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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/9/2026 has been entered.
Response to Amendment
The amendments made to claim 19 in the response filed on 4/9/2026 are acknowledged.
Claims 19, 21-22, 24-30, and 32-41 are still pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim 19 have been considered but are moot because the new ground of rejection (DE 102014013448 A1) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claims 21-22 and 24-30 have been considered but are also moot because the new ground of rejection (DE 102014013448 A1) in claim 19 does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 29 objected to because of the following informalities: “wherein the second surface of the substrate comprises a third area adjacent to the second area, and further wherein the third area defines a perimeter of the adhesive article” should be “wherein the second surface of the substrate comprises a third area adjacent to the second area of the second surface of the substrate, and further wherein the third area of the second surface of the substrate defines a perimeter of the adhesive article” in lines 1-3. Appropriate correction is required.
Claim 40 objected to because of the following informalities: “wherein the second surface of the substrate comprises a third area adjacent to the second area, and further wherein the third area defines a perimeter of the adhesive article” should be “wherein the second surface of the substrate comprises a third area adjacent to the second area of the second surface of the substrate, and further wherein the third area of the second surface of the substrate defines a perimeter of the adhesive article” in lines 1-3. Appropriate correction is required.
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.
Claim 32 is 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. Claims 33-41 are also rejected due to their dependency on claim 32.
Regarding claim 32, the limitation “wherein a first portion of the first surface of the second adhesive layer forms an interface between the second surface of the first adhesive layer and a second portion of the first surface of the second adhesive layer is disposed on the second area of the second surface of the substrate” is unclear. Examiner is unsure of where the first portion of the first surface of the second adhesive layer is in between; the limitation only mentions the second surface of the first adhesive layer. Examiner examined this claim as best understood.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 19, 21, 24, and 26-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rybach et al. (DE 102014013448 A1), with extrinsic evidence provided by “PubChem” for the rejection of claims 24 and 28.
Regarding claim 19, Rybach et al. discloses an adhesive article (see annotated figure 1, a transdermal therapeutic system: paragraph 0008/0014/0016) comprising: an active pharmaceutical ingredient (the adhesive article [annotated figure 1] comprises buprenorphine: paragraph 0008/0014/0016); a substrate (1 – see annotated figure 1, a protective layer: paragraph 0014) comprising a first surface (AA – see annotated figure 1, a first surface of the substrate) and a second surface (AB – see annotated figure 1, a second surface of the substrate), wherein the second surface (AB) comprises a first area (AC – see annotated figure 1, a first area of the second surface) and a second area (AD – see annotated figure 1, a second area of the second surface); a first adhesive layer (2 – see annotated figure 1, a matrix layer comprising the buprenorphine and is a pressure sensitive adhesive: paragraph 0014/0033) disposed on the first area of the second surface of the substrate (AC) (see annotated figure 1, the first adhesive layer [2] is disposed on the first area of the second surface of the substrate [AC]), the first adhesive layer (2) comprising a first surface (AE – see annotated figure 1, a first surface of the first adhesive layer) in contact with the second surface of the substrate (AB) (see annotated figure 1, the first surface of the adhesive layer [AE] is in contact with the second surface of the substrate [AB]) and a second surface (AF – see annotated figure 1, a second surface of the first adhesive layer) opposed to the second surface of the substrate (AB) (see annotated figure 1, the second surface of the first adhesive layer [AF] is opposed to the second surface of the substrate [AB]), wherein the active pharmaceutical ingredient (buprenorphine: paragraph 0008/0014/0016) is present in the first adhesive layer (2) at a first concentration (the first adhesive layer [2] comprises a physiologically effective amount of buprenorphine: paragraph 0008); and a second adhesive layer (3 – see annotated figure 1, an adhesive layer: paragraph 0014) comprising a first surface (AG – see annotated figure 1, a first surface of the second adhesive layer) and a second surface (AH – see annotated figure 1, a second surface of the second adhesive layer) opposed to the first surface (AG) (see annotated figure 1, the second surface [AH] is opposed to the first surface [AG]), wherein a first portion of the first surface of the second adhesive layer (AI – see annotated figure 1, a first portion of the first surface of the second adhesive layer) is in direct contact with the second surface of the first adhesive layer (AF) (see annotated figure 1, the first portion of the first surface of the second adhesive layer [AI] directly contacts the second surface of the first adhesive layer [AF]) and a second portion of the first surface of the second adhesive layer (AJ – see annotated figure 1, a second portion of the first surface of the second adhesive layer) is disposed on the second area of the second surface of the substrate (AD) (see annotated figure 1, the second portion of the first surface of the second adhesive layer [AJ] is disposed on the second area of the second surface of the substrate [AD]), wherein the active pharmaceutical ingredient (buprenorphine: paragraph 0008/0014/0016) in the second adhesive layer (3) proximate the second area of the substrate (AD) is present at a second concentration (the buprenorphine from the first adhesive layer [2] diffuses into the second adhesive layer [3]; therefore, the second adhesive layer [3] proximate the second area of the substrate [AD] comprises a concentration of buprenorphine: paragraph 0029); wherein the second concentration is less than the first concentration (the buprenorphine in the first adhesive layer [2] diffuses into the second adhesive layer [3]; this implies that there is a concentration gradient and that the first concentration from the first adhesive layer [2] is greater than the second concentration in the second adhesive layer [3]: paragraph 0029).
