DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-6, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive).
In regards to claim 1 Elsherbini teaches an assembly comprising:
a pulse oximetry sensor patch configured to be applied to a region of skin of a patient ([0114] Electronics 102 in Fig. 1C can monitor pulse oximetry);
and a stretchable pressure backing configured to secure the pulse oximetry sensor patch against the skin ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor),
wherein the stretchable pressure backing comprises a backing adhesive layer configured to secure at least a portion of the stretchable pressure backing to the skin ([0027] “The patch 100B as illustrated includes an adhesive 110 on a bottom surface 108B of the substrate 104. The bottom surface 108B is opposite the top surface 108A. The bottom surface 108B faces skin 106 of a user”);
wherein the stretchable pressure backing is configured to stretch from an unstretched length to a stretched length ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor).
Elsherbini doesn’t explicitly teach an assembly wherein when the stretchable pressure backing is stretched to the stretched length, the stretchable pressure backing is configured to press the pulse oximetry sensor patch against the skin to apply pressure to reduce venous pulsations in the region of the skin. Hannula teaches a stretchable headband that is stretched to a stretched length, the stretchable pressure backing is configured to press a pulse oximetry sensor patch against the skin to apply around 10 mmHg to 20 mmHg of pressure to reduce venous pulsations in the region of the skin ([0028] “The headband can be used to apply pressure to the oximetry sensor, thus reducing the effects of venous pulsations”, “The user can apply a wide range of pressures to the forehead oximetry sensor depending on the amount of tension which has been applied to the headband during its placement around the wearer's head”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of Elsherbini so it is stretched enough to apply pressure like the headband of Hannula in order to reduce the effects of venous pulsations on the oximetry sensor.
Modified Elsherbini teaches using silicone (polydimethylsiloxane (PDMS)) adhesive to adhere the stretchable backing (Elsherbini [0028] “silicone (polydimethylsiloxane (PDMS)) adhesive“). Modified Elsherbini fails to teach the stretchable pressure backing being removable and repositionable with respect to the pulse oximetry sensor patch. Dupont teaches a repositionable PMDS adhesive (Page 1 Liveo™ MG 7-9960 Soft Skin Adhesive is used in medical device attachments and is repositionable). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the adhesive of the stretchable pressure backing of Elsherbini to be Liveo™ MG 7-9960 Soft Skin Adhesive. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to reposition the backing over the sensor when applying it.
In regards to claim 2 modified Elsherbini teaches the assembly of claim 1, wherein the stretched length is configured to apply pressure in a range from 6 millimeters of mercury (mmHg) to 20 mmHg (Hannula [0028] “Generally, a good pressure range is one where the applied pressure is higher than venous pressure (e.g., 3-5 mm Hg) and lower than the capillary pressure (e.g., 22 mm Hg). Preferably, this is between 10 mm Hg and 20 mm Hg in the adult patient”).
In regards to claim 5 modified Elsherbini teaches the assembly of claim 1, wherein the backing adhesive layer is substantially continuous over an entire surface of the stretchable pressure backing ([0029] [0090] “In one or more embodiments, the adhesive 110 can be located on the electronics 102”). It would be obvious for the entire bottom surface of the substrate to have adhesive on it to cover both the electronics and the skin in contact with the bottom surface.
In regards to claim 6 modified Elsherbini teaches the assembly of claim 1, wherein the backing adhesive layer comprises a first adhesive portion spaced from a second adhesive portion, wherein the first adhesive portion and the second adhesive portion are configured to straddle the pulse oximetry sensor patch ([0029] Fig.1C shows two portions of adhesive on either side of sensor. “The adhesive 110, as illustrated, is located on portions of the substrate 104 around the electronics 102”).
In regards to claim 14 modified Elsherbini teaches the assembly of claim 1, wherein the stretchable pressure backing comprises a non-woven material ([0026] elastomer is a nonwoven material).
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) as applied to claim 1, further in view of Theraband (Xactstretch: The Right Stretch, Every Time- previously cited).
In regards to claim 3 modified Elsherbini teaches the assembly of claim 1. Modified Elsherbini does not teach that the stretched length is at least 20% greater than the unstretched length. Theraband teaches a stretchy kinesiology tape that can stretch up to 100% of its unstretched length ([0003] “Fully stretched, TheraBand Kinesiology Tape reaches 100% of its off paper length”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of modified Elsherbini to be made of the same material as the tape of Theraband. Doing so would allow the pressure backing to stretch to various lengths in order to change the amount of pressure applied to the sensor.
