DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-5, 7-23 and 25-28 are pending.
Claims 1 and 28 are currently amended.
Claims 6 and 24 have been canceled.
Claims 1-5, 7-23 and 25-28 are currently under consideration.
Claims 1-5, 7-23 and 25-28 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/23/2025 has been entered.
Withdrawn Objections and Rejections
In light of the new amendment of claim 28 element b) to recite “the perimeter of said reservoir,” the objection to claim 28 element b) is withdrawn.
In light of the new amendments and/or upon further consideration, the rejections of claims 1 and 28 under 35 U.S.C. § 112(a) for failing to comply with the written description and enablement requirement are withdrawn.
In light of the new amendment in line 16 of claim 1 which now recites, “pressure-sensitive-adhesive-layer-facing surface and the at least one opening,” the rejection of claim 1 under 35 U.S.C. § 112(b) as being indefinite is withdrawn.
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.
Applicant Claims
The instant claims are directed to a transdermal therapeutic system comprising:
an active substance impermeable skin-facing backing layer comprising a first pressure-sensitive-adhesive (PSA) layer for attachment to the skin;
b) an active substance reservoir comprising at least one active substance having
a skin-facing surface,
a first PSA-layer-facing surface and
a side surface defined by the perimeter of said reservoir,
c) an active substance impermeable skin-facing barrier layer having a
first surface that adjoins the active substance reservoir on its skin-facing surface,
a second surface opposite the first surface and
at least one opening in the first surface that extends to the second surface;
d) a removable protective layer,
wherein the backing layer furnished with PSA protrudes beyond the barrier layer on all sides and
the barrier layer is disposed on the active substance reservoir on all surfaces except the first PSA-layer-facing surface and the at least one opening,
the barrier layer contacts the first PSA layer, and
the barrier layer is not furnished with a PSA layer (instant claim 1).
Claims 1, 5, 7, 9, 11-14, 19, 21-23 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Higo et al. (US 6,104,950, pub. 08/15/2000), Hille et al. (US 7,384,651 B2, pub. 06/10/2008), herein referenced Higo and Hille.
Higo discloses a plaster structure for iontophoresis comprising a medicinal substance storing layer (i.e., active substance reservoir) with first and second surfaces in which the first surface is covered by a non-permeable backing layer; a non-permeable protection layer with first and second surfaces wherein the first surface supports the second surface of the medicinal substance storing layer; an adhesive agent layer comprising pressure-sensitive adhesive (PSA) with first and second surfaces in which the first layer is laminated on the second surface of the protection layer, and the second surface is laminated with a liner layer (claim 1). Higo provides Fig. 2 (a) as a longitudinal view showing a central section and Fig. 2(b) to illustrate a releasing passage for active agents (col. 8, lines 39-46). The numbers mean the following: reservoir 1, backing layer 2, electrode 3, protection layer 4, adhesive agent layer made of PSA 5, liner layer 6, notch part 7. Number 8 denotes a releasing passage for physiologically active agents released by a peeling-off of the liner layer 6. It is noted that first surface of 4 is shown as being next to and joined with 1 and the second surface of 4 is next to and joined with 5.
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Higo teaches that the protection layer 4 can be removed together with the liner 6 so as to form the releasing passage (i.e., opening) for the active agents (col. 11, lines 36-39). Higo teaches and suggests that 2 and 4 are sealingly adhered to each other until the plaster is applied to the body to advantageously prevent dispersion and leakage of the active agents from 1 (col. 9, lines 51-56). Upon applying, the mere peeling-off of 6 causes the section of 4 enclosed by 7 to be removed together with 6 to form releasing passage 8 for active agents (col. 9, line 56; claim 4). PSA 5 is not left in the releasing passage of the active agents (col. 9, line 64 – col. 10, line 2; claim 2). Higo provides a structure that allows the medicinal substance storing layer to be brought into contact with skin and active agents can be administered without being influenced by the PSA agent (abstract, col. 12, line 15, see (6)).
Higo discloses an embodiment in which the backing layer, the spacer film layer, the PSA layer and the liner layer are formed to be larger than the reservoir and the protection layer in which spacer film layer is heat sealed so that the protection layer is larger than the heat seal section (col. 2, line 64 – col. 3, line 4). Here the prior art reads on a backing layer that protrudes beyond the barrier layer on all sides.
