DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In view of the amendment, previous 112(a) rejection on claim 3 is hereby withdrawn.
In view of the amendment, previous 112(b) rejection on claims 1, 3, 6-11 and 13-15, previous 112(b) rejection on claim 3 and previous 112(b) rejection on claims 8-10 are hereby withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3, 6, 7, 11, 13-15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brooke et al (EP 1 186 298 B1, which is equivalent to previously cited reference, US 6,328,992 B1) in view of Zumeris et al (US 2007/0232962 A1) (with Dolezal (US 2019/0175956 A1) and Modak et al (US 2013/0230609 A1), which are being cited here merely to support the Examiner’s assertion that clover oil and eucalyptus oil are analgesic agents).
Brooke teaches ([0006]) a skin patch (instant transdermal patch) which contains and administers an effective amount of cannabis during a predetermined period of time to allow for controlled delivery of the active chemicals, such that plasma levels of the cannabis may be controlled in a safe, convenient and effective manner for the patient.
Brooke’s Fig.1 shown below depicts an embodiment of its invention comprising a backing layer, a reservoir of cannabis and a rate controlling membrane (see [0009]). See also an alternative structure 20 in Brooke’s Fig.2, which is similar to the structure 10 in Fig.1 except that the structure 20 in Fig.2 does not require a rate controlling membrane 15 shown in Fig.1 (see [0027]):
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With reference Fig.1, the skin patch structure 10 comprise a backing layer 11, which functions to protect the contents of the structure from environmental conditions, such as evaporation or abrasion (see [0012]-[0013]). Thus, the backing layer 11 teaches instant impermeable layer forming an upper surface of the transdermal patch. The structure 10 in Fig.1 comprises a reservoir means 12, adhesive means 13 and a rate-controlling membrane 15 ([0012] and [0015]).
The reservoir means 12 in Fig.1 comprises a cavity (defined by the backing layer 11 and the rate controlling membrane 15) containing a cannabis preparation 14. Brooke’s cannabis preparation 14 comprises (i) a cannabis solution (instant cannabis drug) extracted from tetrahydrocannabinol (THC), cannabinol (CB), cannabidiol (CBD) or cannabichromene (CBC) and (ii) a liquid or gel carrier (instant at least one pharmaceutically acceptable excipient) combined with oil (see [0016], [0010] and claims 1-2 – in claims 1-2, Brooke teaches that its cannabis preparation can also include skin permeation enhancer having an HLB of from 6 to 30). Brooke also teaches ([0004]) that the ingredients of cannabis such as THC, CB, CBD and CBC, have been used for pain associated with cancer, chemotherapy or AIDS. Thus, it would be naturally obvious to one skilled in the art to have Brooke’s cannabis solution in the amount therapeutically effective for treating or alleviating acute or chronic pain associated with cancer, chemotherapy or AIDS. Thus, Brooke teaches instant first drug layer comprising a first pharmaceutical composition comprising a cannabis drug (THC, CB, CBD or CBC) and at least one pharmaceutically acceptable excipient, wherein the cannabis drug is present in an amount therapeutically effective for treating or alleviating acute or chronic pain associated with a disease or condition of a subject.
Brooke’s adhesive means 13 shown above teaches instant adhesive layer forming at least a portion of a lower surface of the transdermal patch, the adhesive layer being configured to allow passage of the first pharmaceutical composition from the first drug layer to the skin of the subject (Brooke teaches in [0026] that the adhesive means 13 should be compatible with cannabis and should not hinder movement of the cannabis into the patient’s skin).
Brooke further teaches (in relation to another embodiment shown in its Fig.3) the use of a removable protective overlay sheet 35 adhered to the adhesive. It would be obvious to one skilled in the art to have a removable protective overlay sheet 35 adhered to the adhesive means 13 in Brooke’s embodiment shown above in Fig.1 so as to protect the overall skin patch structure prior to use. Thus, Brooke teaches instant removable protective layer disposed on a lower surface of the adhesive layer.
