DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the claim amendments filed on 8/25/2025. As directed by the amendment: claims 1-3, 12, 39-40, and 42 have been amended; claims 10, 20-38, and 41 are cancelled; and no claims have been added. Thus, claims 1-9,11-19, 39-40, and 42 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 8/25/2025 regarding “claims 1 and 42 require a bioactive layer comprising one or more chemokines” are considered persuasive. See amended claim rejections below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 1, 3, 5-9,12-19 and 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0050010 A1 to McAllister et al. in view of US 2009/0092582 A1 to Bogin et al.
In regards to claim 1:
A microneedle array device for transdermal injection comprising a plurality of microneedles (Fig. 1), wherein each microneedle comprises: a base layer (Fig. 1 element 110); a bioactive layer (Para. 31 “In a preferred embodiment, a microneedle array is provided for administration of a drug or other substance of interest into a biological tissue such as skin, wherein the array includes a base substrate having a microneedle side and an opposing back side; a primary funnel portion extending from the microneedle side of the base substrate; and one or more solid microneedles extending from the primary funnel portion, wherein the one or more solid microneedles comprise a substance of interest and a matrix material, and wherein more of the substance of interest is located in the one or more solid microneedles than is located in the primary funnel portion. For example, the primary funnel portion may include from 0% to 20% of the substance of interest present in the combination of the one or more solid microneedles and the primary funnel portion from which the one or more solid microneedles extend. This embodiment advantageously avoids wasting the drug in the funnel portion.”); and a separation layer that dissolves or disperses under physiological conditions (Para. 103 “(e.g., insert a rapidly dissolving or fracturable layer where the microneedles meet their funnels to allow for rapid separation of the microneedles thereby significantly decreasing required administration time).”(emphasis added). Fracturable layer considered a separation layer under broadest reasonable interpretation.), wherein the separation layer is positioned between the base layer and the bioactive layer (Para. 103. Considered to be between the base layer and the bioactive layer due to “where the microneedles meet their funnels to allow for rapid separation of the microneedles”).
McAllister does not explicitly disclose the use of chemokines or said chemokines in a gradient concentration as claimed. Bogin teaches, a bioactive layer comprising one or more chemokines (Para. 376 “Biologically active polypeptides can include, but are not limited to cytokines, chemokines”), wherein the chemokines are present in a gradient concentration in the microneedle array (para. 751 “Multiple coatings of particles can also be utilized to have a gradient of drug concentrations, so that the inner layers, which have a smaller surface area, yield the same drug release per unit time due to a higher concentration of the drug.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the bioactive layer taught by McAllister to comprise chemokines as taught by Bogin. This would have been motivated by increasing the treatment options available to practitioners of the device. Increasing the different drugs and/or bioactive agents able to be delivered by a device increases the different treatments the device is able to achieve.
In regards to claim 3:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer further comprise one or more compounds selected from the group consisting of: an allergen, an antibody or fragment thereof, an affimer, an analgesic agent, an anesthetic agent, an anti- asthmatic agent, an antibiotic, an anti-depressant agent, an anti-diabetic agent, an anti-fungal agent, an antigen with an adjuvant, an antigen without an adjuvant, an anti-hypertensive agent, an anti-inflammatory agent, an anti-neoplastic agent, an aptamer, a type of bacterium, a chemotherapeutic agent, a cosmetic, DNA, a glycoprotein, an immunostimulating agent, an immunosuppressive agent, a lipid, a nucleic acid construct, a nucleotide, an oligonucleotide, an oligosaccharide, a peptide, a polysaccharide, a protein, a protein scaffold, RNA, a small molecule, a vaccine, a vaccine with an adjuvant, a vector, a viral vector, a live virus, an inactivated virus, a wound healing drug or agent, a birth control drug, and a nanoparticle (Para. 158 “In embodiments, the microneedle patches described herein are used to deliver one or more substances of interest (e.g., vaccines, therapeutics, vitamins)”).
