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 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 21, 24, 25, 27, 30, 31, 32, 34, 37, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”).
In relation to independent claim 21, as explained in the non-final office action mailed on 4/1/2026, Brisken discloses:
limitation (a): applying an agent to skin of a body portion of a subject:
Brisken discloses: “This delivery can be accomplished transcutaneously or percutaneously by way of an injection needle or needles, injected in high-velocity, small-volume jets of delivery fluid, or delivered interoperatively. The substance can also be delivered by a controlled release device such as a microsphere. Substance delivery could also be accomplished by positioning the distal end of a delivery device, (such as a catheter or hand-held device), proximal to a target region of tissue… For delivery through the skin or surgical use, the device may be constructed
similarly to a syringe having an ultrasonic driver on or near the needle tip.” (Brisken, [0014].) Brisken further discloses: “The present invention will be useful for delivering a wide variety of drugs, genes, and other therapeutic and/or diagnostic substances to target tissue sites.” (Brisken, [0012].)
limitation (b): applying ultrasound energy to the skin of the body portion of the subject to increase permeability of the skin of the body portion and increase absorption of the agent into the skin of the body portion of the subject:
Brisken discloses: “a method is provided for enhancing cellular absorption of a substance, comprising the steps of: (a) delivering the substance to the target tissue region, and (b) directing vibrational energy to the target region, wherein the vibrational energy is of a type and amount sufficient to enhance absorption of the substance into the cells of the target region.” (Brisken, [0010].) Brisken further discloses: “ultrasound conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].)
In relation to the amendment filed on 7/01/2026, Brisken, does not expressly disclose that the agent is non-percutaneously applied to an external skin or body surface. However, Reed expressly distinguishes non-invasive topical delivery from invasive treatment techniques. Paragraph [0003] states that chemical products provided in “lotion or gel form are non-invasive” and describes therapeutic chemicals that are topically applied to skin. Paragraph [0004] states that it would be preferable to employ a non-invasive procedure for treating skin.
Paragraph [0006] then identifies Reed’s solution as using ultrasound to enhance penetration of a therapeutic agent into the epidermis and dermis “in a non-invasive process.” (Reed ¶¶ [0004]–[0006].) Finally, Paragraph [0007] discloses coupling an ultrasound transducer to a liquid or gel-based skin-care product “applied to the skin.” Reed explains that the product may first be placed directly on the skin surface and that ultrasound-induced oscillation “increases the permeability of the skin” to active agents contained in the product. Reed ¶ [0007].
Based on the above teachings, for an artisan skilled in the art, the application of agents non-percutaneously would have been considered an obvious alternative in the design of the method for treatment.
In relation to independent claim 27, as explained in the non-final office action mailed on 4/1/2026, Brisken discloses:
limitation (a): applying a therapeutic agent to a body portion of a subject:
Brisken discloses: “The present invention will be useful for delivering a wide variety of drugs, genes, and other therapeutic and/or diagnostic substances to target tissue sites.” (Brisken, [0012].) Brisken further discloses: “the substance is delivered to the target cells in the target tissue of the host.” (Brisken, [0014].)
limitation (b): applying ultrasound energy to the body portion of the subject to increase permeability of body portion and increase absorption of the therapeutic agent into the body portion of the subject.
As to limitation (b), Brisken discloses: “directing vibrational energy to the target region, wherein the vibrational energy is of a type and amount sufficient to enhance absorption of the substance into the cells of the target region.” (Brisken, [0010].) Brisken further discloses: “ultrasound conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].)
In relation to the amendment filed on 7/01/2026, Brisken, does not expressly disclose that the agent is non-percutaneously applied to an external skin or body surface. However, Reed expressly distinguishes non-invasive topical delivery from invasive treatment techniques. Paragraph [0003] states that chemical products provided in “lotion or gel form are non-invasive” and describes therapeutic chemicals that are topically applied to skin. Paragraph [0004] states that it would be preferable to employ a non-invasive procedure for treating skin. Paragraph [0006] then identifies Reed’s solution as using ultrasound to enhance penetration of a therapeutic agent into the epidermis and dermis “in a non-invasive process.” (Reed ¶¶ [0004]–[0006].) Finally, Paragraph [0007] discloses coupling an ultrasound transducer to a liquid or gel-based skin-care product “applied to the skin.” Reed explains that the product may first be placed directly on the skin surface and that ultrasound-induced oscillation “increases the permeability of the skin” to active agents contained in the product. (Reed ¶ [0007].)