With respect to instant limitation “actuator with an integrated piezo transducer located on a lower surface of the transdermal patch such that a metal surface of the transducer faces a direction of adhesion of the transdermal patch”, Brooke does not teach such actuator. Zumeris et al teaches ([0007] and abstract) a device for treatment of skin. The device includes a skin-contacting portion (which may be a patch), an actuator incorporated into the skin-contacting portion, the actuator for producing surface acoustic waves on the skin, and a processor for controlling the actuator. Zumeris specifically teaches ([0177] and Fig.40) active pain relief patches including a base material and an adhesive layer, where one or more thin plate type piezo-electric actuators are incorporated into the base material of the active pain relief patches. A separate processor may be provided wherein the processor is in electrical communication with the actuators. Zumeris also teaches ([0179]) the pain relief patch may include a drug layer component. Zumeris teaches ([0179]) that micro streaming and micro pumping due to SAW may result in increased activity of these active (drug) components, thus decreasing pain relief time and increasing efficacy (Zumeris teaches ([0160] that the use of SAW (produced by the actuator) enhances the permeation of compounds, due to elliptical motion of particles during micro vibration on the surface, and due to micro-streaming resulting therefrom). As already discussed above, Brooke teaches a skin patch that contains and administers an effective amount of cannabis during a predetermined period of time for controlled delivery of the active ingredients (such as THC, CB, CBD and CBC) which treat pain associated with cancer, chemotherapy or AIDS. Furthermore, Brooke recognizes (see [0030]) that skin permeability of cannabis is relatively low and states ([0035]) that for a more effective method of transdermal delivery, the cannabinoid structure may be used in conjunction with an auxiliary means for facilitating a transdermal application. In view of Zumeris’s teachings discussed above, it would have been obvious to one skilled in the art to incorporate Zumeris’s piezo-electric actuators (instant actuator with an integrated piezo transducer) into Brooke’s skin patch (as an auxiliary means for facilitating a transdermal application) with a reasonable expectation of decreasing pain relief time and increasing efficacy obtained from the micro streaming and micro pumping due to SAW (produced by the actuator). With respect to the instant location for the actuator (i.e., on a lower surface of the transdermal patch such that a metal surface of the transducer faces a direction of adhesion of the transdermal patch), First of all, as discussed above, Zumeris’s device (for treatment of skin) includes a skin-contacting portion (a patch) and an actuator incorporated into the skin-contacting portion (the patch), the actuator for producing surface acoustic waves on the skin. Since Zumeris’s piezo-electric actuator is being used for producing surface acoustic waves on the skin, it would be obvious for one skilled in the art to locate the piezo-electric actuator on the lower surface of Brooke’s skin patch so as to be as close as possible to the skin (besides, Zumeris teaches ([0060]) that in the case of piezoelectric transducers, direct contact between actuator and the skin is necessary). Furthermore, Zumeris teaches ([0178]) that the piezo-element actuator (which consists of thin piezo material layer glued to a thin metallic plate) is incorporated into the patch in such a manner that the metallic plate faces outward with respect to the skin, and the piezo material plus the adhesive layer of the patch face inward with respect to the skin. Based on Zumeris’s such teachings, it would be obvious for one skilled in the art to locate Zumeris’s piezo-electric actuator on the lower surface of Brooke’s skin patch shown above (e.g., on the adhesive means 13 or in the adhesive means 13) such that the piezo-electric actuator is in direct contact with the skin and the metallic plate of the piezo-element actuator faces outward with respect to the skin, and the piezo material plus the adhesive means of Brooke’s skin patch face inward with respect to the skin (this way, the metal surface of the piezo-element actuator (transducer) would face the direction of adhesion of the patch as instantly recited). Thus, Brooke in view of Zumeris teaches instant actuator with an integrated piezo transducer located on a lower surface of the transdermal patch such that a metal surface of the transducer faces a direction of adhesion of the transdermal patch.
Thus, Brooke in view of Zumeris renders obvious instant claims 1 and 6.
With respect to instant claim 3, as discussed above, Brooke’s skin patch depicted in Fig.1 comprises a reservoir 12 (or cavity) containing Brooke’s cannabis preparation 14 (instant first drug layer comprising instant first pharmaceutical composition) and the rate controlling membrane 15 (instant first rate-controlling microporous membrane on a lower surface of the first drug layer). In the figure, it is shown that the reservoir 12 is defined between the backing layer 11 (instant impermeable layer) and the rate controlling membrane 15 (instant rate-controlling microporous membrane). With respect to instant limitation “wherein the rate-controlling microporous membrane is configured to allow first pharmaceutical composition to permeate therethrough to the subject at a controlled delivery rate”, Brooke teaches ([0007]-[0008]) that its rate controlling membrane is used so as to regulate the flux of the cannabis. Thus, Brooke in view of Zumeris renders obvious instant claim 3.
