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 .
Claim Objections
Claims 7 and 8 are objected to because of the following informalities: the claim depends from claim 3 which has been cancelled. For examination, claim 7 will be considered to depend from claim 1 and claim 8 will depend from claim 7. Appropriate correction is required.
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, 6-9, 14, 15, 18, 20, 22, 23, 25, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeshurun et al. (US 2006/0051404).
Regarding claim 1, Yeshurun et al. (henceforth Yeshurun) discloses a microneedle apparatus (Figures 10a-10c) for engaging a surface (e.g., skin), the apparatus comprising: a housing (body of roller ball applicator) comprising a socket (for receiving rolling element 102); and a microneedle device moveable within the socket (102 with microstructures/microneedles 104; ¶ [0072]), the microneedle device comprising a substantially spherical substrate (rolling element 102 is disclosed as spherical; Figure 10a; ¶ [0072]); and a plurality of microneedles (104) projecting from the substrate (viewable in Figure 10b), wherein the microneedle device is configured to move within the socket and against the surface with 3-dimensional movements (the ball-roller is retained in a cavity and is constrained by the dimensions of the opening receiving the ball; therefore, it is able to move in multiple axes including the z-axis as it will move up and down in the socket depending on application pressure since there is no other constraining structure) such that, in use, the plurality of microneedles engage the surface (¶ [0073] discloses that they can be used to prepare the skin for treatment or used during a treatment).
Regarding claim 6, Yeshurun further discloses wherein the microneedle device is removably attached to the socket (it’s fully capable of being removed as it is only retained by the cap end).
Regarding claim 7, Yeshurun further discloses a reservoir (inside body of 100; ¶ [0072] states that body 100 stores a fluid which is dispensed during a procedure) for storing a substance.
Regarding claim 8, Yeshurun further discloses wherein the socket comprises at least one opening in fluid connection with the reservoir, wherein the microneedle device is configured to receive the substance (¶ [0072] discloses that the substance is dispensed from the reservoir onto the microneedles during use; this implies a direct fluid connection between the reservoir in the housing and the microneedle structures).
Regarding claim 9, Yeshurun further discloses wherein the substrate of the microneedle device comprises pores configured to deliver a substance (¶ [0072] discloses that the microneedles are hollow which would provide them, on the substrate, with internal pores capable of holding and delivering medicine or some substance to the target via said pores; the claim does not require pores separate from the needles themselves).
Regarding claim 14, Yeshurun further discloses wherein the substrate has an aspect ratio which is less than or equal to 1.2 (the ball-roller is disclosed as substantially spherical, since the aspect ratio is disclosed as the ratio of the longest dimension of the substrate and the shortest dimension of the substrate, it will approximate a ratio of 1 since it’s a sphere).
Regarding claim 15, Yeshurun further discloses wherein the microneedles have a height of 0.1 – 10000 µm (¶ [0065] discloses the microneedles have a length of between 20 and 750 microns).
Regarding claim 18, Yeshurun further discloses that the housing (100) is cylindrical (Figure 10a).
Regarding claim 20, Yeshurun further discloses a kit comprising the apparatus of claim 1 (Yeshurun discloses providing the roller-ball applicator of Figures 10a-10c along with a solution or medicament to be administered; this is all that is required of a “kit” absent explicit claiming of components or packaging which would require additional disclosure).
