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 .
DETAILED ACTION
Pursuant to a preliminary amendment filed December 3, 2024, claims 109-128 are currently pending.
Therefore, claims 109-128 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 15, 2024 is a CON of US Patent Application 16323234, filed February 4, 2019, which is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2017/045161, filed on August 2, 2017, which claims the benefit of US Provisional Patent Application 62/508,861, filed May 19, 2017; US Provisional Patent Application 62/460,574, filed February 17, 2017; and US Provisional Patent Application 62/370,416, filed August 3, 2016.
Information Disclosure Statement
No information disclosure statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to the patentability as defined in 37 C.F.R. 1.56.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections/Rejections
Claim Rejections - 35 USC § 112(b)
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 109-128 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 109, 112, 116, 124, 126 and 127 are indefinite for the recitation of the terms “the microtip” or “the microtips” such as recited in claim 109, lines 6 and 8. There is insufficient antecedent basis for the terms “the microtip” or “the microtips” in the claim because claim 109, line 2 recites the term “a plurality of microtips.”
Claims 109 and 111 is indefinite for the recitation of the term “the thickness” such as recited in claim 109, line 9. There is insufficient antecedent basis for the term “the thickness” in the claim because claim 109, line 3 recites the term “a first thickness.” The Examiner suggests that Applicant amend the claim to recite, for example, “is thinner than the first thickness of the starting substrate.”
Claim 109 is indefinite for the recitation of the term “the same” such as recited in claim 109, line 5. There is insufficient antecedent basis for the term “the same” in the claim.
Claim 109 is indefinite for the recitation of the term “the starting substrate” such as recited in claim 109, line 9. There is insufficient antecedent basis for the term “the starting substrate” in the claim because claim 109, line 2 recites the term “a substrate.”
Claim 112 is indefinite for the recitation of the term “each of the reservoirs” such as recited in claim 112, line 1. There is insufficient antecedent basis for the term “each of the reservoirs” in the claim because claim 109, line 3 recites the term “a reservoir.” The Examiner suggests that Applicant amend claim 109 to recite, for example, “each reservoir.”
Claim 112 is indefinite for the recitation of the term “on each of the microtips” such as recited in claim 112, lines 1-2 because claim 112 depends from instant claim 109, wherein claim 109 does not recite that the reservoir is “on the microtip” and, thus, the metes and bounds of the claim cannot be determined.
Claim 114 is indefinite for the recitation of the term “formulated as a sugar glass or a sugar crystal” such as recited in claim 114, lines 1-2 because claim 114 depends from claim 109 and 112, wherein claims 109 and 112 do not recite a formulated substance. Moreover, it is unclear how a reservoir within a microtip delivers a substance that is formulated as a sugar glass or a sugar crystal. The microtip structure recited in claim 109 appears to refer to a microtip that delivers a solution of an agent, while claim 114 appears to be directed at a breakable microtip, where such solid formulations are often delivered to the skin where they dissolve upon contact, such as with dissolving microneedles as evidenced by Loizdou (Abstract) and, thus, the metes and bounds of the claim cannot be determined. The Examiner suggests that Applicant amend the claim to recite, for example, “wherein the active pharmaceutical ingredients is formulated as a sugar glass or a sugar crystal.”
Claim 115 is indefinite for the recitation of the term “formulated as a sugar glass or a sugar crystal” such as recited in claim 115, lines 1-2 because claim 114 depends from claim 109, 112 and 114, wherein claims 114, lines 1-2 already recites that the substance is formulated as a sugar glass or a sugar crystal and, thus, the metes and bounds of the claim cannot be determined.
Claim 119 is indefinite for the recitation of the term “the metal” such as recited in claim 119, line 1. There is insufficient antecedent basis for the term “the metal” in the claim because claim 118, line 2 recites the term “metal sheet.”
Claim 120 is indefinite for the recitation of the term “the substantially planar substrate” such as recited in claim 120, line 1. There is insufficient antecedent basis for the term “the substantially planar substrate” in the claim because claim 109, line 2 recites the term “substrate.” Moreover, claim 120 depends from claim 109, wherein claim 109 does not recite that the substrate is substantially planar and, thus, the metes and bounds of the claim cannot be determined.
Claim 121 is indefinite for the recitation of the term “the plastic” such as recited in claim 121, line 1. There is insufficient antecedent basis for the term “the plastic” in the claim because claim 120, line 2 recites the term “a plastic sheet.”
Claims 124, 126 and 127 are indefinite for the recitation of the term “each of the microtips” such as recited in claim 124, line 1. There is insufficient antecedent basis for the term “each of the microtips” in the claim because claim 109, line 2 recites the term “each microtip of the plurality of microtips.”