In regards to claim 10 modified Elsherbini teaches the assembly of claim 1. Modified Elsherbini fails to teach an assembly wherein the stretchable pressure backing further comprises stretching indicia indicative of a target stretched length. Theraband teaches a stretchable tape comprising stretching indicia indicative of a target stretched length ([0001] Fig. 1 indicators show if the tape is stretched to a desired length in order to get a consistent stretch every time). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of modified Elsherbini to include indicators that indicate a certain stretch length like the device of Theraband in order to get consistent tension in the stretchable pressure backing with each use.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) as applied to claim 1, further in view of Colliou (US 20190388030 A1- previously cited).
In regards to claim 7 modified Elsherbini teaches the assembly of claim 1. Modified Elsherbini fails to teach an assembly wherein the stretchable pressure backing further comprises a backing release liner covering at least a portion of the backing adhesive layer. Colliou teaches release liners that cover the adhesive surface of an adhesive overlay ([0033] release liners 3 and 4). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of modified Elsherbini to include liners that can be removed like the adhesive overlay of Colliou in order to protect the adhesive layer before it is in use.
Claim(s) 8, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 -previously cited) in view of Hannula (US 20040221370 A1 -previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) as applied to claim 1, in view of DelloStritto (US 20120101349 A1 -previously cited).
In regards to claim 8 modified Elsherbini teaches the assembly of claim 1. Modified Elsherbini fails to teach an assembly wherein the pulse oximetry sensor patch further comprises a sensor adhesive layer configured to secure the pulse oximetry sensor patch to the skin. DelloStritto teaches a sensor adhesive layer configured to secure a pulse oximetry sensor patch to the skin of a user ([0013] Adhesive strip 136). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the pulse oximeter of modified Elsherbini to include an adhesive layer to attach the sensor to the skin like the device of DelloStritto.
In regards to claim 12 modified Elsherbini teaches the assembly of claim 1. Modified Elsherbini fails to teach an assembly wherein the pulse oximetry sensor patch further comprises a padding layer. DelloStritto teaches a pulse oximetry sensor comprising a pad with a sensor window ([0013] “disposable pad 128 and an adhesive strip 136 wherein each includes at least one passage 132 and 138, respectively”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to substitute the pulse oximeter of modified Elsherbini be the pulse oximeter sensor of DelloStritto. Doing so would merely be a simple substitution of one pulse oximeter sensor configuration for another in order to obtain predictable results.
In regards to claim 13 modified Elsherbini teaches the assembly of claim 12, wherein the padding layer defines at least one sensor window extending across at least one optical component of the pulse oximetry sensor patch (DelloStritto [0013] “disposable pad 128 and an adhesive strip 136 wherein each includes at least one passage 132 and 138, respectively”).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) in view of DelloStritto (US 20120101349 A1) as applied to claim 8, further in view of Colliou (US 20190388030 A1- previously cited).
In regards to claim 9 modified Elsherbini teaches the assembly of claim 8, wherein the pulse oximetry sensor patch further comprises a sensor release liner covering at least a portion of the sensor adhesive layer. Colliou teaches release liners that cover an adhesive surface ([0033] release liners 3 and 4). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the adhesive layer of the sensor of modified Elsherbini to include liners that can be removed like the liners of Colliou in order to protect the adhesive layer before it is in use.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) further in view of Theraband (Xactstretch: The Right Stretch, Every Time- previously cited) as applied to claim 10, further in view of Gowans (US 20200289347 A1- previously cited).
In regards to claim 11 modified Elsherbini teaches the assembly of claim 10. Modified Elsherbini fails to teach an assembly wherein the stretching indicia comprises a first indicia alignable with a first end of the pulse oximetry sensor patch and a second indicia alignable with a second end of the pulse oximetry sensor patch along the stretched length of the stretchable pressure backing. Gowans teaches alignment features in order to facilitate proper placement of an adhesive wound dressing ([0255-0256] alignment ring on skin lines up with orientation feature 410). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the indicia of modified Elsherbini to line up with markings like the ones of Gowans on each of the ends of the sensor when stretched in order to facilitate proper placement of the stretchable pressure backing.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited).