Higo teaches that as the additive agents for the active agents include propylene glycol (i.e., propane-1,2-diol), polyethylene glycol, dimethyl sulfoxide (col. 4, line 65). Higo teaches that in the case that the protection layer 4 or the liner layer 6 or the backing layer 2 is comprised of two or more synthetic resin layers, enforcing an adhering and a barrier characteristic enhances mechanical strength and increases durability (col. 7, lines 30-36).
Higo does not explicitly teach a barrier layer.
Hille discloses a transdermal therapeutic system (TTS) comprising a detachable protective layer; a pressure-sensitive adhesive (PSA) reservoir layer and a backing layer with or without a coating of PSA (abstract, col. 2, lines 30-48). See Fig-2 below from Hille.
20 - backing
18 - PSA
16 - barrier
14 - reservoir
12 - protective
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TTS 10 features reservoir 14, a removable protective layer 12, a barrier layer 16, and a further PSA layer 18 devoid of active substance wherein layer 18 is necessary when a barrier layer 16 is present (col. 6, lines 33-34). Backing layer 20 and PSA 18 devoid of active substance, protrude beyond the aforementioned laminate on all sides (col. 6, lines 34-37).
Hille teaches that the material of the backing layer can be woven fabric, a nonwoven fabric, or a film (col. 3, lines 48-50). Hille provides examples that utilize a woven polyester fabric in order to produce the unidirectionally elastic backing layer (col. 6, line 41). Where the backing layer comprises a polymer, the said polymer is selected from polyethylene, polypropylene, or polyesters, polyalkylene terephthalates (col. 3, lines 50-53; claim 15). Where a woven or nonwoven fabric or else a porous film is used, the porosity lies within the range from 10-50% (col. 4, line 16). Porosity (i.e., openings) here means the proportion of pores having an area of less than or equal to 400 µm2 (col. 4, lines 18-20).
Regarding the barrier layer is disposed on the AS reservoir on all surfaces except the first PSA-layer-facing surface and the at least one opening, the barrier layer contacts the first PSA layer, and the barrier layer is not furnished with a PSA layer limitation, the figure above shows that the first surface of the barrier layer 16 is next to and joined with the skin-facing surface of the PSA 18 and the second surface of 16 adjoins the first surface of the reservoir 14.While Hille illustrates a mirror image of the spatial relationship recited in the instant claims, Hille is provided to teach a barrier layer, a barrier layer that is in contact with the PSA, and to show a PSA that extends along the side surfaces of the barrier layer and the reservoir layer.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the teachings of Higo and Hille with expected results. One would be motivated to do so with a reasonable expectation of success because Hille teaches that the TTS is particularly suitable for use as a multi-day plaster (abstract) to improve wear comfort while avoiding a curling effect (col. 2, lines 30). This complements Higo’s plaster structure that seeks to provide a controlled amount of physiologically active agents for a specified period of time so as to keep a stable medical effect (col 1, line 46).
Regarding claim 5 (i.e., reservoir is a PSA layer), claim 12 (i.e., matrix), and claim 14 (i.e., polymer), Higo teaches that additive agents for the active agents may include water absorbing macromolecular substances such as poly (meta) acrylate, polyacrylic acid, polyacrylamide (col. 5, line 10). In addition, Hille teaches a PSA reservoir layer wherein this layer may also include a water-absorbing polymer (claim 1).
Regarding claim 7 (i.e., barrier layer), Higo teaches that the backing layer may be made of polyethylene terephthalate , copolymer of plasticizing copolymer of vinyl acetate and vinyl chloride, polyamide, cellulose acetate, ethyl cellulose (col. 5, lines 21-36).
Regarding claims 8, 12, 14, 19 and 22, Higo teaches that as the adhesive agents include natural rubber and cellulose derivatives (col. 6, lines 6-25). Higo teaches rubber adhesives such as polyisobutylene rubber (i.e., butyl rubber)(col. 6, lines 19-21).
Regarding claim 9, Higo teaches additive agents for the active agents may include solvents (col 4, line 58).
Regarding claim 11, Higo discloses that material which is not permeable at least against the active agents is used and as an example of this material either a single layer or a plurality of layers is used as the backing layer (col. 7, line 25) and/or protection layer (col. 8, line 1).
