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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 and 30 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. Regarding claims 1-14, claim 1 recites “a base including an upper surface, a lower surface, and a center”; however, “base” is henceforth never referred back to and a new limitation “the lower layer” (lacking antecedent basis) begins to be used throughout these claims. From analysis of the other claims and the specification, “a base” will be interpreted by the examiner as “a lower layer” in order to make the claims 1-14 coherent.
Regarding claim 10, Claim 10 recites the limitation “the first securement tab and the second securement tab " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examining purposes will be interpreted as dependent on claim 8 instead of claim 1.
Regarding claim 30, Claim 30 recites the limitation "the silicone adhesive" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-14, 24 and 30 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claims 1, 24, 30, the claims recite: “the adhesive is secured to an outer epidermis layer of the infant, the outer epidermis layer coupled to an inner dermis layer of the infant, the adhesive tension between the adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer base and the inner dermis layer”, wherein this appears to be positively reciting that the adhesive secured to the human body. Examiner recommends usage of -configured to- or other functional language to get around this issue.
Claims 2-14 are rejected as being dependent on a rejected claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7-9 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Lavon (US 20190053962 A1).
Regarding claim 1, Kyvik discloses a skin care device for an infant (See Figures 1-7, and Abstract, this is a bandage placed on skin of an infant) comprising:
a base 11 (a lower layer 11, see 112b above) (See Figure 4 and [0013]) including an upper surface 12 (See Figure 4 and [0013]) , a lower surface 13 (See Figure 4 and [0013]) and a center opening 61 (Figure 1 and [0013]) configured to receive an umbilical cord of the infant (See Figures 1-7 and [0012], wherein the opening 61 can be placed on an umbilical cord receiving a catheter 92),
the lower surface 13 having an adhesive (see [0013] wherein there is a medical grade adhesive for adhesion to the skin);
wherein the adhesive is secured to an outer epidermis layer of the infant (see [0013] adhesive on skin of infant, this being inherently an outer epidermis layer).
a liner removably coupled to the adhesive (see [0018], wherein a lower release liner member is present on the bottom of the lower surface 13 to be removed to expose adhesive);
and an upper layer 21 coupled to the upper surface 12 of the lower layer 11 (See Figure 4).
Kyvik does not disclose the lower surface adhesive being a silicone adhesive.
Kyvik does disclose that the adhesive of tabs 31 and 41 (Figures 1-4) being silicone (see [0017]) which is a known medical grade adhesive, and further says that the adhesive on the lower layer may be a hydrocolloid (see [0013]).
Lavon further teaches a skin care device for an infant (Figures 1A-4) that uses an analogous hydrocolloid for attaching to an infant (see [0011, 0013, [0058]), wherein the adhesive then may further be chosen to be silicone (see [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the lower surface adhesive being a silicone adhesive of Kyvik as taught by Kyvik wherein the disclosure already provides adhesive chosen on the device elsewhere being a silicone adhesive, and even further as taught by Lavon wherein Lavon provides silicone adhesive to be a known in the art adhesive for attaching a device to a skin of an infant near an umbilical cord safely.
Kyvik does not explicitly disclose the outer epidermis layer coupled to an inner dermis layer of the infant, the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
However, Kyvik discloses that the invention should be quickly and easily both adhered and removed from the patient (see [0003]), and further recites “whereby the base member 11 can be applied to the skin 91, will remain adhered for a suitable time period, and then easily removed”. The present claim language above is simply stating that the adhesive of the invention will not cause separation of the dermis layers when attempting to be removed. Examiner would assert that any bandage made to be used on the skin of infant especially around an umbilical cord in the case of Kyvik would implicitly provide adhesive that would not harm the infant or baby, and thus the adhesive tension between the adhesive and outer epidermis would always be less than the adhesive tension between the outer epidermis and inner dermis layer. Especially as easy removal as disclosed by Kyvik would require this, as if the adhesive tension on the outer skin was higher, than that would not constitute easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that the adhesive of Kyvik would implicitly and inherently have the function of the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
Regarding claim 2, Kyvik in view of Lavon discloses the invention of claim 1.
