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 . Continued Examination Under 37 CFR 1.114A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on (1 – 13 – 2026) has been entered.
Response to Arguments
Applicant’s arguments and remarks, see (Pgs. 8 – 9), filed on (1 – 13 – 2025), with respect to the amended feature(s) of claim(s) 1 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Robert Pricone (US 20050008821 A1, hereinafter Pricone) in view of Nelson et al. (US 10279533 B1, hereinafter Nelson). 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.
Claim(s) 1 – 3, 5, 6 – 10 & 21 – 27, is/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.
Claim 8 recites the limitation "…the drying step…" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be understood to be equivalent to the solidification of the first and second portions noted in claim 1.
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.
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.
A.) Claim(s) 1 – 3, 5, 7, 9, 11 & 21 – 27 is/are rejected under 35 U.S.C. 103 as obvious over Robert Pricone (US 20050008821 A1, hereinafter Pricone) in view of Nelson et al. (US 10279533 B1, hereinafter Nelson)Regarding claim 1,
A method of forming a microneedle array, wherein the microneedle array includes elongated body portion terminating in a respective sharp tip, the elongated body portion coupled to a polymeric backing layer, the method comprising:
charging a first portion of a biocompatible material to a microneedle mold;
charging a second portion of the biocompatible material to the microneedle mold;
adhering a polymeric backing layer to melted surfaces of the first portion and the second portion to form the microneedle array,
wherein an elastic modulus of the polymeric backing layer is lower than an elastic modulus of the elongated body portion,
wherein the first and second portions are heated with a first heater as the polymeric backing layer is adhered to the melted surfaces of the first and second portions; and
heating, with a second heater, the first and second portions to solidify the first and second portions.
Pricone teaches the following:
& b.) ([0039]) teaches that the simplest form of this invention would be to use a powder version of the acrylic or polycarbonate polymers used in the prior art (U.S. Pat. Nos. 4,486,363 and 4,601,861), then electrostatically apply the powder into a mold, cure the layer with the replicated pattern now locked in the polymer and remove the layer form the mold. ([0097]) teaches (Fig. 12) illustrates one preferred method to make precision microstructures with through-holes or vias using a layer of powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. Where acrylic is understood to be synonymous with Poly(methyl methacrylate) (PMMA) which is a known biocompatible material. As shown, in (Fig. 12) acrylic is applied continuously in a sequential manner at each valley within the mold providing for adding a second portion of the biocompatible material. With (Fig. 10) showing a setup that utilizes two applicator guns to provide a second dose of powdered polymer material. Accordingly, the step of adding a second portion of the biocompatible material is obvious over Nelson as the case law for sequential vs. simultaneous may be recited. Where, on general, the transposition of process steps or the splitting of one step into two, where the processes are substantially identical or equivalent in terms of function, manner and result, was held to be not patentably distinguish the processes. Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959).
([0097]) (Fig. 12) illustrates one preferred method to make precision microstructures with through-holes or vias using a layer of powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63. As such, a polymeric backing layer to melted surfaces of the first portion and the second portion to form the microneedle array.
([0039]) teaches that the powder polymer material comprises acrylic or polycarbonate polymers. ([0097]) teaches that the A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61. Where Polyethylene (PE) is known to have a significantly lower elastic modulus than acrylic (PMMA), Polyethylene (PE): Ranging from 0.1 to 0.8 GPa (or up to 1.2 GPa for some HDPE), while Acrylic (PMMA): Ranging from 2.4 to 3.8 GPa. It is a rigid, stiff, and brittle plastic compared to PE.
([0097]) teaches that powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63. As illustrated in (Fig. 12), the IR cure station 60 provides for a first heater as the polymeric backing layer is adhered to the melted surfaces of the first and second portions. Highlighting, while no discrepancies are perceived to exist regarding the heating with a first heater as the polymeric backing layer is adhered to the melted surfaces of the first and second portions. The case law for sequential vs. simultaneous steps may be recited. Where, generally, no invention is involved in the broad concept of performing simultaneously operations which have previously been performed in sequence. In re Tatincloux, 108 USPQ 125, MPEP 2144.
([0097]) adding that then finally cured at by UV or IR station 64. As such, heating, with a second heater, the first and second portions to solidify the first and second portions by UV or IR station 64 is understood to be disclosed.
