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 .
Response to Amendment
The examiner acknowledges that claims 1, 3-11, 13-20 are now pending in the application with no new amendments being made and the new claim 20 added within the claim set.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-5, 7-8, 11, 13-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franks-Wilson (US Patent No 20210007886 A1) in view of Shudo (US Patent No 20120076850) further in view of Hidaka et al. (US Patent No 20100241199 A1) further in view of Davis (US Patent No 6123717).
Regarding claim 1, Franks-Wilson teaches an adhesive sheet configured to be adhered to a movable part of a human (wearable on user’s face, para [0007]), the adhesive sheet (adhesive layer bonded to strip, para [0007]) comprising: a sheet body having a first region (first side 42, para [0019]), the first region having a surface;
Franks-Wilson does not teach a gel applied directly on the surface of the sheet body.
However, the analogous topical cooling patch of Shudo does teach a gel applied directly on the surface of the sheet body (see fig 1 for the gel adhesive base 12 present on the support layer 14 of the patch, see also para [0018]).
Therefore, it would have been obvious for one skilled in the art to combine the adhesive sheet disclosed by Franks-Wilson with the teachings of Shudo in order to allow for the adhesive sheet to have a gel applied directly to the surface of the sheet body so that full and effective cooling can occur over all of the contact points of the patch to the skin surface as disclosed by Shudo, para [0019].
The combination does not teach where at least one slit formed from a peripheral part of the sheet body toward the inside of the sheet body, and wherein the sheet body comprises a lower end opposite to the upper end, wherein a peripheral edge of the sheet body defines a continuous arc between the side parts at the lower end of the sheet body.
However, Hidaka does teach at least one slit formed from a peripheral part of the sheet body toward an inside of the sheet body (Figure 13, notch 113b).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the adhesive sheet disclosed by Franks-Wilson in view of Shudo in order to add the slit formed as disclosed by Hidaka. The art provided by Hidaka is analogous art as the art disclosed is a therapeutic patch system used to regulate body temperature similar to that of the art disclosed by the combination. One of ordinary skill in the art would have been able to combine the adhesive sheet disclosed by the combination with the slit formed as disclosed by Hidaka in order to smoothly conform the patch to the surface of the skin as stated by Hidaka (para [0057]).
The combination does not teach the adhesive sheet is configured to be adhered to the neck of a human, the sheet body has two side parts with respect to a circumferential direction of the neck, the two side parts bent downward relative to a central part of the sheet body, the downward direction being a direction opposite to an upper end of the central part of the sheet body, and wherein the sheet body comprises a lower end opposite to the upper end, wherein a peripheral edge of the sheet body defines a continuous arc between the side parts at the lower end of the sheet body.
However, the analogous thermal neck wrap of Davis does teach wherein the adhesive sheet is configured to be adhered to the neck of a human (neck wrap, [abstract]), and the sheet body has two side parts with respect to a circumferential direction of the neck (see fig 3, for the two arm portions 14 and 15 which are configured to be wrapped around the neck, [0017]), the two side parts bent downward relative to a central part of the sheet body, the downward direction being a direction opposite to an upper end of the central part of the sheet body (see again fig 3, in which it is shown that the central portion 16 of the neck wrap is seen on the upper end while the side arms 14 and 15 are bent downward to wrap around the neck aperture 31, [0019]) and wherein the sheet body comprises a lower end opposite to the upper end, wherein a peripheral edge of the sheet body defines a continuous arc between the side parts at the lower end of the sheet body (see for example Davis fig 3, in which a lower end and upper end are depicted for the neck wrap, and in which the lower end is continuously arcing from one side peripheral to the other).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the gel layer adhesive sheet taught by the previous combinations with the specific structure and shape of the neck wrap disclosed by Davis as to effectively get the neck wrap to position and stay on the neck of the user as disclosed by Davis, [0018].
Regarding claim 3, the combination teaches the adhesive sheet according to claim 1, wherein the sheet body further comprises a second region wherein there is no gel or there is an amount of gel less than an amount of the gel laid out on the first region (Franks-Wilson, see annotated figure 1 below).