Kyvik as combined does not disclose wherein the lower layer includes a non-woven fabric supporting the silicone adhesive.
However, Lavon further teaches the analogous adhesive 120 (Figure 2B, [0034]) being supported by an analogous lower layer being an attached bandage 102 (Figure 2B, bandage 102 against an analogous umbilical cord is termed a “containment shell”), wherein the analogous lower layer may be a nonwoven fabric (see [0038, [0046]) for being a material that would work well with umbilical cords and being a cheaper cost.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to formed the lower layer supporting the adhesive of Kyvik to be non-woven fabric as taught by Lavon for working better near umbilical cord tissue and for cheaper cost (Lavon [0038, 0046]).
Regarding claim 3, Kyvik in view of Lavon discloses the invention of claim 1.
Kyvik discloses the lower layer 11 is fenestrated (See Figures 1-4, wherein the center opening 61 is a fenestration being a hole in the center, thus the lower layer is fenestrated).
Regarding claim 7, Kyvik in view of Lavon discloses the invention of claim 1.
Kyvik discloses wherein a positioning slot 62 extends within the lower layer 11 outwardly from the center opening 61 (Fig. 1 and [0013]).
Regarding claim 8, Kyvik in view of Lavon discloses the invention of claim 1.
Kyvik discloses wherein the upper layer 21 includes an upwardly extending first securement tab 31 and an upwardly extending second securement tab 41 positioned on opposing sides of the center opening 61 (Figures 1-6).
Regarding claim 9, Kyvik in view of Lavon discloses the invention of claim 8.
Kyvik discloses wherein at least one of the first securement tab 31 and the second securement tab 41 includes an adhesive 52 facing the other of the second securement tab 31 and the first securement tab 41 (Figures 1-6 and [0016-0017]),
the first securement tab 31 being coupled to the second securement tab 41 to define a bridge extending over the center opening 61 (See Figures 1-6 and [0016-0017]) and capturing an umbilical line 92 (catheter 92 [0014] being an umbilical line inserted into an umbilical stump [0012]) between the first securement tab 31 and the second securement tab 41 (See Figures 1-6).
Regarding claim 13, Kyvik in view of Lavon discloses the invention of claim 1.
Kyvik as combined does not disclose wherein the lower layer provides a water vapor transmission rate of at least 2000 g/m2 per 24 hours.
However, Lavon further teaches as an analogous umbilical cord skin care device with an analogous lower layer 110/102 (Figure 2B) with an analogous adhesive 120 (Figure 2B) that the lower layer 110/102 has a water vapor transmission rate of at least 2000 g/m2 per 24 hours (see [0010] wherein there is a moisture vapor transmission rate equal to the TEWL of an infant being preferably 2000 g/m2 per 24 hours, further see [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the lower layer of Kyvik to have a water vapor transmission rate of at least 2000 g/m2 per 24 hours as taught by Lavon in order to promote proper drying of the umbilical cord and prevent wetting therein (Lavon [0014]).
Regarding claim 14, Kyvik in view of Lavon discloses the invention of claim 13.
Kyvik as combined with Lavon discloses wherein the lower layer provides a water vapor transmission rate of between 2000 g/m2 per 24 hours and 3800 g/m2 per 24 hours (see claim 13, wherein Lavon provides a rate of 2000 g/m2 per 24 hours thus meeting this claim range).
Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Lavon (US 20190053962 A1), in further view of Bechert (US 20070203442 A1), with evidentiary reference ICNRP (see attached NPLs).
Regarding claim 4, Kyvik in view of Lavon discloses the invention of claim 3 above.
Kyvik as combined does not disclose wherein the lower layer includes a transparent window.
However, Bechert teaches an analogous wound bandage (title) wherein the entire wound bandage is transparent and thus a transparent window to enable phototherapy for increased wound healing (see [0040-0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the entire device of Kyvik including the lower layer to be transparent thus including a transparent window as taught by Bechert to provide increased wound healing.
Regarding claim 12, Kyvik in view of Lavon discloses the invention of claim 1 above.
Kyvik as combined does not disclose wherein the lower layer is semi-transparent for phototherapy transmissions for phototherapy transmissions up to 490 nm.