With respect to instant claim 7, as discussed above, Brooke’s cannabis preparation 14 (instant first pharmaceutical composition) comprises (i) a cannabis solution (instant cannabis drug) extracted from THC, CB, CBD or CBC and (ii) a liquid or gel carrier (instant at least one pharmaceutically acceptable excipient) combined with oil. Among examples for the oil, Brooke includes clove oil and eucalyptus oil. As evidenced by Dolezal ([0110]) and Modak ([0005]), clove oil and eucalyptus oil are analgesic agents. Since Brooke teaches ([0004]) that the ingredients of its cannabis solution (THC, CB, CBD or CBC) are used for pain associated with cancer, chemotherapy or AIDS, and since Brooke’s cannabis preparation 14 contains oil, which examples include clove oil and eucalyptus oil, it would be obvious to one skilled in the art to use clove oil or eucalyptus oil (instant analgesic agents) together with the cannabis solution (instant cannabis drug) in Brooke’s cannabis preparation 14 with a reasonable expectation of treating pain associated with cancer, chemotherapy or AIDS more effectively. Thus, Brooke in view of Zumeris renders obvious instant claim 7.
With respect to instant claims 11, 13 and 15, as already discussed above, Zumeris’s device includes a skin-contacting portion (active pain relief patch), a piezo-electric actuator incorporated into the skin-contacting portion, the actuator for producing surface acoustic waves on the skin, and a processor for controlling the actuator. As discussed above, Zumeris teaches that a separate processor may be provided wherein the processor is in electrical communication with the actuators. With respect to instant “portable” SAW generating system, Zumeris teaches ([0163] and Fig.38) that its SAW device may be hand held, which implies that the SAW generating device is portable. Thus, Brooke in view of Zumeris teaches a portable SAW generating system comprising the transdermal patch of instant claim 1 (or the transdermal patch of instant claim 6). With respect to instant limitation of claims 11 and 15 “an energy generating module operably coupled to the actuator of the transdermal patch, the energy generating module being configured to generate a driving signal when in an active state, wherein the generated driving signal causes a vibration mode of the actuator to communicate ultrasound energy to the transducer, and wherein the transducer is configured to receive, transform, and emit the ultrasound energy as SAW in a controlled direction through the transdermal patch”, Zumeris teaches (see [0063]-[0064]) that its processor (which is in electrical communication with the actuators) includes a power supply (a power source) for providing electrical energy to its system for treating skin using SAW. The processor further includes a controller for controlling output parameters of the processor, and the controller is in electrical communication with an oscillator for generating signals at various frequencies, a modulator for modulating parameters and a vibration method selector for providing different types of vibrations. Oscillator and modulator are connected to a first switch for selection of signal parameters. Vibration method selector is connected to a second switch for selection of vibration method. The selected signal of the selected vibration type is sent through an amplifier to the piezoelectric actuator ([0064]). The piezoelectric actuator converts the electrical signals received from the processor into mechanical energy, wherein the mechanical energy is transmitted to the skin and creates SAW on the skin surfaces ([0063]). Thus, Brooke in view of Zumeris teaches instant limitation cited above. With respect to instant limitation of claims 11 and 15 “wherein application of the SAW through the transdermal patch results in enhanced administration and transdermal absorption of the first pharmaceutical composition from the transdermal patch”, since Brooke in view of Zumeris teaches instant portable SAW generating system comprising (i) the transdermal patch of instant claim 1 (or the transdermal patch of instant claim 6) and (ii) “an energy generating module operably coupled to the actuator of the transdermal patch, . . . and wherein the transducer is configured to receive, transform, and emit the ultrasound energy as SAW in a controlled direction through the transdermal patch”, the application of the SAW through Brooke’s skin patch would naturally result in enhanced administration and transdermal absorption of Brooke’s cannabis preparation 14 from its skin patch. Thus, Brooke in view of Zumeris teaches instant limitation cited above (besides, Zumeris teaches ([0058]) that the low power, low frequency ultrasound propagated in the form of SAW through its system for treating skin is effective in better drug administering and drug diffusion). Thus, Brooke in view of Zumeris renders obvious instant claims 11, 13 and 15.
With respect to instant claim 14, Zumeris teaches ([0166]) that its processor (300) may be configured to control one or more actuators simultaneously. Assuming that there are two actuators being controlled simultaneously by the processor, since each of the actuators is incorporated in a patch, this implies that there are two patches being connected to a single processor. Thus, Brooke in view of Zumeris renders obvious instant claim 14.
