DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Invention I and Species A, D, E, and H in the reply filed on April 16, 2026 is acknowledged. Claims 1-53 are pending in the application, with claims 11-13, 21-47, 49, and 51 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Note, Applicant’s remarks filed on April 16, 2026 were considered. Group I was intended to be defined as claims 1-20 and 48-53 as applicant has acknowledged. Furthermore, claims 12-13 were withdrawn from consideration as being dependent from a withdrawn claim (i.e., claim 11).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 48, and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitations 20-50 µm and/or 20-150 µm, and the claim also recites about 20 µm and/or 30 µm which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 48 recites “a payload” in line 1, but it is not clear if this recitation is the same as, related to, or different from the recitation “a payload” in claim 15, line 1. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the payload”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 50 is rejected by virtue of its dependence from claim 48.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-10, 14-17, 19-20, 48, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Cannehan et al. (US Patent Application Publication 2012/0172820), hereinafter Cannehan, and in view of Black et al. (US Patent Application Publication 20210052428), hereinafter Cannehan.
Regarding Claim 1, Cannehan teaches a microneedle with a sharp tip (see abstract and Figs. 1 and 3). Cannehan teaches a microneedle ( ¶[0035] and ¶[0038] the microneedles 4/9; Figs. 3 and 5)
comprising a base (¶[0035]-[0036] the portion at the bottom of the elongated body 32 with which the microneedles emerge from; Figs. 3 and 5)
and a tip distal from the base (¶[0036] the tip 31; Figs. 3 and 5),
wherein the microneedle is formed comprising a plurality of channels extending in a substantially uniform direction through the microneedle from a base surface towards an outer surface defined by the tip (¶[0013], ¶[0017], and ¶[0035] the channels/lumens 5/6, Figs. 3 and 5; see also ¶[0040] there may be additional channels/lumens, Figs. 7-9), and
wherein the plurality of channels are adapted to enable flow of a fluid therein (¶[0017] one or more channels may be utilized for a drug delivery and another one or more channels may be utilized for the removal of another liquid).
Cannehan teaches the microneedles may be formed of silicone (see ¶[0030]-[0034]), but does not teach that the microneedle is formed with an anisotropic porous composition.
Black teaches a system and device including a conduit with a proximal and distal end, arranged such that, a first material is transported from the distal end to the proximal end and a second material is resisted at the proximal end (see abstract and Figs. 8A-8C), in which the device may be formed of silicone (see ¶[0150], ¶[0213]-[0219], ¶[0314], and ¶[0341]), in which the conduits are designed with anisotropy to enable preferential transport of a given liquid in one direction while inhibiting transport of this liquid in the opposite direction (see ¶[0229]-[0230], ¶[0249], and ¶[0289]; Figs. 8A-9B), in which the anisotropic may be implemented via interconnected anisotropic pores (see ¶[0229] and ¶[0289]), in which the anisotropic portion may be comprised of a cross-linked polymeric matrix (¶[0149], ¶[0308], and ¶[0353]), such as with alginate or poly(2-hydroxyethyl methacrylate) crosslinking (¶[0150]-[0151], ¶[0353], and ¶[0372]-[0375]), in which the end of the conduit may comprise microneedles (see ¶[0350]; Fig. 40).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the anisotropic pore conduit implement of Black with the channels/lumens of Cannehan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the anisotropic pores may enable transport of liquids in one direction while inhibiting in another, which may have use in sampling of fluids (i.e., don’t want the fluid sample going back to the subject) or drug delivery (i.e., don’t want the drug to not get delivered to the patient or other fluids to pass through) (see Black ¶[0254] and ¶[0265]); and/or (3) such designs enable improved fluid transport (see Black ¶[0201], ¶[0254], and ¶[0265]).
Regarding Claim 2, Cannehan in view of Black teaches the device of claim 1 as stated above. Cannehan further teaches each of the plurality of channels has a substantially uniform channel diameter (¶[0046] the lumens may have symmetrical cross sections, or have asymmetrical cross sections with variable diameters).
Regarding Claim 4, Cannehan in view of Black teaches the device of claim 1 as stated above. The modified Cannehan further teaches the flow of the fluid within the plurality of channels is unidirectional (see Cannehan ¶[0017], the channels that are only for delivery or sampling; see Black ¶[0229]-[0230], ¶[0249], and ¶[0289], the conduits are designed with anisotropy to enable preferential transport of a given liquid in one direction while inhibiting transport of this liquid in the opposite direction, Figs. 8A-8C).