However, Bechert teaches an analogous wound bandage (title) wherein the entire wound bandage is transparent (thus also being classified as being semi-transparent) to enable phototherapy for increased wound healing (see [0040-0041]), wherein the phototherapy received is particularly UV light and infrared light (see [0041]) which is known to be above 490 nm in wavelength according to ICNRP (attached evidentiary NPLs, wherein IR light is from the ranges of 780 nm to 1 mm, and UV light is from 100 to 400 nm) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the entire device of Kyvik including the lower layer to be transparent for phototherapy transmissions up to 490 nm as taught by Bechert to provide increased wound healing (see [0040-0041]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Lavon (US 20190053962 A1), in further view of Seshardi (US 20230329916 A1).
Regarding claim 6, Kyvik in view of Lavon discloses the invention of claim 1 above.
Kyvik as combined does not disclose wherein a temperature probe is supported by the lower layer.
However, Seshardi teaches an analogous skin care device 80 ([0216] and Figures 9A-C), wherein the analogous skin care device 80 can be provided with sensors (see [0216]), wherein the sensors can be temperature sensors 48 (see [0216]), thus the device 80 is supporting a temperature probe.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the skin care device of Kyvik with the temperature probe as taught by Seshardi (see [0216) to remotely monitor the health of the umbilical cord area (Seshardi [0111], wherein temperature monitoring can track changes in wound and thus body health over time), wherein as the lower layer is the base of the skin care device would be supporting the temperature probe of Seshardi therein.
Regarding claim 6, Kyvik in view of Lavon discloses the invention of claim 1 above.
Kyvik as combined does not disclose wherein an ECG probe is supported by the lower layer.
However, Seshardi teaches an analogous skin care device 80 ([0216] and Figures 9A-C), wherein the analogous skin care device 80 can be provided with electrodes 58 (see [0216]), wherein the electrodes 58 can be integrated with an ECG (see [0208]), thus the device 80 is supporting an ECG probe.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the skin care device of Kyvik with the ECG probe as taught by Seshardi (see [0208, 0216) to remotely monitor the health of the umbilical cord area (Seshardi [0214), wherein as the lower layer is the base of the skin care device would be supporting the ECG probe of Seshardi therein.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Lavon (US 20190053962 A1), in further view of Chehab (US 20210106790 A1).
Regarding claim 10, Kyvik in view of Lavon discloses the invention of claim 1 above (interpreted by Examiner as dependent on claim 8 based on 112b above).
Kyvik as combined does not disclose wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
However, Chehab teaches an analogous umbilical securing catheter bandage 10 (Figures 1-2), wherein an entirety of the device 10 may be antimicrobial ([0011, 0245]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the entirety of the device of Kyvik with antimicrobial material/properties as taught by Chehab in order to keep the umbilical area from becoming infected, thus providing wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Lavon (US 20190053962 A1), in further view of Chehab (US 20210106790 A1), in further view of Bjornberg (US 20060129080 A1).
Regarding claim 11, Kyvik in view of Lavon and Chehab discloses the invention of claim 10 above.
Kyvik in view of Lavon and Chehab does not disclose wherein the first antimicrobial comprises dialkylcarbamoyl chloride (DACC), and the second antimicrobial comprises chlorhexidine (CHG).
However, Bjornberg teaches an analogous skin care device being a wound dressing with antimicrobial properties (Title, Abstract), wherein Bjornberg firstly provides that chlorhexidine (CHG) is a known antimicrobial agent used in the bandage field of invention (see [0014]), and further provides that dialkylcarbamoyl chloride (DACC) is good skin contacting antimicrobial that also keepings the wound area hydrophobic allowing good adhesion with skin of a user (see [0029, 0047, 0052]).
Furthermore, Chehab does teach using chlorhexidine for sterilizing an umbilical catheter device (see [0180]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the antimicrobial CHG as taught by both Bjornberg and Chehab and the antimicrobial DACC as taught by Bjornberg to the antimicrobial of the entire device of Kyvik as modified by Chehab as these are antimicrobials that are known in the art and would have been obvious to try antimicrobials in the field of invention when choosing from a known and limited selection as provided by Bjornberg
Claim(s) 15, 18-19, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Chehab (US 20210106790 A1).