Regarding Claim 1, Pricone is silent regarding an elastic modulus of the polymeric backing layer is lower than an elastic modulus of the elongated body portion. In analogous art for a mold use to fabricate microneedles with a bioactive component, (Abstract), Nelson suggests details regarding an elastic modulus of the polymeric backing layer is lower than an elastic modulus of the elongated body portion, and in this regard, Nelson teaches the following:
& b.) (Col. 5, lines 12 – 13) teaches that the mold is filled with a first PMMA polymer 302 as a powder with the excess wiped from the surface 304. Highlighting, as illustrated in (Fig. 3) the mold comprises a plurality of successive cavities used to form the microneedles. Highlighting, that the step of adding a second portion of the biocompatible material is obvious over Nelson as the case law for sequential vs. simultaneous may be recited. Where, on general, the transposition of process steps or the splitting of one step into two, where the processes are substantially identical or equivalent in terms of function, manner and result, was held to be not patentably distinguish the processes. Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959).
(Col. 5, lines 36 – 44) teaches that it has also been determined that using two different PMMA polymers, one to form the microneedles and one to form the base layer, each with a different moduli, such as Evonik OFO26 PMMA with an elastic modulus of 2.7 GPa forming the microneedles and Arkema DR100 PMMA with an elastic modulus of 1.86 GPa forming the base layer can be achieved by thermally bonding the micro-needle body portion and base layer of PMMA having the desired attributes. As such, the elastic modulus of the polymeric backing layer is lower than the elastic modulus of the elongated body portion, noting that tailor the elastic modulus of the polymeric backing layer provides for achieving desired attributes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise a polymeric backing layer is lower than an elastic modulus of the elongated body portion, as taught by Nelson. Highlighting, one would be motivated to modifying the microneedle to comprise a polymeric backing layer is lower than an elastic modulus of the elongated body portion as it provides for a body portion and base layer of PMMA having the desired attributes, (Col. 5, lines 36 – 44). Additionally, the use of known materials, i.e., PMMA polymers for their intended use namely a microneedle array tips and backing layer, in a known environment i.e., microneedles arrays provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
Regarding claim 2 as applied to claim 1,
Further comprising charging a bioactive component to the microneedle mold.
Regarding Claim 2, Pricone is silent regarding charging a bioactive component to the microneedle mold. In analogous art as applied above, Nelson suggests details regarding charging a bioactive component to the microneedle mold, and in this regard, Nelson teaches the following:
(Col. 4, lines 1 – 3) teaches that in addition to holding the wound closed, the microneedles may be provided with a drug delivery or antibiotic coating to enhance healing and minimize infection. Where an antibiotic is understood to be a bioactive component.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise a bioactive component, as taught by Nelson. Highlighting, one would be motivated to modifying the microneedle to comprise a bioactive component namely a drug delivery or antibiotic as it provides for enhancing the healing and minimize infection (Col. 4, lines 1 – 3). Accordingly, the use of known materials, i.e., drug delivery or antibiotic for its intended use, i.e, healing and minimize infection in a known environment i.e., microneedles provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
Regarding claim 3 as applied to claim 1,
Wherein the microneedle mold is on a belt.
Pricone teaches the following:
([0083]) teaches that (Fig. 3), a plurality of sections (13 in Fig. 3) of cured polymeric film 24 with the microstructured pattern 25 are cut and assembled to provide an endless, flexible belt 30 to be used as a mold. Highlighting, while the mold and belt are understood to be a single integral and unitary object. The case law for making separable may be recited. Where, the court has held that if it were considered desirable for any reason to obtain access to the end of (the prior art's) holder to which the cap is applied, it would be obvious to make the cap removable for that purpose. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), MPEP 2144.
Regarding claim 5 as applied to claim 1,
Wherein the elongated body portion of the microneedle has a height no greater than 3 mm and
is attached to a base segment having a thickness in the range of between 25 µm and 250 µm.
Pricone teaches the following:
([0010]) teaches that the current apparatus used to microfabricate precision microstructures, nano-structures and the methods of making polymer molds. Typically, microstructures are considered to be in the range of 0.010 inches (250 microns) to 0.000393 inches (1 micron) and nano-structures to be below 0.00000393 inches (0.001 microns).