In regards to claim 5:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer additionally comprises one or more compounds selected from the group consisting of an antioxidant, a bacteriostat, a buffer, a carbohydrate, a chelating agent, a coloring, a diluent, an emulsifier, an excipient, a flavoring and/or an aromatic substance, a lubricant, a pH buffering agent, a carrier, a polypeptide, a preservative, a salt, a solubilizer, a stabilizer, a surfactant, and a wetting agent (Para. 67 “The fluid solution used in the mold filling processes described herein may include any of a variety of excipients. The excipients may consist of those that are widely used in pharmaceutical formulations or ones that are novel. In a preferred embodiment, the excipients are ones in FDA approved drug products (see the Inactive Ingredient Search for Approved Drug Products at http://www.accessdata.fda.gov/scripts/cder/iig/index.Cfm). None, one, or more than one excipient from the following categories of excipients may be used: stabilizers, buffers, bulking agents or fillers, adjuvants, surfactants, disintegrants, antioxidants” (emphasis added). Para. 158 “In embodiments, the microneedle patches described herein are used to deliver one or more substances of interest (e.g., vaccines, therapeutics, vitamins)” vitamins considered to include the antioxidants previously mentioned as an excipient due to vitamins A, C and E which are antioxidants.).
In regards to claim 6:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer additionally comprises poly lactic-co-glycolic acid (PLGA) (para. 67 “polylactive co-glycolic acid (PLGA)”).
In regards to claim 7:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer additionally comprises carboxymethylcellulose (CMC) (Para. 67 “carboxymethyl cellulose”)
In regards to claim 8:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the separation layer dissolves when exposed to physiological conditions (Para. 103 “(e.g., insert a rapidly dissolving or fracturable layer where the microneedles meet their funnels to allow for rapid separation of the microneedles thereby significantly decreasing required administration time”, para. 158 “The microneedles are preferably dissolvable and once in the intradermal space they dissolve within the interstitial fluid and release the active into the skin”. Considered to be rapidly dissolving or fracturable (separation layer) in physiological conditions as it its stated to dissolve within the skin.).
In regards to claim 9:
The device of claim 8, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the physiological conditions comprise one or more of:(a) an aqueous environment; or (b) a temperature of about 30°C to about 43°C (para. 158 “The microneedles are preferably dissolvable and once in the intradermal space they dissolve within the interstitial fluid and release the active into the skin”. Interstitial fluid considered an aqueous environment. Skin considered to be within the range of 30°C to about 43°C as normal human body temperature is about 37°C).
In regards to claim 12:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister in view of Bogin teaches, wherein all or substantially all of the one or more chemokines are in the bioactive layer (McAllister teaches, Para. 158 “The microneedles are preferably dissolvable and once in the intradermal space they dissolve within the interstitial fluid and release the active into the skin. Once the microneedles are fully dissolved, which generally takes a few minutes (e.g., <20 minutes), the patch can be removed and discarded as non-sharps waste since the microneedles dissolve away. The microneedles can be altered to provide for more rapid release or quicker separation from the patch. They can also be formulated to release active over extended periods. Alternatively, the microneedles can be designed to rapidly separate from the patch, but then dissolve away slowly. A combination of these release features can be contained within a single microneedle patch to provide the desired release profile of the agent.”. Para. 104 “This is followed by one or more final filling steps in which the molds are filled with excipients (which could be the same and or different excipients as in prior fillings) and without active, which provide the microneedles with their mechanical structure once dried.” (emphasis added). Bogin teaches the use of chemokines as the bioactive agent as described in claim 1 rejection above.).