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Regarding claim 4, the combination teaches the adhesive sheet according to claim 3, wherein the second region is laid out at least on a central part of the sheet body (Franks-Wilson, see annotated figure 1 above).
Regarding claim 5, the combination teaches the adhesive sheet according to claim 4, wherein the at least one slit is formed in the second region (Hidaka, Fig 13, notch 113b).
Regarding claim 7, the combination teaches the adhesive sheet according to claim 1, wherein an end part of the at least one slit is tapered (Hidaka, the slit may be an elongated rhombus, para [0057], and therefore suggesting a tapered end due to the shape called out).
Regarding claim 8, the adhesive sheet according to claim 1, wherein an end part of the at least one slit is curved (Hidaka, the slit may be an elongated oval, para [0057], and therefore suggesting a curved slit due to the shape called out).
Regarding claim 11, the combination teaches the adhesive sheet according to claim 1, wherein the two side parts of the sheet body larger than a central part of the sheet body (see from Davis fig 1 in which the two respective side parts extend longer and larger than the central part), the two side parts extending in a circumferential direction around the neck when the adhesive sheet is adhered to the neck (see from Davis in which the side parts contain adhesive patches 24 used to adhere and maintain the positioning of the patch around the circumferential direction of the neck, [0030]).
Regarding claim 13, the combination teaches the adhesive sheet according to claim 1, wherein the two side parts of the sheet body each having a peripheral part having a shape including a curve, the two side parts extending in a circumferential direction around the neck when the adhesive sheet is adhered to the neck (see Davis fig 3, in which it is shown that the central portion 16 of the neck wrap is seen on the upper end while the side arms 14 and 15 are bent in a downward curve to wrap around the neck aperture 31, [0019]).
Regarding claim 14, the combination teaches the adhesive sheet according to claim 13, wherein the peripheral part of each of the two side parts has a smaller curvature radius in a lower aspect compared to the curvature radius in an upper aspect (see from Davis fig 1, in which the upper end has a larger radius of curvature and the lower end has a smaller curve radius).
Regarding claim 15, the combination teaches the adhesive sheet according to claim 1, wherein the gel is configured to adhere the surface of the sheet to the skin (from Shudo, see fig 1 for the gel adhesive base 12 present on the support layer 14 of the patch, see also para [0018]).
Regarding claim 19, the combination teaches the adhesive sheet according to claim 1, wherein no slit is defined in the lower end of the sheet body at the central part (see for example Davis fig 3, in which a lower end and upper end are depicted for the neck wrap, and in which the lower end is continuously arcing from one side peripheral to the other without a slit).
Claim(s) 6 and 9-10, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franks-Wilson (US Patent No 20210007886 A1) in view of Shudo (US Patent No 20120076850) and Hidaka et al. (US Patent No 20100241199 A1), further in view of Hiroshi (US Patent No 20160367395 A1) further in view of Davis (US Patent No 6123717).
Regarding claim 6, the combination of Franks-Wilson, Shudo and Hidaka teach the adhesive sheet according to claim 1.
Hidaka and Franks-Wilson do not teach wherein the at least one slit has a predetermined length from the upper end of the central part of the sheet body when the adhesive sheet is adhered to the neck.
However, Hiroshi does teach wherein the at least one slit has a predetermined length from an upper end of a central part of the sheet body (slit portion 14 extends inwards from the outer circumference, para [0021]) when the adhesive sheet is adhered to the neck.
Therefore, it would have been obvious for one skilled in the art to combine the adhesive sheet disclosed from the prior combination with the slit with a predetermined length as disclosed from Hiroshi. Hiroshi is analogous art as it a body temperature cooling sheet similar to that of the one being claimed. One of ordinary skill in the art, before the effective filing date would have been able to combine the adhesive sheet as previously disclosed with the slit of a predetermined length disclosed by Hiroshi in order to conform the sheet to the user as shown in Hiroshi.