Based on the above teachings, for an artisan skilled in the art, the application of agents non-percutaneously would have been considered an obvious alternative in the design of the method for treatment.
In relation to independent claim 34, as explained in the non-final office action mailed on 4/1/2026, Brisken discloses:
limitation (a): a therapeutic agent configured to be applied to a body portion of a subject:
Brisken discloses: “an injection needle 20 delivering a drug or other substance 21 into a region of target tissue 22 which is comprised of a plurality of cells 24.” (Brisken, [0062].)
limitation (b): an ultrasound energy generator configured to apply ultrasound energy to the body portion of the subject, wherein the ultrasound energy increases permeability of the
body portion and enhances delivery of the therapeutic agent into the body portion of
the subject.
Brisken discloses: “a vibrational emitter 30, may be used to emit ultrasound waves 32 into the target tissue 22 in a type and in an amount sufficient such that drug 21 is instead readily absorbed into cells 24.” (Brisken, [0063].) Brisken further discloses: “ultrasound conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].)
In relation to the amendment filed on 7/01/2026, Brisken, does not expressly disclose that the agent is non-percutaneously applied to an external skin or body surface. However, Reed expressly distinguishes non-invasive topical delivery from invasive treatment techniques. Paragraph [0003] states that chemical products provided in “lotion or gel form are non-invasive” and describes therapeutic chemicals that are topically applied to skin. Paragraph [0004] states that it would be preferable to employ a non-invasive procedure for treating skin. Paragraph [0006] then identifies Reed’s solution as using ultrasound to enhance penetration of a therapeutic agent into the epidermis and dermis “in a non-invasive process.” (Reed ¶¶ [0004]–[0006].) Finally, Paragraph [0007] discloses coupling an ultrasound transducer to a liquid or gel-based skin-care product “applied to the skin.” Reed explains that the product may first be placed directly on the skin surface and that ultrasound-induced oscillation “increases the permeability of the skin” to active agents contained in the product. (Reed ¶ [0007].)
Based on the above teachings, for an artisan skilled in the art, the application of agents non-percutaneously would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 24, Brisken discloses: “The bio-effects of ultrasonic energy are typically mechanical in nature (cavitational or pressure effects) or thermal in nature (heat due to absorption of
energy or energy conversion).” (Brisken, [0064].) Brisken further discloses: “MI values over 1 to 2 represent acoustic levels which can cause mechanical bio-effects including excessive membrane damage and cell necrosis due to inertial cavitation, microstreaming, or radiation pressure.” (Brisken, [0067].) Brisken further discloses: The presence of microbubbles enhances cavitation which improves the efficiency of transfections.” (Brisken, [0089].) Brisken further discloses: “ultrasound conditions
which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 25, Brisken discloses: “The presence of microbubbles enhances cavitation which improves the efficiency of transfections.” (Brisken, [0087].) Brisken further discloses: “ultrasound
conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 30, Brisken discloses: “The presence of microbubbles enhances cavitation which improves the efficiency of transfections.” (Brisken, [0087].) Brisken further discloses: “ultrasound conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 31, Brisken discloses: “Substances of interest will typically be delivered through the internal walls and membranes of organs (particularly the epicardium and endocardium when targeting the myocardium), blood vessels, and the like, as well as through the skin.” (Brisken, [0015].) Brisken further discloses: “catheter 42a is received into a intraluminal cavity 60. Intraluminal cavity 60 can either be a naturally occurring cavity in a patient’s body or a cavity formed by injection of a needle into the patient’s body. A drug or other substance is delivered into a target region of tissue by puncturing cavity wall 62 of intraluminal cavity 60 by injection needles 201.” (Brisken, [0105].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 32, Brisken discloses: “Substances of interest will typically be delivered through the internal walls and membranes of organs (particularly the epicardium and endocardium when targeting the myocardium), blood vessels, and the like, as well as through the skin.” (Brisken, [0015].) Brisken further discloses: “The cells may be muscle or fat cells receiving transcutaneous, intraoperative, or percutaneous injection.” (Brisken, [0009].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 37, Brisken discloses: “The presence of microbubbles enhances cavitation which improves the efficiency of transfections.” (Brisken, [0087].) Brisken further discloses: “ultrasound
conditions which favor a high mechanical index yet preferably produce only a low temperature elevation in the tissue are used to induce a preferred cellular response which promotes increased porosity and subsequent uptake of therapeutic agents.” (Brisken, [0070].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 38, Brisken discloses: “Substances of interest will typically be delivered through the internal walls and membranes of organs (particularly the epicardium and endocardium when targeting the myocardium), blood vessels, and the like, as well as through the skin.” (Brisken, [0015].) Brisken further discloses: “The substance can also be delivered by a controlled release device such as a microsphere.” (Brisken, [0014].) Delivery via a controlled release device such as a microsphere does not require an injection. In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
In relation to claim 39, Brisken discloses: “Substances of interest will typically be delivered through the internal walls and membranes of organs (particularly the epicardium and endocardium when targeting the myocardium), blood vessels, and the like, as well as through the skin.” (Brisken, [0015].) Brisken further discloses: “The cells may be muscle or fat cells receiving transcutaneous, intraoperative, or percutaneous injection.” (Brisken, [0009].) In view of the demonstrated conventionality of this enhancement, its implementation in the invention of this application would have been considered an obvious alternative in the design of the method for treatment.