In regards to claim 13:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer has a top cross sectional area, the separation layer has a middle cross sectional area, and the base layer has a bottom cross sectional area, wherein the top cross sectional area is less than the middle cross sectional area, and the middle cross sectional area is less than the bottom cross sectional area (Annotated Fig. 20 below. Para. 158 “The microneedles are preferably dissolvable and once in the intradermal space they dissolve within the interstitial fluid and release the active into the skin. Once the microneedles are fully dissolved, which generally takes a few minutes (e.g., <20 minutes), the patch can be removed and discarded as non-sharps waste since the microneedles dissolve away. The microneedles can be altered to provide for more rapid release or quicker separation from the patch. They can also be formulated to release active over extended periods. Alternatively, the microneedles can be designed to rapidly separate from the patch, but then dissolve away slowly. A combination of these release features can be contained within a single microneedle patch to provide the desired release profile of the agent.”. Para. 104 “This is followed by one or more final filling steps in which the molds are filled with excipients (which could be the same and or different excipients as in prior fillings) and without active, which provide the microneedles with their mechanical structure once dried.”. Considered evidence of a dissolvable separation layer between the base substrate layer and the active layer. McAllister teaches layered shape as shown in annotated Fig. 20 below.).
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Annotated Fig. 20
In regards to claim 14:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the bioactive layer has a shape that tapers to a point (Fig. 1 element 130 conical shape).
In regards to claim 15:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the microneedle has a pyramidal shape or a conical shape (Fig. 1 element 130 conical shape).
In regards to claim 16:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the microneedle has a height of between about 50 µm to about 2500 µm (Para. 39 “The length (height) of a funnel (L.sub.FUN) may be between about 10 μm and 1 cm. In most cases funnels are between about 200 μm and 2000 μm, and more preferably between about 500 μm and 1500 μm” (emphasis added)).
In regards to claim 17:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the microneedle has a length or a width of between about 100 µm to about 1000 µm (Para. 39 “The length of a microneedle (L.sub.MN) may be between about 50 μm and 2 mm. In most cases they are between about 200 μm and 1200 μm, and ideally between about 500 μm and 1000 μm”(emphasis added)).
In regards to claim 18:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister does not appear to explicitly teach, wherein a total length and a total width of the device ranges from about 1 to 100 mm by about 1 to 100 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of McAllister to have a total length and a total width of the device ranges from about 1 to 100 mm by about 1 to 100 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of McAllister would not operate differently with the claimed total width and total length, and since the device is designed as a microneedle patch it would function appropriately having the claimed total length and total width. Further, applicant appears to place no criticality on the range claimed.
In regards to claim 19:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister teaches, wherein the device includes at least 50 microneedles (Fig. 1 elements 130, one hundred shown. Para. 45 “The number of microneedles per patch is generally between 1 and 10,000, and in most cases is between about 20 and 1000 and more preferably between about 50 and 500. The number of funnels per patch is generally between about 1 and 10,000, and in most cases is between about 5 and 500 and more preferably between about 10 and 500.“ (emphasis added)).
In regards to claim 39:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister in view of Bogin teaches, wherein the bioactive layer comprises nanoparticles comprising the one or more chemokines (McAllister teaches, Para. 118 “This process also can useful be to drive larger molecules (e.g., the active) down into the microneedles and their tips while the filling fluid is still in the solution state. The term “larger molecules” is used to mean molecules that are larger than those of the liquid vehicle, or solvent, and can also include nanoparticles, microparticles and other particles made up of many molecules.” (emphasis added). Bogin teaches the use of chemokines as the bioactive agent as described in claim 1 rejection above).
In regards to claim 40:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister in view of Bogin teaches, wherein the separation layer further comprises nanoparticles comprising the one or more chemokines (McAllister teaches, Para. 103 “In other embodiments, a single filling step or more than two filling steps may be used. A single filling step may be desirable, for example, if the active is inexpensive and the excess active in the funnel and base can be wasted.” (emphasis added). Para. 118 “This process also can useful be to drive larger molecules (e.g., the active) down into the microneedles and their tips while the filling fluid is still in the solution state. The term “larger molecules” is used to mean molecules that are larger than those of the liquid vehicle, or solvent, and can also include nanoparticles, microparticles and other particles made up of many molecules”. Bogin teaches the use of chemokines as the bioactive agent as described in claim 1 rejection above).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0050010 A1 to McAllister et al. in view of US 2009/0092582 A1 to Bogin et al. further in view of US 2014/0188041 A1 to Moore et al.
