DETAILED ACTION
This action is in response to the Supplemental Response filed 6/23/2026. Currently, claims 21-35 and 41-45 are pending in the application. Claims 1-20 and 36-40 are cancelled by Applicant. New claims 41-45 are added by Applicant.
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 .
Election/Restrictions
Applicant’s election without traverse of Species I, claims 21-35 and 41-45 in the reply filed on 6/23/2026 is acknowledged.
Claim Objections
Claim 21 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the assembly” in line 3 of the claim should be amended to recite ---the anatomical closure assembly---. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a user” in line 4 of the claim should be amended to recite ---the user---. Appropriate correction is required.
Claims 21-23, 28, 32 and 41-44 are objected to because of the following informalities: the claims recite a “first patch,” which is a claim limitation lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the patch” in line 3 of the claim should be amended to recite ---the respective patch---. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the patch” in line 3 of the claim should be amended to recite ---the respective patch---. Appropriate correction is required.
Claim 42 is objected to because of the following informalities: in order to improve the clarity of the claim(s), all recitations of “the patch” (recited twice) should be amended to recite ---the respective patch---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 42 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 42 recites “at least one of the first patch or the second patch includes at least one perforation.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach a configuration in which only one of the patches (20) includes the recited perforation(s) (as permitted by the recitation of “at least one” in the claim). Rather, Applicant’s original disclosure teaches that “the flexible body 20 includes at least one perforation” (see [0073] of the publication of the present application) and teaches two such flexible bodies 20 in at least Figure 1. There is no teaching of only one body 20 including perforation(s).
Claim 43 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 43 recites “at least one of the first patch or the second patch defines an outer periphery including a pair of enlarged end portions separated by a narrow middle portion.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach a configuration in which only one of the patches (20) defines an outer periphery including a pair of enlarged end portions separated by a narrow middle portion (as permitted by the recitation of “at least one” in the claim). Rather, Applicant’s original disclosure teaches that “the flexible body 20 defines outer periphery including a pair of enlarged end portions 21 separated by a narrow middle portion 23” (see [0068] of the publication of the present application) and teaches two such flexible bodies 20 in at least Figure 1. There is no teaching of only one body 20 defining an outer periphery including a pair of enlarged end portions separated by a narrow middle portion.
Claim 44 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 44 recites “the at least one of the first patch or the second patch is elongate, having a length greater than a width, and is configured to extend generally along one of an upper lip or a lower lip of the user.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach a configuration in which only one of the patches (20) is elongate, having a length greater than a width, and is configured to extend generally along one of an upper lip or a lower lip of the user (as permitted by the recitation of “at least one” in the claim). Rather, Applicant’s original disclosure explicitly teaches that “each [or, both] of the tabs 300 may be elongate in configuration (e.g., having a length greater than a width) and configured to extend in a direction generally along one of the upper lip and the lower lip” (see [0104] of the publication of the present application). There is no teaching of only one body 20 being elongate, having a length greater than a width, and being configured to extend generally along one of an upper lip or a lower lip of the user.
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 26 and 27 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 26 recites “anatomical locations” line 2 of the claim. It is unclear if these recited “anatomical locations” include, or are distinct from, the “first anatomical location” and the “second anatomical location” previously recited in claim 21 (upon which claim 26 depends). Claim 27 depends on claim 26 and therefore, includes the same error.
Claim 41 is 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 41 recites the limitation "the complementary hook-and-loop material" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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) 21, 22, 24, 26, 27, 29, 32-35 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (US 4,883,072 A) in view of Noda et al. (US 2015/0051530 A1).