In regards to claim 15 Hannula teaches a method comprising:
applying a pulse oximetry sensor patch to a region of skin of a patient ([0044] forehead oximetry sensor 300 is inherently placed on the user first before the headband);
positioning a stretchable pressure backing across the pulse oximetry sensor patch, comprising moving the stretchable pressure backing with respect to the applied pulse oximetry sensor ([0044] “Next, as shown in FIG. 10C, the elastic segment side is rolled over the patient's forehead covering the sensor 300”);
and stretching the stretchable pressure backing across the pulse oximetry sensor patch from an unstretched length to a stretched length to cause the pulse oximetry sensor patch to apply pressure against the skin to reduce venous pulsations in the region of the skin ([0044] “Next, as shown in FIG. 10D, the tab 206 is pulled until the elastic portion 204 reaches the stop 207 and indicator or visible portion 211 of the band is no longer visible”).
Hannula fails to teach adhering a backing adhesive layer of the stretchable pressure backing to the skin around the pulse oximetry sensor patch. Elsherbini teaches stretchable pressure backing that comprises a backing adhesive layer configured to secure at least a portion of the stretchable pressure backing to the skin ([0027] “The patch 100B as illustrated includes an adhesive 110 on a bottom surface 108B of the substrate 104. The bottom surface 108B is opposite the top surface 108A. The bottom surface 108B faces skin 106 of a user”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the method of Hannula use a stretchable backing with an adhesive layer like the device of Elsherbini in order to apply the pressure. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of adhering the pressure backing to the user’s skin so it doesn’t move out of place when sensing.
In regards to claim 16 modified Hannula teaches the method of claim 15, wherein the stretched length is configured to apply pressure in a range from 6 millimeters of mercury (mmHg) to 20 mmHg ([0028] “Generally, a good pressure range is one where the applied pressure is higher than venous pressure (e.g., 3-5 mm Hg) and lower than the capillary pressure (e.g., 22 mm Hg). Preferably, this is between 10 mm Hg and 20 mm Hg in the adult patient”).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited) as applied to claim 15, further in view of Universal Companies (Canyon Rose Stretch Terry Headband / 3pc - previously cited).
In regards to claim 17 Hannula teaches the assembly of claim 15, wherein the headband is made of a terry band ([0033] The elastic material may be made of a material as is described above, or made using other suitable material such as a terry band). Hannula does not teach that the stretched length is at least 20% greater than the unstretched length. Universal Companies teaches a terry band that can stretch up to 31.5% of its unstretched length (Description 4" Wide. 18.25" without stretch, 24" stretched). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the elastic material of modified Hannula to be the elastic material of Universal Companies. Doing so would merely be combining prior art elements according to known methods in order to achieve a stretch of more than 20% than the unstretched length of the band.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited) as applied to claim 15, in view of Quinn (US 20100298747 A1 - previously cited).
In regards to claim 18 Hannula teaches the method of claim 15. Hannula fails to teach a method further comprising: adhering, before the stretching, a first portion of the stretchable pressure backing on a first side of the pulse oximetry sensor patch to the patient’s skin; and adhering, after the stretching, a second portion of the stretchable pressure backing on a second side of the pulse oximetry sensor patch to the patient’s skin. Quinn teaches a method of applying kinesiology tape comprising: adhering, before the stretching, a first portion of the stretchable pressure backing on a first side of the patient’s skin ([0029] “This can facilitate placement of the kinesiology tape 100 by allowing the user to only work with desired sections of the kinesiology tape 100 or to apply the tape with a specific amount of stretch by first anchoring only the exposed adhesive and then applying the rest of the tape with desired amount of stretch”); and adhering, after the stretching, a second portion of the stretchable pressure to the patient’s skin ([0029] “This can facilitate placement of the kinesiology tape 100 by allowing the user to only work with desired sections of the kinesiology tape 100 or to apply the tape with a specific amount of stretch by first anchoring only the exposed adhesive and then applying the rest of the tape with desired amount of stretch”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the method of Hannula to use kinesiology tape in place of the headband and apply it like the method of Quinn in order to adhere the stretchable pressure backing to the skin with desired amount of stretch.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited) as applied to claim 15, in view of Theraband (Xactstretch: The Right Stretch, Every Time- previously cited).
