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 .
Election / Restriction
Applicant's election with traverse of Species A, claims 1-10 and 14-20, Fig. 34 in the reply filed on 23 September 2026 is acknowledged.
The traversal is on the ground(s) that the embodiment shown in Figs. 35-37, which shows devices that can be adapted to fit on a user's eye socket, can contain the transdermal delivery device of Fig. 34 (remarks p. 2). Applicant reasons that specifically, paragraph [0057] of the present specification states that "FIG. 34 is a cross-sectional view of a passive transdermal delivery device that includes an enhanced drug delivery feature, in accordance with an exemplary embodiment of the present disclosure" (remarks p. 2). Examiner acknowledges that Fig. 34 represents an embodiment of the invention. The basis for the election of species requirement is based on Fig. 34 depicting features that do not appear in Figs. 35-37.
Applicant contends that moreover, claim 14 includes the flexible plate shown in Fig. 37, as well as the three layered structure of the transdermal delivery device of Fig. 34 (remarks p. 2). Examiner acknowledges that claim 14 is part of species A, which corresponds to Fig. 34. Fig. 37 does not describe details of an adhesive strip, but instead describes only a flexible plate and its sockets.
The requirement is still deemed proper and is therefore made final.
Claims 11-13 are withdrawn from further consideration and claims 1-10 and 14-20 are examined on their merits.
Claim Objections
The claims contain minor informalities.
In claim 6, the language “… wherein the movement of the pressure [[place]] plate toward …” should be changed for clarity.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 2 and 7-10 are under 35 U.S.C. 103 as being unpatentable over Sun, Ying et al. (US 20020115957 A1) in view of Herschkowitz; Samuel et al. (US 20090042970 A1).
Regarding claim 1, Sun discloses a transdermal delivery device (¶ [0002], [0003], [0008], [0026] In one aspect, the present invention relates an apparatus for transporting an active agent across a barrier membrane; ¶ [0028] Referring to FIG. 1, the apparatus 100);
comprising: a first layer including an absorbent material (¶ [0050] When used to administer a compound such as a drug, the reservoir 110 may comprises a fluid carrier … The reservoir 100 may in addition to or in lieu of contain a suspending material … Examples of suspending materials include hydrophilic, highly absorbent, porous materials. Examples of suitable porous materials include … polymeric foam and sponge-like materials comprised of polyurethane, polyester and/or other polymers);
containing a skin-permeable drug (¶ [0027] Active agents which may be delivered with this apparatus include … organic compounds; drug substances; nutrients; and macromolecular compounds such as polypeptides, proteins, and nucleic acid materials comprising DNAs and antisenses …vitamin E, vitamin D, cysteine and N-acetyl cysteine, herbal extracts, and derivatives thereof; ¶ [0049] A reservoir 110 is in communication with the channels 108 to either permit compounds (e.g., active agents));
a second layer arranged adjacent to the first layer (¶ [0053] The electrode 112 may be a noble metal, such as platinum or gold, or conductive carbon. The electrode 112 may be plated onto a substrate, such as metal or conductive polymer);
a cover layer, wherein the first layer, the second layer and the cover layer define an internal volume (¶ [0028] Referring to FIG. 1, the apparatus 100 comprises a vessel 102 … The vessel 102 may be comprised of silicone rubber; synthetic rubber; natural rubber … The vessel 102 may be any shape, such as, for example, circular, oval, or rectangular).
Sun teaches the invention substantially as claimed by Applicant but does not explicitly disclose a third layer containing a spring. Herschkowitz discloses a transdermal delivery device (¶ [0002], [0010], [0013], The methods include administering desmopressin … transdermal or intradermal administration methods; ¶ [0076] FIG. 3 depicts a passive embodiment of the invention designed for transdermal operation; ¶ [0077] FIG. 4 schematically illustrates a structure of a device which delivers the drug intradermally);
comprising: a first layer containing a skin-permeable drug (¶ [0076] FIG. 3 depicts a passive embodiment … It comprises a desmopressin solution disposed within depot 50; ¶ [0077] FIG. 4 schematically illustrates a structure of a device … drug depot 50);
a second layer arranged adjacent to the first layer (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62);
a third layer arranged on a side of the second layer opposite to the first layer, the third layer containing a spring (¶ [0078] Pressure is applied … and powered by a spring 64 so as to apply pressure to the depot; ¶ [0079], the spring 64 presses on piston 62 applying pressure on the liquid in depot 50); and
a cover layer, wherein the first layer, the second layer, the third layer and the cover layer define an internal volume (¶ [0076], housing 52).
