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 .
Claims 1-6 are the currently pending claims hereby under examination.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) based on Japanese Application No. 2024-037121, filed March 11, 2024. The conditions for receiving the benefit of that filing date have not been met because a certified copy of the foreign application has neither been filed by Applicant nor received by the Office, as required by 35 U.S.C. 119(b) and 37 CFR 1.55.
The application file contains a Priority Document Exchange Failure Status Report indicating that the Office’s attempt to electronically retrieve Japanese Application No. 2024-037121 under the priority document exchange program was unsuccessful on August 11, 2025.
Under 37 CFR 1.55(i), the requirement of 37 CFR 1.55(f) for a timely filed certified copy is considered satisfied where the foreign application was filed in a participating foreign intellectual property office, the priority claim is presented in an application data sheet identifying the foreign application by application number, country, and filing date, and a copy of the foreign application is received by the Office from the participating office, or a certified copy is filed by Applicant, within the period set forth in 37 CFR 1.55(g)(1). Applicant may therefore satisfy the requirement by filing a certified copy of Japanese Application No. 2024-037121 during the pendency of this application and before the patent is granted.
Applicant is reminded that Applicant bears the ultimate responsibility for ensuring that the priority document is filed during the pendency of the application and before the patent is issued. See 37 CFR 1.55 and MPEP § 215.02(a).
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
In claim 1, line 8: “wherein the supporting member including:” is grammatically incorrect and should be revised to “wherein the supporting member includes:”; and
in claim 2, line 2: “wherein the foldable portion includes a groove at which thickness of the sheet is reduced” is grammatically incorrect and should be revised to “wherein the foldable portion includes a groove at which the thickness of the sheet is reduced”.
Appropriate correction is required.
Claim Interpretations
Claims 1 and 6 recite “a first supporting portion supporting and covering the light emitter” and “a second supporting portion supporting and covering the light detector” in lines 9-10 of claim 1 and lines 5-6 of claim 6. Under the broadest reasonable interpretation consistent with the specification, “supporting and covering” does not require the supporting portion to completely enclose the light emitter or light detector or to block the optical path between the respective component and the body of the subject. The Instant Application at ¶[0030] describes the first supporting portion 141 as supporting and covering light emitter 11 and the second supporting portion 142 as supporting and covering light detector 12. The Instant Application at ¶¶[0033]-[0034] further describes first and second translucent portions 144a and 144b facing the light emitter and light detector, respectively, and ¶[0043] explains that light passes through those portions between the optical components and the finger. Accordingly, a supporting portion may support and cover the respective optical component while providing an opening, window, translucent portion, or other optical access path that permits light to pass between the component and the body of the subject.
Claims 1 and 6 further require a foldable portion including a portion whose cross-sectional shape is changed so as to increase foldability of the sheet. Under the broadest reasonable interpretation, the changed cross-sectional shape is changed relative to adjacent portions of the sheet and need not have one particular configuration. This interpretation is consistent with the Instant Application, which discloses a reduced-thickness groove, through-holes, and scored grooves that do not substantially change sheet thickness as alternative cross-sectional configurations for increasing foldability (IA, ¶¶[0044]-[0050]). The requirement that the foldable portion extend across a portion facing the third supporting portion requires the foldable portion to traverse at least a sheet region corresponding to the third supporting portion, but does not require the boundaries of the foldable portion and third supporting portion to be exactly coextensive.
Regarding claim 3, the recited through-hole is understood in its ordinary sense as an opening extending through the sheet.
Regarding claim 4, the limitation that the foldable portion faces the attachment-assisting information with the adhesive face in between describes the opposed or corresponding layer relationship in the flat, pre-use configuration. It does not require physical contact, exact coextensiveness, or point-for-point registration between the foldable portion and the information. The Instant Application places the information on the front face side of supporting member 14, identifies adhesive face 144 as being on the back face side, and states that foldable portion 151 of sheet 15 faces the information with that adhesive face in between (IA, ¶¶[0036], [0051]). Accordingly, the adhesive face must lie between the information and the sheet, but the claim does not require the adhesive face to be the only intervening material and does not exclude supporting material from also lying along that facing relationship.
