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 Amendment
The amendments made to claim 19 in the response filed on 10/21/2025 are acknowledged.
Claims 19, 21-22, and 24-30 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 6, filed 10/21/2025, with respect to the objection claim 19 has been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant's arguments, see pages 6-10, filed 10/21/2025, with respect to the rejection of claim 19 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “For example, nothing in Tolia teaches or suggests a first portion of the first surface of the alleged second adhesive layer is in contact with the second surface of the alleged first adhesive layer (as shown in FIG. 1 of Tolia reproduced below as annotated by the Examiner). As illustrated, the first portion of the first surface of the alleged second adhesive layer 212 (labeled "I") is in contact with the impermeable backing 222, not the second surface of the alleged first adhesive layer 221 (labeled "F"). The impermeable backing 222 is clearly between the first portion of the first surface of the alleged second adhesive layer 212 and the second surface of the alleged first adhesive layer”; however, examiner respectfully disagrees. Claim 19 is a “comprising” claim which can consist of intervening structures; Tolia discloses the first portion of the first surface of the second adhesive layer (I – see annotated figure 1) in contact with the second surface of the first adhesive layer (F – see annotated figure 1) via the impermeable backing layer (222 – see annotated figure 1). Furthermore, the claim language does not require the first portion of the first surface of the second adhesive layer to be in “direct” contact with the second surface of the first adhesive layer; therefore, Tolia still reads on this limitation in claim 19.
Applicant argues “Further, for example, nothing in Tolia teaches or suggests an active pharmaceutical ingredient in the alleged second adhesive layer 212 proximate a second area of an alleged substrate 230 that is present at a second concentration, where the second concentration is less than the first concentration as is recited in claim 19. Instead, the Examiner asserts that because Tolia includes an impermeable backing that helps minimize migration of active agents, the second adhesive layer impliedly has a concentration of an active pharmaceutical ingredient. See Office Action at page 6. The Examiner's reasoning appears to be unsupported by the cited reference and is conclusory rather than grounded in evidence provided in the cited reference”, “The Examiner has not provided any teaching or suggestion that the outer adhesive overlay (i.e., the alleged second adhesive layer 212) includes an active pharmaceutical ingredient”, and “Even if one of skill in the art would understand that Tolia describes a pharmaceutical ingredient disposed in the alleged second adhesive layer 212, the Examiner has failed to provide any teaching or suggestion in the reference that describes that such pharmaceutical ingredient is in the alleged second adhesive layer proximate the second area of the alleged substrate 230 as recited in claim 19”; however, examiner respectfully disagrees. In Tolia, it was disclosed that inner active reservoir layer backing (222 – figure 2) extends on all sides of the active reservoir layer (221 – figure 2). The purpose of the inner active reservoir layer backing (222) is to minimize the migration of active agents from the active reservoir layer (221) to the outer adhesive overlay (212 – figure 2) (paragraph 0004/0009). 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). By ensuring that the migration of active agents is minimized (hence, the first concentration in the active reservoir layer [221] is greater than the second concentration in the outer adhesive overlay [212]), it can prevent unfavorable effects to product characteristics such as efficacy, adhesion, and drug release/delivery profile over its shelf-life (paragraph 0004). Therefore, Tolia still reads on this limitation “wherein the second concentration is less than the first concentration” in claim 19.
Applicant's arguments, see pages 10-11, filed 10/21/2025, with respect to the rejection of claims 21-22, 24-28, and 29-30 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments above.
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.
Claims 19, 21, 25-27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tolia et al. (US 20170290779 A1).
Regarding claim 19, Tolia et al. discloses an adhesive article (200 – see annotated figure 1, a dermal device: paragraph 0043) comprising: an active pharmaceutical ingredient (the inner active reservoir [221 – see annotated figure 1] comprises pharmaceutical agents: paragraph 0043/0064); a substrate (230 – see annotated figure 1, a removable release liner: paragraph 0043) comprising a first surface (A – see annotated figure 1, first surface of the substrate) and a second surface (B – see annotated figure 1, a second surface of the substrate), wherein the second surface (B) comprises a first area (C – see annotated figure 1, first area of the second surface of the substrate) and a second area (D – see annotated figure 1, second area of the second surface of the substrate); a first adhesive layer (221 – see annotated figure 1, 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 1, 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 1, first surface of the first adhesive layer) in contact with the second surface of the substrate (B) (see annotated figure 1, 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 1, second surface of the first adhesive layer) opposed to the second surface of the substrate (B) (see annotated figure 1, 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 1, an outer disk overlay adhesive: paragraph 0043) comprising a first surface (G – see annotated figure 1, first surface of the second adhesive layer) and a second surface (H – see annotated figure 1, second surface of the second adhesive layer) opposed to the first surface (G) (see annotated figure 1, 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 1, first portion of the first surface of the second adhesive layer) is in contact with the second surface of the first adhesive layer (F) (see annotated figure 1, the first portion of the first surface of the second adhesive layer [I] is in contact with the second surface of the first adhesive layer [F] via the inner active reservoir layer backing [222 – see annotated figure 1]: paragraph 0043) and a second portion of the first surface of the second adhesive layer (J – see annotated figure 1, 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 1, 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 1: transdermal device 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 21, Tolia et al. discloses the invention as discussed in claim 19. Tolia et al. further discloses a backing layer (211 – see annotated figure 1, an outer disk overlay backing: paragraph 0043) in contact with the second surface of the second adhesive layer (H) (see annotated figure 1, the backing layer [211] is in contact with the second surface of the second adhesive layer [H]: paragraph 0043).
Regarding claim 25, Tolia et al. discloses the invention as discussed in claim 19. Tolia et al. further discloses an outer perimeter of the second area of the second surface of the substrate (L – see annotated figure 1, 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 26, Tolia et al. discloses the invention as discussed in claim 19. Tolia et al. further discloses wherein the first adhesive layer (221) 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 27, Tolia et al. discloses the invention as discussed in claim 19. 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 29, Tolia et al. discloses the invention as discussed in claim 19. Tolia et al. further discloses wherein the second surface of the substrate comprises a third area (K – see annotated figure 2, 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 1/annotated figure 2, 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 2: planar view of transdermal device of Tolia et al.
Regarding claim 30, Tolia et al. discloses the invention as discussed in claim 19. Tolia et al. further discloses a penetration enhancer (the first adhesive layer [221] can comprise additional excipients such as enhancers to promote the penetration of the active agent through the skin: paragraph 0060).
Claim 22 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 22, Tolia et al. discloses the invention as discussed in claim 21.
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 0.5 and 20cm2 (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).
Claims 24 and 28 are 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 claims 24 and 28.
Regarding claim 24, Tolia et al. discloses the invention as discussed in claim 19.
However, Tolia et al. fails to disclose wherein the active pharmaceutical ingredient has a molecular weight of less than 500 Daltons.
Weimann et al. teaches wherein an analogous active pharmaceutical ingredient has a molecular weight of less than 500 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 less than 500 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.).
Regarding claim 28, Tolia et al. discloses the invention as discussed in claim 19.
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
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 ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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