Regarding claim 15, Kyvik discloses a skin care device for an infant (See Figures 1-7, and Abstract, this is a bandage placed on skin of an infant) comprising:
a lower layer 11 (See Figure 4 and [0013]) including an upper surface 12 (See Figure 4 and [0013]), a lower surface 13 (See Figure 4 and [0013]) and a center opening 61 (Figure 1 and [0013]) configured to receive an umbilical cord of the infant (See Figures 1-7 and [0012], wherein the opening 61 can be placed on an umbilical cord receiving a catheter 92),
wherein a positioning slot 62 extends within the lower layer 11 outwardly from the center opening 61 (Fig. 1 and [0013]).
the lower surface 13 having an adhesive (see [0013] wherein there is a medical grade adhesive for adhesion to the skin);
wherein the upper layer 21 includes an upwardly extending first securement tab 31 and an upwardly extending second securement tab 41 positioned on opposing sides of the center opening 61 (Figures 1-6).
Kyvik does not disclose wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
However, Chehab teaches an analogous umbilical securing catheter bandage 10 (Figures 1-2), wherein an entirety of the device 10 may be antimicrobial ([0011, 0245]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the entirety of the device of Kyvik with antimicrobial material/properties as taught by Chehab in order to keep the umbilical area from becoming infected, thus providing wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
Regarding claim 18, Kyvik in view of Chehab discloses the invention of claim 15.
Kyvik discloses wherein at least one of the first securement tab 31 and the second securement tab 41 includes an adhesive 52 facing the other of the second securement tab 31 and the first securement tab 41 (Figures 1-6 and [0016-0017]),
the first securement tab 31 being coupled to the second securement tab 41 to define a bridge extending over the center opening 61 (See Figures 1-6 and [0016-0017]) and capturing an umbilical line 92 (catheter 92 [0014] being an umbilical line inserted into an umbilical stump [0012]) between the first securement tab 31 and the second securement tab 41 (See Figures 1-6).
Regarding claim 19, Kyvik in view of Chehab discloses the invention of claim 18.
Kyvik does not disclose an upwardly extending third securement tab and an upwardly extending fourth securement tab positioned on opposing sides of the center opening; and wherein at least one of the third securement tab and the fourth securement tab includes an adhesive facing the other of the fourth securement tab and the third securement tab, wherein the third securement tab is coupled to the fourth securement tab to define a second bridge extending over the center opening and capturing a second umbilical line between the third securement tab and the fourth securement tab.
However, the claim language of claim 19 effectively presents duplicates of the first and second securement tabs to make a second duplicate bridge for capturing a second umbilical line therein. Applicant’s instant disclose does not appear to provide any unpredictable results that arrive through providing a second duplicate set of identical structures wherein one of ordinary skill in the art would have found it readily obvious to provide a duplicate set of structures in Kyvik if a second umbilical catheter line was provided.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided “an upwardly extending third securement tab and an upwardly extending fourth securement tab positioned on opposing sides of the center opening; and wherein at least one of the third securement tab and the fourth securement tab includes an adhesive facing the other of the fourth securement tab and the third securement tab, wherein the third securement tab is coupled to the fourth securement tab to define a second bridge extending over the center opening and capturing a second umbilical line between the third securement tab and the fourth securement tab” as duplicate structures of the first and second securement tabs forming a bridge as discussed above, since it has been held that duplication of parts “has no patentable significance unless a new and unexpected result is produced” (see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)) (see MPEP 2144.04 VI B).
Regarding claim 24, Kyvik in view of Chehab discloses the invention of claim 15.
Kyvik discloses wherein the adhesive is secured to an outer epidermis layer of the infant (see [0013] adhesive on skin of infant, this being inherently an outer epidermis layer).