Claims 110, 113, 117, 118, 122, 123, 125 and 128 are indefinite insofar as they ultimately depend from instant claim 109.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 114 and 120 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 114 recites (in part): “wherein the substance is formulated as a sugar glass or sugar crystal” such as recited in claim 114, lines 1-2 because claim 114 depends from instant claim 109, wherein claim 109 does not recite a formulated substance. Thus, claim 114 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 120 recites (in part): “wherein the substantially planar substrate comprises a plastic sheet” such as recited in claim 120, lines 1-2 because claim 120 depends from instant claim 109, wherein claim 109 does not recite a that the substrate is substantially planar. Thus, claim 120 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 109-113, 116-126 and 128 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Cormier et al. (hereinafter “Cormier”) (US Patent Application Publication 20070118070, published May 24, 2007).
Regarding claim 109, Cormier teaches in Figures 4 & 5 a blade array patterns comprising a plurality of microtips and substrate each having a thickness (interpreted as an array of microprojections; and a substrate having a thickness, claim 109) (paragraphs [0014]-[0015]; and Figures 4 & 5). Figures 4 & 5 are shown below:
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Figure 4 Figure 5
Cormier teaches in Figure 9, a view of angled blades , wherein the blades are all aligned at an angle between about 1° and about 89° degrees, about 10° to about 60°, or about 20° to 45° to facilitate the device being slid along and into the skin (interpreted as a plurality of microprojections, claim 109) (paragraphs [0019]; and [0051], lines 6-9). Figure 9 is shown below:
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Cormier teaches in Figures 10-14, prong 68 is etched in the side of some or all of the blades 4, and punched lightly so as to protrude outward from the plane of each of the blades, as illustrated in Figures 10 and 14, such that after the punching of the prongs, the blades can be repunched to regain their substantially vertical orientation, and hinges 72 (Figure 13) can be used to control the retention force of the barb for anchoring, wherein the hinges allow for the retention force to be tailored independently of the size of the blade because the force required to bend or punch the prong is set independently of the size of the blades by the shape or size of the hinge, wherein the force can be tailored by the amount of attachment of the prong to the plate, the greater the attachment, the greater the force (interpreted as microprojections comprising hinges; and modifying etching to be thinner to tailor the retention force, including up to 80% less thickness, where the less attachment, the less force, claims 109 and 111) (paragraph [0056]; and Figures 10-14). Figures 10-14 are shown below:
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Figure 10 Figure 11 Figure 12
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Figure 13 Figure 14
Cormier teaches that each blade has a width and thickness that facilitates penetration of the stratum corneum without bending (interpreted as substrate and blade having a thickness, claim 109 and 11) (paragraph [0044], lines 7-9). Cormier teaches that in the case of therapeutic agent (e.g., drug) delivery, the drug is released from a drug-containing reservoir (not shown in Figure 2) through microslits formed by the micro-blades cutting through the stratum corneum, migrating down the outer surfaces of the micro-blades and through the stratum corneum to achieve local or systemic therapy (interpreted as comprising a reservoir in the micro-blade, claim 109) (paragraph [0040], lines 8-13).
Regarding claims 110 and 124, Cormier teaches that the device comprises a sheet having a plurality of openings therethrough, a plurality of micro-blades integral therewith and extending downward therefrom and means for anchoring the device to a body surface (interpreted as the substrate being substantially planar, claim 110) (paragraph [0009], lines 1-5). Cormier teaches in Figure 9, a view of angled blades , wherein the blades are all aligned at an angle between about 1° and about 89° (interpreted as a plurality of microprojections; and projecting at an angle relative to the substrate, claims 1110 and 124) (paragraphs [0019]; and [0051], lines 6-9).
Regarding claim 111, Cormier teaches that blades 4 can be patterned with resist on both sides 48,49 and subsequently etched simultaneously from both sides (Figure 7); and/or the blades 4 can be patterned and etched from one side (i.e., side 49) only (Figure 6), such that when etching from one side only, the etching process can be controlled to etch selective depths in the plate 6 along the length of the blades (e.g., at the blade tips) to produce a single angle 60 at the tip of the blade which maximizes the sharpness of the knife-like edge of the blade; and the lithography process produces a portion of the blade that is thinner than the remainder of the thickness of the blade and of the sheet, such that the lithography process also can produce very small dimensioned elements for the anchoring and the penetration aspects of the invention (interpreted as modifying etching to be thinner to tailor the retention force, including a thickness of up to 80% less thickness than the substrate, claims 109 and 111) (paragraph [0047]).
