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 .
Response to Arguments
Applicant’s arguments, see page 5, filed 30JUL2025, with respect to the rejection(s) of claim(s) 70 and 82 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Cernasov in view of Tai.
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) 70, 74, and 82-88 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170202711 A1 (Cernasov et al.) in view of US 20160287101 A1 (Tai et al.).
Regarding claim 70, Cernasov teaches a wound dressing (200) (Figs. 8a and 8b) comprising:
a flexible wound contact layer (606 and associated carrier plate 104) [0034] including an opening (616) configured to allow liquid to pass through the wound contact layer [0035] and a first side (wound facing Fig. 8b) supporting a plurality of electronic components (at least 610 and 612);
wherein the first side is coated with a first biocompatible coating (814), and one or more remaining areas of the first side of the wound contact layer and a second side of the wound contact layer opposite the first side are coated with a second biocompatible coating (806), the second biocompatible coating extending through the flexible wound contact layer as described in [0039] and illustrated for a single pad protrusion in Cernasov Annotated Figs. 8a and 8b below.
Cernasov fails to teach the second biocompatible coating covers at least one of the plurality of electronic components or the first biocompatible coating has a different stretchability from the second biocompatible coating.
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Cernasov Annotated Figs. 8a and 8b
Tai teaches a medical device (800) (Figs. 8 and 9) intended for implantation, which is therefore considered to contact a wound, the device comprising:
a wound contact layer (820) including a first side (the side containing 852 and 854) supporting a plurality of electronic components (pressure sensor 810, Tai further teaching use with other sensors [0060]);
wherein the first side is coated with a first biocompatible coating (840) [0047], and
wherein one or more remaining areas of the first side of the wound contact layer (the remaining area located away from the sensor), at least one of the plurality of electronic components (Fig. 9), and a second side (the opposing side) of the wound contact layer opposite the first side are coated with a second biocompatible coating (910), and
wherein the first biocompatible coating has a different stretchability from the second biocompatible coating (silicone oil being a liquid [0047] and the parylene coating being a flexible coating [0083, 0006].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating arrangement of Cernasov to incorporate the coating arrangement of Tai wherein the second coating covers one or more remaining areas of the first side of the wound contact layer, at least one of the plurality of electronic components and a second side of the wound contact layer in order to ensure the electronics are protected in a biocompatible device [Tai 0077].
Regarding claim 74, Cernasov in view of Tai teaches the wound dressing of claim 70.
Cernasov fails to teach the first biocompatible coating and the second biocompatible coating are hydrophobic.
Tai further teaches the first biocompatible coating (840) is hydrophobic [0030], and second biocompatible coating (910) is hydrophobic, being formed of silicone or poly(p-xylylene) which are both hydrophobic [0030].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first biocompatible coating and the second biocompatible coating of Cernasov in view of Tai to be hydrophobic as taught by Tai to ensure operational components do not contact harmful environmental agents [Tai 0031].
Regarding claim 82, Cernasov teaches a wound dressing (200) (Figs. 8a and 8b) comprising:
a flexible wound contact layer (606 and associated carrier plate 104) [0034] including an opening (616) configured to allow liquid to pass through the wound contact layer [0035] and having a first side (wound facing Fig. 8b) supporting a plurality of electronic components (at least 610 and 612);
wherein the first side is coated with a first biocompatible coating (814), and one or more remaining areas of the first side of the wound contact layer and a second side of the wound contact layer opposite the first side are coated with a second biocompatible coating (806), the second biocompatible coating extending through the flexible wound contact layer as described in [0039] and illustrated for a single pad protrusion in Cernasov Annotated Figs. 8a and 8b below.
Cernasov fails to teach the first biocompatible coating and the second biocompatible coating are hydrophobic.
Tai teaches a medical device (800) (Figs. 8 and 9) intended for implantation, which is therefore considered to contact a wound, the device comprising:
a wound contact layer (820) including a first side (the side containing 852 and 854) supporting a plurality of electronic components (pressure sensor 810, Tai further teaching use with other sensors [0060]);
wherein the first side is coated with a first biocompatible coating (840) [0047], and
wherein one or more remaining areas of the first side of the wound contact layer (the remaining area located away from the sensor), at least one of the plurality of electronic components (Fig. 9), and a second side (the opposing side) of the wound contact layer opposite the first side are coated with a second biocompatible coating (910), and
wherein the first biocompatible coating has a different stretchability from the second biocompatible coating (silicone oil being a liquid [0047] and the parylene coating being a flexible coating [0083, 0006].