Regarding Claim 3, Pricone is silent regarding the elongated body portion height no greater than 3 mm and the attached to a base segment having a thickness in the range of between 25 µm and 250 µm. In analogous art as applied above, Nelson suggests details regarding the elongated body portion height no greater than 3 mm and the attached to a base segment having a thickness in the range of between 25 µm and 250 µm, and in this regard, Nelson teaches the following:
& b.) (Col. 4, lines 22 – 30) teaches that provided in (Fig. 1) is an enlarged photograph of a single microneedle 101 that was formed in accordance with one method disclosed herein. In this case, a microneedle 101 has a base portion 120 and an elongated body portion 130 ending in a sharp tip 110 of 30 μm radius or less, such as, for example, 1 μm to 20 μm, or 2 μm to 10 μm. The microneedle 101 is formed of PMMA with a height of 500 μm to 2,000 μm from the tip 110 to the base portion of the needle 120 where the microneedle intersects with the base layer 140. With a base portion 120 or layer 140 that is 125 μm thick. This base thickness is later expanded to 25 μm and 250 μm.As such, the height of the tip is understood to be a height of 500 μm to 2,000 μm minus the thickness of the base, i.e, 125 μm providing tip height with a range of 375 μm to 1875 μm. Accordingly, a tip height of 375 μm to 1875 μm and base height of 125 μm is understood to fall within applicant’s range of elongated body portion of the microneedle has a height no greater than 3 mm and a base segment having a thickness in the range of between 25 µm and 250 µm, respectively.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise a microneedle 101 with a tip height of 375 μm to 1875 μm and a base height of 125 μm, as taught by Nelson. Highlighting, one would be motivated to modifying the microneedle to comprise a tip height of 375 μm to 1875 μm and a base height of 25 µm and 250 as it provides for a package for use in wound closure, (Col. 4, lines 40 – 43). Highlighting, the case law for the change in size may be recited. Where, the mere scaling up or down of a prior art process capable of being scaled up or down would not establish patentability in a claim to an old process so scaled, In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), MPEP 2144.
Regarding claim 7 as applied to claim 1,
Wherein the elongated body portion has a shape selected from the group consisting of: a pyramid, rectangle, cone, or blade.
Pricone teaches the following:
As illustrated in (Fig. 12) the elongated body portion has a shape of a pyramid.
Regarding claim 7 as applied to claim 1,
Wherein the elongated body portion has a shape selected from the group consisting of: a pyramid, rectangle, cone, or blade.
Regarding Claim 7, Pricone is silent regarding the elongated body portion shape. In analogous art as applied above, Nelson suggests details regarding the elongated body shape, and in this regard, Nelson teaches the following:
(Claim 3) teaches that the elongated body portion may have a shape selected from the group consisting of: a pyramid, rectangle, cone, or blade.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise elongated body portion may have a shape selected from the group consisting of a pyramid, rectangle, cone, or blade, as taught by Nelson. Highlighting, one would be motivated to modifying the microneedle to comprise an elongated body portion having the shape selected from the group consisting of: a pyramid, rectangle, cone, or blade as it provides for an ending with an elongated sharper end referenced as the tip which is intended to enter the skin adjacent the wound to be closed, (Col. 1, lines 53 – 58). Highlighting, the case law for the change in shape may be recited. Where, the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, In re Dailey, 357 F.2d 669,149 USPQ47 (CCPA 1966), MPEP 2143.
Regarding claim 9 as applied to claim 1,
Wherein the backing layer comprises a polymer having an elastic modulus in a range of approximately 2.4 Gigapascals (GPa) to 1.6 GPa.
Regarding Claim 9, Pricone is silent regarding the backing layer comprises a polymer having an elastic modulus in a range of approximately 2.4 Gigapascals (GPa) to 1.6 GPa. In analogous art as applied above, Nelson suggests details regarding the backing layer comprises a polymer having an elastic modulus in a range of approximately 2.4 Gigapascals (GPa) to 1.6 GPa, and in this regard, Nelson teaches the following:
(Col. 5, lines 36 – 44) teaches that Arkema DR100 PMMA with an elastic modulus of 1.86 GPa was used for the base layer. As such, an elastic modulus of 1.86 GPa for the base layer / backing layer is understood to fall within applicant’s range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise a backing layer formed from Arkema DR100 PMMA, as taught by Nelson. Highlighting, one would be motivated to include a backing layer comprised of Arkema DR100 PMMA as it provides for an elastic modulus of 1.86 GPa for the base layer / backing layer. Highlighting, the use of known materials, i.e., Arkema DR100 PMMA for its intended purposes, namely, to form a backing in a known environment specifically molding a microneedle array provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.Regarding claim(s) 21 & 23 – 24 as applied to claim 1 respectively,
Wherein the microneedle mold includes a converging edge to be inserted into the polymeric backing layer as the polymeric backing layer is adhered to the first and second portions.
Including inserting a portion of the microneedle mold into the polymeric backing layer as the polymeric backing layer is adhered to the first and second portions.
Including applying, via at least one roller positioned between the first and second heaters, pressure to the polymeric backing layer against the microneedle mold.