Claims 22, 28, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”), as discussed above, and in further view of D’Sa et al. (US 6,322,532B1; hereinafter “D’Sa”).
In relation to claim 22, Brisken discloses the method of claim 21 as set forth above. However, Brisken does not explicitly disclose applying a separate interface material to the skin of the body portion of the subject and applying the ultrasound energy through the interface material. D’Sa discloses: “a drug-containing matrix layer 30, best seen in FIG. 2, is disposed at the bottom surface of the flexible disk 12. The matrix layer 30 may preferably be made of a sponge-like or other absorbent material that can retain a therapeutically effective amount of a drug-containing liquid in position beneath the transducer assembly.” (D’Sa, Col. 8, lines 15–22.) D’Sa further discloses: “a liquid, gel, or cream composition could be coated on the bottom surface of the transducer assembly or directly to the skin/mucosa prior to use.” (D’Sa, Col. 8, lines 26–28.) D’Sa further discloses: “Another option is to use a separate drug-containing adhesive patch over which the flexure mode transducer can be placed.” (D’Sa, Col. 8, lines 29–31.)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Brisken to include applying an interface material to the skin of the body portion of the subject and applying the ultrasound energy through the interface material, as taught by D’Sa. The motivation to combine is that D’Sa teaches that a coupling medium or matrix layer disposed between the transducer and the skin/mucosa is necessary to ensure efficient acoustic transmission of ultrasound energy into the tissue and to retain the therapeutic agent in proper position for delivery, as is well known in the sonophoresis art.
In relation to claim 28, Brisken discloses the method of claim 27 as set forth above. However, Brisken does not explicitly disclose applying a separate interface material to the body portion of the subject over the therapeutic agent and applying the ultrasound energy through the interface material.
D’Sa discloses: “a liquid, gel, or cream composition could be coated on the bottom surface of the transducer assembly or directly to the skin/mucosa prior to use.” (D’Sa, Col. 8, lines 26-28.) D’Sa further discloses: “a drug-containing matrix layer 30… disposed at the bottom surface of the flexible disk 12. The matrix layer 30 may preferably be made of a sponge-like or other absorbent material that can retain a therapeutically effective amount of a drug-containing liquid in position beneath the transducer assembly.” (D’Sa, Col. 8, lines 15–22.)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Brisken to include applying an interface material to the body portion of the subject over the therapeutic agent and applying the ultrasound energy through the interface material, as taught by D’Sa. The motivation to combine is that D’Sa teaches that a coupling medium or matrix layer disposed between the transducer and the skin/mucosa is necessary to ensure efficient acoustic transmission of ultrasound energy into the tissue and to retain the therapeutic agent in proper position for delivery, as is well known in the sonophoresis art.
In relation to claim 35, Brisken discloses the system of claim 34 as set forth above. However, Brisken does not explicitly disclose an interface agent configured to be applied to the body portion of
the subject over the therapeutic agent. D’Sa discloses: “a drug-containing matrix layer 30… disposed at the bottom surface of the flexible disk 12. The matrix layer 30 may preferably be made of a sponge-like or other absorbent material that can retain a therapeutically effective amount of a drug containing
liquid in position beneath the transducer assembly.” (D’Sa, Col. 8, lines 15–21.) D’Sa further discloses: “a liquid, gel, or cream composition could be coated on the bottom surface of the transducer assembly or directly to the skin/mucosa prior to use.” (D’Sa, Col. 8, lines 26–28.)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Brisken to include an interface agent configured to
be applied to the body portion of the subject over the therapeutic agent, as taught by D’Sa. The motivation to combine is that D’Sa teaches that a coupling medium or matrix layer disposed between the transducer and the skin/mucosa is necessary to ensure efficient acoustic transmission of ultrasound energy into the tissue and to retain the therapeutic agent in proper position for delivery, as is well known in the sonophoresis art.