Regarding claim 21, Bessler teaches in Figures 1-3
a first patch (pad 10a) configured to be adhesively secured to a first skin region (skin of first cheek) of a user adjacent (as shown in Figure 1; column 3, lines 14-16 teaches “the pads 10a and 10b are constructed from sheet material with a layer of adhesive material 14a and 14b applied to the bottom of each”) a first anatomical location (first cheek, as shown in Figure 1);
a second patch (pad 10b) configured to be adhesively secured to a second skin region (skin of second cheek) of the user adjacent (as shown in Figure 1; column 3, lines 14-16 teaches “the pads 10a and 10b are constructed from sheet material with a layer of adhesive material 14a and 14b applied to the bottom of each”) a second anatomical location (second cheek, as shown in Figure 1); and
a band (band 13) configured to be extendable between (as shown in Figures 1-3; column 3, lines 7-9 teaches “a plurality of elongated bands 11, 12 and 13 are bonded or otherwise secured at their ends to the pads 10a and 10b by any suitable means”) the first patch (pad 10a) and the second patch (pad 10b), the band (band 13) having a first end region (as defined in the annotated copy of Figure 3 provided below) and a second end region (as defined in the annotated copy of Figure 3 provided below).
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Bessler teaches in column 3, lines 7-9 that the “plurality of elongated bands 11, 12 and 13 are bonded or otherwise secured at their ends to the pads 10a and 10b by any suitable means.”
Bessler does not explicitly teach wherein the first end region is configured to releasably engage the first patch by a first hook-and-loop interface and the second end region is configured to releasably engage the second patch by a second hook- and-loop interface, wherein the first and second hook-and-loop interfaces are arranged to provide shear resistance along a shear axis extending between the first anatomical location and the second anatomical location, such that engagement of the band to the first patch and the second patch maintains approximation of the first anatomical location and the second anatomical location under shear.
However, Noda et al. teaches in Figure 23 and [0073] an analogous device wherein the first end region (first arm 506, shown in Figure 23) is configured to releasably engage the first patch (first footing 508, shown in Figure 23) by a first hook-and-loop interface (shown in Figure 23; [0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”) and the second end region (second arm 506, shown in Figure 23) is configured to releasably engage the second patch (second footing 508, shown in Figure 23) by a second hook- and-loop interface (shown in Figure 23; [0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”), wherein the first and second hook-and-loop interfaces are arranged to provide (via hook and loop fasteners, as taught in [0073]) shear resistance along a shear axis extending between the first anatomical location (on which first footing 508 can be positioned) and the second anatomical location (on which second footing 508 can be positioned), such that engagement of the band (pad 500) to the first patch (first footing 508, shown in Figure 23) and the second patch (second footing 508, shown in Figure 23) maintains approximation of (via the “tensioned state” taught in [0073]) the first anatomical location (on which first footing 508 can be positioned) and the second anatomical location (on which second footing 508 can be positioned) under shear (as taught in [0073]).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the first and second end regions of Bessler such that the first end region is configured to releasably engage the first patch by a first hook-and-loop interface and the second end region is configured to releasably engage the second patch by a second hook- and-loop interface, wherein the first and second hook-and-loop interfaces are arranged to provide shear resistance along a shear axis extending between the first anatomical location and the second anatomical location, such that engagement of the band to the first patch and the second patch maintains approximation of the first anatomical location and the second anatomical location under shear as taught by Noda et al. because this element is known to be a suitable alternative for a similar adhesive engagement, as Noda et al. teaches in [0073].
Regarding claim 22, Bessler and Noda et al. teach the apparatus of claim 21. Bessler teaches that the first patch (pad 10a) and the second patch (pad 10b) each comprise a flexible substrate (column 3, lines 22-25 teaches “the two pads 10a and 10b may be cut from various sheet materials, and any material capable of supporting the bands will be suitable, for example rubber or cloth reinforced with fiber glass;” rubber and cloth are known flexible substrates; column 3, lines 25-27 teaches “In an actual reduction to practice of the invention, a plastic tape material was used;” plastic tape is a flexible material) and a medical-grade skin adhesive layer (adhesive material 14a and 14b; column 3, lines 14-16 teaches “the pads 10a and 10b are constructed from sheet material with a layer of adhesive material 14a and 14b applied to the bottom of each;” adhesive material 14a and 14b can be considered “medical grade” inasmuch as it is taught to be used for a medical/therapeutic purpose for application to the skin) configured to secure the patch (10a, 10b) to skin (as shown in Figure 1).