Pricone teaches the following:
, 23a.) & 24a.) ([0097]) teaches that as illustrated in (Fig. 12) powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63 and then finally cured at by UV or IR station 64. Highlighting, that (Fig. 12 & 12 A) shows the soft polymer sheet 61 is pressed by a series of rollers uniformly to some specific level. ([0098]) adding that illustrating mold 42 being partially filled with polymer 63 and the mold protuberances penetrating the soft, top layer of polymer film. Accordingly, (Fig. 12 & 12 A) best shows the mold comprising a converging edge to be inserted into the polymeric backing layer 61 as the polymeric backing layer is adhered to the first and second portions of the deposited polymeric powder within the mold. As illustrated, at least one roller positioned between the first heater 60 and second heater 64, to provide pressure to the polymeric backing layer against the microneedle mold
Regarding claim 22 as applied to claim 1,
Including heating the polymeric backing layer as the polymeric backing layer is adhered to the first and second portion.
Pricone teaches the following:
([0097]) teaches that a soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63 and then finally cured at by UV or IR station 64. As illustrated in (Fig. 12), the IR cure station 60 provides for a first heater as the polymeric backing layer is adhered to the melted surfaces of the first and second portions. Highlighting, while no discrepancies are perceived to exist regarding the heating with a first heater as the polymeric backing layer is adhered to the melted surfaces of the first and second portions. The case law for sequential vs. simultaneous steps may be recited. Where, generally, no invention is involved in the broad concept of performing simultaneously operations which have previously been performed in sequence. In re Tatincloux, 108 USPQ 125, MPEP 2144.
Regarding claim 22 as applied to claim 1,
Including heating the polymeric backing layer as the polymeric backing layer is adhered to the first and second portion.
Regarding Claim 22, Pricone is silent regarding the heating of the polymeric backing layer as the polymeric backing layer is adhered to the first and second portion. In analogous art as applied above, Nelson suggests details regarding the polymeric backing layer as the polymeric backing layer is adhered to the first and second portion, and in this regard, Nelson teaches the following:
(Col. 5, lines 15 – 23) teaches under the heat and pressure of the embossing process, the powdered PMMA polymer 302 melts and fuses to the backing layer 303. After cooling, the microneedles and backing layer are removed as a single sheet having the microneedles as one polymer and the backing layer as a second polymer. As such, heating the polymeric backing layer as the polymeric backing layer is adhered to the first and second portions is understood to be disclosed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise heating the polymeric backing layer as the polymeric backing layer is adhered to the first and second portion, as taught by Nelson. Highlighting, one would be motivated to provide a heat and pressure to the backing layer as it provides for adhered to the first and second portion of the microneedle array, (Col. 5, lines 15 – 23). Accordingly, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Where, "A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." KSR int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143. Regarding claim 25 as applied to claim 24,
Wherein the first heater is upstream from the second heater and includes an infrared heater.
Pricone teaches the following:
([0097]) teaches that (Fig. 12) illustrates one preferred method to make precision microstructures with through-holes or vias using a layer of powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63 and then finally cured at by UV or IR station 64. The sheet 61 then may be removed and separated from the film having the vias formed thereon. The shape of the vias will be determined by the shape of the mold protuberances 59. As such, the first heater IR cure station 60 acting as applicant’s first heater is found to be upstream from UV or IR station 64 acting as applicant’s second heater.
Regarding claim 26 as applied to claim 24,
Wherein the second heater is downstream from the first heater,
the polymeric backing layer folded and pressed onto the microneedle mold at a position closer to the second heater than the first heater.
Pricone teaches the following:
([0097]) teaches that (Fig. 12) illustrates one preferred method to make precision microstructures with through-holes or vias using a layer of powdered polymer 57 that is applied onto the mold by gun 58 to some predetermined level so it only partially fills the mold depth after being melted at 59 by IR cure station 60. A soft polymer sheet 61 of polyethylene, polyester or similar resiliency then is applied to the surface 61 and pressed into the mold 42 to press the film layer 61 uniformly to some specific level 63 and then finally cured at by UV or IR station 64. The sheet 61 then may be removed and separated from the film having the vias formed thereon. The shape of the vias will be determined by the shape of the mold protuberances 59. As such, UV or IR station 64 acting as applicant’s second heater is downstream from the first heater IR cure station 60 acting as applicant’s first heater. Additionally, the polymeric backing layer folded and pressed onto the microneedle mold at a position closer to the UV or IR station 64 than the IR cure station 60. Highlighting, while no discrepancies are perceived to exist regarding the position of the polymeric backing layer being folded and pressed onto the microneedle mold in relation to the second heater. However, the case law for the rearrangement of parts may be recited. Where, it has generally been recognized by the courts that to shift location of parts when the operation of the device is not otherwise changed is within the level of ordinary skill in the art, In re Japikse, 86 USPQ 70; In re Gazda, 104 USPQ 400, MPEP 2144.