Regarding claim 112, Cormier teaches that in the case of therapeutic agent (e.g., drug) delivery, the drug is released from a drug-containing reservoir (not shown in Figure 2) through microslits formed by the micro-blades cutting through the stratum corneum, migrating down the outer surfaces of the micro-blades and through the stratum corneum to achieve local or systemic therapy (interpreted as comprising a reservoir in the micro-blade being loaded with a substance including an active pharmaceutical ingredient, claim 112) (paragraph [0040], lines 8-13). Cormier teaches that the invention has utility in connection with the delivery of drugs within any of the broad class of drugs normally delivered through body surfaces and membranes, including skin including drugs in all of the major therapeutic areas including, but not limited to, antiinfectives such as antibiotics and antiviral agents, analgesics including fentanyl, sufentanil, buprenorphine and analgesic combinations, anesthetics, anorexics, antiarthritics, etc. (interpreted as comprising active pharmaceutical ingredients, claim 112) (paragraph [0079], lines 1-8).
Regarding claim 113, Cormier teaches that the invention can be used in conjunction with the delivery of nucleotidic drugs, including oligonucleotide drugs, polynucleotide drugs, and genes
(interpreted as encompassing RNA, claim 113) (paragraph [0079], last 4 lines).
Regarding claim 116, Cormier teaches that the invention has a blade density of at least about 10 blades/cm2 and less than 1000 blades/cm2 (interpreted as encompassing a density of 10 to 100 microtips per cm2, claim 116) (paragraph [0060], lines 13-15).
Regarding claims 117, 119, 120 and 121, Cormier teaches that the sheet and blades can be made from materials that have sufficient strength and manufacturability to produce blades, such as, glasses, ceramics, rigid polymers, metals and metal alloys including, but are not limited to stainless steel, iron, steel, tin, zinc, copper, platinum, aluminum, germanium, nickel, zirconium, titanium and titanium alloys consisting of nickel, molybdenum and chromium, metals plated with nickel, gold, rhodium, iridium, titanium, platinum, and the like, wherein glasses include a devitrified glass such as "Photoceram" available from Corning in Corning, N.Y; as well as, including but not limited to polystyrene, polymethylmethacrylate, polypropylene, polyethylene "Bakelite", cellulose acetate, ethylcellulose, styrene/acrylonitrile copolymers stryrenetbutadiene copolymers, acrylonitrile/butadiene/styrene (ABS) copolymers, polyvinyl chloride and acrylic acid polymers including polyacrylates and polymethacrylates (interpreted as aluminum, stainless steel, gold, etc.; polystyrene as a plastic; and polyethylene as a thermoplastic, claims 117, 119, 120 and 121),
Regarding claim 118, Cormier teaches that the width of each blade is between about 137.5 microns to about 175 microns and the length is about 250 microns (interpreted as encompassing a thickness of 25 to 150 microns; and a length of 10 to 1000 microns, claims 118 and 126) (paragraph [0044], lines 12-14). Cormier teaches that a thin sheet or plate 6 of metal such as stainless steel or titanium is etched photo-lithographically with patterns containing blade-like structures, wherein a thin laminate dry resist or wet resist is applied on a sheet about 7 µm to about 100 µm thick (interpreted as a metal sheet having a thickness of 25 to 150 microns, claim 118) (paragraph [0045], lines 3-7).
Regarding claims 122 and 123, Cormier teaches that the blades 4 can be patterned with resist on both sides 48,49 and subsequently etched simultaneously from both sides (Figure 7), such that to achieve maximum pattern resolution for a given sheet thickness and to produce a knife-like edge that cannot be achieved with conventional stamping and punching process (interpreting a knife-like edge as a beveled edge, known as an alternate top bevel edge, claims 122 and 123) (paragraph [0047, lines 1-6).
Regarding claim 125, Cormier teaches in Figure 9, a view of angled blades , wherein the blades are all aligned at an angle between about 1° and about 89° degrees, about 10° to about 60°, or about 20° to 45° to facilitate the device being slid along and into the skin (interpreted as microprojections having an angle from 50o to about 90o, claim 125) (paragraphs [0019]; and [0051], lines 6-9).
Regarding claim 126, Cormier teaches that the length of the blades is about 25 microns to about 400 microns (interpreted as microtips having a length of 10 to 1000 microns, claim 126) (paragraph [0044], least 3 lines).
Regarding claim 128, Cormier teaches that the plurality of micro-blades 4 for puncturing the stratum corneum are present on one face surface 48 of the device 2 in any predetermined arrangement, for example, as a cluster of blades spaced in rows having any desired number, or in any spaced apart relation of one blade to each other, wherein the device 2 of the embodiment shown in Figures 1 and 2 is produced by the pattern shown in Figure 3 (interpreted as microptips in rows and columns on the substrate, claim 128) (paragraph [0044], lines 1-7).
