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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the limitations in claim 19 sets forth the percent volume of hyaluronidase in the injected agent to be between about 5% to about 20% of the total volume. The specification fails to explicitly state this percentage range of volume. While there is disclosure of varying the amount of hyaluronidase in the composition to control tissue dispersion, there is no clear disclosure of the percentage volume of the compound as claimed. Therefore, it is unclear from the disclosure that such a range is supported for claim 19.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-8, 12-14, and 22-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buss (US 2016/0089527).
Regarding claim 1, Buss discloses a method of enhancing delivery of an agent into tissue, comprising: placing a housing (e.g., handpiece 202) that defines a chamber (for receiving the cartridge with reservoir 204b) adjacent to a surface of the tissue (¶ [0031] discloses simultaneous application of vacuum and fluid administration to the skin treatment site), wherein the placing step locates the chamber adjacent to an injection site at which the agent was injected into the tissue (e.g., ¶ [0031] discloses the needle roller being applied to the tissue and the simultaneous application of vacuum and infusion during treatment; this meets the limitation since the needles are forming injection sites along the treatment area during a procedure); applying vacuum pressure to the chamber and into the chamber; and moving the housing relative to the tissue while the vacuum pressure is applied for enhancing agent delivery into the tissue (¶¶ [0031]-[0034] disclose the method of use wherein the roller is moved along the tissue treatment site to allow for simultaneous vacuum and infusion at the site during the procedure as claimed).
Regarding claim 2, Buss further discloses wherein the moving step comprises translating the housing along a path of travel that causes at least a portion of the chamber to traverse a center of the injection site (the device is moved all around the treatment site and every needle passage creates a new injection site which the device moves over during treatment).
Regarding claim 3, Buss further discloses wherein the placing step locates the chamber at a first location that is spaced from a center of the injection site at a first offset distance measured from the center of the injection site along a direction, the translating step comprises translating the housing from the first location and across the center of the injection site along the direction to a second location, wherein the second location is spaced from the center of the injection site at a second offset distance measured along the direction (this step may be considered anticipated by Buss since each roller comprises a plurality of needles for creating injection sites during movement of the device around the treatment site; therefore, as the roller is moved, the housing will be offset from an injection site which will be formed by a needle as it moves along the roller during manipulation of the device).
Regarding claims 4 and 5, Buss further discloses wherein at least one of the first and second offset distances is no less than a maximum interior dimension of the chamber measured along the direction. As above for claim 3, the treatment device of Buss is moved around a tissue area. The treatment distance may be arbitrarily determined to be at least as long as the device housing itself (or the chamber interior dimensions as per claim 5) which would allow for the formation of an injection site which is the same distance away from the initial treatment point as the length of the housing, assuming the treatment site is at least as wide as the length of the housing.
Regarding claims 6-8, Buss further discloses the step of translating the housing from the first location to the second location is performed at least twice (see e.g., ¶ [0014] which discloses that the device is moved repeatedly over the treatment site during use; this also anticipates the step of moving the device in a second direction, opposite a first direction, as per claim 7 since the device is moved repeatedly along the treatment site; also the back and forth movement anticipates claim 8).
Regarding claim 12, Buss further discloses a portion of the tissue being drawn into contact with at least one protrusion of the housing located within the chamber, thereby deforming the tissue that contacts the protrusion (¶ [0039], Buss discloses that the vacuum is applied to pull the skin against the wheel which would located it within the opening formed by the distal end of the housing as in Figure 3).
Regarding claim 13, Buss discloses a method of enhancing delivery of an agent into tissue, comprising: injecting an agent into tissue of the subject (via microneedles on surface 222; ¶ [0032]), thereby defining an injection site at a surface of the tissue; placing a housing that defines a chamber at or adjacent the injection site (¶¶ [0031]-[0034]); applying vacuum pressure to the chamber, thereby drawing a portion of the tissue through an opening of the chamber and into the chamber (via application of vacuum as in ¶ [0039]); and moving the housing relative to the tissue while the vacuum pressure is applied for enhancing agent delivery in the tissue (see e.g., ¶ [0012] which discloses applying vacuum and moving the roller around the treatment site).