Regarding claim 27 as applied to claim 1,
Including cooling the heated mixture with cooling rolls.
Pricone teaches the following:
([0087]) teaches that a higher melting point carrier film such as 0.002″ (50 micron) PENN 51 is heated by hot roll 52 to a temperature of 425 °F (137 °C). A plurality (4 in FIG. 6) of pressure rolls 53 at 150 psi (10.5 bar), flow the polymer into the Fresnel pattern on the metal mold 30 in the path 40. Highlighting, that the pressure rolls are understood to be at room temperature, which is cooler than the hot roll 52 at a temperature of 425 °F (137 °C), providing for a cold(er) surface to the film as the rolls 53 apply pressure.
Regarding claim 27 as applied to claim 1,
Including cooling the heated mixture with cooling rolls.
Pricone teaches the following:
([0087]) teaches that a higher melting point carrier film such as 0.002″ (50 micron) PENN 51 is heated by hot roll 52 to a temperature of 425 °F (137 °C). A plurality (4 in FIG. 6) of pressure rolls 53 at 150 psi (10.5 bar), flow the polymer into the Fresnel pattern on the metal mold 30 in the path 40. Highlighting, that the pressure rolls are understood to be at room temperature, which is cooler than the hot roll 52 at a temperature of 425 °F (137 °C), providing for a cold(er) surface to the film as the rolls 53 apply pressure.
Regarding Claim 27, Pricone is silent regarding cooling the heated mixture with cooling rolls. In analogous art as applied above, Nelson suggests details regarding cooling the heated mixture with cooling rolls, and in this regard, Nelson teaches the following:
(Col. 6, lines 41 – 56) teaches is being wrapped around a metal cooling roll 405. The cooling roll keeps the base of the array below the glass transition temperature, so the microneedles don't lean at the base, but rather bend uniformly along an arc. Provided the base remains cooler while the needles are at the right temperature, the desired bend will occur. An airflow 402 of 130 °C is directed by a shroud 403 heating the polymeric needles 401 at the correct zone while the cooling roll 405 maintains the base layer 410 at a lower temperature. When the microneedles 404 reach the shear roll 406, the gap 407 between the shear roll 406 and the cooling roll 405 determines the amount and degree of bend 408. As such, the mixture is heated by the shroud 403 via airflow 402 of 130 °C, which is above the softening point / glass transition of PMMA (105 °C) while the base layer is being cooled on cooling roll 405 to remain below the softening point / glass transition of PMMA. As such, providing for cooling the heated mixture with cooling rolls.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle fabrication to include cooling the heated mixture with cooling rolls, as taught by Nelson. Highlighting, one would be motivated to include cooling the heated mixture with cooling rolls as it provides for tailoring the degree of bend 408 that is provided to the needle array, (Col. 6, lines 56 – 59). Accordingly, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Where, "A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." KSR int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143.
B.) Claim(s) 2 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pricone in view of Nelson and in further view of Chandrashekhar Pathak (US 20190046479 A1, hereinafter Pathak)
Regarding claim 2 & 10 as applied to claim 1,
Further comprising charging a bioactive component to the microneedle mold.
Wherein the biocompatible material comprises a sugar.
Regarding Claim 2, Pricone is silent regarding charging a bioactive component to the microneedle mold. In analogous art as applied above, Nelson suggests details regarding charging a bioactive component to the microneedle mold, and in this regard, Nelson teaches the following:
(Col. 4, lines 1 – 3) teaches that in addition to holding the wound closed, the microneedles may be provided with a drug delivery or antibiotic coating to enhance healing and minimize infection. Where an antibiotic is understood to be a bioactive component.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle to comprise a bioactive component, as taught by Nelson. Highlighting, one would be motivated to modifying the microneedle to comprise a bioactive component namely a drug delivery or antibiotic as it provides for enhancing the healing and minimize infection (Col. 4, lines 1 – 3). Accordingly, the use of known materials, i.e., drug delivery or antibiotic for its intended use, i.e, healing and minimize infection in a known environment i.e., microneedles provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
Regarding claim(s) 2 & 10, Pricone in view of Nelson is silent on charging a bioactive component to the microneedle mold. In analogous art for a mold use to fabricate microneedles (Abstract), Pathak suggests details regarding charging a bioactive component to the microneedle mold, and in this regard, Pathak teaches the following:
& 10a.) ([0162]) teaches that dissolvable microneedle array is used to create porosity. Various small compounds (with molecular weight below 2000 g/mole)/sugars can be used to make dissolvable microneedles or micro-implants with drug and these include but limited to: xylitol, sucrose, maltose, mannose, cyclodextrin, stachyose, inositol, mallorol, melitose, iso-maltulose, dextran, lactulose, trehalose, turanose, fructose, icodextrin, raffinos, maltodextrin, glucose, lactose, sorbitol, mannitol, melezitose, palatinit, maltulose and the like or combinations thereof. Where stachyose, fructose, melezitose, amongst others are understood to be a bioactive component that may be dispersed into the microneedle mold.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone in view of Nelson. By further modifying the microneedle composition to include a bioactive component that is discharged into the mold, as taught by Pathak. Highlighting, one would be motivated to modifying the microneedle composition to include a bioactive component that is discharged into the mold as it provides for dissolvable microneedles or micro-implants with drugs, ([0162]). Highlighting, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Wherein, "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143. Additionally, the use of a known material, i.e., bioactive component / sugar, in a known environment, namely a microneedle composition, for its intended use, i.e, drug delivery. Provides for the recitation of known material in the art case law. Where, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), MPEP 2144.07.
