B is shown not attached to the device 20a); a peripheral section (Fig. 4, second region 32) extending outwardly from a periphery of the first section (A) and outwardly from a periphery of the second section (B), the peripheral section (32) including a first surface (Fig. 1, part of surface 30b part of second region 32) adhered to the body surface adhered to the body surface of the living body (para. 0042) so that the peripheral section (32) of the sheet-shaped attachment member (30) is retained on the body surface of the living body (para. 0041); the peripheral section (32) including a lateral extension part (Fig. 4 above, lateral extension part LEP 1) that extends parallel to the arrangement direction (Fig. 4 above, LEP 1 is shown extending parallel to AD); the lateral extension part (LEP 1) including: a boundary adjacent part (Fig. 4 above, BAP) through which passes an imaginary extension of the linear boundary (LB); a first section adjacent part (Fig. 4 above, first section adjacent part C) adjacent to the boundary adjacent part (BAP1) and the first section (Fig. 4 above, part C is adjacent to both section A and BAP1); and a second section adjacent part (Fig. 4 above, second section adjacent part D) adjacent to the boundary adjacent part (BAP1) and the second section (Fig. 4 above, part D is adjacent to both section B and BAP1); and the boundary adjacent part (BAP1) possessing a width (Fig. 4 above, width W1) measured transverse to the arrangement direction (AD) that is equal to or greater than a maximum width of the first section adjacent part (Fig. 4 above, W1 is shown to have an equal width to section C) and greater than a maximum width (Fig. 4 above, W2) of the second section adjacent part (Fig. 4 above, W1 is shown to be larger than W2); and administering the medicine from the medicine supply source to the patient. When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
Nishimura does not expressly disclose performing a medical procedure on the patient; indwelling an administration unit on a body surface of the patient after the performing of the medical procedure on the patient; connecting the administration unit to a medicine supply source; and administering medicine by way of the administration unit that is indwelled on the body surface of the patient.
Caspers teaches performing a medical procedure on the patient (Caspers: Fig. 7, step S2, wipe sterilizing pad over injection site; para. 0043); indwelling an administration unit (Fig. 6, needle 13) on a body surface of the patient (Fig. 7, step S5, needle 13 is moved to pierce skin to administer delivery; para. 0044) after the performing of the medical procedure on the patient (Fig. 7, step S5 occurs after step S2); connecting the administration unit (13) to a medicine supply source (needle 13 is engaged for delivery; para. 0044); and administering medicine (Fig. 7, step S5) by way of the administration unit (13) that is indwelled on the body surface of the patient (para. 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Nishimura such that it comprised performing a medical procedure on the patient; indwelling an administration unit on a body surface of the patient after the performing of the medical procedure on the patient; connecting the administration unit to a medicine supply source; and administering medicine by way of the administration unit that is indwelled on the body surface of the patient as taught by in order to sterilize the injection site prior to delivery (Caspers: para. 0043) and to administer medicament to the user (para. 0044).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Cabiri, in further view of Cabiri et al. (US Patent Publication No. 20190381239 A1), hereinafter Cabiri2.
Regarding claim 22, Nishimura in view of Cabiri discloses the method above.
Nishimura does not expressly disclose starting the administering of the medicine to the patent after a predetermined time has elapsed after finishing the medical procedure, the predetermined time being at least 0.5 hour.
Cabiri2 teaches starting an administering of a medicine to a patent after a predetermined time has elapsed, the predetermined time being at least 0.5 hour (Cabiri2: apparatus is programmed to wait a fixed time delay ranging between 20 minutes to an hour; para. 0146).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Nishimura such that it comprised starting the administering of the medicine to the patent after a predetermined time has elapsed after finishing the medical procedure, the predetermined time being at least 0.5 hour as taught by Cabiri2 in order to wait for a temperature sensitive component of the apparatus to reach a preferred working temperature (Cabiri2: para. 0146).
Allowable Subject Matter
Claim 17 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.
The following is a statement of reasons for the indication of allowable subject matter:
Nishimura in view of Cabiri discloses the device above, including a plate-shaped intermediate member (Cabiri: Fig. 4A, stiffener 216) positioned between a main body (infuser; para. 0109) and an attachment member (Fig. 4A, adhesive substrate 218), wherein the intermediate member (216) includes a base part (Fig. 4A, base of rib 328a and start location 234) overlapping the first section (Fig. 4A, defined by area of interface 430), the intermediate member (216) also including a first extending part (Fig. 4A, start location 234) and a second extending part (Fig. 4A, rib 328c) that both extend from the base part (base of 328c and 234) and are parallel to each other (Fig. 4A, location 234 and rib 328c are shown parallel to each other), the first extending part (234) and the second extending part (328a) overlapping the second section (Fig. 4A, defined by area where interface 430 is not present) further comprising a first adhesive part (Fig. 4A, underside surface of start location 234) adhered to the attachment member (218) and also adhered to the base part (base of 328a and 234) of the intermediate member (216) and to the first extending part (Fig. 4A, location 234 is attached to substrate 218), the first extending part (234) not stuck to the main body (infuser), a second adhesive part (Fig. 4A, extension 438) adhered to the main body (infuser) and also adhered to the base part (base of 328a and 234) and to the second extending part (Fig. 4A, extension 438 adheres rib 328c to infuser; para. 0109 and 0111).
Nishimura in view of Cabiri does not expressly disclose, and the second extending part is not stuck to the attachment member.
It would not have been obvious to one of ordinary skill in the art before the effective filing date to combine the inventions of Nishimura in view of Cabiri.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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