Claims 23 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”), as discussed above, and in further view of Chang (WO 2015/164348A2).
In relation to claim 23, Brisken discloses the method of claim 21 as set forth above. However, Brisken does not explicitly disclose applying negative pressure to the body portion to enhance penetration of the agent into the body portion of the subject. Chang discloses: “The combination of the electrical induced therapies and microdermabrasion create aqueous pathways to increase the permeability of the drugs and/or fluids which are delivered from a supply and return reservoir by a
vacuum system within the device.” (Chang, WO 2015⁄164348 A2, [0013].) Chang further discloses: “a vacuum 124 may be applied to the surface of the skin from a vacuum pump… through the vacuum conduit 112 and vacuum entry port 126 on the tip 104 of the device.” (Chang, WO 2015⁄164348 A2, [0084].)
In relation to claim 29, Brisken discloses the method of claim 27 as set forth above. However, Brisken does not explicitly disclose applying negative pressure to the body portion to enhance
penetration of the therapeutic agent into the body portion of the subject. Chang discloses: “a vacuum 124 may be applied to the surface of the skin from a vacuum pump… through the vacuum conduit 112 and vacuum entry port 126 on the tip 104 of the device.” (Chang, WO 2015⁄164348 A2, [0084].) Chang further discloses: “The combination of the electrical induced therapies and microdermabrasion create
aqueous pathways to increase the permeability of the drugs and/or fluids which are delivered from a supply and return reservoir by a vacuum system within the device.” (Chang, WO 2015⁄164348 A2, [0013].)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Brisken to include applying negative pressure to
the body portion to enhance penetration of the therapeutic agent into the body portion of the subject, as taught by Chang. The motivation to combine is that Chang teaches that applying negative pressure via a vacuum system to the skin surface creates aqueous pathways and increases skin permeability, thereby further enhancing the penetration and delivery of therapeutic agents into the skin, which is the same
goal sought by the ultrasound-based method of Brisken.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”) and D’Sa et al. (US 6,322,532B1; hereinafter “D’Sa”), as discussed above, and in further view of Chang (WO 2015/164348A2).
In relation to claim 36, Brisken in view of D’Sa discloses the system of claim 35 as set forth above. However, neither Brisken nor D’Sa explicitly discloses a vacuum source configured to apply a negative pressure to the body portion of the subject, wherein the negative pressure applied to the body portion is configured to enhance penetration of the therapeutic agent into the body portion of the subject.
Chang discloses: “a vacuum 124 may be applied to the surface of the skin from a vacuum pump… through the vacuum conduit 112 and vacuum entry port 126 on the tip 104 of the device.” (Chang, WO 2015⁄164348 A2, [0084].) Chang further discloses: “The combination of the electrical induced therapies and microdermabrasion create aqueous pathways to increase the permeability of the drugs and/or fluids which are delivered from a supply and return reservoir by a vacuum system within the device.” (Chang, WO 2015⁄164348 A2, [0013].)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Brisken and D’Sa to include a vacuum source configured to apply a negative pressure to the body portion of the subject to enhance penetration of the therapeutic agent, as taught by Chang. The motivation to combine is that Chang teaches that a vacuum system applied to the skin surface creates aqueous pathways and increases skin permeability, thereby further enhancing the penetration and delivery of therapeutic agents into the skin, which is the same goal sought by the ultrasound-based system of Brisken.
Claim 26 is are rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”), as discussed above, and in further view of McDaniel (US 6,030,374).
