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 .
In light of the amendments to the claims filed 03/11/2026 in which 15, 19, and 22-24 were amended, claims 15-24 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a continuation of U.S. Application no. 17/930,291 filed on 09/07/2022 and 16/982,475 filed on 09/18/2020 which is a 371 of PCT/DK2019/050097 filed on 03/20/2019 which claims priority to DKPA/2019/00131 filed on 01/30/2019 and DKPA/2018/00132 filed on 03/21/2018.
Claims 15-24 receive priority to the prior-filed application, filed on 03/21/2018.
Response to Arguments
Objections to the Drawings/Specification
The objections to the drawings and the specification are withdrawn in view of the amendments to the drawings and the specification filed 03/11/2026.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 03/11/2026.
Rejections of the Claims under 35 U.S.C. 112(b)
The rejections of the claims under 112(b) are withdrawn in view of the amendments to the claims filed 03/11/2026.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 03/11/2026 have been fully considered but they are not persuasive.
Regarding claims 15-24, the applicant asserts on pg. 16-18 that the characterization of Lam as inherently comprising the properties claimed is not correct.
In response to the applicant’s argument, the examiner respectfully disagrees. Turning to the Specification, Applicant discloses that DOW Corning MG 7-9900 Soft Skin Adhesive is a suitable cross-linked polymer that comprises the claimed HMDSO absorption percentage (see Specification at pg. 29, “Sample Description”: Test Article TA-F; pg. 29-30, “Results”: Test Article TA-F). Lam also discloses the use of DOW Corning MG 7-9900 Soft Skin Adhesive as a suitable cross-linked silicone gel (para. 0031). Accordingly, the Lam reference teaches the use of a silicone adhesive comprising a cross-linked silicone gel with a HMDSO absorption within the range of 1100 to 2500%.
The applicant (remarks pg. 18) asserts there is no discussion in Lam to change the silicone gel adhesive to the claimed HMDSO. As Lam discloses the identical chemical structure as claimed in the instant application, Lam would not have to change the silicone gel adhesive to the claimed HMDSO as this is considered a property of the chemically cross-linked silicone gel adhesive of Lam.
Further regarding claims 15-24, the applicant asserts on pg. 18-19 that Salamone teaches away from the current invention.
In response to the applicant’s argument, the examiner respectfully disagrees. The applicant asserts (remarks pg. 18-19) that Salamone’s teachings are to weaken the bond between the medical device and the skin of the patient via a two component adhesive system such that Salamone teaches away from the current invention. The applicant further notes that the current invention is directed to the claimed combination which is shown to have a significantly positive effect on bond strength between the skin of a patient and the device connected to the patient. Unless a reference criticizes, discredits, or otherwise discourages a specific combination, the reference does not constitute a “teaching away” from a claimed combination (see MPEP 2145(X)(D)(1)). In the instant case, Applicant has not provided evidence that Salamone discourages the combination proposed by the Examiner.
While the text of the rejections have been rephrased to address applicant’s misapprehension, the grounds of rejection are maintained.
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 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.
Claims 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent no. 8,263,720 B1 to Salamone in view of US/2013/0274696 A1 to Lam.
Regarding claim 15, Salamone discloses a medical system comprising: a. a solution comprising a first silicone adhesive dissolved in a solvent suitable for application to the skin; said first silicone adhesive solution is adapted to leave an adhesive film on the skin after application and, b. a medical device having a surface comprising an adhesive (col. 3 ln. 31-65, liquid polymer-containing coating materials that create sacrificial adhesive coatings; col. 4 ln. 42-55; col. 25 ln. 23-67 and col. 26 ln. 1-2, method for applying solution comprising applying solution to skin, allowing solvent to evaporate to leave the adhesive sacrificial polymer coating, and applying a medical device comprising a barrier adhesive to a portion of the adhesive coating on the skin; medical system comprises solution to create sacrificial adhesive coatings and any medical device comprising adhesive applied to the sacrificial adhesive coatings).
Salamone differs from the instantly claimed invention in that Salamone fails to disclose a medical device having a surface comprising a second silicone adhesive comprising a cross-linked silicone gel; and characterized in that the second silicone adhesive has a HexaMethylDiSilOxane absorption (HMDSO) of 1100 to 2500%.