C.) Claim(s) 3, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pricone in view of Nelson and in further view of Takao Tomono (US 20090234301 A1, hereinafter Tomono)
Regarding claim 3 as applied to claim 1,
Wherein the microneedle mold is on a belt.
Pricone teaches the following:
([0083]) teaches that (Fig. 3), a plurality of sections (13 in FIG. 3) of cured polymeric film 24 with the microstructured pattern 25 are cut and assembled to provide an endless, flexible belt 30 to be used as a mold.
Regarding Claim 3, Pricone as modified by Nelson is silent on the microneedle mold being on a belt. In analogous art for a mold use to fabricate microneedles (Abstract), Tomono suggests details regarding the mold use to fabricate microneedles being on a belt, and in this regard, Tomono teaches the following:
([0033]) teaches that as illustrated in (Figs. 2A – B), on the conveyor belt 12, a mold 17 for forming the microneedle 2 is installed. As detailed, in (Figs. 2A – B) the microneedle mold is on a belt.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone as modified by Nelson. By further modifying the microneedle mold to be placed on a conveyor belt, as taught by Tomono. Highlighting, one would be motivated to place the microneedle mold onto a conveyor belt as it provides for a continuous fabrication process, ([0033] – [0039], (Figs. 2A – B). Additionally, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Wherein, "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143.D.) Claim(s) 3, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pricone in view of Nelson and in further view of Shastry et al. (US 20160374939 A1, hereinafter Shastry)Regarding claim 3 as applied to claim 1,
Wherein the microneedle mold is on a belt.
Pricone teaches the following:
([0083]) teaches that (Fig. 3), a plurality of sections (13 in FIG. 3) of cured polymeric film 24 with the microstructured pattern 25 are cut and assembled to provide an endless, flexible belt 30 to be used as a mold.
Regarding Claim 3, Pricone in view of Nelson is silent on the microneedle mold being on a belt. In analogous art for a mold use to fabricate microneedles (Abstract), Shastry suggests details regarding the mold use to fabricate microneedles being on a belt, and in this regard, Shastry teaches the following:
([0075]) teaches that the embodiment as shown in FIG. 1 is a continuous or conveyer type system 10 where the mold comprising cavities 18 is moved through sections including the soluble gas (e.g. CO2) dispensing section 12 (optional), the vacuum application section 14, and the formulation dispensing section 16, as shown. It will be appreciated that further sections including, but not limited to one or more drying sections 20 and further dispensing/vacuum sections may be included with the system. It will further be appreciated that the present methods may be performed sequentially but without the use of a continuous system. Highlighting, as illustrated in (Fig. 1), the continuous or conveyer type system 10 is illustrated as a belt such that the mold comprising cavities 18 is moved / conveyed through the various molding / fabrication sections.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Nelson. By modifying the microneedle mold to encompass a belt, as taught by Shastry. Highlighting, one would be motivated to implement a mold that encompasses a belt as it provides for fabricating and molding a microneedle array continuously, ([0075]). Accordingly, while the mold is understood to comprise a belt. The case law for making separable may be recited. Where, the court has held that if it were considered desirable for any reason to obtain access to the end of (the prior art's) holder to which the cap is applied, it would be obvious to make the cap removable for that purpose. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961), MPEP 2144.E.) Claim(s) 6, is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Kaspar et al. (US 20170209553 A1, hereinafter Kaspar)
Regarding claim 6 as applied to claim 1,
Wherein the microneedles of the microneedle array are in an array having a density of approximately 1 microneedle per centimeter squared (cm2) to 1 microneedle per 10 cm2 and a pitch of 30 pm to 1 centimeter (cm).