Brisken discloses the method of claim 21 as set forth above. However, Brisken does not explicitly disclose wherein the agent comprises at least one of Botox, collagen, cream, enhancer, water, wrinkle reducing agent, or combinations thereof. McDaniel discloses: “[t]he present invention, in a preferred embodiment, may be used to: deliver agents which enhance, speed or promote wound healing; deliver anesthetic agents to the skin and subcutaneous tissues; improve skin tone and ‘tighten’ loose skin; to reduce the appearance of cellulite; reduce wrinkles or scars.” (McDaniel, Col. 11, lines 46-48 to Col. 12, lines 1-3.) McDaniel further discloses: “[i]n another embodiment of the invention sonophoresis may be used alone, without a topical agent, to produce a thermal effect (rather than to drive drugs in) to stimulate the skin (e.g. make fibroblasts, produce new collagen, elastin, etc.).”
(McDaniel, Col. 8, line 8-11.) McDaniel further discloses that examples of active agents include “bleaching cremes, vitamin C, the vitamin A family, and topical anesthetics.” (McDaniel, Col. 5, lines 46-47.) McDaniel further discloses that the active agent may be “dissolved in an appropriate vehicle medium, such as a gel or a liquid.” (McDaniel, Col. 4, 21-22.)
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Brisken to use an agent comprising at least one of
Botox, collagen, cream, enhancer, water, or wrinkle reducing agent, as taught by McDaniel. The motivation to combine is that McDaniel teaches that ultrasound enhanced transdermal delivery (sonophoresis) is particularly effective for delivering cosmetic and anti-aging agents such as collagen-stimulating compounds and wrinkle reducing agents to the skin, and that such agents are well known in the art for improving skin appearance. A person of ordinary skill in the art would have been motivated to apply the ultrasound-enhanced delivery method of Brisken to the cosmetic agents disclosed by McDaniel in order to achieve improved transdermal delivery of those agents.
Claims 33 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Brisken et al. (US 2003/0009153A1; hereinafter “Brisken”) in view of Reed et al. (US 2009/0318852A1; hereinafter “Reed”), as discussed above, and in further view of McDaniel (US 6,030,374) and D’Sa et al. (US 6,322,532B1; hereinafter “D’Sa”).
Brisken discloses the method of claim 27 as set forth above. Brisken further discloses that the therapeutic agent may comprise RNA or DNA segments: “The present invention will be useful for delivering a wide variety of drugs, genes, and other therapeutic and/or diagnostic substances to target tissue sites… The substances will usually have a pharmological or biological effect and may range from those generally classified as small molecule drugs… to those generally classified as large molecule
drugs… such as large proteins, complete regulatory and structural genes.” (Brisken, [0012].) Brisken further discloses delivery of chemotherapy drugs: “The methods of the present invention are useful with a wide variety of nucleic acid types… The methods are not limited to such naked nucleic acids, however, they are also suitable for the delivery of nucleic acids incorporated into liposomes and cationic polymer
complexes.” (Brisken, [0013].) However, Brisken does not explicitly disclose wherein the therapeutic agent comprises Arnica, Voltaren, Morphine, salicylic acid, narcotics, cannabidiols, or antiviral agents.
McDaniel discloses that examples of active agents for ultrasound-enhanced transdermal delivery include: “salicylic acid; antioxidant triad compound… antibiotics; antifungals; antivirals.” (McDaniel, Col. 8, lines 17-19.) McDaniel further discloses delivering “anesthetic agents to the skin and subcutaneous tissues.” (McDaniel, Col. 11, last line to Col. 12, line 1.)
D’Sa discloses that drugs for use with sonophoresis include “narcotic analgesics (e.g., butorphanol, morphine)” (D’Sa, Col. 5, lines 57–58.) D’Sa further discloses “anti-inflammatories (e.g., diclofenac, ketoprofen, nabumetone, etodolac, oxaprozin, mesalamine, naproxen).” (D’Sa, claim 18.) Voltaren is the brand name for diclofenac, which is explicitly disclosed by D’Sa.
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Brisken to use a therapeutic agent comprising at least one of Arnica, Voltaren (diclofenac), Morphine, salicylic acid, narcotics, cannabidiols, or antiviral agents, as taught by McDaniel and D’Sa. The motivation to combine is that both McDaniel and D’Sa teach that sonophoresis is effective for delivering a wide variety of therapeutic agents through the skin, including analgesics, anti-inflammatory agents, narcotics, and antiviral agents. A person of ordinary skill in the art would have been motivated to apply the ultrasound-enhanced delivery method of Brisken to the therapeutic agents disclosed by McDaniel and D’Sa in order to achieve improved transdermal delivery of those agents for the treatment of pain, inflammation, and other conditions.
Response to Arguments
Applicant’s arguments with respect to the pending claims 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
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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