Regarding claim 24, Bessler and Noda et al. teach the apparatus of claim 21. Bessler and the originally relied upon embodiment of Noda et al. do not teach that the band includes an adjustable length feature to set a desired tension while maintaining shear resistance at the first and second hook-and-loop interfaces.
However, Noda et al. teaches in Figure 22, [0038], [0072] and [0074] an alternate embodiment wherein the band (strap system 400) includes (as shown in Figure 22) an adjustable length feature (plural strap assemblies 10) to set a desired tension while maintaining shear resistance at (as taught in [0038] and [0074]) the first and second hook-and-loop interfaces (anchors 406, 408; [0072] teaches “the bottom surfaces of the footings include hook (or loop) fasteners and engage complementarily-configured loops (or hooks) on the top surfaces of respective replaceable anchors 406, 408”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the band of Bessler as modified by the originally relied upon embodiment of Noda et al. to include an adjustable length feature to set a desired tension while maintaining shear resistance at the first and second hook-and-loop interfaces as taught by the alternate embodiment of Noda et al. because this element is known to enable the user “to re-adjust the tension of” the band as needed, as Noda et al. teaches in [0041].
Regarding claim 26, Bessler and Noda et al. teach the apparatus of claim 21. Bessler teaches in Figures 1-3 that the shear axis extends between anatomical locations positioned to maintain closure of a mouth of the user by resisting jaw-opening forces (the device taught in Figures 1-3 it capable of being positioned vertically such that the shear axis extends between anatomical locations positioned to maintain closure of a mouth of the user by resisting jaw-opening forces).
Regarding claim 27, Bessler and Noda et al. teach the apparatus of claims 21 and 26. Bessler teaches in Figure 1 that the first anatomical location (first cheek, as shown in Figure 1) is adjacent a first lip (the first cheek is positioned near a first lip; inasmuch as both anatomical structures are on a user’s face and therefore, can be considered near each other) or cheek region (the examiner interprets the first anatomical location as corresponding to a first cheek) and the second anatomical location (second cheek, as shown in Figure 1) is adjacent an opposing lip (the second cheek is positioned near an opposing lip; inasmuch as both anatomical structures are on a user’s face and therefore, can be considered near each other), cheek (the examiner interprets the first anatomical location as corresponding to a second cheek), or jaw region (the second cheek is positioned near the jaw region; inasmuch as both anatomical structures are on a user’s face and therefore, can be considered near each other).
Regarding claim 29, Bessler and Noda et al. teach the apparatus of claim 21. Bessler teaches in Figure 3 that the first (pad 10a) and second (pad 10b) patches and the band (band 13) are configured such that detachment of at least one of the first end region (as defined in the annotated copy of Figure 3 provided above) or the second end region (as defined in the annotated copy of Figure 3 provided above) is performed by peeling the respective end region (as defined in the annotated copy of Figure 3 provided above) away from the corresponding patch (pad 10a, 10b) along a predetermined peel direction that is generally perpendicular to a surface of the corresponding patch (pad 10a, 10b) (Figure 3 teaches the device being structured such that a user can detach the first or second end region from the corresponding pad 10a or 10b by applying a force (manually or using a tool) to peel the first or second end region thereaway in a direction that is generally perpendicular to a surface of the corresponding pad 10a or 10b).