Regarding Claim 5, Cannehan in view of Black teaches the device of claim 4 as stated above. The modified Cannehan further teaches the plurality of channels have a first physical property when the fluid flows into the microneedle, and a second physical property when the fluid flows out of the microneedle, and wherein the first physical property is different from the second physical property (see Cannehan ¶[0017], the channels that are only for delivery or sampling, see also Fig. 3 the geometry of the bottom portion of the microneedle 4 is different than the top portion openings 7/8, which falls under the BRI of morphological property; see Black ¶[0229]-[0230], ¶[0249], and ¶[0289], the conduits are designed with anisotropy to enable preferential transport of a given liquid in one direction while inhibiting transport of this liquid in the opposite direction, Figs. 8A-8C).
Regarding Claim 6, Cannehan in view of Black teaches the device of claim 5 as stated above. The modified Cannehan further teaches the first and second physical properties include morphological property, mechanical property, pore structure, and young's modulus (see Cannehan Fig. 3, the geometry of the bottom portion of the microneedle 4 is different than the top portion openings 7/8, which falls under the BRI of morphological property; see Black ¶[0229]-[0230], ¶[0249], and ¶[0289], the conduits are designed with anisotropy to enable preferential transport of a given liquid in one direction while inhibiting transport of this liquid in the opposite direction, Figs. 8A-8C).
Regarding Claim 7, Cannehan in view of Black teaches the device of claim 1 as stated above. The modified Cannehan further teaches the anisotropic porous composition is formed with a cross-linked polymeric matrix (see Black ¶[0149], ¶[0308], and ¶[0353], the anisotropic portion may be comprised of a cross-linked polymeric matrix, ¶[0150]-[0151], ¶[0353], and ¶[0372]-[0375], such as with alginate or poly(2-hydroxyethyl methacrylate) crosslinking).
Regarding Claim 8, Cannehan in view of Black teaches the device of claim 7 as stated above. The modified Cannehan further teaches the cross-linked polymeric matrix includes a plurality of monomers selected from a group consisting of gelatin, alginate, polyvinyl alcohol (PVA), poly 2-hydroxyethylmethacrylate (PHEMA), polyacrylamide (PAAm), vinylgroup- modified hyaluronic acid (HA), methactylated hyaluronic acid (MeHA) and a combination thereof (see Black ¶[0149], ¶[0308], and ¶[0353], the anisotropic portion may be comprised of a cross-linked polymeric matrix, ¶[0150]-[0151], ¶[0353], and ¶[0372]-[0375], such as with alginate or poly(2-hydroxyethyl methacrylate) crosslinking).
Regarding Claim 9, Cannehan in view of Black teaches the device of claim 1 as stated above. Cannehan further teaches a microneedle patch comprising a substrate and at least a microneedle according to claim 1 disposed on the substrate (¶[0036], ¶[0038], and ¶[0052] the portion below the bottom of the elongated body 32 with which the microneedles 4/9 emerge from, which is interconnected between the plurality of microneedles and/or the patch reservoir; Figs. 3 and 5).
Regarding Claim 10, Cannehan in view of Black teaches the device of claim 9 as stated above. Cannehan further teaches the substrate is unitary formed with the microneedle (see Figs. 3 and 5, the portion below the bottom of the elongated body 32 with which the microneedles 4/9 emerge from, which is interconnected between the plurality of microneedles),
and wherein the plurality of channels extend through both the substrate and the microneedle, from an outer surface of the substrate towards the outer surface defined by the tip of the microneedle (see Fig. 3, the channels/lumens 5/6 extend from an outer surface (on the bottom) of the substrate through the elongated body 32 to the openings 7/8 on the tip 31).
Regarding Claim 14, Cannehan in view of Black teaches the device of claim 9 as stated above. Cannehan teaches that the device may be utilized for sampling (see ¶[0017]-[0018] and ¶[0053]); however, the modified Cannehan does not specifically teach an electrochemical sensor attached to the substrate.
Black further teaches that sensors may be utilized with the device (see ¶[0061], ¶[0206], ¶[0231], and ¶[0322]-[0323]; Figs. 35A-35B), including via remote monitoring of the data transmitted via an antenna (see ¶[0322]-[0323]; Figs. 35A-35B). The biomarkers included sensed values that would include an electrochemical sensor given the electrical data in computer readable form transmitted to an external device, and such sensors are known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sensing of Black with the substrate (i.e., where the sampled material is designed to go in the modified Cannehan) in the modified Cannehan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the sensed and transmitted values would give the subject and/or a medical professional real time and easily accessible data on the subject’s condition.