Tai further teaches the first biocompatible coating (840) is hydrophobic [0030], and second biocompatible coating (910) is hydrophobic, being formed of silicone or poly(p-xylylene) which are both hydrophobic [0030].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating arrangement of Cernasov to incorporate the coating arrangement of Tai wherein the second coating covers one or more remaining areas of the first side of the wound contact layer, at least one of the plurality of electronic components and a second side of the wound contact layer in order to ensure the electronics are protected in a biocompatible device [Tai 0077], and to have modified the first biocompatible coating and the second biocompatible coating of Cernasov in view of Tai to be hydrophobic as taught by Tai to ensure operational components do not contact harmful environmental agents [Tai 0031].
Regarding claim 83, Cernasov in view of Tai teaches the wound dressing of claim 70.
Cernasov further teaches the one or more remaining areas of the first side comprise areas of the wound contact layer on which there are no electronic components, springs (818) not being electronic components [0039].
Regarding claim 84, Cernasov in view of Tai teaches the wound dressing of claim 82.
Cernasov further teaches the one or more remaining areas of the first side comprise areas of the wound contact layer on which there are no electronic components, springs (818) not being electronic components.
Regarding claim 85, Cernasov fails to explicitly teach the first biocompatible coating is substantially non-stretchable.
Tai in the device of claim 70 is considered to teach the first biocompatible coating (840) is substantially non-stretchable as the coating is a liquid [0079] and liquids are not considered “stretchable”.
Regarding claim 86, Cernasov further teaches use of an adhesive (202) configured to adhere the flexible wound contact layer to skin [0025].
Regarding claim 87, Cernasov further teaches an absorbent layer (such as a sponge or gauze) above the wound contact layer [0026], said layer seen extending above the contact layer in Fig. 3a.
Regarding claim 88, Cernasov further teaches an absorbent layer (such as a sponge or gauze) above the wound contact layer [0026], said layer seen extending above the contact layer in Fig. 3a.
Claim(s) 72, 75 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Cernasov in view of Tai and further in view of US 20150091588 A1 (Wickboldt et al.).
Regarding claims 72 and 76, Cernasov in view of Tai teaches the wound dressing of claim 70.
Cernasov fails to teach the first biocompatible coating comprises at least one of Dymax 20351, Dymax 20558, Dymax 9001-E, or Loctite 3211, or the first biocompatible coating has viscosity of no more than about 50,000 centipoise.
Wickboldt teaches a biocompatible device with embedded electronics (Fig. 1) wherein the first biocompatible coating comprises Dymax 9001-E [0051], said coating having a viscosity of 4,500 cP (Dymax 9001-E Data Sheet).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the biocompatible coating of Cernasov in view of Tai with the biocompatible coating of Wickboldt as a simple substitution of one known element for another to obtain a predictable result when choosing from the plurality of biocompatible coatings taught by Wickboldt [0051] MPEP 2143 I.
Regarding claim 75, Cernasov in view of Tai teaches the wound dressing of claim 70.
Cernasov fails to specify the first biocompatible coating and the second biocompatible coating are formed from material compliant with IEC 60601 standard.
Wickboldt teaches a biocompatible device with embedded electronics (Fig. 1) wherein the first biocompatible coating comprises Dymax 9001-E [0051], said coating having a viscosity of 4,500 cP (Dymax 9001-E Data Sheet).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the biocompatible coating of Cernasov in view of Tai with the biocompatible coating of Wickboldt as a simple substitution of one known element for another to obtain a predictable result when choosing from the plurality of biocompatible coatings taught by Wickboldt [0051] MPEP 2143 I.
Based on the instant specification [0008], materials such as Dymax 9001-E are considered to fulfill the claim requirement wherein the material is compliant with IEC 60601 standards. See MPEP 2112.
Claim(s) 73 is rejected under 35 U.S.C. 103 as being unpatentable over Cernasov in view of Tai and further in view of US 20180235646 A1 (Locke et al.).
Regarding claim 73, Cernasov in view of Tai teaches the wound dressing of claim 70.
Cernasov fails to teach the wound contact layer is formed at least partially from hydrophilic material.
Locke teaches a wound dressing (102) (Fig. 1) supporting a plurality of electronic components (120 and 122) wherein the wound contact layer (108) is formed at least partially from hydrophilic material [0062].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wound contact layer of Cernasov in view of Tai with the hydrophilic layer of Locke to control the fluid distribution at the wound without interrupting pressure distribution [Locke 0062].
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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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