Regarding claim 5, the axisymmetric shape is interpreted as the external shape of the supporting member relative to the straight line connecting the emitter and detector. This interpretation is consistent with the Instant Application at ¶[0054] and Fig. 1, which apply the stated symmetry to supporting member 14 as a whole.
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (US 2016/0066824 A1), hereinafter Al-Ali, in view of Buus (US 2011/0245789 A1), hereinafter Buus.
Regarding claim 1, Al-Ali teaches a medical sensor (Al-Ali, ¶[0024]: a disposable optical sensor 800 attaches to a fingertip 1 to optically analyze blood constituents, wherein sensor 800 is a medical optical sensor configured for attachment to the body).
Al-Ali further teaches at least one light emitter configured to emit light (Al-Ali, ¶[0043]: emitter 1100 sequentially illuminates a tissue site, such as a fingertip, with four discrete wavelengths of optical radiation, wherein emitter 1100 emits light into the fingertip).
Al-Ali further teaches at least one light detector configured to output a signal corresponding to an amount of incident light (Al-Ali, ¶¶[0043]-[0044]: detector 1200 is “responsive to the optical radiation after absorption by pulsatile blood flow within the tissue site,” and emitter 1100 and detector 1200 are mounted to flex circuit assembly 1050 so as to transmit detector signals to a monitor via connector 935, wherein detector 1200 outputs a signal responsive to incident light after attenuation through the tissue).
Al-Ali further teaches a supporting member having an adhesive face adapted to be attached to a body of a subject (Al-Ali, ¶¶[0039]-[0042]; Figs. 8A-B, 10; claim 13: the tape-based supporting assembly comprising adhesive butterfly wrap 810 and head tape assembly 900, including top head tape 1070 and bottom head tape 1080, carries emitter 1100, detector 1200, and the internal foam and flex-circuit components and removably attaches the sensor to the fingertip).
Al-Ali further teaches a sheet peelably attached to the adhesive face (Al-Ali, ¶¶[0039], [0042]; Figs. 8A-B, 10: sensor 800 has adhesive butterfly wrap 810, head assembly 900, and release liner 840, and “[t]he release liner 840 is removed from the adhesive butterfly wrap 810 so as to attach the sensor head 910 to a fingertip,” wherein release liner 840 peelably covers the adhesive face before attachment).
Al-Ali further teaches a first supporting portion supporting and covering the light emitter (Al-Ali, ¶¶[0040], [0042]-[0044]; Figs. 9B, 9D, 10; claims 13 and 15: emitter 1100 is mounted within the tape assembly in bottom-half region 905, emitter window 914 provides optical access toward the fingertip, and the emitted wavelengths enter a fingernail portion of the tissue site, wherein bottom-half region 905 supports and covers emitter 1100 while permitting emitted light to reach the tissue).
Al-Ali further teaches a second supporting portion supporting and covering the light detector (Al-Ali, ¶¶[0040], [0042]-[0044]; Figs. 9B-C, 10; claims 13 and 16: detector 1200 is mounted within the tape assembly in top-half region 908, detector window 912 provides optical access from the fingertip, and the transmitted wavelengths are detected at a fingertip portion of the tissue site, wherein top-half region 908 supports and covers detector 1200 while permitting detector 1200 to receive light).
Al-Ali further teaches a third supporting portion located between the first supporting portion and the second supporting portion (Al-Ali, ¶[0040]; Figs. 9A-B: head tape assembly 900 includes “a printed fold line 907 separating the top half 908 and bottom half 905,” and sensor head 910 is attached by “folding the sensor head at the fold line 907 and over the fingertip,” wherein the central neck portion of the tape-based supporting assembly at fold line 907 lies between emitter-supporting bottom-half region 905 and detector-supporting top-half region 908).