Regarding Claim 15, Cannehan in view of Black teaches the device of claim 9 as stated above. Cannehan further teaches a payload pre-loaded within the microneedle patch (¶[0052] the microneedles may be utilized for delivery of at least two drugs from a patch reservoir).
Regarding Claim 16, Cannehan in view of Black teaches the device of claim 15 as stated above. Cannehan further teaches the payload is selected from a group consisting of a cell, a drug, an extracellular vesicle, a macromolecule, and a combination thereof (¶[0052] the microneedles may be utilized for delivery of at least two drugs from a patch reservoir).
Regarding Claim 17, Cannehan in view of Black teaches the device of claim 16 as stated above. Cannehan further teaches wherein the cell is selected from a group consisting of an immune cell, an antigen cell, a stem cell, a fibroblast, a melanocyte, a hair follicle cell, a beta cell, a therapeutic cell, a prophylactic cell, and a combination thereof. Claim 16 requires 5 alternatives for the payload element (i.e., a cell, a drug, an extracellular vesicle, a macromolecule, and a combination thereof), wherein finding one of the alternatives meets the elements of claim 16. The instant claim is an extension of the cell alternative. Since only the drug alternative was mapped to the prior art in claim 16, only finding the drug alternative is necessary to hold the instant claim as obvious, because the cell alternative is not necessary when at least the drug alternative is found.
Alternatively and/or additionally, Black further teaches that the conduit may allow entry of a third material from the proximal end to the distal end (see ¶[0130]), in which the third material may include stem cells and/or cellular therapeutics (see ¶[0147]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the stem cells and/or cellular therapeutics of Black as the drug (i.e., therapeutic) of the modified Cannehan because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the modified Cannehan teaches the usage of a drug/therapeutic patch and Black teaches one such alternative therapeutic capable of usage with the patch.
Regarding Claim 19, Cannehan in view of Black teaches the device of claim 16 as stated above. Cannehan further teaches the macromolecule is selected from a group consisting a genetic material, a polypeptide, a protein, a deoxyribonucleic acid sequence (DNA), a ribonucleic acid sequence (RNA), an enzyme, an antibody, and a combination thereof. Claim 16 requires 5 alternatives for the payload element (i.e., a cell, a drug, an extracellular vesicle, a macromolecule, and a combination thereof), wherein finding one of the alternatives meets the elements of claim 16. The instant claim is an extension of the macromolecule alternative. Since only the drug alternative was mapped to the prior art in claim 16, only finding the drug alternative is necessary to hold the instant claim as obvious, because the macromolecule alternative is not necessary when at least the drug alternative is found.
Alternatively and/or additionally, Black further teaches that the conduit may allow entry of a third material from the proximal end to the distal end (see ¶[0130]), in which the third material may include proteins (see ¶[0147]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the proteins of Black as the drug (i.e., therapeutic) of the modified Cannehan because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the modified Cannehan teaches the usage of a drug/therapeutic patch and Black teaches one such alternative therapeutic capable of usage with the patch.
Regarding Claim 20, Cannehan in view of Black teaches the device of claim 9 as stated above. Cannehan further teaches a plurality of microneedles forming a microneedle array disposed on the substrate (¶[0036], ¶[0038], and ¶[0052] the portion below the bottom of the elongated body 32 with which the microneedles 4/9 emerge from, which is interconnected between the plurality of microneedles; Figs. 3 and 5).
Regarding Claim 48, Cannehan in view of Black teaches the device of claim 15 as stated above. Cannehan further teaches a method of delivery of a payload comprising the step of applying the microneedle patch of claim 15 to an area of application to deliver the payload from the microneedle patch to the area of application (¶[0052]-[0053] the microneedles may be utilized for delivery of at least two drugs from a patch reservoir, the patch may be applied so as to be used for delivery of the drug).
Regarding Claim 52, Cannehan in view of Black teaches the device of claim 9 as stated above. Cannehan further teaches a method of collecting a sample comprising the step of contacting the sample with the microneedle patch of claim 9 to collect the sample (¶[0017]-[0018] and ¶[0053] the device may be utilized for sampling at least one substance).
Regarding Claim 53, Cannehan in view of Black teaches the method of claim 52 as stated above. The modified Cannehan is silent regarding that the sample is a tear.
Black further teaches that the first substance may include a tear (see ¶[0145] and ¶[0199]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sampling of tears of Black as the sampling of the modified Cannehan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Cannehan teaches the usage of the device for sampling and Black teaches one such alternative substance to sample.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cannehan in view of Black as applied to claim 2 above, and in view of Schilling et al. (German Patent Document DE102008052749A1 – citing to translation from Espacenet.com), hereinafter Schilling.