Regarding claims 13 and 23, Higo teaches cotton as gauze in the plaster (col. 4, lines 51-52).
Regarding claim 21, Higo teaches that as the additive agents for the active agents include propylene glycol (i.e., propane-1,2-diol), polyethylene glycol (col. 4, line 65).
Regarding claims 25-26, as mentioned above, Higo discloses that PSA 5 is not left in the releasing passage of the active agents (col. 9, line 64 – col. 10, line 2; claim 2). Higo teaches that the reservoir can be directly contacted with the disease part and active agents can be administered without being influenced by the PSA agent (col. 12, line 15, see (6)).
Regarding claim 27, Higo teaches that in yet a further contemplated embodiment the plaster structure for iontophoresis has a configuration in which the protection layer is comprised of two or more synthetic resin layers (col. 2, line 55).
Regarding claim 28, Hille shows no pressure-sensitive-adhesive layer on the barrier layer second surface (Fig. 2).
Claims 2-4, 10, 15-18 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Higo and Hille as applied to claims 1, 5, 7, 9, 11-14, 19, 21-23 and 25-28 above, and further in view of Howard et al. (US 2005/0002997 A1, pub. 01/06/2005).
The teachings of Higo and Hille above are incorporated herein.
Howard discloses a transdermal dosage form comprising an active agent component comprising an active agent and an adverse agent component comprising an adverse agent, wherein the active agent component defines at least one channel extending substantially there through (abstract). Howard discloses an embodiment comprising an active agent containing component (an "active agent component”) having a proximal surface and a distal surface, and an adverse agent-containing component (an "adverse agent component”) disposed distally of the active agent component, wherein the active agent component defines at least one channel extending substantially from the proximal surface to the distal surface ([0007]).
FIGS.13a, b show a schematic cross-section (13a) and a plan view (13b) of an embodiment of the present invention where the skin-contacting component comprises a disk with a plurality of cylindrical air channels, the barrier comprises a disk with a plurality of cylindrical air channels, and the barrier is aligned with the skin-contacting component (as in FIG. 6a,b) ([0038]). In this embodiment the backing and an overlay PSA extend beyond the reservoir, barrier, and skin-contacting components ([0038]).
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As shown in FIGS. 13a and 13b, an overlay backing 870 extends beyond the area of the adverse agent or reservoir component 860, barrier 850, and active agent or skin-contacting component 810 to a sufficient extent to allow the peripheral edge of overlay backing 870 to contact the skin surface of a patient ([0149]). An additional channel or channels may also be present in the area between the overlay backing 870 and the adverse agent or reservoir component 860, barrier 850, and/or active agent or skin-contacting component 810 ([0149]).
The edges of the overlay backing 870 are coated with an overlay pressure sensitive adhesive (PSA) 880 that is used to secure the edges of the overlay backing 870 to a skin surface ([0150]). Any pressure sensitive adhesive suitable for use in skin-contacting applications, as previously described, can be used as the overlay PSA 880 ([0150]). Typical examples of flexible backing materials employed as conventional tape backings which may be useful for the present invention include those made of polymer films such as polypropylene; polyethylene, particularly low density polyethylene, linear low density polyethylene, metallocene polyethylenes, and high density polyethylene, polyvinyl chloride, polyester (e.g., polyethylene terephthalate); ethylene-vinyl acetate copolymer, polyurethane; cellulose acetate; and ethyl cellulose ([0150]). Backings that are componented, such as polyethylene terephthalate-aluminum-polyethylene composites, are also suitable ([0150]). Fabrics and non-wovens are also suitable ([0150]). In certain embodiments, the overlay backing 870 is large enough to define an air channel 890 between the periphery of the adverse agent component, the barrier and the active agent component and the inner periphery of the overlay PSA 880 ([0151]).
FIG. 18 shows a schematic cross-section of an embodiment of the present invention similar to FIG. 16, except that the overlay PSA is coated uniformly across the overlay backing, instead of being present only at the outer edges of the overlay backing ([0043]).