Kyvik does not explicitly disclose the outer epidermis layer coupled to an inner dermis layer of the infant, the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
However, Kyvik discloses that that invention should be quickly and easily both adhered and removed from the patient (see [0003]), and further recites “whereby the base member 11 can be applied to the skin 91, will remain adhered for a suitable time period, and then easily removed”. The present claim language above is simply stating that the adhesive of the invention will not cause separation of the dermis layers when attempting to be removed. Examiner would assert that any bandage made to be used on the skin of infant especially around an umbilical cord in the case of Kyvik would implicitly provide adhesive that would not harm the infant or baby, and thus the adhesive tension between the adhesive and outer epidermis would always be less than the adhesive tension between the outer epidermis and inner dermis layer. Especially as easy removal as disclosed by Kyvik would require this, as if the adhesive tension on the outer skin was higher, than that would not constitute easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that the adhesive of Kyvik would implicitly and inherently have the function of the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
Claim(s) 16, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Chehab (US 20210106790 A1) in view of Lavon (US 20190053962 A1).
Regarding claim 16, Kyvik in view of Chehab discloses the invention of claim 15 above.
Kyvik as combined does not disclose wherein the lower layer includes a non-woven fabric supporting the adhesive.
However, Lavon teaches a skin care device for an infant (Figures 1A-4) with an analogous adhesive 120 (Figure 2B, [0034]) being supported by an analogous lower layer being an attached bandage 102 (Figure 2B, bandage 102 against an analogous umbilical cord is termed a “containment shell”), wherein the analogous lower layer may be a nonwoven fabric (see [0038, [0046]) for being a material that would work well with umbilical cords and being a cheaper cost.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to formed the lower layer supporting the adhesive of Kyvik to be non-woven fabric as taught by Lavon for working better near umbilical cord tissue and for cheaper cost (Lavon [0038, 0046]).
Regarding claim 22, Kyvik in view of Chehab discloses the invention of claim 15.
Kyvik as combined does not disclose wherein the lower layer provides a water vapor transmission rate of at least 2000 g/m2 per 24 hours.
However, Lavon further teaches as an analogous umbilical cord skin care device with an analogous lower layer 110/102 (Figure 2B) with an analogous adhesive 120 (Figure 2B) that the lower layer 110/102 has a water vapor transmission rate of at least 2000 g/m2 per 24 hours (see [0010] wherein there is a moisture vapor transmission rate equal to the TEWL of an infant being preferably 2000 g/m2 per 24 hours, further see [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the lower layer of Kyvik to have a water vapor transmission rate of at least 2000 g/m2 per 24 hours as taught by Lavon in order to promote proper drying of the umbilical cord and prevent wetting therein (Lavon [0014]).
Regarding claim 23, Kyvik in view of Chehab and Lavon discloses the invention of claim 22.
Kyvik as combined with Lavon discloses wherein the lower layer provides a water vapor transmission rate of between 2000 g/m2 per 24 hours and 3800 g/m2 per 24 hours (see claim 13, wherein Lavon provides a rate of 2000 g/m2 per 24 hours thus meeting this claim range).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Chehab (US 20210106790 A1), in further view of Seshardi (US 20230329916 A1).
Regarding claim 17, Kyvik in view of Chehab discloses the invention of claim 15 above.
Kyvik as combined does not disclose wherein the lower layer includes a sensor opening, and a temperature probe received within the sensor opening.
However, Seshardi teaches an analogous skin care device 80 ([0216] and Figures 9A-C), wherein the analogous skin care device 80 can be provided with sensors (see [0216]), wherein the sensors can be temperature sensors 48 (see [0216]), thus the device 80 is supporting a temperature probe, wherein the temperature sensors 46 can be receiving in openings of the device being an analogous lower layer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the lower layer of Kyvik including a sensor opening, and a temperature probe received within the sensor opening as taught by Seshardi (see [0216) to remotely monitor the health of the umbilical cord area (Seshardi [0111], wherein temperature monitoring can track changes in wound and thus body health over time).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Chehab (US 20210106790 A1), in further view of Bjornberg (US 20060129080 A1).
Regarding claim 20, Kyvik in view of Lavon and Chehab discloses the invention of claim 15 above.
Kyvik in view of Chehab does not disclose wherein the first antimicrobial comprises dialkylcarbamoyl chloride (DACC), and the second antimicrobial comprises chlorhexidine (CHG).