Herschkowitz augments or regulates a drug delivery rate by applying pressure to a liquid drug (¶ [0078], A combination of springs, a dashpot, or other micromechanical elements may be adapted to control and fix force dynamics. The flux rate is controlled by a combination of factors including the force behavior of the spring or other force exerting mechanical element, the flow properties of the solution in the depot, the concentration of desmopressin in the solution, and the interior diameter, flow through properties, and number of microneedles). One would be motivated to modify Sun with Herschkowitz’s spring since Sun suggests to pressurize the reservoir (¶ [0097] In addition to the electro-transport methods … other processes well known in the art can also be used (e.g., in addition to or in lieu of electro-transport) such as ultrasound, audible sound, mechanical movement, pressure (i.e., positive pressure or negative pressure), osmotic pressure). Therefore, it would have been obvious to modify Sun with Herschkowitz’s third layer containing a spring in order to deliver a drug more quickly through a patient’s skin.
Regarding claims 2 and 7-9, Sun does not explicitly disclose a flexible, impermeable membrane or a removable layer. Herschkowitz discloses a device wherein the second layer comprises a flexible, impermeable membrane that separates the absorbent material from the second layer (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals);
further comprising a removable layer positioned on the first layer adjacent to the absorbent material on a side opposite the second layer, such that the internal volume is enclosed by the removable layer; wherein the removable layer is configured to be removable to allow the skin-permeable drug to flow outward from the transdermal delivery device when removed; further comprising an adhesive layer arranged between the removeable layer and the first layer, arranged to allow for the transdermal delivery device to be adhered to a user's skin (¶ [0076], In operation, once a protective release cover strip (not shown) is peeled away and the device is adhered to a selected area of the skin of the patient, the drug in the depot 50 is delivered by absorption into and through the permeable membrane 54).
Herschkowitz pressurizes a drug reservoir in order to deliver a drug more quickly, and also protects the delivery device before a user desires to activate it. One would be motivated to modify Sun with Herschkowitz’s impermeable membrane since the impermeable membrane operates in combination with the spring. Herschkowitz’s removable layer protects the device from contamination and also prevents the active drug from leaking before use. Therefore, it would have been obvious to modify Sun with Herschkowitz’s impermeable membrane and removable layer in order to dispense a drug at higher pressure and also to preserve the drug before use.
Regarding claim 10, Sun discloses a device capable of being positioned on a patient’s body (¶ [0008] In one aspect, the invention features an apparatus for transporting a compound across a barrier membrane of a mammal, such as the skin or mucosa membrane of a human; ¶ [0046] The adhesive affixes the apparatus to the barrier membrane (e.g., the skin) so that it is not easily separated from or moved along the skin).
Sun and Herschkowitz are silent whether the first layer is configured to be positioned on an Abreu brain thermal tunnel (ABTT) terminus.
A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114(II). In the instant case, the language “configured to be positioned on an Abreu brain thermal tunnel (ABTT) terminus” does not describe a structure which differentiates Sun’s delivery device from the claimed delivery device. Sun’s delivery device can be placed anywhere on a patient’s body, including the ABTT terminus. This claim does not describe any shape or size that distinguishes the device from Sun’s device. Therefore, Sun’s device is capable of performing the claimed function of being positioned on an ABTT terminus.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sun and Herschkowitz in view of Gabel, Jonathan B. et al. (US 20030187395 A1).
Regarding claim 3, Sun and Herschkowitz are silent whether the flexible, impermeable membrane has a curved cross section. Gabel discloses a delivery device wherein a flexible, impermeable membrane has a curved cross section when viewed along a plane of a second layer (¶ [0051] As shown in FIGS. 6-7 … Cartridge 14 includes a body 64 having a top wall 66, a bottom wall 68 and a side wall 70; ¶ [0056], Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72; ¶ [0057] In the embodiment illustrated, top wall 66 has a substantially dome shape having a convex outer surface 114 and a concave inner surface 116).
Gabel demonstrates how to pressurize and dispense fluids with an integrally formed impermeable membrane. In contrast, Herschkowitz requires a sliding seal to define the first layer and its internal volume (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals). One would be motivated to modify Sun and Herschkowitz with Gabel’s curved membrane to avoid the need for a seal or separate element. Therefore, it would have been obvious to modify Sun and Herschkowitz with Gabel’s curved membrane in order to simplify the device and minimize its manufacturing cost.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sun and Herschkowitz in view of Lee; Seung Seob et al. (US 20110046557 A1).
Regarding claim 4, Sun and Herschkowitz lack a slide plate. Lee discloses a delivery device comprising a slide plate arranged in a slot located between a second layer and a third layer, the slide plate being slidably removable from the delivery device in a direction parallel to a plane of the second layer, wherein the slide plate divides the internal volume into an upper volume located in the third layer and a lower volume located in the second layer (¶ [0041], In FIG. 4, similar to the case of FIG. 3, the drug-containing capsule 3 is positioned spaced apart from the capsule-disrupting micro-projections 22 of the microneedle device 2 … Likewise, a fixing cap 4 is positioned to prevent the contact between the drug-containing capsule 3 and the capsule-disrupting micro-projections 22. During the use of the microneedle drug delivery system, the fixing cap 4 is removed and then a certain pressure is applied to the top of the drug-containing capsule 3 so that the drug can be delivered in vivo through the microneedles).