Regarding claims 32, 34 and 35, Bessler teaches in Figures 1-3
securing a first patch (pad 10a) to a first skin region adjacent a first anatomical location by an adhesive on the first patch (the abstract teaches “first and second spaced pressure sensitive adhesive pads applied to the cheeks of a user at the corners of the user's mouth;” also shown in Figure 1; column 3, lines 39-41 teaches that the user “applies the pads 10a and 10b to the cheeks at the opposite corners of the lips”);
securing a second patch (pad 10b) to a second skin region adjacent a second anatomical location by an adhesive on the second patch (the abstract teaches “first and second spaced pressure sensitive adhesive pads applied to the cheeks of a user at the corners of the user's mouth;” also shown in Figure 1; column 3, lines 39-41 teaches that the user “applies the pads 10a and 10b to the cheeks at the opposite corners of the lips”);
positioning a band (band 13) to extend between (the abstract teaches “the ends of one or more bands being connected to the pads;” column 3, lines 7-9 teaches “a plurality of elongated bands 11, 12 and 13 are bonded or otherwise secured at their ends to the pads 10a and 10b by any suitable means”) the first patch (pad 10a) and the second patch (pad 10b), the band (band 13) having a first end region and a second end region (the abstract teaches “the ends of one or more bands”);
and wherein maintaining approximation includes resisting jaw-opening forces to maintain closure of a mouth of the user; and wherein maintaining approximation includes resisting jaw-opening forces to maintain closure of a mouth of the user ([0114] teaches “the user has to remove the strip if the user intends to open the mouth”).
Bessler does not teach engaging the first end region to the first patch by a first hook-and-loop interface and engaging the second end region to the second patch by a second hook-and-loop interface, wherein the first and second hook-and-loop interfaces are arranged to provide shear resistance along a shear axis extending between the first anatomical location and the second anatomical location, such that engagement of the band to the first patch and the second patch maintains approximation of the first anatomical location and the second anatomical location under shear, and wherein detachment is performed by peeling at least one of the first end region or the second end region away from the corresponding patch in a direction generally perpendicular to a surface of the corresponding patch.
However, Noda et al. teaches in Figure 23 and [0073] an analogous method that includes engaging ([0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”) the first end region (first arm 506, shown in Figure 23) to the first patch (first footing 508, shown in Figure 23) by a first hook-and-loop interface (shown in Figure 23; [0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”) and engaging ([0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”) the second end region (second arm 506, shown in Figure 23) to the second patch (second footing 508, shown in Figure 23) by a second hook-and-loop interface (shown in Figure 23; [0073] teaches “instead of adhesive on the arms 506, adhesive footings 508 may be provided and the arms adhered to the footings 508 with, e.g., hook and loop fasteners”), wherein the first and second hook-and-loop interfaces are arranged to provide (via hook and loop fasteners, as taught in [0073]) shear resistance along a shear axis extending between the first anatomical location (on which first footing 508 can be positioned) and the second anatomical location (on which second footing 508 can be positioned), such that engagement of the band (pad 500) to the first patch (first footing 508, shown in Figure 23) and the second patch (second footing 508, shown in Figure 23) maintains approximation of (via the “tensioned state” taught in [0073]) the first anatomical location (on which first footing 508 can be positioned) and the second anatomical location (on which second footing 508 can be positioned) under shear (as taught in [0073]), and wherein detachment is performed by peeling at least one of the first end region (first arm 506, shown in Figure 23) or the second end region (second arm 506, shown in Figure 23) away from the corresponding patch (first or second footing 508) in a direction generally perpendicular to (Figure 23 teaches the arms 506 being removed from the footings 508 in a position generally perpendicular thereto; this is an understood method of disengaging hook and loop engagement) a surface of the corresponding patch (first or second footing 508).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Bessler to include engaging the first end region to the first patch by a first hook-and-loop interface and engaging the second end region to the second patch by a second hook-and-loop interface, wherein the first and second hook-and-loop interfaces are arranged to provide shear resistance along a shear axis extending between the first anatomical location and the second anatomical location, such that engagement of the band to the first patch and the second patch maintains approximation of the first anatomical location and the second anatomical location under shear, and wherein detachment is performed by peeling at least one of the first end region or the second end region away from the corresponding patch in a direction generally perpendicular to a surface of the corresponding patch as taught by Noda et al. because this element is known to be a suitable alternative method for removable engagement, as Noda et al. teaches in [0073].