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Annotated figure 1: adhesive article of Rybach et al.
Regarding claim 21, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses a backing layer (4 – see annotated figure 1, a covering layer: paragraph 0014) in contact with the second surface of the second adhesive layer (AH) (see annotated figure 1, the backing layer [4] is in contact with the second surface of the second adhesive layer [AH]).
Regarding claim 24, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses wherein the active pharmaceutical ingredient has a molecular weight of less than 500 Daltons (the active pharmaceutical ingredient is buprenorphine; buprenorphine has a molecular weight of 467.6 g/mol or Daltons [as evidenced by “PubChem”] which is less than 500 g/mol or Daltons).
Regarding claim 26, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses wherein the first adhesive layer (2) is configured to be applied to and remain in contact with the skin of a user (the first adhesive layer [2] is applied to and remain in contact with the skin of a user: paragraph 0030/0033-0035).
Regarding claim 27, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses wherein the active pharmaceutical ingredient is present in the adhesive article (annotated figure 1) at a therapeutic amount (the adhesive article [annotated figure 1] comprises a physiologically effective amount of buprenorphine: paragraph 0008).
Regarding claim 28, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses wherein the active pharmaceutical ingredient has a molecular weight of no more than 600 Daltons (the active pharmaceutical ingredient is buprenorphine; buprenorphine has a molecular weight of 467.6 g/mol or Daltons [as evidenced by “PubChem”] which is less than 600 g/mol or Daltons).
Regarding claim 29, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses wherein the second surface of the substrate (AB) comprises a third area (AL – see annotated figure 1, a third area) adjacent to the second area (AD) (see annotated figure 1, the third area [AL] is adjacent to the second area [AD]), and further wherein the third area (AL) defines a perimeter of the adhesive article (annotated figure 1) (see annotated figure 1, the third area defines the perimeter of the adhesive article [annotated figure 1]).
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Rybach et al. (DE 102014013448 A1) in view of Tapolsky et al. (US 20050147658 A1).
Regarding claim 22, Rybach et al. discloses the invention as discussed in claim 21.
However, Rybach et al. fails to disclose wherein the backing layer has a surface area of between 5 and 100 cm2.
Tapolsky et al. teaches wherein an analogous backing layer (1 – figure 1, a backing layer: paragraph 0020) has a surface area of between 5 and 100cm2 (figure 1, the backing layer [1] can be approximately the same size as the other layers and are laminated together; the surface area of the device can be preferably 0.5cm2 to about 20cm2. The prior art’s range overlaps the claimed range of 5-100cm2: paragraph 0058/0064-0065).
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified surface area of the backing layer from 0.5-20cm2 to 5-100cm2 to allow the adhesive article to be cut and sized depending on location of application and purpose (paragraph 0065, Tapolsky et al.). Additionally, the claimed value lies within the range disclosed by the prior art (please see MPEP 2144.05 I., “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”). Further, applicant places no criticality on the range claimed, indicating simply that the surface area of the backing layer has a surface area of between 5 and 100cm2, 5 and 40cm2, or 5 and 20cm2 (specification paragraph: 0032/0040).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Rybach et al. (DE 102014013448 A1).
Regarding claim 25, Rybach et al. discloses the invention as discussed in claim 19. Rybach et al. further discloses an outer perimeter of the second area of the second surface of the substrate (AK – see annotated figure 1, an outer perimeter of the second area of the second surface of the substrate).