Regarding claim 14, Buss further discloses the step of translating the housing along a path of travel that causes at least a portion of the chamber to traverse a center of the injection site one or more times (¶ [0014]; the device is moved all around the treatment site and every needle passage creates a new injection site which the device moves over during treatment).
Regarding claim 22, Buss further discloses wherein the injecting step comprises injecting a total volume of the agent into the tissue, wherein the total volume is partitioned into a plurality of sub-volumes, such that the injecting step comprises performing a plurality of injections into the tissue at a plurality of respective injection sites (see e.g., ¶ [0040] of Buss which discloses that each needle comprises a channel for the injectate to flow through as the device is moved along the skin thereby forming a plurality of injection sites which each deliver a portion of the total dose volume), each of the plurality of injections injecting a respective one of the plurality of sub-volumes into the tissue (each microneedle channel delivers a volume as it enters the skin at the site); and the moving step comprises translating the housing along a path of travel that causes the chamber to traverse at least a majority of the plurality of injection sites (¶ [0038] discloses moving the roller around the treatment site).
Regarding claim 23, Buss discloses a system for vacuum-enhanced agent delivery into tissue in vivo, comprising: a housing (202) defining a chamber (for receiving cartridge 204a) and an opening into the chamber (Figure 2); at least one port (vacuum port) extending through the housing, wherein the at least one port is remote from the at least one opening (it’s separate from the reservoir to allow for the application of negative pressure) and is connectable to a vacuum source (¶ [0031], not shown in Figure 2), such that the at least one port is configured to communicate vacuum pressure from the vacuum source to the chamber (¶ [0031]), wherein the housing is configured to communicate a vacuum field to a portion of the tissue and thereby draw the portion of tissue through the opening and at least momentarily hold the portion of the tissue in the chamber (e.g., ¶ [0034] discloses using the vacuum to pull the skin against the roller), and the housing is further configured to move relative to the tissue while the vacuum field is communicated to the tissue (¶ [0038]; the embodiment of Figure 4 operates in the same manner as Figure 2 wherein the roller is moved along the skin during treatment), wherein the relative motion deforms at least some of the tissue (via application of pressure and deformation due to vacuum application); and one or more features (roller 208) disposable between a distal end of the housing and a surface of the tissue (Figure 2; ¶ [0032]) for reducing sliding friction between the housing and the tissue (the roller allows the distal end of the device to be moved with reduced friction against the skin compared to a device without a roller assembly).
Regarding claim 24, Buss further discloses wherein the feature is one or more rollers (208; Figure 2; ¶ [0032]).
Regarding claim 25, Buss further discloses wherein the housing is attachable to a handle member (for this purpose the actuation button may be considered a handle member as it’s separate from the device body and is holdable; the actuation button is depicted in Figures 2 and 4 but only labeled as element 404 in Figure 4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buss.
Regarding claim 9, Buss discloses the claimed invention substantially as set forth above for claim 1, and discloses moving the device around the treatment site, but does not disclose a circular path as claimed.
However, there is no evidence of record that establishes that changing the path of Buss to be circular would result in a difference in function of the device. Further, a person having ordinary skill in the art, being faced with modifying the method of use of the device of Buss, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed treatment path. Lastly, applicant has not disclosed that the claimed circular path solves any stated problem, indicating that the path may be any desired route including elliptical, spiral, triangular, zig-zag, and virtually innumerable others (see ¶ [0118] of the instant application disclosure), and therefore there appears to be no criticality placed on the circular path as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of use of the device of Buss as an obvious matter of use choice within the skill of the art.
Claim(s) 10, 11, 15-19, 26, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buss in view of Fisher et al. (US 2021/0290941).
Regarding claims 10, 11, 15, and 26, Buss discloses the claimed method substantially as set forth above for claim 1 but fails to explicitly disclose the applied vacuum being in the claimed range.