Regarding Claim 3, Cannehan in view of Black teaches the device of claim 2 as stated above. The modified Cannehan is silent regarding that the channel diameter is about 20 µm; or about 30 µm; or between 20-50 µm; or between 20-150 µm; or between 85-145 µm.
Schilling teaches a needle with a piercing end, particularly for microneedles and microneedle assemblies for microinvasive intradermal or transdermal interfaces (see abstract and ¶[0001]; Figs. 1A-1C), in which the microneedles may have channels run longitudinally therethrough (see ¶[0026]-[0027] and ¶[0053]-[0054]; Figs. 1A-1C), in which the diameter of the channels may range from 40 μm to 200 μm and from 50 μm to 300 μm (see ¶[0027] and ¶[0054]; Fig. 1C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize either of the channel diameters of Schilling as the channel/lumen diameter of the modified Cannehan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Cannehan requires a channel/lumen diameter and Schilling teaches two of such diameter ranges.
The 40 μm to 200 μm and/or 50 μm to 300 μm range of the modified Cannehan suggests the range of the present claim because between 20-50 µm; or between 20-150 µm; or between 85-145 µm overlaps with the range of 40 μm to 200 μm and/or 50 μm to 300 μm. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cannehan in view of Black as applied to claim 16 above, and in view of Yu et al. (“Microneedle-array patches loaded with hypoxia-sensitive vesicles provide fast glucose-responsive insulin delivery”, PNAS, vol. 112, no. 27, 8260/8265, July 07, 2015), hereinafter Yu.
Regarding Claim 18, Cannehan in view of Black teaches the device of claim 16 as stated above. Cannehan further teaches wherein the extracellular vesicle is selected from a group consisting of an exosome, a microvesicle, an apoptotic body, an autophagic extracellular vesicle, a matrix vesicle, a stressed extracellular vesicle, and a combination thereof. Claim 16 requires 5 alternatives for the payload element (i.e., a cell, a drug, an extracellular vesicle, a macromolecule, and a combination thereof), wherein finding one of the alternatives meets the elements of claim 16. The instant claim is an extension of the extracellular vesicle alternative. Since only the drug alternative was mapped to the prior art in claim 16, only finding the drug alternative is necessary to hold the instant claim as obvious, because the extracellular vesicle alternative is not necessary when at least the drug alternative is found.
Alternatively and/or additionally, Yu teaches about an insulin, closed-loop, delivery system with glucose responsive vesicles (GRVs) to treat type 1 diabetes with a microneedle array patch (see abstract and pg. 8261 ¶1-2; Fig. 1), in which the average diameter of the GRVs was about 118 nm (see abstract and § Results, §§ Synthesis and Characterization of GRVs, ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the GRVs of Yu as the drug (i.e., therapeutic) of the modified Cannehan because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the modified Cannehan teaches the usage of a drug/therapeutic patch and Yu teaches one such alternative therapeutic capable of usage with the patch. Note, that the GRVs (i.e., average diameter of 118 nm) would fall under the BRI of a microvesicle.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Cannehan in view of Black as applied to claim 48 above, and in view of Prausnitz et al. (US Patent 6,503,231), hereinafter Prausnitz.
Regarding Claim 50, Cannehan in view of Black teaches the method of claim 48 as stated above. Black teaches that the eye may be sampled (¶[0145] and ¶[0199]); however, the modified Cannehan does not specifically teach that the area of application is an ocular surface.
Prausnitz teaches microneedle devices for transport of therapeutic and diagnostic materials and/or energy across tissue barriers (see abstract and Fig. 3), in which drugs may be delivered to the eye (see col. 11 ln. 24-45).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the drug delivery to the eye of Prausnitz as with the device of the modified Cannehan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Cannehan teaches the usage of the device for drug delivery and Prausnitz teaches one such drug delivery location.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lalwani et al. (US Patent Application Publication 2020/0345994) teaches a cleavable microneedle for delivery of a therapeutic agent (see abstract and Figs. 2A-4), in which drugs may be delivered to different anatomic membranes, including the eye (see ¶[0064], ¶[0073], ¶[0111], ¶[0122], and ¶[0185]).
Ross (US Patent Application Publication 2011/0144591) teaches a transdermal delivery device which is suitable for the transdermal delivery or removal of substances, and in particular relates to a transdermal delivery device having a support and a plurality of microneedles projecting outwardly from the support (see abstract and Figs. 1-7), in which a channel may extend from the support through an exterior surface of the microneedles (see ¶[0005]-[0008] and ¶[0024]; Figs. 1-3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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