In regards to claim 19 Hannula teaches the method of claim 15, including a sensor outline on the elastic portion of the headband ([0044] It may be preferable to provide a sensor design outline on the elastic portion of the headband, in which case it is preferred to align the sensor outline on the elastic band portion of the forehead sensor approximately with the sensor 300). Hannula fails to teach wherein the stretching comprises stretching the stretchable pressure backing such that a first stretching indicia of the stretchable pressure backing aligns with a first end of the pulse oximetry sensor patch and a second stretching indicia of the stretchable pressure backing aligns with a second end of the pulse oximetry sensor patch along the stretched length of the stretchable pressure backing. Theraband teaches indica that stretches with the band to indicate when the band has hit a target stretched length ([0001] Fig. 1 indicators show if the tape is stretched to a desired length in order to get a consistent stretch every time). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the method of Hannula to use a sensor design outline that stretches with the band like the one of Theraband which would allow the user to line up the first end of the outline and second end of the outline with the ends of the sensor. Doing so would ensure the stretchable pressure backing is aligned with the sensor when it stretches.
In regards to claim 20 Hannula Elsherbini a kit comprising:
a pulse oximetry sensor patch configured to be applied to a region of skin of a patient ([0114] Electronics 102 in Fig. 1C can monitor pulse oximetry);
and a stretchable pressure backing configured to secure the pulse oximetry sensor patch against the skin ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor),
wherein the stretchable pressure backing comprises a backing adhesive layer configured to secure at least a portion of the stretchable pressure backing to the skin ([0027] “The patch 100B as illustrated includes an adhesive 110 on a bottom surface 108B of the substrate 104. The bottom surface 108B is opposite the top surface 108A. The bottom surface 108B faces skin 106 of a user”);
wherein the stretchable pressure backing is configured to stretch from an unstretched length to a stretched length ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor).
Elsherbini doesn’t explicitly teach an kit wherein when the stretchable pressure backing is stretched to the stretched length, the stretchable pressure backing is configured to press the pulse oximetry sensor patch against the skin to apply pressure to reduce venous pulsations in the region of the skin. Hannula teaches a stretchable headband that is stretched to a stretched length, the stretchable pressure backing is configured to press a pulse oximetry sensor patch against the skin to apply around 10 mmHg to 20 mmHg of pressure to reduce venous pulsations in the region of the skin ([0028] “The headband can be used to apply pressure to the oximetry sensor, thus reducing the effects of venous pulsations”, “The user can apply a wide range of pressures to the forehead oximetry sensor depending on the amount of tension which has been applied to the headband during its placement around the wearer's head”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of Elsherbini so it is stretched enough to apply pressure like the headband of Hannula in order to reduce the effects of venous pulsations on the oximetry sensor.
Modified Elsherbini teaches using silicone (polydimethylsiloxane (PDMS)) adhesive to adhere the stretchable backing (Elsherbini [0028] “silicone (polydimethylsiloxane (PDMS)) adhesive“). Modified Elsherbini fails to teach the stretchable pressure backing being removable and repositionable with respect to the pulse oximetry sensor patch. Dupont teaches a repositionable PMDS adhesive (Page 1 Liveo™ MG 7-9960 Soft Skin Adhesive is used in medical device attachments and is repositionable). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the adhesive of the stretchable pressure backing of Elsherbini to be Liveo™ MG 7-9960 Soft Skin Adhesive. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to reposition the backing over the sensor when applying it.
Modified Elsherbini fails to teach at least two stretchable pressure backings configured to secure the pulse oximetry sensor patch against the skin, wherein one of the at least two stretchable pressure backings comprises a different shape or size than the other of the at least two stretchable pressure backings. Freeman teaches a kit with a “plurality of sizes and shapes of adhesive pads in a single kit so that an adhesive pad can be selected for the individual patient” ([0078]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the kit of modified Elsherbini to include multiple shapes and sizes of adhesive backings. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to choose the backing size/shape best suited to the individual and placement of the patch (ex. Children may need smaller backings than an adult).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) in view of Freeman (US 20190255340 A1).