Also, regarding claim 1, Al-Ali does not fully teach wherein the sheet is formed with a foldable portion extending across a portion facing the third supporting portion and including a portion whose cross-sectional shape is changed so as to increase foldability of the sheet. Rather, Al-Ali teaches a release liner in a facing relationship with the central region but not a fold-enhancing change in the liner's cross section. Figure 8B depicts release liner 840 as a continuous outermost sheet extending beneath adhesive butterfly wrap 810 and sensor head 910 in the assembled flat configuration, without depicting an opening at the central neck. Figure 10 likewise places release liner 840 at the base of the exploded stack beneath bottom head tape 1080 and the head assembly. Al-Ali identifies printed fold line 907 as the central location at which the head assembly folds between bottom half 905 and top half 908, but does not teach forming release liner 840 itself with a changed-cross-section foldable portion extending across the liner region corresponding to that third supporting portion (Al-Ali, ¶¶[0039]-[0042]; Figs. 8A-B, 9A-B, 10).
Buus teaches a release liner having a predefined folding line at which the liner “will bend sharply when it is folded.” A first liner portion is detached from the adhesive and folded over a second liner portion while the remaining adhesive stays covered, so the article is “applied stepwise, using only one release liner.” After the exposed adhesive is applied, the remaining liner is removed by displacement transverse to the folding line and the remaining adhesive is attached (Buus, ¶¶[0028]-[0036]).
Buus further teaches forming the folding line as “a weakened line where the material is thinner and/or softer than the rest of the release liner.” The folding line may be “a line with reduced thickness” formed by partially cutting the liner or applying heat or pressure to “produce a depression in the liner,” thereby providing a changed cross section at which the liner naturally bends (Buus, ¶¶[0041]-[0042]).
Buus expressly recites a folding line that “extends through a central portion of the release liner,” and depicts that central folding line in the liner (Buus, claim 9; ¶¶[0050]-[0053], [0117]-[0119]; Figs. 1-3).
Al-Ali and Buus are in the same field of endeavor because both concern flexible, skin-adhered medical adhesive articles having a release liner over a skin-facing adhesive. The Instant Application describes an attachment operation in which a first region of the sheet is peeled to expose adhesive at the first supporting portion, the exposed adhesive is applied to the nail side of the finger, the supporting member is then bent with the third supporting portion facing the tip of the finger so that the second supporting portion is placed against the ball of the finger, and retaining portions are wrapped around the finger (IA, ¶¶[0036]-[0042]). Al-Ali’s optical fingertip sensor is attached by a corresponding operation (Al-Ali, ¶[0040]), confirming that the claimed invention and Al-Ali concern the same field and the same manner of attachment to a fingertip.
Buus is also reasonably pertinent to the particular problem with which the inventor was concerned. The Instant Application states that the foldable portion makes it possible “to suppress occurrence of a situation that the adhesive face 144 that is excessively exposed obstructs an initial stage of the attachment operation” (IA, ¶[0046]). Buus states that its folding line “serves as a natural stop for detachment of the release liner thus avoiding that a too large part of the adhesive surface may be exposed, thereby rendering the handling of the wafer difficult” (Buus, ¶[0119]). Buus thus addresses the same problem of controlled partial exposure of the adhesive during application that the Instant Application identifies as the purpose of its foldable liner configuration (IA, ¶¶[0046]-[0048]), and further addresses avoiding premature adhesive contact and improving positioning during application (Buus, ¶¶[0012], [0032]-[0036]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified release liner 840 of Al-Ali in view of Buus by forming Buus's reduced-thickness predefined folding line through the continuous central region of release liner 840, as depicted in Fig. 8B and in accordance with Buus claim 9, at the portion facing the third supporting portion, that is, the central neck region of sensor head 910 at fold line 907. Al-Ali already instructs attachment by “placing the fingernail target 906 over a fingernail, folding the sensor head at the fold line 907 and over the fingertip so as to place the finger pad target on a finger pad” (Al-Ali, ¶[0040]). A person of ordinary skill would have been motivated to use Buus's liner folding line at the corresponding central region so that a first portion of liner 840 could be peeled and folded for controlled placement while adhesive associated with the portion not yet positioned remained covered. Buus explains that the folded liner can be “brought close and more parallel to the skin” and “serves as a natural stop” that limits unintended adhesive exposure (Buus, ¶[0119]). Buus also teaches removing the remaining liner transverse to the folding line after positioning the first exposed adhesive region, so the liner would be removed before or as Al-Ali's head assembly is folded over the fingertip and would not obstruct the optical windows or butterfly wrap (Buus, ¶¶[0032]-[0036]). A skilled artisan would have reasonably expected success because the modification affects only removable liner 840 and uses Buus's partial-cutting, heat, or pressure techniques while leaving Al-Ali's optical components and tape-based supporting assembly unchanged (Buus, ¶¶[0042], [0047]). The modification would result in release liner 840 having a changed-cross-section foldable portion extending across the central liner region facing the third supporting portion.