Lee configures a delivery device to remain sealed or inactive until a user desires to activate the device. One would be motivated to modify Sun and Herschkowitz with Lee’s slide plate since Herschkowitz suggests to activate the device (¶ [0072], and the device is activated at 10:00 P.M. FIG. 1 shows illustrative and exemplary blood desmopressin concentrations and the flux rates for this patient at various times following application or activation of the device; ¶ [0073] FIG. 2 illustrates another exemplary embodiment … The device is activated (if necessary)). Therefore, it would have been obvious to modify Sun and Herschkowitz with Lee’s slide plate in order to control when the device is capable of dispensing its contents.
Regarding claims 5 and 6, Sun lacks a pressure plate. Herschkowitz discloses a delivery device further comprising a pressure plate, wherein the spring and a pressure plate are positioned in the upper volume; and are configured such that the spring forcibly causes the pressure plate to move toward the flexible, impermeable membrane (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals, and powered by a spring 64);
wherein the movement of the pressure plate toward the flexible, impermeable membrane is sufficient to place pressure on the flexible, impermeable membrane to force the skin-permeable drug in the absorbent material outward from the transdermal delivery device (¶ [0078], Spring 64 here is used illustratively as a means for applying variable pressure to obtain variable flux rates).
Herschkowitz propels a fluid drug with another known technique. Regarding the rationale and motivation to modify Sun with Herschkowitz’s pressure plate and spring, see the discussion of claim 1 above.
Sun and Herschkowitz lack a slide plate. Lee discloses a delivery device comprising a slide plate as discussed for claim 4 above (¶ [0041], In FIG. 4 … a fixing cap 4). This rejection adds Lee’s slide plate to the combination of Sun and Herschkowitz such that the slide plate blocks Herschkowitz’s spring until the slide plate is removed.
Regarding the rationale and motivation to modify Sun and Herschkowitz with Lee ’s slide plate, see the discussion of claim 4 above.
Claims 14, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun and Herschkowitz in view of Igaki, Michihito et al. (US 20040035410 A1).
Regarding claim 14, Sun and Herschkowitz describe a drug container comprising first, second and third layers as discussed for claim 1 above. Sun and Herschkowitz lack a support device comprising a flexible plate and at least one socket positioned in the support device. Igaki discloses an eye-use steam-generating heating sheet (¶ [0002], [0007], [0021] FIG. 1-x is a plan view of the eye-use steam-generating heating sheet 1A);
comprising: a support device comprising a flexible plate (¶ [0022], a first moisture-permeable sheet 3);
at least one socket positioned in the support device; and at least one container arranged in the at least one socket, and configured to be positioned on a user's eye socket (¶ [0022] This eye-use steam-generating heating sheet 1A comprises a steam-generating composition 2 that fills a space formed between a backing sheet 6 and a first moisture-permeable sheet 3).
Igaki holds and positions a therapeutic composition near a specific part of a user’s body, namely the wearer’s eyes (¶ [0002] The present invention relates to a steam-generating heating sheet for the eyes … in order to relieve eyestrain, alleviate dryness of the eyes, and provide a pleasant sensation). One would be motivated to modify Sun and Herschkowitz with Igaki’s support device to mount the device on a specific region of the wearer’s body since Sun and Herschkowitz are otherwise silent regarding where the device is positioned. Therefore, it would have been obvious to modify Sun and Herschkowitz with Igaki’s support device in order to arrange a delivery device near a specific region of a wearer’s body.
Regarding claims 15 and 20, Sun does not explicitly disclose a flexible, impermeable membrane or a removable layer. Herschkowitz discloses a device wherein the second layer comprises a flexible, impermeable membrane that separates the absorbent material from the second layer (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals);
further comprising a removable layer positioned on the first layer adjacent to the absorbent material on a side opposite the second layer, such that the internal volume is enclosed by the removable layer (¶ [0076], In operation, once a protective release cover strip (not shown) is peeled away and the device is adhered to a selected area of the skin of the patient, the drug in the depot 50 is delivered by absorption into and through the permeable membrane 54).
Herschkowitz pressurizes a drug reservoir in order to deliver a drug more quickly, and also protects the delivery device before a user desires to activate it. One would be motivated to modify Sun with Herschkowitz’s impermeable membrane since the impermeable membrane operates in combination with the spring. Herschkowitz’s removable layer protects the device from contamination and also prevents the active drug from leaking before use. Therefore, it would have been obvious to modify Sun with Herschkowitz’s impermeable membrane and removable layer in order to dispense a drug at higher pressure and also to preserve the drug before use.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sun, Herschkowitz and Igaki in view of Gabel, Jonathan B. et al. (US 20030187395 A1).