Regarding Claim 6, Pricone is silent on the microneedles of the microneedle array are in an array having a density of approximately 1 microneedle per centimeter squared (cm2) to 1 microneedle per 10 cm2 and a pitch of 30 pm to 1 centimeter (cm). In analogous art as applied above, Nelson suggests details regarding the microneedles of the microneedle array are in an array having a density of approximately 1 microneedle per centimeter squared (cm2) to 1 microneedle per 10 cm2 and a pitch of 30 pm to 1 centimeter (cm), and in this regard, Nelson teaches the following:
(Col. 4, lines 65 – 66) teaches that the microneedles may have a density on the needle arrays of 0.053 needles/mm2 to 0.16 needles/mm2, where 0.053 needles/mm2 to 0.16 needles/mm2 is equivalent to 5.3 needles/cm2 to 16 needles/cm2
(Claim 2) teaches wherein said at least one curved polymeric microneedle is an array of microneedles having a pitch of 30 μm to 1 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone. By modifying the microneedle molding process to produce a microneedle array comprising a density on the needle arrays of 0.053 needles/mm2 to 0.16 needles/mm2, where 0.053 needles/mm2 to 0.16 needles/mm2 is equivalent to 5.3 needles/cm2 to 16 needles/cm2 and at least one curved polymeric microneedle is an array of microneedles having a pitch of 30 μm to 1 cm, as taught by Nelson. Highlighting, one would be motivated to fabricate a microneedle having the aforementioned density and pitch as it provides for bending of straight microneedles but that will also hold a wound closed without the microneedles breaking, (Col. 4, lines 6 – 10). Accordingly, the case law for the change in size and change of shape may be recited. Where, the mere scaling up or down of a prior art process capable of being scaled up or down would not establish patentability in a claim to an old process so scaled, In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), MPEP 2144. Additionally, where, it has been held that a mere change in shape without affecting the functioning of the part would have been within the level of ordinary skill in the art, In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et aI., 3 USPQ 23.
Regarding Claim 6, Pricone as modified by Nelson is silent on the microneedle array having a density of 1 microneedle per cm2 to 1 microneedle per 10 cm2. In analogous art to produce a microneedle array via molding (Abstract), Kaspar suggests details regarding the microneedle array having a density of 1 microneedle per cm2 to 1 microneedle per 10 cm2, and in this regard, Kaspar teaches the following:
([0062]) teaches that the microneedles can be spaced on the base portion at a density of from about 1 microneedle per square centimeter (cm2) to about 2500 microneedles per cm2. Which is found to overlap with applicant’s microneedle array density range.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone as modified by Nelson. By further modifying the microneedle molding process to produce a microneedle array comprising a density of 1 microneedle per cm2, as taught by Kaspar. Highlighting, one would be motivated to fabricate a microneedle array comprising a density of 1 microneedle per cm2 as it provides for tailoring the spacing of the needles in the array, ([0062]) and the amount / dose of drug applied over a particular surface area , ([0063]). Accordingly, the case law for the change of shape may be recited. Where, it has been held that a mere change in shape without affecting the functioning of the part would have been within the level of ordinary skill in the art, In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et aI., 3 USPQ 23.F.) Claim(s) 8, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pricone in view of Nelson and in further view of Traverso et al. (US 20200324095 A1, hereinafter Traverso)
Regarding claim 8 as applied to claim 1,
Wherein heat for the drying step is applied in a range of approximately 95 degrees Celsius (°C) to 130 °C.
Regarding Claim 8, Pricone in view of Nelson is silent on the dying temperature being in a range of 95 °C to 130 °C. In analogous art to produce a microneedle array via molding (Abstract), Traverso suggests details regarding the dying temperature being in a range of 95 °C to 130 °C, and in this regard, Traverso teaches the following:
([0268]) teaches that the tissue interfacing component, in some embodiments, is formed at a temperature of greater than or equal to 50 °C and less than or equal to 130 °C. Highlighting, that the range of greater than or equal to 50 °C and less than or equal to 130 °C is found to overlap with applicant’s range of 95 °C to 130 °C. Highlighting, ([0276]) teaches that various binders that may be suitable include sugar such as sorbitol and sucrose, gelatin, polymers such as polyvinyl alcohol (PVA), polyethylene glycol (PEG), polycaprolactone (PCL), and polyvinylpyrrolidone (PVP). Highlighting, ([0061]) teaching an example in which magnesium stearate and 10% PEG 35k w/w exposed to 3 metric tons of pressure at 100° C. for 2 min.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone in view of Nelson. By further modifying the microneedle molding process to include a drying step in a range of 95 °C to 130 °C, as taught by Traverso. Highlighting, one would be motivated to include a drying step in a range of 95 °C to 130 °C as it provides for form the tissue interfacing component. Accordingly, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application of a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Wherein, "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143.