Regarding claim 9, the combination teaches the adhesive sheet according to claim 6, wherein the predetermined length is 0.5 cm to 3 cm (Hiroshi, having a length of 0.5 - 1.5cm, para [0021]).
Regarding claim 10, the combination teaches the adhesive sheet according to claim 6, wherein a width of the at least one slit is 2 cm or less (Hiroshi, having a length of 0.5 - 1.5cm, para [0021]).
Regarding claim 17, the combination teaches the adhesive sheet according to claim 1, wherein the at least one slit extends to a peripheral edge of the sheet body defined at the upper end of the central part of the sheet body (Hiroshi, slit portion 14 extends inwards from the outer circumference, para [0021], see also fig 1 showing the slit 14 found on the distal edge of the sheet).
Claim(s) 16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franks-Wilson (US Patent No 20210007886 A1) in view of Bourdillon (US Patent No 20210077295) further in view of Hidaka et al. (US Patent No 20100241199 A1) and further in view of Davis (US Patent No 6123717).
Regarding claim 16, the Franks-Wilson teaches an adhesive sheet configured to be adhered to a movable part of a human (From Franks-Wilson, wearable on user’s face, para [0007]), the adhesive sheet (From Franks-Wilson, adhesive layer bonded to strip, para [0007]) comprising: a sheet body having a first region (From Franks-Wilson, first side 42, para [0019]),
Franks Wilson does not teach the first region and a second region both, the first region having a surface on which a gel is laid out, wherein the gel is laid out on the second region in a lesser amount than on the first region.
However, the analogous cooling pad of Bourdillon does teach the first region and a second region both, the first region having a surface on which a gel is laid out, wherein the gel is laid out on the second region in a lesser amount than on the first region; (From Bourdillon, see fig 4 which shows a first region and a second region in which there are perforations for conforming and allowing the gel material to seep through and create contact on the skin surface. In which there are more perforations or holes 114 in the first region than there are in the second region thereby allowing a lesser amount of gel to be laid out on the contact surface, see also para [0048] in which it is disclosed how the foam layer 132 which is a hydrogel layer may have varying thickness between 1mm to 30mm across the sheet, therefore allowing for variable gel thicknesses between regions);
Therefore, it would have been obvious for one skilled in the art to combine the adhesive sheet disclosed by Franks-Wilson with the teachings of Bourdillon in order to allow for the adhesive sheet to have variable gel thickness across different regions in order to allow for better conformability to the contact surface and increased treatment effectiveness as disclosed by Bourdillon, para [0048].
The previous combination does not teach the at least one slit formed from a peripheral part of the sheet body toward an inside of the sheet body.
However, the analogous adhesive sheet of Hidaka does teach the at least one slit formed from a peripheral part of the sheet body toward an inside of the sheet body (From Hidaka, Figure 13, notch 113b);
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the adhesive sheet disclosed by Franks-Wilson in view of Shudo in order to add the slit formed as disclosed by Hidaka. The art provided by Hidaka is analogous art as the art disclosed is a therapeutic patch system used to regulate body temperature similar to that of the art disclosed by the combination. One of ordinary skill in the art would have been able to combine the adhesive sheet disclosed by the combination with the slit formed as disclosed by Hidaka in order to smoothly conform the patch to the surface of the skin as stated by Hidaka (para [0057]).
The previous combination does not teach two side parts of the sheet body bent downward relative to a central part of the sheet body, the two side parts being configured to extend in a circumferential direction around a neck of a wearer when the adhesive sheet is adhered to the neck.