Fisher et al. (henceforth Fisher) teaches a vacuum assisted delivery device (Figure 1) which applies vacuum in a range of approximately -5 mmHg to -760 mmHg (¶ [0132] discloses applying vacuum in a range of about -0.1 psi to -14.7 psi; thereby overlapping both claimed ranges).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Buss to apply vacuum in the claimed range since Fisher teaches that such a pressure range is known for use in vacuum assisted treatment devices for pulling the skin layer into the device to delimit the treatment zone relative to the device end during use.
Regarding claim 16, Buss discloses that the tissue is skin tissue but fails to explicitly disclose the injection is a Mantoux injection.
Fisher teaches the step of performing a Mantoux injection with the device (e.g., ¶¶ [0068], [0086], and ¶ [0206]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Buss to comprise the step of performing a Mantoux injection during the skin treatment so as to increase the immunogenicity of the delivered compound as taught by Fisher.
Regarding claims 17 and 18, Fisher further teaches the use of hyaluronidase as a spreading agent (e.g., ¶ [0234] discloses using hyaluronidase to allow the injection to spread favorably laterally through the skin).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Buss to include the use of hyaluronidase in the injectate as a means of improving the spreadability of the solution at the injection site as taught by Fisher.
Regarding claim 19, Buss/Fisher teach the claimed invention substantially as set forth above for claim 18 but fail to explicitly disclose the percent volume of hyaluronidase in the injection volume. Fisher teaches the use of hyaluronidase as an addition to the composition but fails to explicitly disclose the percentage volume of the compound in the agent. However, Fisher further teaches that hyaluronidase should be added to the injectate formulation to provide for favorable spreading through the skin and for higher injection volumes (see ¶¶ [0234] and [0239]). Furthermore, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the method of Buss/Fisher to have the claimed percentage volume of hyaluronidase as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Buss/Fisher to comprise a percentage weight in the composition of hyaluronidase to be in a range from about 5% to about 20% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 27, Buss further discloses wherein the chamber has a circular cross-sectional shape in a plane orthogonal to a central axis of the chamber (depicted in Figure 3 of Buss wherein the chamber 304 is cylindrical) and further discloses varying the diameter of the outlet depending on the viscosity of the solution (¶ [0035]). However, Buss fails to explicitly disclose the chamber diameter as between about 5 mm to about 15 mm. It appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the device of Buss to have a chamber of the claimed diameter as it involves only adjusting a dimension of a component disclosed to require adjustment (e.g., parameters such as total volume to inject and the viscosity of the injectate). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Buss to comprise a chamber having a diameter of about 5 mm to about 15 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buss in view of Fisher, and further in view of Kallan et al. (EP 2680881B1).
Regarding claim 21, Buss/Fisher teach the claimed invention substantially as set forth above for claim 13 but fail to explicitly disclose the use of mRNA and lipid nanoparticles.
Kallan et al. (henceforth Kallan) teaches the use of plasmid containing mRNA and lipid nanoparticles (see e.g., ¶¶ [0001], [0057], which discloses the DNA molecule forming the matrix of at least one mRNA of interest may be prepared by fermentative proliferation and subsequent isolation as part of a plasmid; and ¶ [0150] which discloses that “Preferred as adjuvants suitable for depot and delivery are cationic or polycationic compounds as defied above…nanoparticles”).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Buss/Fisher to comprise the use of mRNA and lipid nanoparticles, as taught by Kallan, for the purpose of administering a DNA-based therapeutic to a target site on the skin via the device and method of Buss/Fisher which allows for desired spreadability and tissue penetration of such a compound at the target site.
Regarding claim 21, Buss/Fisher teach the claimed invention substantially as set forth above for claim 13 but fail to explicitly disclose a plasmid containing DNA-launched nanoparticles.
Kallan teaches the composition comprises DNA launched replicons and naked mRNA are administered by intradermal electroporation (see ¶ [0057], as above for claim 20 which discloses the use of the DNA molecule which forms the matrix of an mRNA of interest as well as ¶ [0150] which teaches the use of a plasmid for delivery).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Buss/Fisher to comprise the use of mRNA and lipid nanoparticles, as taught by Kallan, for the purpose of administering a DNA-based therapeutic to a target site on the skin via the device and method of Buss/Fisher which allows for desired spreadability and tissue penetration of such a compound at the target site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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