In regards to claim 2:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister does not explicitly teach the separation layer comprises PVA or PVP as claimed. Moore teaches, wherein the separation layer comprises polyvinyl alcohol (PVA) and/or polyvinyl pyrrolidone (PVP) (Para. 22 “In connection with this embodiment, the microneedle-forming composition may comprise an active substance, such that when the microneedle dissolves upon application to the skin, the active substance is delivered into the underlying tissue of the subject.” And para. 24 “The dissolvable material may comprise one or a combination of materials selected from the following: polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP),”. Para. 47 “FIG. 2. Schematic diagram of dissolvable microneedle array fabrication process with formulation concentrated in the needle tips. (A) Water was applied to a PDMS mold under vacuum or by spraying. (B) Excess water was removed from the surface using sharp blade. (C and D) Small amount of concentrated drug solution in water was applied directly on top of needle cavities. (E) Concentration of drug solution was equilibrated in the upper bulb and microneedle mould as the result of diffusion between highly concentrated formulation in the bulb and water in the cavities. (F) The drug solution was dried to give formulation concentrated in the needle tips. (G) Second solvent (96% ethanol) was applied to a mold and (H) excess is removed using sharp blade. (I and J) Solution of polyvinylpyrrolidone (PVP) in 96% ethanol (6) was added on top of dry formulation and dried. (K) Flexible adhesive tape was applied on top of the mold to adhere to needle bases and lifted (L) giving an array of dissolvable microneedles with drug filled in the needle tips and hard support base made of PVP (M).” Steps I and J are considered to be the formation of the separation layers made of PVP.).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the fracturable layer taught by McAllister to comprise PVA and/or PVP as taught Moore. As McAllister does not explicitly teach how to form the fracturable layer one of ordinary skill in the art would have been motivated to find a material to achieve the taught fracturable layer. One of ordinary skill in the art would have been motivated to use PVA and PVP as taught by Moore para. 22 “In connection with this embodiment, the microneedle-forming composition may comprise an active substance, such that when the microneedle dissolves upon application to the skin, the active substance is delivered into the underlying tissue of the subject.” (emphasis added).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0050010 A1 to McAllister et al. in view of US 2009/0092582 A1 to Bogin et al. further in view of US 2014/0200509 A1 to Cohen et al.
In regards to claim 4:
The device of claim 3, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister does not appear to explicitly teach the cosmetic as claimed. Cohen teaches, wherein the cosmetic is selected from the group consisting of an anti-aging compound, an anti-wrinkle compound, a dermal filler, an ink for a tattoo, and a skin brightening compound (Para. 27 “A variety of cosmetic ingredients may be delivered as components of the dissolvable microneedle array herein. For example, whitening ingredients, antiwrinkle ingredients, blood circulation promotion ingredients, dietary aid, antibacterial agents; vitamins may be included in the microneedle compositions.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the microneedles active agent taught by McAllister to include a cosmetic agent as taught by Cohen. This would have been motivated by Cohen para. 4 and 5 “These formulations should be applied to the skin. Thus, they are readily lost or removed under various conditions, such as perspiration, washing and external pressure. Further, they need the permeation of cosmetic actives into skin obtain optimal efficacy. However, it is difficult deliver optimal efficacy of many cosmetic actives due to the barrier properties of skin which prohibits the entrance of foreign materials. [0005] Recently, to solve these problems, microneedles fabricated of metal or plastic coated with cosmetic agents on their surface have been used as an approach to actually deliver cosmetic agents to a desired site of skin. However, with this approach, a small quantity of cosmetic agents can be administrated, and there is a risk that solid microneedle fragments will remain in skin. Therefore, their use raises many safety concerns”.).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0050010 A1 to McAllister et al. in view of US 2009/0092582 A1 to Bogin et al. further in view of US 2004/0260251 A1 to Chang et al.