Regarding claim 16, Sun, Herschkowitz and Igaki are silent whether the flexible, impermeable membrane has a curved cross section. Gabel discloses a delivery device wherein a flexible, impermeable membrane has a curved cross section when viewed along a plane of a second layer (¶ [0051] As shown in FIGS. 6-7 … Cartridge 14 includes a body 64 having a top wall 66, a bottom wall 68 and a side wall 70; ¶ [0056], Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72; ¶ [0057] In the embodiment illustrated, top wall 66 has a substantially dome shape having a convex outer surface 114 and a concave inner surface 116).
Gabel demonstrates how to pressurize and dispense fluids with an integrally formed impermeable membrane. In contrast, Herschkowitz requires a sliding seal to define the first layer and its internal volume (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals). One would be motivated to modify Sun, Herschkowitz and Igaki with Gabel’s curved membrane to avoid the need for a seal or separate element. Therefore, it would have been obvious to modify Sun, Herschkowitz and Igaki with Gabel’s curved membrane in order to simplify the device and minimize its manufacturing cost.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sun, Herschkowitz and Igaki in view of Lee; Seung Seob et al. (US 20110046557 A1).
Regarding claim 17, Sun, Herschkowitz and Igaki lack a slide plate. Lee discloses a delivery device comprising a slide plate arranged in a slot located between a second layer and a third layer, the slide plate being slidably removable from the delivery device in a direction parallel to a plane of the second layer, wherein the slide plate divides the internal volume into an upper volume located in the third layer and a lower volume located in the second layer (¶ [0041], In FIG. 4, similar to the case of FIG. 3, the drug-containing capsule 3 is positioned spaced apart from the capsule-disrupting micro-projections 22 of the microneedle device 2 … Likewise, a fixing cap 4 is positioned to prevent the contact between the drug-containing capsule 3 and the capsule-disrupting micro-projections 22. During the use of the microneedle drug delivery system, the fixing cap 4 is removed and then a certain pressure is applied to the top of the drug-containing capsule 3 so that the drug can be delivered in vivo through the microneedles).
Lee configures a delivery device to remain sealed or inactive until a user desires to activate the device. One would be motivated to modify Sun, Herschkowitz and Igaki with Lee’s slide plate since Herschkowitz suggests to activate the device (¶ [0072], and the device is activated at 10:00 P.M. FIG. 1 shows illustrative and exemplary blood desmopressin concentrations and the flux rates for this patient at various times following application or activation of the device; ¶ [0073] FIG. 2 illustrates another exemplary embodiment … The device is activated (if necessary)). Therefore, it would have been obvious to modify Sun, Herschkowitz and Igaki with Lee’s slide plate in order to control when the device is capable of dispensing its contents.
Regarding claims 18 and 19, Sun lacks a pressure plate. Herschkowitz discloses a delivery device further comprising a pressure plate, wherein the spring and a pressure plate are positioned in the upper volume; and are configured such that the spring forcibly causes the pressure plate to move toward the flexible, impermeable membrane (¶ [0078] Pressure is applied to the depot 50 via an axially moveable piston 62 mounted for downward movement, fitted with seals, and powered by a spring 64);
wherein the movement of the pressure plate toward the flexible, impermeable membrane is sufficient to place pressure on the flexible, impermeable membrane to force the skin-permeable drug in the absorbent material outward from the transdermal delivery device (¶ [0078], Spring 64 here is used illustratively as a means for applying variable pressure to obtain variable flux rates).
Herschkowitz propels a fluid drug with another known technique. Regarding the rationale and motivation to modify Sun with Herschkowitz’s pressure plate and spring, see the discussion of claim 1 above.
Sun and Herschkowitz lack a slide plate. Lee discloses a delivery device comprising a slide plate as discussed for claim 4 above (¶ [0041], In FIG. 4 … a fixing cap 4). This rejection adds Lee’s slide plate to the combination of Sun and Herschkowitz such that the slide plate blocks Herschkowitz’s spring until the slide plate is removed.
Regarding the rationale and motivation to modify Sun, Herschkowitz and Igaki with Lee ’s slide plate, see the discussion of claim 4 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hyson; Morton Isaac US 5700238 A
Igaki; Michihito et al. US 6409746 B1
Harkless; Willie E. US 6719734 B1
Schnall; Robert P US 20060064024 A1
MacDonald; J. Gavin et al. US 20090149925 A1
Tokumoto; Seiji et al. US 20130226098 A1
Arami; Shunsuke et al. US 20150314117 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