With respect to instant claim 21, Brooke’s Fig.1 shows that the adhesive layer 13 is disposed around a periphery of the lower surface of the skin patch (instant transdermal patch), such that the rate controlling membrane 15 (instant rate-controlling microporous membrane) constitutes a central portion of the lower surface of the transdermal patch that is configured to contact the skin of the subject. Thus, Brooke in view of Zumeris renders obvious instant claim 21.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Brooke et al (EP 1 186 298 B1, which is equivalent to previously cited reference, US 6,328,992 B1) in view of Zumeris et al (US 2007/0232962 A1) as applied to claim 3 above, and further in view of Epner et al (US 2011/0129521 A1) and Jackson et al (US 2009/0142390 A1).
Brooke does not teach a multi-layer type transdermal patch as described in instant claim 8. However, as evidenced by Epner ([0024]) and Jackson et al (see abstract), a multi-layer transdermal patch having multiple layers of different pharmaceutical compositions (having different delivery profiles) that are layered one above the other, with each layer separated from the other by a membrane, is already known in the art. In such multi-layer transdermal patch, one pharmaceutical composition layer can be made to deliver the pharmaceutical composition more quickly or more slowly (in a controlled delivery rate) than the other pharmaceutical composition layer(s) through the selection of different polymeric matrices (see abstract in Jackson)). It would have been obvious to one skilled in the art to make Brooke’s transdermal patch into a multi-layer transdermal patch having two (or more) layers of different pharmaceutical compositions (for example, one layer made of Brooke’s cannabis preparation 14 and another layer made of a pharmaceutical composition containing a therapeutic agent for cancer or AIDS, or alternatively, two layers, both containing the same cannabis solutions but each having a different polymeric matrix), with each layer separated from the other by a rate-controlling membrane, and make one pharmaceutical composition layer deliver the pharmaceutical composition more slowly (in a controlled delivery rate) than the other pharmaceutical composition layer (by selecting two different polymeric matrices, for example) so as to be able to selectively modify and control the delivery profile of the two pharmaceutical compositions (which is not possible with a single layer transdermal patch). Thus, Brooke in view of Zumeris, and further in view of Epner and Jackson renders obvious instant claims 8-9.
With respect to instant claim 10, instant limitation “[a] portable surface acoustic wave (SAW) generating system, comprising . . . and emit the ultrasound energy as SAW in a controlled direction through the transdermal patch,” was already addressed above by the Examiner in relation to instant claims 11 and 15. Furthermore, since Brook in view of the other cited prior arts teaches such limitation, the application of the SAW through Brooke’s skin patch (as modified by the teachings of Epner and Jackson) would naturally result in enhanced administration and transdermal absorption of the first and second pharmaceutical compositions in a predetermined temporal pattern and at optimum rates comprising a delayed onset of a therapeutic effect of the second pharmaceutical composition as recited in claim 10. Thus, Brooke in view of Zumeris, and further in view of Epner and Jackson renders obvious instant claim 10.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Brooke et al (EP 1 186 298 B1, which is equivalent to previously cited reference, US 6,328,992 B1) in view of Zumeris et al (US 2007/0232962 A1) as applied to claim 3 above, and further in view of Epner et al (US 2011/0129521 A1).
As discussed above, Brooke’s Fig.1 shows that the adhesive layer 13 is disposed around a periphery of the lower surface of the skin patch (instant transdermal patch). However, as evidenced by Epner (see Fig.2 and [0025]), a transdermal patch where an adhesive layer (see adhesive layer 16 in Fig.2) is provided across the lower surface of the transdermal patch is also known in the art, and it is the Examiner’s position that having the adhesive layer across the lower surface of the transdermal patch (as opposed to having it around a periphery of the lower surface of the patch) would be an obvious matter of design choice. See MPEP 2144.04 (VI)(C), which cites In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Brooke teaches ([0045]) that there are suitable adhesive materials that may function as a matrix to carry the active cannabis and enhancer preparations. It is the Examiner’s position that such adhesive materials provided across the lower surface of the transdermal patch would allow Brooke’s cannabis preparation (instant first pharmaceutical composition ) to pass through. Thus, Brooke in view of Zumeris, and further in view of Epner renders obvious instant claim 22.
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Brooke et al (EP 1 186 298 B1, which is equivalent to previously cited reference, US 6,328,992 B1) in view of Zumeris et al (US 2007/0232962 A1) as applied to claim 1 above, and further in view of Sanni et al (“Powering low-power implants using PZT transducer discs operated in the radial mode”, Smart Materials and Structure, vol.22 (2013), 115005 (12 pages)).