Lam teaches a medical device having a surface comprising a second silicone adhesive comprising a cross-linked silicone gel (Fig. 1, adhesive wafer 1 of an ostomy system comprising soft adhesive 5 comprising a cross-linked silicone gel with an HMDSO absorption of 1100-2500% for connection to a waste bag; para. 0030-0033).
Applicant discloses the use of DOW Corning MG 7-9900 as the cross-linked silicone gel adhesive (pg. 27 ln. 1-18, well-known silicone gel adhesives [Dow-Corning MG 7-9900 SSA]; pg. 29, “Sample Description”: Test Article TA-F; pg. 29-30, “Results”: Test Article TA-F) which Applicant discloses has a known HMDSO absorption of 1800% (which is within the range claimed by Applicant). Lam teaches the use of DOW Corning MG 7-9900 as a suitable ostomy adhesive. A person of ordinary skill in the art would see that Lam's disclosure drawn to using DOW Corning MG 7-9900 adhesive would take into account the known properties of DOW Corning MG 7-9900. That is, the mere use of DOW Corning MG 7-9900 adhesive teaches the use of an adhesive comprising a cross-linked silicone gel with a HMDSO absorption of 1100 to 2500%.
Further, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the medical system of Salamone to be used with the medical device of Lam, because Lam discloses an ostomy flange that comprises silicone pressure sensitive adhesives and silicone gel adhesives (para. 0019; para. 0027-0033), Salamone discloses using their medical system with ostomy devices (col. 3 ln. 48-65; col. 3 ln. 59-60), and Salamone further discloses that while silicone pressure sensitive adhesives and silicone gel adhesives are considered the most comfortable adhesives for painless removal from the skin, they have a disadvantage in not being applied as a liquid adhesive which limits their ability to intimately conform to a contoured skin surface or wounded, damaged, or inflamed skin (col. 2 ln. 35-45) that may be common in the peristomal area.
Regarding claim 16, the combination of Salamone and Lam suggests the invention of claim 15.
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose wherein the second silicone adhesive has a Gel-percentage of 60 to 100.
Lam teaches a medical device having a surface comprising a second silicone adhesive comprising a cross-linked silicone gel (Fig. 1, adhesive wafer 1 of an ostomy system comprising soft adhesive 5 comprising a cross-linked silicone gel with a Gel-percentage of 60 to 100 for connection to a waste bag; para. 0030-0033).
Applicant discloses the use of DOW Corning MG 7-9900 as the cross-linked silicone gel adhesive (pg. 27 ln. 1-18, well-known silicone gel adhesives [Dow-Corning MG 7-9900 SSA]; pg. 29, “Sample Description”: Test Article TA-F; pg. 29-30, “Results”: Test Article TA-F) which Applicant discloses has a known gel percentage of 76% (which is within the range claimed by Applicant). Lam teaches the use of DOW Corning MG 7-9900 as a suitable ostomy adhesive. A person of ordinary skill in the art would see that Lam's disclosure drawn to using DOW Corning MG 7-9900 adhesive would take into account the known properties of DOW Corning MG 7-9900. That is, the mere use of DOW Corning MG 7-9900 adhesive teaches the use of an adhesive comprising a cross-linked silicone gel with a Gel-percentage of 60 to 100.
Regarding claim 17, the combination of Salamone and Lam suggests the invention of claim 15. Lam further discloses: wherein the second silicone adhesive has a Modulus of less than 100 kPa (para. 0034).
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose wherein the second silicone adhesive has a Modulus of 0.35 to 0.65 N/mm.
Lam discloses (para. 0030-0038) that a significant difference between hydrocolloid adhesives and silicone gel adhesives is that the soft silicone gel adhesives are much softer and have a better “wetting ability”. These differences enable the soft adhesive to be given a lower specific adhesiveness which needs to be optimized such that the adhesion shall be as strong as possible without the risk of the surface layer of the epidermis being removed by the adhesive layer; therefore, the modulus modifies the specific adhesiveness and may be considered a result effective variable. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Lam device to have a modulus within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lam by making the modulus of the second silicone adhesive be between 0.35 and 0.65 N/mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, the combination of Salamone and Lam suggests the invention of claim 15. Lam further discloses: wherein the second silicone adhesive is attached in an average thickness of from 0.01-20 mm on a surface of the medical device (para. 0057; 1 micron = 0.001 mm).
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose wherein the second silicone adhesive is attached in an average thickness of from 0.5 to 5.0 mm on a surface of the medical device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the second silicone adhesive of Lam from between 0.01-20 mm to between 0.5-5.0 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 11 ln. 16-22 indicating that the value is simply within the claimed range).