However, the analogous thermal neck wrap of Davis does teach wherein the adhesive sheet is configured to be adhered to the neck of a human (neck wrap, [abstract]), and the sheet body has two side parts with respect to a circumferential direction of the neck (see fig 3, for the two arm portions 14 and 15 which are configured to be wrapped around the neck, [0017]), the two side parts bent downward relative to a central part of the sheet body, the downward direction being a direction opposite to an upper end of the central part of the sheet body (see again fig 3, in which it is shown that the central portion 16 of the neck wrap is seen on the upper end while the side arms 14 and 15 are bent downward to wrap around the neck aperture 31, [0019]) and wherein the sheet body comprises a lower end opposite to the upper end, wherein a peripheral edge of the sheet body defines a continuous arc between the side parts at the lower end of the sheet body (see for example Davis fig 3, in which a lower end and upper end are depicted for the neck wrap, and in which the lower end is continuously arcing from one side peripheral to the other).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the gel layer adhesive sheet taught by the previous combinations with the specific structure and shape of the neck wrap disclosed by Davis as to effectively get the neck wrap to position and stay on the neck of the user as disclosed by Davis, [0018].
Regarding claim 20, the combination teaches the adhesive sheet according to claim 3, wherein in the second region there is an amount of gel less than an amount of the gel laid out on the first region, and wherein the second region comprises the central part of the sheet body (From Bourdillon, see fig 4 which shows a first region and a second region in which there are perforations for conforming and allowing the gel material to seep through and create contact on the skin surface. In which there are more perforations or holes 114 in the first region than there are in the second region thereby allowing a lesser amount of gel to be laid out on the contact surface, see also para [0048] in which it is disclosed how the foam layer 132 which is a hydrogel layer may have varying thickness between 1mm to 30mm across the sheet, therefore allowing for variable gel thicknesses between regions).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franks-Wilson (US Patent No 20210007886 A1) in view of Shudo (US Patent No 20120076850) further in view of Hidaka et al. (US Patent No 20100241199 A1) and further in view of Davis (US Patent No 6123717) further in view of Hiroshi (US Patent No 20160367395 A1).
Regarding claim 18, the previous combination teaches the adhesive sheet according to claim 16.
The previous combination does not explicitly teach the at least one slit extends to a peripheral edge of the sheet body defined at an upper end of the central part of the sheet body, wherein the downward direction is opposite to the upper end of the central part of the sheet body.
However, the analogous body temperature adjustment sheet of Hiroshi does state the at least one slit extends to a peripheral edge of the sheet body defined at an upper end of the central part of the sheet body, wherein the downward direction is opposite to the upper end of the central part of the sheet body (Hiroshi, slit portion 14 extends inwards or downwards away from the upper end from the outer circumference, para [0021], see also fig 1 showing the slit 14 found on the distal edge of the sheet).
Therefore, it would have been obvious for one skilled in the art to combine the adhesive sheet disclosed from the prior combination with the slit with a predetermined form as disclosed from Hiroshi. One of ordinary skill in the art, before the effective filing date would have been able to combine the adhesive sheet as previously disclosed with the slit of a predetermined form disclosed by Hiroshi in order to conform the sheet to the user as shown in Hiroshi.
Response to Arguments
Applicant’s arguments, see Applicant Remarks , filed 12/315, with respect to the rejection(s) of claim(s) 1 and 16 as well as all underlying dependent claims have been fully considered and have been found partially persuasive.
With regards to the remarks claiming that the prior art of Hidaka relies on features from two distinct embodiments without being provided a rationale for the combination of embodiments, has been considered and found persuasive. Therefore, the prior rejection involving the different embodiments of Hidaka has been removed. However, upon further consideration it has been found that the previous prior art of record of Davis contains the disclosure of a peripheral edge of the sheet body which defines a continuous arc between the side parts at the lower end of the sheet body, in which this limitation was previously being relied upon by the secondary embodiment of the Hidaka reference. Specifically, the Davis reference teaches wherein the sheet body comprises a lower end opposite to the upper end, wherein a peripheral edge of the sheet body defines a continuous arc between the side parts at the lower end of the sheet body (see for example Davis fig 3, in which a lower end and upper end are depicted for the neck wrap, and in which the lower end is continuously arcing from one side peripheral to the other). Therefore, as the limitation which was originally relied upon by the second embodiment of Hidaka, is also taught by the prior art of record Davis, the rejected claim 1 and 16 as well as all relevant dependent claims remain rejected under the newly considered prior art of record rejection of the single embodiment art of Hidaka in view of Davis set forth in the present office action.