Regarding claim 2, the modified Al-Ali does not fully teach wherein the foldable portion includes a groove at which thickness of the sheet is reduced. Rather, the modified Al-Ali includes the reduced-thickness folding line of Buus as established regarding claim 1 (Buus, ¶¶[0041]-[0042]), but that modification does not require the reduced-thickness folding line to be formed as a groove.
Buus further teaches that the folding line may be “a line with reduced thickness” produced by applying heat or pressure to “produce a depression in the liner,” and the thickness along the line may be smaller than the overall liner thickness. Figure 2 depicts folding line 5 as such a depression, wherein the elongated depression forms a groove having reduced sheet thickness (Buus, ¶¶[0042], [0118]; Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Al-Ali in view of Buus to form the previously incorporated reduced-thickness folding line as the depression taught by Buus. Buus expressly teaches forming such a depression by heat or pressure as a means of producing the reduced-thickness weakened line. A person of ordinary skill would have been motivated to use Buus's depressed configuration because the reduced-thickness weakened line causes the release liner to bend naturally at the predetermined folding location (Buus, ¶¶[0041]-[0042]). The modification would have constituted the selection and use of a known implementation from the alternatives taught by Buus for forming the folding line, and would have resulted in an elongated depression, that is, a groove, at which the thickness of release liner 840 is reduced.
Regarding claim 3, the modified Al-Ali does not fully teach wherein the foldable portion includes at least one through-hole. Rather, the modified Al-Ali includes the reduced-thickness predefined folding line established regarding claim 1, but that modification does not itself require a through-hole in the foldable portion.
Buus further teaches that the predefined folding line may be “a number of spaced smaller lines or points, forming a perforated line” (Buus, ¶[0045]; claim 6). Buus is read for what its disclosure would reasonably convey to a person of ordinary skill in the art, and its use of “perforated line” conveys a line pierced by spaced openings. Applicant's own usage corroborates that understanding: the Instant Application at ¶[0049] describes a foldable portion having multiple through-holes as exhibiting a perforated appearance. Accordingly, a person of ordinary skill would understand Buus's perforated line to include at least one opening through the release liner. Buus also teaches maintaining enough liner material between the first and second parts to provide sufficient cohesion and prevent the parts from being ripped apart during handling and removal (Buus, ¶[0043]). Buus's percentage ranges for reduced thickness and its methods of using an impression roll or cutting into the liner concern other disclosed embodiments or manufacturing techniques and do not redefine or limit the separately recited perforated-line alternative (Buus, ¶¶[0044]-[0046]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Al-Ali in view of Buus to provide the previously incorporated reduced-thickness folding line with Buus's perforated-line configuration by forming at least one spaced through-opening along the folding line. Buus identifies reduced thickness and perforation as known constructions for localizing bending at a predefined folding line, and dependent claims 6 and 7 are coordinate alternatives from claim 1 that do not state the constructions are mutually exclusive (Buus, ¶¶[0041]-[0045]; claims 1, 6-7). A person of ordinary skill would have been motivated to combine the known weakening features by known methods because each performs the same function of localizing a fold, the intervening liner material retains the cohesion required by Buus, and the combination would predictably provide a sharply defined bend while resulting in the foldable portion of release liner 840 including at least one through-hole. See MPEP § 2143(I)(A).