Regarding claim 19, the combination of Salamone and Lam suggests the invention of claim 15. Salamone further discloses: wherein the first silicone adhesive solution is intended to leave the adhesive film on the skin after the solvent has evaporated, said adhesive film having an average thickness of 0.0787 or 0.08331 mm (col. 27 ln. 1-32; 1 mil = 0.0254 mm).
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose wherein the first silicone adhesive solution is intended to leave a film on the skin, after the solvent has evaporated, said first adhesive film having an average thickness of at most 0.5 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Salamone to have an average thickness of at most 0.5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Salamone would not operate differently with the claimed thickness and since Salamone provides two thickness values of the first adhesive film below 0.5 mm, the device would function appropriately having the claimed thickness. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the thickness is simply within the claimed range (pg. 12 ln. 5-10).
Regarding claim 20, the combination of Salamone and Lam suggests the invention of claim 15. Salamone further discloses: wherein the concentration of the first silicone adhesive in the solution is from 1-50 w/w percent (col. 7 ln. 62-67) and a colourant is present in the solution (col. 9 ln. 42-51).
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose wherein the concentration of the first silicone adhesive in the solution is from 45 to 65 w/w percent and a colourant is present in a concentration of 0.8 to 2.0 percent in the solution.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of the first silicone adhesive of Salamone from between 1-50 weight percent to between 45-65 weight percent since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pg. 13 ln. 12-21 indicating the weight percent is simply within the claimed range).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of the colourant of Salamone to be between 0.8-2.0 weight percent since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Salamone would not operate differently with the claimed colourant concentration and since Salamone discloses the use of a colourant and the amount is largely negligible, the device would function appropriately having the claimed concentration. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the concentration is simply within the claimed range (specification pg. 13 ln. 19-21).
Regarding claim 21, the combination of Salamone and Lam suggests the invention of claim 15. Lam further discloses: wherein the medical device comprises: a. a non-replaceable part; and b. optionally, a replaceable part, said replaceable part to be replaced more frequently than the non-replaceable part; wherein the non-replaceable part comprises the second silicone adhesive (Fig. 1, adhesive wafer 1 as the non-replaceable part of an ostomy system comprising soft adhesive 5 for connection to a waste bag; para. 0003, medical device considered adhesive wafer 1 and waste bag; para. 0030-0033).
Regarding claim 22, the combination of Salamone and Lam suggests the invention of claim 15. Salamone and Lam further suggest: method for producing a medical system according to claim 15 (as explained above and including the rejection of claim 15), the method comprising the steps of: a. providing the solution comprising the first silicone adhesive dissolved in the solvent suitable for application to the skin; said first silicone adhesive solution is adapted to leave the adhesive film on the skin after application; b. providing the medical device having the surface comprising the second silicone adhesive comprising the cross-linked silicone gel having the HexaMethylDiSilOxane absorption (HMDSO) of 1100 to 2500% (Salamone: col. 3 ln. 31-65, liquid polymer-containing coating materials that create sacrificial adhesive coatings; col. 4 ln. 42-55; col. 25 ln. 23-67 and col. 26 ln. 1-2, method for applying solution comprising applying solution to skin, allowing solvent to evaporate to leave the adhesive sacrificial polymer coating, and applying a medical device comprising a barrier adhesive to a portion of the adhesive coating on the skin; medical system comprises solution to create sacrificial adhesive coatings and any medical device comprising adhesive applied to the sacrificial adhesive coatings; Lam: Fig. 1, adhesive wafer 1 of an ostomy system comprising soft adhesive 5 for connection to a waste bag; para. 0003, medical device considered adhesive wafer 1 and waste bag; para. 0030-0033).
The prior art differ from the instantly claimed invention in that the prior art fail to explicitly disclose packing at least the medical device.
It would be considered obvious to one of ordinary skill in the art to pack the medical device, as it is well-known in the art to provide packaging for medical devices.