Regarding claim 33, Bessler and Noda et al. teach the method of claim 32. Bessler and the originally relied upon embodiment of Noda et al. do not teach the step of adjusting a length of the band prior to engaging the first and second hook-and-loop interfaces to set a desired closing force along the shear axis.
However, Noda et al. teaches in Figure 22 an alternate embodiment that includes the step of adjusting a length of the band (strap system 400) prior to engaging (inasmuch as a length of the strap system 400 is understood to be established during manufacture) the first and second hook-and-loop interfaces (anchors 406, 408; [0072] teaches “the bottom surfaces of the footings include hook (or loop) fasteners and engage complementarily-configured loops (or hooks) on the top surfaces of respective replaceable anchors 406, 408”) to set a desired closing force along the shear axis (that is established during manufacture; could be zero force).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the band of Bessler as modified by the originally relied upon embodiment of Noda et al. to include the step of adjusting a length of the band prior to engaging the first and second hook-and-loop interfaces to set a desired closing force along the shear axis as taught by the alternate embodiment of Noda et al. because this element is known to provide a mechanism that enables the user “to re-adjust the tension of” the band as needed during use thereof, as Noda et al. teaches in [0041].
Regarding claim 43, Bessler and Noda et al. teach the apparatus of claim 21. Bessler teaches in column 3, lines 27-28 that the first and second patches (pad 10a, pad 10b) can have “any shape.”
Bessler and Noda et al. do not teach that at least one of the first patch or the second patch defines an outer periphery including a pair of enlarged end portions separated by a narrow middle portion.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that at least one of the first patch or the second patch defines an outer periphery including a pair of enlarged end portions separated by a narrow middle portion, since it has been held hat a change in the shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F. 2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 23 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (US 4,883,072 A), in view of Noda et al. (US 2015/0051530 A1) and further in view of Eaves et al. (US 2019/0133582 A1).
Regarding claim 23, Bessler and Noda et al. teach the apparatus of claims 21 and 22. Bessler and Noda et al. do not teach that at least one of the first patch or the second patch further comprises ventilation features to reduce moisture accumulation beneath the patch.
However, Eaves et al. teaches in Figures 13A-13C and [0149] an analogous device wherein at least one of (both of) the first patch (first flange 1526, first inner adhesive layers 1538, first inner sheet 1536) or the second patch (second flange 1526, second inner adhesive layers 1538, second inner sheet 1536) further comprises (as shown in Figured 13A-13C; [0149] teaches “catch holes 1556 can extend through the foot plates or flanges 1526” and “lower holes 1527 in the inner adhesive layers 1538 and inner sheets 1536”) ventilation features (holes 1527, 1556) to reduce moisture accumulation beneath the patch ([0149] teaches “the holes 1527, 1556 (e.g., open widows) can provide pathways for ventilation/moisture transmission”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the at least one of the first patch or the second patch of Bessler as modified by Noda et al. to further comprise ventilation features to reduce moisture accumulation beneath the patch as taught by Eaves et al. because this element is known to “provide pathways for ventilation/moisture transmission,” as Eaves et al. teaches in [0149].
Regarding claim 42, Bessler and Noda et al. teach the apparatus of claims 21 and 22. Bessler and Noda et al. do not teach that at least one of the first patch or the second patch includes at least one perforation extending through the patch to ventilate skin beneath the patch.
However, Eaves et al. teaches in Figures 13A-13C and [0149] an analogous device wherein at least one of (both of) the first patch (first flange 1526, first inner adhesive layers 1538, first inner sheet 1536) or the second patch (second flange 1526, second inner adhesive layers 1538, second inner sheet 1536) includes (as shown in Figured 13A-13C; [0149] teaches “catch holes 1556 can extend through the foot plates or flanges 1526” and “lower holes 1527 in the inner adhesive layers 1538 and inner sheets 1536”) at least one perforation (holes 1527, 1556) extending through the patch (as shown in Figures 13A-13C) to ventilate skin beneath the patch ([0149] teaches “the holes 1527, 1556 (e.g., open widows) can provide pathways for ventilation/moisture transmission”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the at least one of the first patch or the second patch of Bessler as modified by Noda et al. to include at least one perforation extending through the patch to ventilate skin beneath the patch as taught by Eaves et al. because this element is known to “provide pathways for ventilation/moisture transmission,” as Eaves et al. teaches in [0149].