Regarding claim 4, the modified Al-Ali teaches wherein a surface of the supporting member is provided with information for assisting attachment to the body of the subject; and wherein the foldable portion is arranged so as to face the information with the adhesive face in between (Al-Ali, ¶¶[0039]-[0042]; Figs. 8A-B, 9A-B, 10; claims 13 and 15-16).
Al-Ali states that the “first head tape side has an imprinted fingernail target 906 on a bottom half 905” and that the “second head tape side has an imprinted finger pad target 909 on a top half 908 and a printed fold line 907 separating the top half 908 and bottom half 905.” Al-Ali instructs attachment by “placing the fingernail target 906 over a fingernail, folding the sensor head at the fold line 907 and over the fingertip so as to place the finger pad target on a finger pad” (Al-Ali, ¶[0040]; Figs. 9A-B). The two targets and printed line are therefore information for assisting attachment.
First, fingernail target 906 is imprinted on the first head-tape side. Figure 9A specifically depicts the distal end of target 906 at the fingertip transition adjoining the central neck where Al-Ali instructs the head assembly to fold at line 907. In the modified Al-Ali, the foldable portion extending across the corresponding central region of liner 840 therefore faces the distal portion of fingernail target 906 through the tape-based supporting assembly, with the skin-facing adhesive face also lying between the information and the sheet. Claims 15 and 16 confirm the nail-to-fingertip orientation by reciting that emitted wavelengths enter a fingernail portion and are detected at a fingertip portion. Under the interpretation above, claim 4 does not require the foldable portion to contact, exactly coextend with, or be registered point-for-point with the information (Al-Ali, ¶[0040]; Fig. 9A; claims 15-16).
Second, and alternatively, Figs. 9B and 10 place finger-pad target 909 and printed fold line 907 on the second side of head tape assembly 900 carried by bottom head tape 1080, with release liner 840 below that tape-based assembly in the exploded stack. Because Al-Ali describes target 909 and line 907 as imprinted or printed features of a head-tape side, a person of ordinary skill would understand the information to be carried by the tape support rather than printed on removable release liner 840 or on the adhesive itself. Al-Ali further teaches that liner 840 is removed from adhesive butterfly wrap 810 to expose the skin-facing adhesive for attachment. Read together, the text and figures support the alternative finding that the central foldable portion of liner 840 faces the information-bearing second head-tape side across the intervening skin-facing adhesive interface. This alternative does not require a finding that Al-Ali expressly identifies the sequence in which the tape was printed and adhesive was coated (Al-Ali, ¶¶[0039]-[0042]; Figs. 8B, 9B, 10). Printed fold line 907, which indicates where the head assembly is to be folded, further corresponds to the guide information described in the Instant Application as “information 147 providing a guide indicating the position at which the supporting member 14 is to be bent when the attachment to the finger 20 is performed” (IA, ¶[0051]).
Regarding claim 5, the modified Al-Ali further teaches wherein the supporting member exhibits an axisymmetric shape relative to a straight line connecting the light emitter and the light detector (Al-Ali, ¶¶[0039]-[0042]; Figs. 8B, 9A-D, 10: emitter window 914 and detector window 912 are positioned along the longitudinal centerline of the tape-based supporting assembly, and the external perimeter of adhesive butterfly wrap 810 and head tape assembly 900 is bilaterally symmetric about that same centerline, wherein the straight line connecting emitter 1100 and detector 1200 coincides with the symmetry axis of the supporting member). This mapping concerns the external shape of the tape-based supporting assembly rather than the internal arrangement of flex circuit assembly 1050 or foam tape insulators 1040 and 1060 (Al-Ali, ¶[0042]; Fig. 10).