However, Bjornberg teaches an analogous skin care device being a wound dressing with antimicrobial properties (Title, Abstract), wherein Bjornberg firstly provides that chlorhexidine (CHG) is a known antimicrobial agent used in the bandage field of invention (see [0014]), and further provides that dialkylcarbamoyl chloride (DACC) is good skin contacting antimicrobial that also keepings the wound area hydrophobic allowing good adhesion with skin of a user (see [0029, 0047, 0052]).
Furthermore, Chehab does teach using chlorhexidine for sterilizing an umbilical catheter device (see [0180]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the antimicrobial CHG as taught by both Bjornberg and Chehab and the antimicrobial DACC as taught by Bjornberg to the antimicrobial of the entire device of Kyvik as modified by Chehab as these are antimicrobials that are known in the art and would have been obvious to try antimicrobials in the field of invention when choosing from a known and limited selection as provided by Bjornberg.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Chehab (US 20210106790 A1), in further view of Bechert (US 20070203442 A1), with evidentiary reference ICNRP (see attached NPLs).
Regarding claim 21, Kyvik in view of Chehab discloses the invention of claim 15 above.
Kyvik as combined does not disclose wherein the lower layer is semi-transparent for phototherapy transmissions for phototherapy transmissions up to 490 nm.
However, Bechert teaches an analogous wound bandage (title) wherein the entire wound bandage is transparent (thus also being classified as being semi-transparent) to enable phototherapy for increased wound healing (see [0040-0041]), wherein the phototherapy received is particularly UV light and infrared light (see [0041]) which is known to be above 490 nm in wavelength according to ICNRP (attached evidentiary NPLs, wherein IR light is from the ranges of 780 nm to 1 mm, and UV light is from 100 to 400 nm) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the entire device of Kyvik including the lower layer to be transparent for phototherapy transmissions up to 490 nm as taught by Bechert to provide increased wound healing (see [0040-0041]).
Claim(s) 25 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Seshardi (US 20230329916 A1), in further view of Bechert (US 20070203442 A1), with evidentiary reference ICNRP (see attached NPLs), in view of Lavon (US 20190053962 A1).
Regarding claim 25, Kyvik discloses a skin care device for an infant (See Figures 1-7, and Abstract, this is a bandage placed on skin of an infant) comprising:
a lower layer 11 (See Figure 4 and [0013]) including an upper surface 12 (See Figure 4 and [0013]), a lower surface 13 (See Figure 4 and [0013]) and a center opening 61 (Figure 1 and [0013]) configured to receive an umbilical cord of the infant (See Figures 1-7 and [0012], wherein the opening 61 can be placed on an umbilical cord receiving a catheter 92),
wherein a positioning slot 62 extends within the lower layer 11 outwardly from the center opening 61 (Fig. 1 and [0013]).
the lower surface 13 having an adhesive (see [0013] wherein there is a medical grade adhesive for adhesion to the skin);
wherein the upper layer 21 includes an upwardly extending first securement tab 31 and an upwardly extending second securement tab 41 positioned on opposing sides of the center opening 61 (Figures 1-6),
wherein at least one of the first securement tab 31 and the second securement tab 41 includes an adhesive 52 facing the other of the second securement tab 31 and the first securement tab 41 (Figures 1-6 and [0016-0017]),
the first securement tab 31 being coupled to the second securement tab 41 to define a bridge extending over the center opening 61 (See Figures 1-6 and [0016-0017]) and capturing an umbilical line 92 (catheter 92 [0014] being an umbilical line inserted into an umbilical stump [0012]) between the first securement tab 31 and the second securement tab 41 (See Figures 1-6).
Kyvik does not disclose wherein the lower layer includes a sensor opening, and a temperature probe received within the sensor opening.
However, Seshardi teaches an analogous skin care device 80 ([0216] and Figures 9A-C), wherein the analogous skin care device 80 can be provided with sensors (see [0216]), wherein the sensors can be temperature sensors 48 (see [0216]), thus the device 80 is supporting a temperature probe, wherein the temperature sensors 46 can be receiving in openings of the device being an analogous lower layer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the lower layer of Kyvik including a sensor opening, and a temperature probe received within the sensor opening as taught by Seshardi (see [0216) to remotely monitor the health of the umbilical cord area (Seshardi [0111], wherein temperature monitoring can track changes in wound and thus body health over time).