Claim(s) 25 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (US 4,883,072 A), in view of Noda et al. (US 2015/0051530 A1) and further in view of WARING (US 2021/0228403 A1).
Regarding claim 25, Bessler and Noda et al. teach the apparatus of claim 21. Bessler and Noda et al. do not teach that the band is contoured to conform to facial curvature while maintaining shear resistance at the first and second hook-and-loop interfaces.
However, WARING teaches in Figure 3 and [0112] an analogous device wherein the band (elastic non-adhesive strip of tape/bridging strip 301) is contoured to conform to facial curvature (as shown in Figure 3) while maintaining shear resistance at ([0112] teaches “one approximately three inch long by approximately one inch wide strip of tape (100, 301) is placed between the two strips over the lips, bridging the two and holding the lips shut through hook and loop attachments”) the first and second hook-and-loop interfaces (hook and loop attachments 300, 302).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the band of Bessler as modified by Noda et al. to be contoured to conform to facial curvature while maintaining shear resistance at the first and second hook-and-loop interfaces as taught by WARING because this element is known to enable the band to more comfortably and discretely accommodate the user’s facial anatomy while positioned thereon, as WARING teaches in [0112].
Regarding claim 41, Bessler and Noda et al. teach the apparatus of claim 21. Bessler and Noda et al. do not teach that the band comprises a strip of fabric having the complementary hook-and-loop material thereon, the band having limited elasticity to restrict opening of a mouth of the user when the band is attached to the first patch and the second patch.
However, WARING teaches in Figure 1, [0056] and [0112] an analogous device wherein the band (bridging piece of tape 100) comprises a strip of fabric (shown in Figure 1 to be structured as a strip of material; [0056] teaches “three strips of medical-grade hypoallergenic adhesive tape that makes up the device”) having the complementary hook-and-loop material thereon ([0056] teaches “the three-inch by one-inch bridging piece of tape (100) is placed between the two strips mentioned previously (101, 102) and over the lips, holding the lips shut through hook and loop attachments”), the band (bridging piece of tape 100) having limited elasticity ([0112] teaches “the non-adhesive strip of tape (100, 301) can be optionally made of elastic materials”) to restrict opening of a mouth of the user when the band (bridging piece of tape 100) is attached to (as taught in [0112]) the first patch and the second patch (101, 102).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the band of Bessler as modified by Noda et al. to comprise a strip of fabric having the complementary hook-and-loop material thereon, the band having limited elasticity to restrict opening of a mouth of the user when the band is attached to the first patch and the second patch as taught by WARING because this element is known to provide that “when the user relaxes (without exerting force on muscles), the elastic non-adhesive band will return to its original height and keep the mouth in closed condition again,” as WARING teaches in [0112].
Claim(s) 28 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (US 4,883,072 A), in view of Noda et al. (US 2015/0051530 A1) and further in view of Christiansen et al. (US 2020/0205833 A1).
Regarding claim 28, Bessler and Noda et al. teach the apparatus of claim 21. Bessler and Noda et al. do not teach that at least one of the first patch or the second patch includes a substrate configured to enhance adhesion for users with facial hair.