Regarding claim 6, Al-Ali teaches a sensor supporting member adapted to attach, to a body of a subject, a medical sensor provided with at least one light emitter configured to emit light and at least one light detector configured to output a signal corresponding to an amount of incident light (Al-Ali, ¶¶[0024], [0039]-[0044]; Figs. 8A-B, 10; claim 13: the tape-based supporting assembly comprising adhesive butterfly wrap 810 and head tape assembly 900, including top head tape 1070 and bottom head tape 1080, carries emitter 1100, detector 1200, and the internal foam and flex-circuit components and removably attaches them to a fingertip; emitter 1100 emits optical radiation into the tissue, and detector 1200 outputs detector signals responsive to received radiation through flex circuit assembly 1050 and connector 935).
Al-Ali further teaches a first supporting portion supporting and covering the light emitter (Al-Ali, ¶¶[0040], [0042]-[0044]; Figs. 9B, 9D, 10; claims 13 and 15: emitter 1100 is mounted within the tape assembly in bottom-half region 905, emitter window 914 provides optical access toward the fingertip, and the emitted wavelengths enter a fingernail portion of the tissue site, wherein bottom-half region 905 supports and covers emitter 1100 while permitting emitted light to reach the tissue).
Al-Ali further teaches a second supporting portion supporting and covering the light detector (Al-Ali, ¶¶[0040], [0042]-[0044]; Figs. 9B-C, 10; claims 13 and 16: detector 1200 is mounted within the tape assembly in top-half region 908, detector window 912 provides optical access from the fingertip, and the transmitted wavelengths are detected at a fingertip portion of the tissue site, wherein top-half region 908 supports and covers detector 1200 while permitting detector 1200 to receive light).
Al-Ali further teaches a third supporting portion located between the first supporting portion and the second supporting portion (Al-Ali, ¶[0040]; Figs. 9A-B: head tape assembly 900 includes “a printed fold line 907 separating the top half 908 and bottom half 905,” and sensor head 910 is attached by “folding the sensor head at the fold line 907 and over the fingertip,” wherein the central neck portion of the tape-based supporting assembly at fold line 907 lies between emitter-supporting bottom-half region 905 and detector-supporting top-half region 908).
Al-Ali further teaches an adhesive face adapted to be attached to the body (Al-Ali, ¶[0039]; Figs. 8A-B, 10: sensor 800 includes adhesive butterfly wrap 810, and release liner 840 is removed from adhesive butterfly wrap 810 to attach sensor head 910 to a fingertip, wherein the skin-facing adhesive surface provides the adhesive face for attachment).
Al-Ali further teaches a sheet peelably attached to the adhesive face (Al-Ali, ¶¶[0039], [0042]; Figs. 8A-B, 10: sensor 800 includes adhesive butterfly wrap 810 and release liner 840, and “[t]he release liner 840 is removed from the adhesive butterfly wrap 810 so as to attach the sensor head 910 to a fingertip,” wherein release liner 840 peelably covers the adhesive face).
Also, regarding claim 6, Al-Ali does not fully teach the sheet being formed with a foldable portion extending across a portion facing the third supporting portion and including a portion whose cross-sectional shape is changed so as to increase foldability of the sheet. Rather, Al-Ali teaches a release liner in a facing relationship with the central region but not a fold-enhancing change in the liner's cross section. Figure 8B depicts release liner 840 as a continuous outermost sheet extending beneath adhesive butterfly wrap 810 and sensor head 910 in the assembled flat configuration, without depicting an opening at the central neck. Figure 10 likewise places release liner 840 at the base of the exploded stack beneath bottom head tape 1080 and the head assembly. Al-Ali identifies printed fold line 907 as the central location at which the head assembly folds between bottom half 905 and top half 908, but does not teach forming release liner 840 itself with a changed-cross-section foldable portion extending across the liner region corresponding to that third supporting portion (Al-Ali, ¶¶[0039]-[0042]; Figs. 8A-B, 9A-B, 10).