With regards to the argument presented that the prior art of Franks-Wilson and Shudo are not analogous prior art and would have no reason to combine the two as Shudo contains a different type of cooling agent, has been considered but ultimately found unpersuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, just because Franks-Wilson discloses a temperature therapy gel and the disclosure of Shudo teaches a physiological therapy gel does not mean they are non-analogous art references. As both references contain the usage of a therapeutic gel for a cooling attribute in a patch form, the references would then produce motivation to combine for one of ordinary skill in the art. Furthermore, the examiner would like to remind the applicant that the prior art of record is searched and considered with the broadest reasonable interpretation of the claims in mind. In this particular instance, the claims of the instant application do not specifically detail whether the gel is a thermal gel or physiological gel, nor any specific type of gel. Therefore, as analyzed under the broadest reasonable interpretation of the claims, the prior art is considered pertinent art of record if it contains therapeutic gel disposed in a sheet or patch form as it is taught in both Franks-Wilson and Shudo.
With regards to the argument regarding claim 13 and how the Hidaka reference contained issues with relying on multiple embodiments, this argument has been considered but ultimately falls moot. As described previously the second embodiment of Hidaka has been removed from the rejection and the limitations which were previously taught by the second embodiment of Hidaka are now disclosed by the newly considered prior art of record of Davis. The newly considered prior art of Davis also teaches the limitations of the neck adhesive configuration with a patch circumference around the neck of the user when wearing, which was taught by the previously used prior art of Maruyama. Therefore, as the newly considered prior art of Davis contains the teachings which were previously taught by the second embodiment of Hidaka as well as the previous art of Maruyama, the claim 13 remains rejected in view of the new consideration of the art of Davis set forth in the present office action.
With regards to the argument made that the previous prior art of record does not teach limitation of claim 16 that “a first region and a second region both, the first region having a surface on which a gel is laid out, wherein the gel is laid out on the second region in a lesser amount than on the first region,” has been considered but ultimately falls unpersuasive. The examiner would like to reemphasize the teachings of the analogous cooling pad of Bourdillon in figure 4 and paragraphs [0046] to [0048] in which it is disclosed that the first region and a second region both, the first region having a surface on which a gel is laid out, wherein the gel is laid out on the second region in a lesser amount than on the first region as seen in figure 4 which shows a first region and a second region in which there are perforations for conforming and allowing the gel material to seep through and create contact on the skin surface. In which there are more perforations or holes 114 in the first region than there are in the second region thereby allowing a lesser amount of gel to be laid out on the contact surface as also described in the disclosure. Furthermore, in regards to the argument that the perforations of Bourdillon avoid “compromising contact between the pad 110 and the skin,” has been considered but is found unpersuasive. The examiner would like to emphasize the full disclosure of Bourdillon paragraph [0046], which explains that the “hour glass” shape of the perforations is configured that way as to not compromise contact between the pad 110 and skin layer in the area. This meaning the hourglass shape of the perforations has set apart areas of the patch as seen in figure 4 which are meant to contact the skin, however the holes or perforations 114 serve the purpose of diverting a liquid gel to be dispersed throughout the holes and therefore teach a surface where the gel is laid out. Therefore, as the prior art of Bourdillon teaches all the limitations of the claim 16, the application remains rejected under the new prior art of record set forth in the present office action of Franks-Wilson in view of Bourdillon.
Furthermore, in regards to the new claim 20, the previously used prior art of record Bourdillon discloses a first region and a second region both, the first region having a surface on which a gel is laid out, wherein the gel is laid out on the second region in a lesser amount than on the first region and therefore the new claim 20 remains rejected under the previous prior art of record rejection.
All other claims remain rejected as they are dependent on the rejected claim limitations of claim 1 and 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794 /LINDA C DVORAK/Primary Examiner, Art Unit 3794
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