However, Rybach et al. fails to explicitly disclose wherein an outer perimeter of the second area of the second surface of the substrate comprises a circular or ovular shape.
It would have been an obvious matter of design choice to make the outer perimeter of the second area of the second surface of the substrate of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, applicant places no criticality on the shape claimed, indicating simply that the shape “may” form various shapes or patterns, including circular, ovular, square, rectangle, heart-shaped, or any other shape suitable for application to the skin (written specification: paragraph 0023).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Rybach et al. (DE 102014013448 A1) in view of Tolia et al. (US 20170290779 A1).
Regarding claim 30, Rybach et al. discloses the invention as discussed in claim 21.
However, Rybach et al. fails to disclose a penetration enhancer.
Tolia et al. teaches an analogous adhesive article (200 – figure 2, a dermal device: paragraph 0043) comprising a penetration enhancer (the first adhesive layer [221 – figure 2] of the adhesive article [200] can comprise additional excipients such as enhancers: paragraph 0060).
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 provided the adhesive article of Rybach et al. with a penetration enhancer as taught by Tolia et al. in order to provide an improved adhesive article that promotes the penetration of active agents through the user’s skin (paragraph 0060, Tolia et al.).
Claims 32-33, 35-38, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Tolia et al. (US 20170290779 A1).
Regarding claim 32, Tolia et al. discloses an adhesive article (200 – see annotated figure 2, a dermal device: paragraph 0043) comprising: an active pharmaceutical ingredient (the inner active reservoir [221 – see annotated figure 2] comprises pharmaceutical agents: paragraph 0043/0064); a substrate (230 – see annotated figure 2, a removable release liner: paragraph 0043) comprising a first surface (A – see annotated figure 2, first surface of the substrate) and a second surface (B – see annotated figure 2, a second surface of the substrate), wherein the second surface (B) comprises a first area (C – see annotated figure 2, first area of the second surface of the substrate) and a second area (D – see annotated figure 2, second area of the second surface of the substrate); a first adhesive layer (221 – see annotated figure 2, an inner disk active reservoir that can include pressure sensitive adhesives: paragraph 0043/0066-0068) disposed on the first area of the second surface of the substrate (C) (see annotated figure 2, the first adhesive layer [221] is disposed on the first area of the second surface of the substrate [C]), the first adhesive layer (221) comprising a first surface (E – see annotated figure 2, first surface of the first adhesive layer) in contact with the second surface of the substrate (B) (see annotated figure 2, the first surface [E] is in contact with the second surface of the substrate [B] when assembled) and a second surface (F – see annotated figure 2, second surface of the first adhesive layer) opposed to the second surface of the substrate (B) (see annotated figure 2, the second surface [F] is opposite of the second surface of the substrate [B]), wherein the active pharmaceutical ingredient is present in the first adhesive layer (221) at a first concentration (the first adhesive layer [221] comprises active agents at a concentration: paragraph 0043/0064); and a second adhesive layer (212 – see annotated figure 2, an outer disk overlay adhesive: paragraph 0043) comprising a first surface (G – see annotated figure 2, first surface of the second adhesive layer) and a second surface (H – see annotated figure 2, second surface of the second adhesive layer) opposed to the first surface (G) (see annotated figure 2, the second surface [H] is opposed to the first surface [G]), wherein a first portion of the first surface of the second adhesive layer (I – see annotated figure 2, a first portion of the first surface of the second adhesive layer) forms an interface between the second surface of the first adhesive layer (F) and a second portion of the first surface of the second adhesive layer (J – see annotated figure 2, a second portion of the first surface of the second adhesive layer) is disposed on the second area of the second surface of the substrate (D) (see annotated figure 2, the first portion of the first surface of the second adhesive layer [I] forms an interface with the inner active reservoir layer backing [222 – see annotated figure 2] that is located between the second surface of the first adhesive layer [F] and the second portion of the first surface of the second adhesive layer [J]; the second portion of the first surface of the second adhesive layer [J] is disposed on the second area of the second surface of the substrate [D]).
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Annotated figure 2: adhesive article of Tolia et al.
However, Tolia et al. fails to explicitly disclose wherein the active pharmaceutical ingredient in the second adhesive layer proximate the second area of the substrate is present at a second concentration; wherein the second concentration is less than the first concentration.