Buus teaches a release liner having a predefined folding line at which the liner “will bend sharply when it is folded.” A first liner portion is detached from the adhesive and folded over a second liner portion while the remaining adhesive stays covered, so the article is “applied stepwise, using only one release liner.” After the exposed adhesive is applied, the remaining liner is removed by displacement transverse to the folding line and the remaining adhesive is attached (Buus, ¶¶[0028]-[0036]).
Buus further teaches forming the folding line as “a weakened line where the material is thinner and/or softer than the rest of the release liner.” The folding line may be “a line with reduced thickness” formed by partially cutting the liner or applying heat or pressure to “produce a depression in the liner,” thereby providing a changed cross section at which the liner naturally bends (Buus, ¶¶[0041]-[0042]).
Buus expressly recites a folding line that “extends through a central portion of the release liner,” and depicts that central folding line in the liner (Buus, claim 9; ¶¶[0050]-[0053], [0117]-[0119]; Figs. 1-3).
Al-Ali and Buus are in the same field of endeavor because both concern flexible, skin-adhered medical adhesive articles having a release liner over a skin-facing adhesive. The Instant Application describes an attachment operation in which a first region of the sheet is peeled to expose adhesive at the first supporting portion, the exposed adhesive is applied to the nail side of the finger, the supporting member is then bent with the third supporting portion facing the tip of the finger so that the second supporting portion is placed against the ball of the finger, and retaining portions are wrapped around the finger (IA, ¶¶[0036]-[0042]). Al-Ali’s optical fingertip sensor is attached by a corresponding operation (Al-Ali, ¶[0040]), confirming that the claimed invention and Al-Ali concern the same field and the same manner of attachment to a fingertip.
Buus is also reasonably pertinent to the particular problem with which the inventor was concerned. The Instant Application states that the foldable portion makes it possible “to suppress occurrence of a situation that the adhesive face 144 that is excessively exposed obstructs an initial stage of the attachment operation” (IA, ¶[0046]). Buus states that its folding line “serves as a natural stop for detachment of the release liner thus avoiding that a too large part of the adhesive surface may be exposed, thereby rendering the handling of the wafer difficult” (Buus, ¶[0119]). Buus thus addresses the same problem of controlled partial exposure of the adhesive during application that the Instant Application identifies as the purpose of its foldable liner configuration (IA, ¶¶[0046]-[0048]), and further addresses avoiding premature adhesive contact and improving positioning during application (Buus, ¶¶[0012], [0032]-[0036]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified release liner 840 of Al-Ali in view of Buus by forming Buus's reduced-thickness predefined folding line through the continuous central region of release liner 840, as depicted in Fig. 8B and in accordance with Buus claim 9, at the portion facing the third supporting portion, that is, the central neck region of sensor head 910 at fold line 907. Al-Ali already instructs attachment by “placing the fingernail target 906 over a fingernail, folding the sensor head at the fold line 907 and over the fingertip so as to place the finger pad target on a finger pad” (Al-Ali, ¶[0040]). A person of ordinary skill would have been motivated to use Buus's liner folding line at the corresponding central region so that a first portion of liner 840 could be peeled and folded for controlled placement while adhesive associated with the portion not yet positioned remained covered. Buus explains that the folded liner can be “brought close and more parallel to the skin” and “serves as a natural stop” that limits unintended adhesive exposure (Buus, ¶[0119]). Buus also teaches removing the remaining liner transverse to the folding line after positioning the first exposed adhesive region, so the liner would be removed before or as Al-Ali's head assembly is folded over the fingertip and would not obstruct the optical windows or butterfly wrap (Buus, ¶¶[0032]-[0036]). A skilled artisan would have reasonably expected success because the modification affects only removable liner 840 and uses Buus's partial-cutting, heat, or pressure techniques while leaving Al-Ali's optical components and tape-based supporting assembly unchanged (Buus, ¶¶[0042], [0047]). The modification would result in release liner 840 having a changed-cross-section foldable portion extending across the central liner region facing the third supporting portion.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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