With respect to instant limitation “wherein the integrated piezo transducer has a profile height of 6 mm or less”, although Zumeris does not explicitly teach such limitation, as evidenced by Sanni et al (see Table 1), the thickness of a piezo electric transducer is known to be around 1 mm. It would have been obvious to one skilled in the art to have the thickness of Zumeris’s piezo transducer (that is to be integrated into Brooke’s skin patch) to be around 1 mm according to the known practice of the art. Thus, Brooke in view of Zumeris, and further in view of Sanni renders obvious instant claim 23.
Response to Arguments
Applicant first argue that there is insufficient motivation to modify Brooke’s skin patch by incorporating the piezo-electric actuators of Zumeris. Citing Virtek Vision International ULC v. Assembly Guidance Systems, Inc., No. 2022-1998 (Fed. Cir. Mar. 27, 2024), applicant argue that while one could have modified Brooke as suggested in the Office Action to include the piezo-electric actuators of Zumeris, one skilled in the art would not have been motivated to have made the proposed modification because Brooke not only mentions the relatively low skin permeability of cannabis and recognizes the need for providing an auxiliary means for facilitating a transdermal application, but also provides its own solutions, such as application of a patch containing low dosage on a portion of the patient’s skin containing artificially induced pores created by pin pricks or using chemical/pharmaceutical permeation enhancers (the latter being preferred). Applicant further argue that in view of the fact that Brooke especially emphasizes the use of chemical/pharmaceutical permeation enhancers for the transdermal delivery of cannabinoids, one of ordinary skill in the art would not have been motivated to have made the proposed modification by substituting Zumeris’s piezo-electric actuators for Brooke’s permeation enhancers .
The Examiner disagrees. The Examiner never asserted that it would be obvious to substitute Zumeris’s piezo-electric actuator for Brooke’s chemical/pharmaceutical permeation enhancers. Brooke already teaches (claim 1) that its cannabis preparation comprises (i) a cannabis solution extracted from THC, CB, CBD or CBC, (ii) transdermal carrier (a liquid or gel carrier) and (iii) a skin permeation enhancer having an HLB of 6-30. However, it was and still is the Examiner’s position that (i) since Zumeris teaches ([0170]) that micro streaming and micro pumping due to SAW may result in increased activity of these active (drug) components, thus decreasing pain relief time and increasing efficacy and teaches ([0160] that the use of SAW (produced by the actuator) enhances the permeation of compounds, due to elliptical motion of particles during micro vibration on the surface, and due to micro-streaming resulting therefrom; (ii) since Brooke teaches a skin patch that administers an effective amount of cannabis for controlled delivery of the active ingredients (THC, CB, CBD and CBC) which treat pain (associated with cancer, chemotherapy or AIDS); and (iii) since Brooke recognizes that skin permeability of cannabis is relatively low and teaches that for a more effective method of transdermal delivery, the cannabinoid structure may be used in conjunction with an auxiliary means for facilitating a transdermal application, one skilled in the art would have found a sufficient motivation to incorporate Zumeris’s piezo-electric actuators into Brooke’s skin patch (even if it already contains a permeation enhancer) with a reasonable expectation of decreasing pain relief time and increasing efficacy obtained from the micro streaming and micro pumping due to SAW (produced by the actuator). The fact that Brooke’s cannabis preparation already contains a permeation enhancer should not prevent one from further incorporating Zumeris’s piezo-electric actuators into Brooke’s skin patch. Although Brooke teaches that its cannabinoid structure may be used in conjunction with an auxiliary means for facilitating a transdermal application and gives two examples of such auxiliary means, Brooke is not excluding the use of different auxiliary means for facilitating a transdermal application. Brooke’s permeation enhancer is being taught as an effective means to increase transdermal permeability of the cannabis formulation. As discussed above, Zumeris also teaches that the use of SAW (produced by the piezo-electric actuator) enhances the transdermal permeation of (drug) compounds. Since both Brooke’s permeation enhancer and Zumeris’s piezo-electric actuator are being individually taught by the prior arts to be useful for the same purpose, it would be obvious to one skilled in the art to incorporate Zumeris’s piezo-electric actuator into Brooke’s skin patch (having a permeation enhancer) contained in the cannabis preparation with a reasonable expectation of further enhancing transdermal permeability of the cannabis preparation. MPEP 2144.06 states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose . . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Applicant next argue that the primary purpose of applying SAW in Zumeris is for pain relief by enhancing diathermy and biological processes, for which the active drug component is not necessary. Applicant then cite [0179] of Zumeris which states “[i]n some embodiments the pain relief patch 524 may include a drug layer component (liquid, cream or slow release component of the patch). Micro streaming and micro pumping due to SAW may result in increased activity of these active components, thus decreasing pain relief time and increasing efficacy.” Applicant argue the Zumeris’s disclosure is thus noncommittal regarding the increased activity of drugs owing to an applied SAW, only informing the reader that an increase in the activity of the active drug activity is a possible result of SAW, not that one should reasonably expect it in every situation. Applicant argue that as Zumeris is silent regarding the specific active drugs which may experience increased activity due to SAW, there is no reason to understand from Zumeris that SAW increased the activity of all drugs and certainly not specifically cannabinoids. Applicant argue that Zumeris indicates that there has been “some investigation” into its effect on chemotherapy- indicating that the effects of SAW on the effects of a particular drug are determined through investigation. Thus, applicant argue that without suitable investigation, one would not reasonably expect that the SAW would increase the effects of a transdermally delivered cannabinoid. Applicant also argue that although Zumeris, through the disclosed experiment, found SAW to be effective in increasing the permeability of dye into skin, one skilled in the art would not necessarily be likely to have a reasonable expectation of similar results with a cannabinoid because as noted in Brooke, THC is a lipophilic molecule and the permeability of low-lipophilic Trypan Blue has limited relevance regarding the permeability of THC. Citing Sanofi v. Watson Laboratories Inc., 875 F.2d 636 (Fed. Cir. 2017), in which the Federal Circuit has established that cautious optimism is not sufficient to establish a reasonable expectation of success, argue that such case law provides sufficient basis for being cautious about any expectation one may have had regarding the effects of SAW on cannabinoids. Thus, applicant argue that even if one of ordinary skilled in the art would have been motivated to modify Brooke in order to enhance transdermal delivery of cannabinoids, it would not be obvious to have made the modification by introducing SAW as taught by Zumeris.
The Examiner disagrees. Throughout its specification, it is clear that Zumeris is not simply expressing “cautious optimism” with regard to the increased activity of drugs (and their penetration) due to an applied SAW. Zumeris starts by stating ([0058]) that their theoretical constructions and experimental results proved that low-power, low-frequency ultrasound propagated in the form of SAW is effective in achieving one or more results including better drug administering and intensity of drug diffusion. Zumeris teaches ([0107]) that mechanical vibrations activated by its actuators enable deeper penetration of a disinfecting liquid to the skin layers, providing better results. After discussing ([0159]) that the skin is a multi-layered organ, and the stratum corneum presents principal resistance to the penetration of topically applied compounds, so that the number of molecules currently used in topical and cosmetic dermal delivery is quite limited, Zumeris teaches ([0160]) that SAW actuated device and disposable patches can enhance the permeation of compounds (due to elliptical motion of particles during micro vibration on the surface and due to micro-streaming resulting therefrom). Thus, micro-electronic skin care products provide “a significant increase” in the percentage of active cosmetic ingredients that can be delivered onto the upper layers of the skin (and many cosmetic ingredients are lipophilic). In [0180], Zumeris teaches that although the mechanisms are only partially understood, using ultrasound for transdermal drug delivery is well known in the art. The high-frequency waves open tiny holes in cell membranes, which make the cells temporarily permeable in localized areas and allow for better drug penetration into the blood vessels below the skin, thus enhancing drug effectiveness, reducing dosage requirements and toxicity. Zumeris then demonstrates ([0181]) similar effectiveness of using SAW in penetrating liquid molecules into skin layers by showing that Trypan Blue dye penetrated into guinea pig skin as a result of exposure to SAW (even though applicant argues that one skilled in the art would not necessarily have a reasonable expectation of similar results with a cannabinoid due to its lipophilic character, as discussed above, Zumeris teaches that the SAW actuated device provide a significant increase in the percentage of active cosmetic ingredients delivered into the upper layers of the skin, and many cosmetic ingredients are lipophilic) . It is the Examiner’s position that one skilled in the art reading Zumeris would have a reasonable expectation (not mere cautious optimism) that the SAW generated by Zumeris’s piezo electric actuator incorporated into Brooke’s skin patch (having permeating enhancer) would further enhance or increase penetration of Brooke’s cannabis preparation into the skin. Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
For the reasons stated above, instant 103 rejections over Brooke in view of Zumeris still stand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/Primary Examiner, Art Unit 1613 January 23, 2026