In regards to claim 11:
The device of claim 1, taught by McAllister in view of Bogin as described in parent claim rejection above.
McAllister does not appear to explicitly teach the base layer as claimed. Chang teaches, wherein the base layer comprises polydimethylsiloxane (PDMS) (Para. 33 “flexible substrate 320, such as silicon rubber, polymethyl methacrylate (PMMA), polydimethyl siloxane (PDMS), polyethylene (PE), polypropylene (PP), etc. with reference to FIG. 3A” (emphasis added). Fig. 3a element 320).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the microneedles base layer taught by McAllister to be PDMS as taught by Chang. This would have been motivated by Chang (Para. 33 “because the microneedle arrays structure 300 can be easily deformed, hence, the microneedle arrays structure 300 with reference to FIG. 3B can easily attaches itself to a rough surface 330, such as skin.”). Considered to be motivation as improved adhesion to the treatment site would result in improved treatment with the device.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0050010 A1 to McAllister et al. in view of US 2014/0200509 A1 to Cohen et al. further in view of US 2009/0092582 A1 to Bogin et al.
In regards to claim 42:
McAllister teaches, A microneedle array device for transdermal injection comprising a plurality of microneedles (Fig. 1), wherein each microneedle comprises: a base layer (Fig. 1 element 110); a bioactive layer (Para. 31 “In a preferred embodiment, a microneedle array is provided for administration of a drug or other substance of interest into a biological tissue such as skin, wherein the array includes a base substrate having a microneedle side and an opposing back side; a primary funnel portion extending from the microneedle side of the base substrate; and one or more solid microneedles extending from the primary funnel portion, wherein the one or more solid microneedles comprise a substance of interest and a matrix material, and wherein more of the substance of interest is located in the one or more solid microneedles than is located in the primary funnel portion. For example, the primary funnel portion may include from 0% to 20% of the substance of interest present in the combination of the one or more solid microneedles and the primary funnel portion from which the one or more solid microneedles extend. This embodiment advantageously avoids wasting the drug in the funnel portion.”); and a separation layer that dissolves or disperses under physiological conditions, wherein the separation layer is positioned between the base layer and the bioactive layer (Para. 103 “(e.g., insert a rapidly dissolving or fracturable layer where the microneedles meet their funnels to allow for rapid separation of the microneedles thereby significantly decreasing required administration time).”(emphasis added). Fracturable layer considered a separation layer under broadest reasonable interpretation.);
McAllister does not appear to explicitly describe the pyramidal shape as claimed. Cohen teaches, wherein the base layer includes an extruded portion that extrudes into a pyramidal shape of the microneedle (Para. 25 “In detail, the shape of the microneedles 1 is preferred to be circular cone or polygonal pyramid such as triangulate pyramid, quadrangular pyramid, hexagonal pyramid and octagonal pyramid.”
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the shape of microneedle taught by McAllister to be a pyramidal shape as taught by Cohen. This would have been motivated by design choice as merely picking between known microneedle shapes is considered to be within the level of ordinary skill in the art.
McAllister does not explicitly disclose the use of chemokines or said chemokines in a gradient as claimed. Bogin teaches, a bioactive layer comprising one or more chemokines (Para. 376 “Biologically active polypeptides can include, but are not limited to cytokines, chemokines”), wherein the chemokines are present in a gradient concentration in the microneedle array (para. 751 “Multiple coatings of particles can also be utilized to have a gradient of drug concentrations, so that the inner layers, which have a smaller surface area, yield the same drug release per unit time due to a higher concentration of the drug.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the bioactive layer taught by McAllister to comprise chemokines as taught by Bogin. This would have been motivated by increasing the treatment options available to practitioners of the device. Increasing the different drugs and/or bioactive agents able to be delivered by a device increases the different treatments the device is able to achieve.
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.
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/M.A.I./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783