Kyvik as combined does not disclose wherein the lower layer is semi-transparent for phototherapy transmissions for phototherapy transmissions up to 490 nm.
However, Bechert teaches an analogous wound bandage (title) wherein the entire wound bandage is transparent (thus also being classified as being semi-transparent) to enable phototherapy for increased wound healing (see [0040-0041]), wherein the phototherapy received is particularly UV light and infrared light (see [0041]) which is known to be above 490 nm in wavelength according to ICNRP (attached evidentiary NPLs, wherein IR light is from the ranges of 780 nm to 1 mm, and UV light is from 100 to 400 nm) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the entire device of Kyvik including the lower layer to be transparent for phototherapy transmissions up to 490 nm as taught by Bechert to provide increased wound healing (see [0040-0041]).
Kyvik as combined does not disclose wherein the lower layer provides a water vapor transmission rate of at least 2000 g/m2 per 24 hours.
However, Lavon further teaches as an analogous umbilical cord skin care device with an analogous lower layer 110/102 (Figure 2B) with an analogous adhesive 120 (Figure 2B) that the lower layer 110/102 has a water vapor transmission rate of at least 2000 g/m2 per 24 hours (see [0010] wherein there is a moisture vapor transmission rate equal to the TEWL of an infant being preferably 2000 g/m2 per 24 hours, further see [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the lower layer of Kyvik to have a water vapor transmission rate of at least 2000 g/m2 per 24 hours as taught by Lavon in order to promote proper drying of the umbilical cord and prevent wetting therein (Lavon [0014]).
Regarding claim 28, Kyvik as combined discloses the invention of claim 25.
Kyvik does not disclose an upwardly extending third securement tab and an upwardly extending fourth securement tab positioned on opposing sides of the center opening; and wherein at least one of the third securement tab and the fourth securement tab includes an adhesive facing the other of the fourth securement tab and the third securement tab, wherein the third securement tab is coupled to the fourth securement tab to define a second bridge extending over the center opening and capturing a second umbilical line between the third securement tab and the fourth securement tab.
However, the claim language of claim 19 effectively presents duplicates of the first and second securement tabs to make a second duplicate bridge for capturing a second umbilical line therein. Applicant’s instant disclose does not appear to provide any unpredictable results that arrive through providing a second duplicate set of identical structures wherein one of ordinary skill in the art would have found it readily obvious to provide a duplicate set of structures in Kyvik if a second umbilical catheter line was provided.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided “an upwardly extending third securement tab and an upwardly extending fourth securement tab positioned on opposing sides of the center opening; and wherein at least one of the third securement tab and the fourth securement tab includes an adhesive facing the other of the fourth securement tab and the third securement tab, wherein the third securement tab is coupled to the fourth securement tab to define a second bridge extending over the center opening and capturing a second umbilical line between the third securement tab and the fourth securement tab” as duplicate structures of the first and second securement tabs forming a bridge as discussed above, since it has been held that duplication of parts “has no patentable significance unless a new and unexpected result is produced” (see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)) (see MPEP 2144.04 VI B).
Regarding claim 29, Kyvik as combined discloses the invention of claim 25.
Kyvik as combined with Lavon discloses wherein the lower layer provides a water vapor transmission rate of between 2000 g/m2 per 24 hours and 3800 g/m2 per 24 hours (see claim 25, wherein Lavon provides a rate of 2000 g/m2 per 24 hours thus meeting this claim range).
Regarding claim 30, Kyvik as combined discloses the invention of claim 25.
Kyvik discloses wherein the adhesive is secured to an outer epidermis layer of the infant (see [0013] adhesive on skin of infant, this being inherently an outer epidermis layer).