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As shown in FIG. 18, the overlay backing 170 is continuously coated with an overlay pressure sensitive adhesive (PSA) 180 that is used to secure the edges of the overlay backing 170 to a skin surface. In this embodiment, the overlay PSA 180 serves a dual purpose ([0194]). The area of the overlay PSA 180 extending beyond the area of the porous medium 165, adverse agent reservoir 160, barrier 150, and active agent component 110 serves to secure the dosage form to a skin surface ([0194]). The area of the overlay PSA 180 that does not extend beyond the adverse agent or reservoir component 160 provides secure lamination of the overlay backing 170 to the porous medium 165 ([0194]). An optional barrier component may be placed between the overlay PSA 180 and the porous medium 165 in order to prevent any interaction between the overlay PSA 180 and the porous medium 165 ([0194]). This optional component is preferably a flexible backing material as described above and is more preferably a polyethylene film ([0194]).
The porous medium 165 is a material or construct characterized in that it has openings that allow the passage or absorption of liquids ([0195]). Examples of a porous medium include microporous films, such as microporous films formed by extruding polyethylene or polypropylene with mineral oil; fibrous webs, woven fabrics and textiles and other open, mesh-like materials ([0195]). A porous medium may have the appearance of a solid matrix characterized by a fine network of microscopic openings ([0195]). In another aspect, it may be a structured slab or film having channels or grooves that allow the passage of liquid ([0195]). Howard teaches that certain structures with open channels or grooves will act as a porous medium when the open channels or grooves are adjacent to another component, such as the adverse agent reservoir ([0195]).
As shown in FIG. 16, the porous medium 165 is adjacent to the adverse agent reservoir 160, such that if the dosage form 100 is immersed in a solvent bath, then the porous medium 165 allows for fluid communication of the solvent with the top surface of the reservoir 160 ([0196]). The porous medium 165 may align with the adverse agent reservoir 160 ([0196]). The porous medium 165 may extend beyond the area of the adverse agent reservoir 160 and may fill part or all of the void area shown in FIG. 16 where the fluid communication, i.e., the two-sided arrow 185 between the porous medium 165 and the skin-contacting surface 120 takes place ([0196], [0200]).
Regarding claims 2 and 15-16, Howard teaches that the barrier thickness is in a range from 1-100 µm ([0116-0122]).
Regarding claims 3-4 and 17-18, Howard provides Example 1 wherein evenly-spaced holes (i.e., circular), each with an area of 0.013 cm2 (i.e., 0.13 mm2) were punched through the full thickness of each 3.5 cm2 patch ([0270]). MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. The adjustment of particular conventional working conditions (e.g., creating channels or holes in the laminate) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Regarding claim 10, Howard teaches the total amount of penetration enhancer and solubilizer is less than about 40% by weight based on the total weight of the composition. In another embodiment, the total amount of penetration enhancer and solubilizer is less than about 30% based on the total weight of the composition ([0157]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to combine the thicknesses and areas and other features i.e., area, of the device taught by Howard with teachings of Higo and Hille with expected results. One would be motivated to do so with a reasonable expectation of success because all of the references are concerned with preventing leakage (Higo col. 9, line 54), or preventing active substance loss (Hille col. 6, line 26), or as in the case with Howard substantially preventing the diffusion of active agent into the adverse agent component and diffusion of adverse agent into the active agent component in the absence of a solvent ([0150], [0193], claim 60). In other words, the prior art demonstrates a concerted effort to improve the control of delivery within these systems. As Higo teaches that the space film layer 9 which contacts with the lower (second) surface of the reservoir 1 and the lower (second) surface of the backing layer 2, has a thickness from 1 to 500 µm (col. 10, lines 29). Higo teaches a range of thickness to suggest that it is possible to control the administering of the active agent to the most-suitable administering amount while maintaining safety (col. 10, lines 46-53). Howard improves upon this by teaching a narrower range for the active agent component ([0094], [0169]) to suggest improved conformability to skin surface ([0168]). As mentioned above, Howard’s evenly-spaced holes (i.e., circular), each with an area of 0.013 cm2 (i.e., 0.13 mm2) suggest improved uniformity compared to Higo’s pores having an area of less than or equal to 400 µm2 (col. 4, lines 18-20) to contribute to the art absence evidence to the contrary.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 and 25-28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 1-5, 7-23 and 25-28 are rejected; no claims are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614