Regarding claim 23, the combination of Salamone and Lam suggests the invention of claim 15. Salamone and Lam further suggest: a method for attaching a medical system according to claim 15 to a skin surface (as explained above and including the rejection of claim 15), the method comprising the steps of: a. applying the solution comprising the first silicone adhesive dissolved in the solvent suitable for application to the skin on the skin surface; b. evaporating a sufficient amount of the solvent to leave the adhesive film on the skin; and c. applying the medical device comprising the second silicone adhesive comprising the cross-linked silicone gel having a HexaMethylDiSilOxane absorption (HMDSO) of 1100 to 2500% to at least a portion of the adhesive film on the skin (Salamone: col. 3 ln. 31-65, liquid polymer-containing coating materials that create sacrificial adhesive coatings; col. 4 ln. 42-55; col. 25 ln. 23-67 and col. 26 ln. 1-2, method for applying solution comprising applying solution to skin, allowing solvent to evaporate to leave the adhesive sacrificial polymer coating, and applying a medical device comprising a barrier adhesive to a portion of the adhesive coating on the skin; medical system comprises solution to create sacrificial adhesive coatings and any medical device comprising adhesive applied to the sacrificial adhesive coatings; col. 25 ln. 23-67 and col. 26 ln. 1-2, method for applying solution comprising applying solution to skin, allowing solvent to evaporate to leave the adhesive sacrificial polymer coating, and applying a medical device comprising a barrier adhesive to a portion of the adhesive coating on the skin; Lam: Fig. 1, adhesive wafer 1 of an ostomy system comprising soft adhesive 5 for connection to a waste bag; para. 0003, medical device considered adhesive wafer 1 and waste bag; para. 0030-0033).
Regarding claim 24, Salamone discloses a dual adhesive system for attaching a medical device to the skin, said dual adhesive system comprising: a. a solution comprising a first silicone adhesive being dissolved in a solvent for application on the skin; said first adhesive after application on the skin being adapted to leave an adhesive film on the skin; b. a second adhesive adapted to be attached to a medical device (col. 3 ln. 31-65, liquid polymer-containing coating materials that create sacrificial adhesive coatings; col. 4 ln. 42-55; col. 25 ln. 23-67 and col. 26 ln. 1-2, method for applying solution comprising applying solution to skin, allowing solvent to evaporate to leave the adhesive sacrificial polymer coating, and applying a medical device comprising a barrier adhesive to a portion of the adhesive coating on the skin; medical system comprises solution to create sacrificial adhesive coatings and any medical device comprising adhesive applied to the sacrificial adhesive coatings).
Salamone differs from the instantly claimed invention in that Salamone fails to disclose a second silicone adhesive comprising a cross-linked silicone gel; and adapted to be attached to a medical device; and characterized in that the second silicone adhesive has a HMDSO-absorption of 1100 to 2500%.
Lam teaches a medical device having a surface comprising a second silicone adhesive comprising a cross-linked silicone gel (Fig. 1, adhesive wafer 1 of an ostomy system comprising soft adhesive 5 comprising a cross-linked silicone gel with an HMDSO absorption of 1100-2500% for connection to a waste bag; para. 0030-0033).
Applicant discloses the use of DOW Corning MG 7-9900 as the cross-linked silicone gel adhesive (pg. 27 ln. 1-18, well-known silicone gel adhesives [Dow-Corning MG 7-9900 SSA]; pg. 29, “Sample Description”: Test Article TA-F; pg. 29-30, “Results”: Test Article TA-F) which Applicant discloses has a known HMDSO absorption of 1800% (which is within the range claimed by Applicant). Lam teaches the use of DOW Corning MG 7-9900 as a suitable ostomy adhesive. A person of ordinary skill in the art would see that Lam's disclosure drawn to using DOW Corning MG 7-9900 adhesive would take into account the known properties of DOW Corning MG 7-9900. That is, the mere use of DOW Corning MG 7-9900 adhesive teaches the use of an adhesive comprising a cross-linked silicone gel with a HMDSO absorption of 1100 to 2500%.
Further, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the medical system of Salamone to be used with the medical device of Lam, because Lam discloses an ostomy flange that comprises silicone pressure sensitive adhesives and silicone gel adhesives (para. 0019; para. 0027-0033), Salamone discloses using their medical system with ostomy devices (col. 3 ln. 48-65; col. 3 ln. 59-60), and Salamone discloses that while silicone pressure sensitive adhesives and silicone gel adhesives are considered the most comfortable adhesives for painless removal from the skin, they have a disadvantage in not being applied as a liquid adhesive which limits their ability to intimately conform to a contoured skin surface or wounded, damaged, or inflamed skin (col. 2 ln. 35-45) that may be common in the peristomal area.
Conclusion
THIS ACTION IS MADE FINAL. 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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 22 May 2026
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