Tolia et al. teaches wherein the active pharmaceutical ingredient in the second adhesive layer (212) proximate the second area of the substrate (D) (see annotated figure 1, the second adhesive layer [212] is proximate to the second area of the substrate [D]; the second adhesive layer [212] is affixed to the second area of the substrate [D]: paragraph 0043) is present at a second concentration (the present invention of Tolia et al. is an alternative double disk configuration where there is an impermeable backing [222] that extends in all directions from the inner active reservoir film [221]; this helps minimize the migration of active agents from the inner active reservoir film [221, first adhesive layer] to the outer adhesive overlay [212, second adhesive layer]. Therefore, it is implied that there is a concentration amount of the active pharmaceutical ingredient in the second adhesive layer [212] proximate the second area of the substrate [D]. The term “minimize” is defined as “to reduce or keep to a minimum” by https://www.merriam-webster.com/dictionary/minimize; based on the definition of “minimize”, it can be implied that there is some kind of concentration amount, whether it is small or large, of the active pharmaceutical ingredient in the outer adhesive overlay [212] due to how the inner active reservoir layer backing [222] only minimizes the migration of active agents from the active reservoir layer [221] to the outer adhesive overlay [212]. The term “minimize” does not mean that all of the active agents are contained within the active reservoir layer [221] by the inner active reservoir layer backing [222]: paragraph 0004/0009); wherein the second concentration is less than the first concentration (it can also be implied that the second concentration of active pharmaceutical ingredient is less than the first concentration of active pharmaceutical ingredient because it was noted that incorporating an impermeable backing [222] that extends in all directions from the inner active reservoir film [221, first adhesive layer] helps minimize the migration of active agents from the inner active reservoir film [221, first adhesive layer] to the outer adhesive overlay [212, second adhesive layer]. The term “minimize” is defined as “to reduce or keep to a minimum” by https://www.merriam-webster.com/dictionary/minimize; based on the definition of “minimize”, it can be implied that there is some kind of concentration amount, whether it is small or large, of the active pharmaceutical ingredient in the outer adhesive overlay [212] due to how the inner active reservoir layer backing [222] only minimizes the migration of active agents from the active reservoir layer [221] to the outer adhesive overlay [212]. The term “minimize” does not mean that all of the active agents are contained within the active reservoir layer [221] by the inner active reservoir layer backing [222]: paragraph 0004/0009).
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 the second adhesive layer of Tolia et al. with a second concentration that is less than the first concentration as taught by Tolia et al. in order to provide an improved adhesive article to prevent unfavorable effects to product characteristics such as efficacy, adhesion, and drug release/delivery profile over its shelf-life (paragraph 0004, Tolia et al.).
Regarding claim 33, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses a backing layer (211 – see annotated figure 2, an outer disk overlay backing: paragraph 0043) in contact with the second surface of the second adhesive layer (H) (see annotated figure 2, the backing layer [211] is in contact with the second surface of the second adhesive layer [H]: paragraph 0043).
Regarding claim 35, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses wherein the adhesive article (200) has a first thickness (N – see annotated figure 3, a first thickness) proximate the first area of the second surface of the substrate (C) (see annotated figure 2/annotated figure 3, the first thickness [N] is proximate to the first area of the second surface of the substrate [C]; the term “proximate” is defined as “ very near” by PROXIMATE Definition & Meaning - Merriam-Webster. The first thickness [N] is near the first area of the second surface of the substrate [C]) and a second thickness proximate (M – see annotated figure 3, a second thickness) the second area of the second surface of the substrate (D) (see annotated figure 2/annotated figure 3, the second thickness [M] is proximate to the second area of the second surface of the substrate [D]; the term “proximate” is defined as “ very near” by PROXIMATE Definition & Meaning - Merriam-Webster. The second thickness [M] is near the second area of the second surface of the substrate [D]), wherein the first thickness (N) is less than the second thickness (M) (see annotated figure 3, the second adhesive layer [212] is affixed to the substrate [230] and extends/surrounds on all sides of the first adhesive layer [221]; therefore, the first thickness [N] would be less than the second thickness [M]: paragraph 0043), and further wherein the first thickness (N) and the second thickness (M) are measured in a direction orthogonal to the second surface of the substrate (B) (see annotated figure 2/annotated figure 3, the first thickness [N] and second thickness [M] are measured in a direction orthogonal to the second surface of the substrate [B]).
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Annotated figure 3: thicknesses of Tolia et al.
Regarding claim 36, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses an outer perimeter of the second area of the second surface of the substrate (L – see annotated figure 2, an outer perimeter of the second area of the second surface of the substrate).