Kyvik does not explicitly disclose the outer epidermis layer coupled to an inner dermis layer of the infant, the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
However, Kyvik discloses that that invention should be quickly and easily both adhered and removed from the patient (see [0003]), and further recites “whereby the base member 11 can be applied to the skin 91, will remain adhered for a suitable time period, and then easily removed”. The present claim language above is simply stating that the adhesive of the invention will not cause separation of the dermis layers when attempting to be removed. Examiner would assert that any bandage made to be used on the skin of infant especially around an umbilical cord in the case of Kyvik would implicitly provide adhesive that would not harm the infant or baby, and thus the adhesive tension between the adhesive and outer epidermis would always be less than the adhesive tension between the outer epidermis and inner dermis layer. Especially as easy removal as disclosed by Kyvik would require this, as if the adhesive tension on the outer skin was higher, than that would not constitute easy removal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have understood that the adhesive of Kyvik would implicitly and inherently have the function of the adhesive tension between the silicone adhesive and the outer epidermis layer being less than the adhesive tension between the outer epidermis layer and the inner dermis layer.
Kyvik does not disclose the lower surface adhesive being a silicone adhesive.
Kyvik does disclose that the adhesive of tabs 31 and 41 (Figures 1-4) being silicone (see [0017]) which is a known medical grade adhesive, and further says that the adhesive on the lower layer may be a hydrocolloid (see [0013]).
Lavon further teaches a skin care device for an infant (Figures 1A-4) that uses an analogous hydrocolloid for attaching to an infant (see [0011, 0013, [0058]), wherein the adhesive then may further be chosen to be silicone (see [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the lower surface adhesive being a silicone adhesive of Kyvik as taught by Kyvik wherein the disclosure already provides adhesive chosen on the device elsewhere being a silicone adhesive, and even further as taught by Lavon wherein Lavon provides silicone adhesive to be a known in the art adhesive for attaching a device to a skin of an infant near an umbilical cord safely.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Seshardi (US 20230329916 A1), in further view of Bechert (US 20070203442 A1), with evidentiary reference ICNRP (see attached NPLs), in view of Lavon (US 20190053962 A1) in further view of Chehab (US 20210106790 A1).
Regarding claim 26, Kyvik as combined discloses the invention of claim 25 above.
Kyvik as combined does not disclose wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
However, Chehab teaches an analogous umbilical securing catheter bandage 10 (Figures 1-2), wherein an entirety of the device 10 may be antimicrobial ([0011, 0245]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the entirety of the device of Kyvik with antimicrobial material/properties as taught by Chehab in order to keep the umbilical area from becoming infected, thus providing wherein the lower layer includes a first antimicrobial, and at least one of the first securement tab and the second securement tab includes a second antimicrobial.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyvik (US 20120316504 A1) in view of Seshardi (US 20230329916 A1), in further view of Bechert (US 20070203442 A1), with evidentiary reference ICNRP (see attached NPLs), in view of Lavon (US 20190053962 A1) in further view of Chehab (US 20210106790 A1), in further view of Bjornberg (US 20060129080 A1).
Regarding claim 27, Kyvik in view of Seshardi, Bechert, Lavon discloses the invention of claim 26 above.
Kyvik as combined does not disclose wherein the first antimicrobial comprises dialkylcarbamoyl chloride (DACC), and the second antimicrobial comprises chlorhexidine (CHG).
However, Bjornberg teaches an analogous skin care device being a wound dressing with antimicrobial properties (Title, Abstract), wherein Bjornberg firstly provides that chlorhexidine (CHG) is a known antimicrobial agent used in the bandage field of invention (see [0014]), and further provides that dialkylcarbamoyl chloride (DACC) is good skin contacting antimicrobial that also keepings the wound area hydrophobic allowing good adhesion with skin of a user (see [0029, 0047, 0052]).
Furthermore, Chehab does teach using chlorhexidine for sterilizing an umbilical catheter device (see [0180]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the antimicrobial CHG as taught by both Bjornberg and Chehab and the antimicrobial DACC as taught by Bjornberg to the antimicrobial of the entire device of Kyvik as modified by Chehab as these are antimicrobials that are known in the art and would have been obvious to try antimicrobials in the field of invention when choosing from a known and limited selection as provided by Bjornberg.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 4915694 A
US 4915694 A
US 6875200 B1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786