However, Christiansen et al. teaches in Figure 23 and [0110-0112] an analogous device wherein at least one of the first patch (receiving base 204, first hair coupler 232) or the second patch (second hair coupler 234, anchor base 202) includes (both are taught to include; [0111] teaches “first hair coupler 232 which comprises a first adhesive 236” and “the second hair coupler 234 comprises a second adhesive 242”) a substrate (first adhesive 236 and second adhesive 242; see also the “strong adhesive” taught in [0110]) configured to enhance adhesion for users with facial hair ([0110] teaches “when using the tissue closing device 200 with hair securement mechanisms, a strong adhesive may be used to connect the tissue closing device 200 to a patient's hair”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify at least one of the first patch or the second patch of Bessler as modified by Noda et al. to include a substrate configured to enhance adhesion for users with facial hair as taught by Christiansen et al. because this element is known to provide a strong adhesive to connect the device to the user’s hair such that the sections of patient’s hair can be pulled together in use of the device, as Christiansen et al. teaches in [0010].
Regarding claim 44, Bessler, Noda et al. and Christiansen et al. teach the apparatus of claims 21 and 28. Bessler teaches in Figures 1 and 2 that the at least one of (both of) the first patch (pad 10a) or the second patch (pad 10b) is elongate (Figures 1 and 1 teach the pads 10a, 10b being ovular such that they have an elongate length), having a length greater than a width (as shown in Figures 1 and 2), and is configured to extend generally along one of an upper lip or a lower lip of the user (the device taught in Figures 1 and 2 can be positioned vertically such that the pads 10a, 10b extend generally horizontally along the user’s respective upper and lower lip).
Claim(s) 30, 31 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (US 4,883,072 A), in view of Noda et al. (US 2015/0051530 A1) and further in view of Walton (US 2016/0338870 A1).
Regarding claims 30, 31 and 45, Bessler and Noda et al. teach the apparatus of claim 21. Bessler and Noda et al. do not teach that the first and second patches are integrated into a single, integrated adhesive body; and wherein the single, integrated adhesive body includes a slit extending between the first and second patches; and the slit is configured to extend generally along an intersection between an upper lip and a lower lip of the user and to allow flexing of the single, integrated adhesive body while the single, integrated adhesive body remains adhered to the user.
However, Walton teaches in Figure 14, [0059-0060] and [0066] an analogous device wherein the first and second patches (bottom arcuate side 82 and top arcuate side 81) are integrated into a single, integrated (as shown in Figure 14, bottom arcuate side 82 and top arcuate side 81 are joined together to form a single unit) adhesive ([0060] teaches “the device 80 has a front surface 84 and a rear surface 84 to which the adhesive is placed on”) body (device 80); and wherein the single, integrated adhesive body (device 80) includes ([0059] teaches “device 80 has an aperture 88”) a slit (aperture 88) extending between (as shown in Figure 14) the first and second patches (bottom arcuate side 82 and top arcuate side 81); and the slit (aperture 88) is configured to extend generally along an intersection between an upper lip and a lower lip of the user (Figure 14 teaches the aperture extending horizontally through the middle of device 80 such that the aperture 88 can be positioned generally along an intersection between an upper lip and a lower lip of the user in use) and to allow flexing of the single, integrated adhesive body (device 80) while the single, integrated adhesive body (device 80) remains adhered to the user (Figure 14 teaches the aperture 88 providing a space between the bottom arcuate side 82 and top arcuate side 81 such that the bottom arcuate side 82 and top arcuate side 81 can move toward or away from each other in use; [0060] teaches that “the membrane or sheet is thin and flexible”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the first and second patches of Bessler as modified by Noda et al. to be integrated into a single, integrated adhesive body; and wherein the single, integrated adhesive body includes a slit extending between the first and second patches; and the slit is configured to extend generally along an intersection between an upper lip and a lower lip of the user and to allow flexing of the single, integrated adhesive body while the single, integrated adhesive body remains adhered to the user as taught by Walton because this element is known to maintain approximation of the user’s first and second anatomical locations while providing “an air vent which allows the user who may need to cough, sneeze or take that extra breath through the mouth if needed,” as Walton teaches in [0059].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pavletic (US 5,234,462 A)
Pierce (US 4,825,866 A)
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 7/22/2026
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