In regards to claim 20 Hannula Elsherbini a kit comprising:
a pulse oximetry sensor patch configured to be applied to a region of skin of a patient ([0114] Electronics 102 in Fig. 1C can monitor pulse oximetry);
and a stretchable pressure backing configured to secure the pulse oximetry sensor patch against the skin ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor),
wherein the stretchable pressure backing comprises a backing adhesive layer configured to secure at least a portion of the stretchable pressure backing to the skin ([0027] “The patch 100B as illustrated includes an adhesive 110 on a bottom surface 108B of the substrate 104. The bottom surface 108B is opposite the top surface 108A. The bottom surface 108B faces skin 106 of a user”);
wherein the stretchable pressure backing is configured to stretch from an unstretched length to a stretched length ([0026] Substrate 104 in Fig. 1C is stretchable and is applied over the sensor).
Elsherbini doesn’t explicitly teach an kit wherein when the stretchable pressure backing is stretched to the stretched length, the stretchable pressure backing is configured to press the pulse oximetry sensor patch against the skin to apply pressure to reduce venous pulsations in the region of the skin. Hannula teaches a stretchable headband that is stretched to a stretched length, the stretchable pressure backing is configured to press a pulse oximetry sensor patch against the skin to apply around 10 mmHg to 20 mmHg of pressure to reduce venous pulsations in the region of the skin ([0028] “The headband can be used to apply pressure to the oximetry sensor, thus reducing the effects of venous pulsations”, “The user can apply a wide range of pressures to the forehead oximetry sensor depending on the amount of tension which has been applied to the headband during its placement around the wearer's head”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the stretchable pressure backing of Elsherbini so it is stretched enough to apply pressure like the headband of Hannula in order to reduce the effects of venous pulsations on the oximetry sensor.
Modified Elsherbini teaches using silicone (polydimethylsiloxane (PDMS)) adhesive to adhere the stretchable backing (Elsherbini [0028] “silicone (polydimethylsiloxane (PDMS)) adhesive“). Modified Elsherbini fails to teach the stretchable pressure backing being removable and repositionable with respect to the pulse oximetry sensor patch. Dupont teaches a repositionable PMDS adhesive (Page 1 Liveo™ MG 7-9960 Soft Skin Adhesive is used in medical device attachments and is repositionable). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the adhesive of the stretchable pressure backing of Elsherbini to be Liveo™ MG 7-9960 Soft Skin Adhesive. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to reposition the backing over the sensor when applying it.
Modified Elsherbini fails to teach at least two stretchable pressure backings configured to secure the pulse oximetry sensor patch against the skin, wherein one of the at least two stretchable pressure backings comprises a different shape or size than the other of the at least two stretchable pressure backings. Freeman teaches a kit with a “plurality of sizes and shapes of adhesive pads in a single kit so that an adhesive pad can be selected for the individual patient” ([0078]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the kit of modified Elsherbini to include multiple shapes and sizes of adhesive backings. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to choose the backing size/shape best suited to the individual and placement of the patch (ex. Children may need smaller backings than an adult).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited) as applied to claim 15, further in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive).
In regards to claim 21 modified Hannula teaches the method of claim 15. Modified Hannula fails to teach a method further comprising removing the stretchable pressure backing from the region of skin and repositioning the stretchable pressure backing with respect to the pulse oximetry sensor patch. Dupont teaches a repositionable PMDS adhesive (Page 1 Liveo™ MG 7-9960 Soft Skin Adhesive is used in medical device attachments and is repositionable). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date to modify the adhesive of the stretchable pressure backing of Elsherbini to be Liveo™ MG 7-9960 Soft Skin Adhesive. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to reposition the backing over the sensor when applying it which would ensure the placement/tension can be adjusted.
Response to Arguments
Applicant’s arguments, see remarks, filed 05/15/2026, with respect to the rejection(s) of claim(s) 1-2, 14-16, and 20 under 35 U.S.C 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) and/or Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited).
Applicant’s arguments, see remarks, filed 05/15/2026, with respect to the rejection(s) of claim(s) 1-2, 4-6, and 14 under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Elsherbini (US 20180020982 A1 - previously cited) in view of Hannula (US 20040221370 A1 - previously cited) in view of Dupont (Dupont™ Liveo™ MG 7-9960 Soft Skin Adhesive) and/or Hannula (US 20040221370 A1 - previously cited) in view of Elsherbini (US 20180020982 A1 - previously cited).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
Prosecution Insights