F.) Claim(s) 27, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pricone in view of Nelson and in further view of de Brouwer (US 20190381299 A1, hereinafter de Brouwer)Regarding claim 27 as applied to claim 1,
Including cooling the heated mixture with cooling rolls.
Pricone teaches the following:
([0087]) teaches that a higher melting point carrier film such as 0.002″ (50 micron) PENN 51 is heated by hot roll 52 to a temperature of 425 °F (137 °C). A plurality (4 in FIG. 6) of pressure rolls 53 at 150 psi (10.5 bar), flow the polymer into the Fresnel pattern on the metal mold 30 in the path 40. Highlighting, that the pressure rolls are understood to be at room temperature, which is cooler than the hot roll 52 at a temperature of 425 °F (137 °C), providing for a cold(er) surface to the film as the rolls 53 apply pressure.
Regarding Claim 27, Pricone as modified by Nelson is silent regarding cooling the heated mixture with cooling rolls. In analogous art as applied above, de Brouwer suggests details regarding cooling the heated mixture with cooling rolls, and in this regard, de Brouwer teaches the following:
([0023]) teaches that the as shown in FIG. 2, to form a microneedle array, a band mold 200 (comprising a plurality of conical depressions 202 formed by laser-drilling at a surface of the band mold 200) may be disposed adjacent an embossing roll 204 to form a chill roll 206. A substrate 208 may be deposited via an extrusion die apparatus 210 at a surface of the band mold 200 comprising the conical depressions 202. While the band mold 200 is disposed adjacent the embossing roll 204, heat may be applied via an external heat source 212 causing the substrate 208 to deform and move into the conical depressions 202 of the band mold 200. Heat may be applied to the band mold 200 at, or adjacent, a point of contact between the substrate 208 and the band mold 200. The chill roll 206 may thus operate as a heat sink by absorbing heat during the application of heat. As such, the chill roll 206 working as heat sink works as applicant’s cooling roll, providing for cooling the heated mixture with cooling rolls
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the production method and apparatus for manufacturing a molded microneedle array of Pricone as modified by Nelson. By modifying the microneedle fabrication to include cooling the heated mixture with cooling rolls, as taught by de Brouwer. Highlighting, one would be motivated to include cooling the heated mixture with cooling rolls as it provides for absorbing heat during the application of heat for form one or more projections 216, ([0023]). Accordingly, the use of known technique to improve similar devices (methods, or products) in the same way and/or the application a known technique to a known device (method, or product) ready for improvement to yield predictable results provides for the recitation of KSR case law. Where, "A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." KSR int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 USPQ2d 1385 (2007), MPEP 2143. Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Howard A. Kingsford (US 20080269670 A1) – teaches in the (Abstract) that the skin attachment member having first and second surface with a plurality of skin penetrating elements extending integrally from the first surface of the backing to a distal tip. The skin penetrating elements are sized to avoid contact with nerves below the epidermal skin layer and have a foam disposed between at least some of the skin penetrating elements.
Cree et al. (US 20040161586 A1) – teaches in the (Abstract) that a film for use in absorbent articles is first microscopically textured and then macroscopically apertured while maintaining the microscopic texture. The micro-texturing may be done by a variety of means including vacuum forming and may include micro-apertures.
Takao Tomono (US 20090234301 A1) – teaches in the (Abstract) a method for producing a microneedle includes feeding a resin fluid to a forming mold having a needle-forming portion with an opening diameter of 50 to 200 μm and a depth of 100 to 500 μm, charging the fed resin fluid into the needle-forming portion, and cooling and solidifying the charged resin fluid.
Bay et al. (US 20130251945 A1) – teaches in the (Abstract) that an article having a first major surface with at least first and second regions, the first region comprising a plurality of first structures having a first surface roughness, the second region comprising a plurality of second structures having a second surface roughness, wherein at least a portion of the at least first and second regions have a surface roughness difference between them that together exhibit at least a portion of a first image.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrés E. Behrens Jr. whose telephone number is (571)-272-9096. The examiner can normally be reached on Monday - Friday 7:30 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison Hindenlang can be reached on (571)-270-7001. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Andrés E. Behrens Jr./Examiner, Art Unit 1741
/JaMel M Nelson/Primary Examiner, Art Unit 1743