However, Tolia et al. fails to explicitly disclose wherein an outer perimeter of the second area of the second surface of the substrate comprises a circular or ovular shape.
It would have been an obvious matter of design choice to make the outer perimeter of the second area of the second surface of the substrate of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, applicant places no criticality on the shape claimed, indicating simply that the shape “may” form various shapes or patterns, including circular, ovular, square, rectangle, heart-shaped, or any other shape suitable for application to the skin (written specification: paragraph 0023).
Regarding claim 37, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses wherein the first adhesive layer (211) is configured to be applied to and remain in contact with the skin of a user (see annotated figure 1, the first adhesive layer [221] can be pressure sensitive adhesives that are dermatologically acceptable; the first adhesive layer [221] is applied to and remains in contact with the skin of the user: abstract and paragraph 0066-0068).
Regarding claim 38, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses wherein the active pharmaceutical ingredient is present in the adhesive article (200) at a therapeutic amount (the adhesive article [200] is used for administrating one or more active agents from the first adhesive layer [221] to the skin of a host; it is inherent that the amount of active agent [active pharmaceutical ingredient] administered is a therapeutic amount: abstract).
Regarding claim 40, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses wherein the second surface of the substrate (B) comprises a third area (K – see annotated figure 4, third area of the second surface of the substrate) adjacent to the second area (D) (see annotated figure 1/annotated figure 2, the third area [K] is adjacent to the second area [D]), and further wherein the third area (K) defines a perimeter of the adhesive article (200) (see annotated figure 2/annotated figure 4, the third area [K] defines the perimeter of the adhesive article [200]; the third area [K] comprises the edge of the adhesive article [100/200]).
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Annotated figure 4: planar view of transdermal device of Tolia et al.
Regarding claim 41, Tolia et al. discloses the invention as discussed in claim 32. Tolia et al. further discloses wherein the substrate (230) is a release liner (the substrate [230] is a removable release liner: paragraph 0043).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Tolia et al. (US 20170290779 A1) in view of Tapolsky et al. (US 20050147658 A1).
Regarding claim 34, Tolia et al. discloses the invention as discussed in claim 33.
However, Tolia et al. fails to disclose wherein the backing layer has a surface area of between 5 and 100 cm2.
Tapolsky et al. teaches wherein an analogous backing layer (1 – figure 1, a backing layer: paragraph 0020) has a surface area of between 5 and 100cm2 (figure 1, the backing layer [1] can be approximately the same size as the other layers and are laminated together; the surface area of the device can be preferably 0.5cm2 to about 20cm2. The prior art’s range overlaps the claimed range of 5-100cm2: paragraph 0058/0064-0065).
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified surface area of the backing layer from 0.5-20cm2 to 5-100cm2 to allow the adhesive article to be cut and sized depending on location of application and purpose (paragraph 0065, Tapolsky et al.). Additionally, the claimed value lies within the range disclosed by the prior art (please see MPEP 2144.05 I., “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”). Further, applicant places no criticality on the range claimed, indicating simply that the surface area of the backing layer has a surface area of between 5 and 100cm2, 5 and 40cm2, or 5 and 20cm2 (specification paragraph: 0032/0040).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Tolia et al. (US 20170290779 A1) in view of Weimann et al. (US 20060034904 A1), with extrinsic evidence provided by “Tocris Bioscience” for the rejections of claim 39.
Regarding claim 39, Tolia et al. discloses the invention as discussed in claim 32.
However, Tolia et al. fails to disclose wherein the active pharmaceutical ingredient has a molecular weight of no more than 600 Daltons.
Weimann et al. teaches wherein an analogous active pharmaceutical ingredient has a molecular weight of no more than 600 Daltons. (figure 1, the active substance in the transdermal drug delivery device [100] can be hydrocortisone [same active substance listed in Applicant’s written specification: paragraph 0044); hydrocortisone has a molecular weight of 362.46 [as evidenced by Tocris Bioscience]: paragraph 0069).
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 provided the active pharmaceutical ingredient of Tolia et al. with an active pharmaceutical ingredient that has a molecular weight of no more than 600 Daltons as taught by Weimann et al. in order to provide an adhesive article that has an improved active pharmaceutical ingredient to allow the active pharmaceutical ingredient to passively diffuse through the outermost layer of the skin at rates that enable therapeutic effects (paragraph 0006, Weimann et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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