Cormier does not specifically exemplify that the substance is formulated as a sugar glass or a sugar crystal (claim 114); that the sugar glass comprises sucralose, glucose, galactose, fructose, trehalose, maltose, or a combination thereof (claim 115); and where the microtips have a length of about 600-800 microns (claim 127).
Cormier meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and
103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for
the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
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 109-128 are rejected under 35 U.S.C. 103 as being unpatentable over Cormier et al. (hereinafter “Cormier”) (US Patent Application Publication 20070118070, published May 24, 2007) in view of Chan et. al. (hereinafter “Chan”) (US Patent Application Publication No. 20070293815, published December 20, 2007).
The teachings of Cormier as applied to claims 109-113, 116-126 and 128 are described supra.
Cormier does not specifically exemplify that the substance is formulated as a sugar glass or a sugar crystal (claim 114); that the sugar glass comprises sucralose, glucose, galactose, fructose, trehalose, maltose, or a combination thereof (claim 115); and where the microtips have a length of about 600-800 microns (claim 127).
Regarding claims 114, 115 and 127, Chan et al. teach a transdermal delivery system with microprojections for disrupting a body surface to an individual, wherein at least some of the microprojections have a depression for increasing drug loading by a drug coating including an elongated depression on the surface of the microprojection (Abstract; and paragraph [0010]). Chan et al. teach that the tiny stratum corneum piecing/cutting elements are meant to make correspondingly small microslits/microcuts in the stratum corneum for enhanced transdermal agent delivery or transdermal body analyte sampling therethrough, such that perforated skin provides improved flux for sustained agent delivery or sampling through the skin; and that when microprojection arrays are used to improve delivery or sampling of agents through the skin, consistent, complete, and repeatable microprojection penetration is desired (paragraphs [0006], lines 22-28; and [0007], liens 1-4).
Chan et al. teach that the microprojections have a drug coating with a drug (e.g., on or near the tip of the microprojections), wherein at least some of the micro-blades have depressions 91 on at least a face of the micro-blades, such that a depression will increase the surface area on which drug coatings can adhere on the micro-blades 90 compared with micro-blades without the depression, wherein some or all of the micro-blades in the microprojection member can have one or more such depressions including depressions of different shapes by methods known in the art as found in agent delivery and sampling patches such as found in US20020016562, US 6537264, WO 97/48440, WO 97/48441 and WO 97/48442 incorporated herein by reference (paragraphs [0056]). Chan et al. teach the depressions on the microprojections are less wide than the microprojections, and no deeper than the thickness of the microprojections (interpreted as encompassing 80% thickness, claims 117 and 127) (paragraph [0058]). Chan et al. teach that the coating formulation includes a biocompatible carrier, which can comprise, without limitation, human albumin, bioengineered human albumin, polyglutamic acid, polyaspartic acid, polyhistidine, pentosan polysulfate, polyamine acids, sucrose, trehalose, melezitose, raffinose, stachyose, mannitol, and other sugar alcohols; as well as, a non-reducing sugar, a polysaccharide, or a reducing sugar including sucrose, trehalose, stachyose, raffinose, apiose, arabinose, lyxose, ribose, xylose, digitoxose, fucose, quercitol, quinovose, rhamnose, allose, altrose, fructose, galactose, glucose, gulose, hamamelose, idose, mannose, tagatose, and the like (interpreted as the substance is formulated as a sugar glass, including trehalose, claim 127) (paragraphs [0095]; [0097]; [0098]; and [0100]). Chan teaches that the microprojection array of Figure 2 without a drug reservoir or a drug coating can also be applied alone as a skin pre-treatment, such that the microprojections have a projection length of less than 1000 microns (interpreted as a length of 600-800 microns, claim 127) (paragraph [0056], lines 17-21; and Figure 2). Figure 2 is shown below:
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“It 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). Moreover, “it is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view the benefits of transdermal drug delivery and/or sampling using microprojections as exemplified by Chan et al., it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the micro-blade array to include or replace the micro-blades comprising reservoirs for the delivery and/or sampling of agents as disclosed by Cormier to include a depression reservoir and/or biocompatible formulations for coating an agent on the face of the micro-blades that can comprise drug coatings in a biocompatible carriers such as sugars including sucrose, trehalose, glucose, etc. as taught by Chan with a reasonable expectation of success in producing a transdermal and/or intradermal agent delivery patch having improved skin attachment with minimal or no skin irritation; in producing skin-piercing micro-blades having enhanced transdermal flux; and/or in increasing transdermal delivery rates and/or reducing the degradation of an agent by co-delivering a beneficial agent with a skin permeation enhancer.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly
rejected under 35 USC §103(a) as obvious over the art.
Conclusion
Claims 109-128 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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/AMY M BUNKER/
Primary Examiner, Art Unit 1684
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