Regarding claim 22, Yeshurun discloses a method of engaging a surface and delivering a substance, a mixture or a formulation to the surface, the method comprising: handling a microneedle apparatus (Figures 10a-10c) comprising a housing (100) with a reservoir (100 comprises a fluid to be delivered; ¶ [0072]), a socket (for receiving roller ball 102), and a microneedle device (ball 102 with microneedles 104) within the socket, wherein the socket is in fluid connection with the reservoir and wherein the reservoir contains the substance (¶ [0072]), the mixture or the formulation, further wherein the microneedle device comprises a substantially spherical substrate (¶ [0072] discloses the ball as spherical) and a plurality of microneedles (104) projecting from the substrate (Figure 10b); engaging the surface via the plurality of microneedles (¶¶ [0072]-[0073] disclose rolling on the surface to increase penetration of the solution at the target site); dispensing the substance, the mixture or the formulation from the reservoir to the microneedle device via the socket; moving a microneedle device within the socket and against the surface with 3-dimensional movements (this is how a ball-rolling applicator functions; the ball rolls in the socket along multiple axes since it is only constrained by the geometry of the tip and can therefore move in three dimensions as claimed), and delivering the substance via the engagement of the microneedle onto the surface (e.g., ¶¶ [0072]-[0073] disclose the reservoir providing the solution to the microneedles and the microneedle substrate being applied to the target site which anticipates the delivery of said substance via the microneedle substrate as claimed).
Regarding claim 23, Yeshurun further discloses forming openings on the surface (¶¶[0072]-[0073] disclose rolling the ball on the surface to increase penetration; since the ball comprises microneedles that are not configured to break or shear during use, they will necessarily create pores in the skin during use; this is substantiated by the disclosure of the device to increase penetration of the substance during use) as the microneedle device moves against the surface (again, as the applicator is rolled along the surface, the needles will create pores at the treatment site); and delivering the substance via the openings formed on the surface (the cited paragraphs clearly disclose the spherical microneedle substrate increasing penetration of the solution which is also disclosed as being delivered to the microneedles during use from the reservoir).
Regarding claim 25, Yeshurun further discloses the step of detecting one or more properties of the surface (the claimed method provides no structure, such as a sensor, for performing this function; a user can readily be expected to feel surface topography during a rolling application (e.g., rolling over a scar, lesion, bone, etc.) which is considered to meet the claim limitation since the user is detecting the surface as they move the applicator).
Regarding claim 27, Yeshurun further discloses wherein the socket has a spherical cavity (for constraining the roller ball applicator therein), and wherein the socket has an open angle of less than or equal to 180 degrees (as per Figure 5 of the instant application, the open angle is taken from one edge of a socket constraining feature to the centerline of the spherical substrate; it is clear from Yeshurun that the ball and socket assembly meet this limitation since the socket cavity is at most 180 degrees; since the ball is constrained and does not fall out of the socket, the claimed angle must be less than 180 degrees as claimed).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of Brandwein et al. (US 2008/0208146).
Regarding claim 4, Yeshurun discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose one or more sensors to detect properties of the surface.
Brandwein et al. (henceforth Brandwein) teaches a microneedle application device (Figures 1-2) which utilizes a sensor to detect one or more properties of the surface and engagement of the applicator thereon (¶¶ [0053] and [0070] disclose one or more sensors on the collar of the device to detect an orientation of the device on the skin surface).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Yeshurun to comprise the orientation sensing of Brandwein so as to allow a user to distribute the application force of the microneedle device evenly to ensure equal distribution along the treatment site as taught by Brandwein (¶ [0053]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of Gieux et al. (US 2017/0027302).
Regarding claim 10, Yeshurun discloses the claimed invention as set forth above for claim 1, but fails to explicitly teach the socket and/or microneedle device comprising a magnetic material.
Gieux et al. (henceforth Gieux) teaches (Figures 14-16) a ball-roller application device which utilizes a magnetic attraction system to retain the ball (8) at the tip in its housing socket (6).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the applicator of Yeshurun to comprise the use of a magnetic holding feature for retaining the spherical substrate in the cavity, since Gieux teaches that it is known to utilize such a holding feature in roller-ball application device to maintain the ball in a specific location relative to the housing during use. In this manner, the magnet could replace the cavity cover retention means of Yeshurun or could be used in conjunction with it to provide a slight magnetic holding force to bias the spherical substrate toward the housing during use along with the collar for preventing removal of the substrate from the device.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of Dornbusch et al. (US 2017/0027302).
Regarding claim 11, Yeshurun discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose an adhesive or holding later between the microneedle device and the socket.
Dornbusch et al. (henceforth Dornbusch) teaches a rolling applicator device (Figures 1, 3, and 4) which comprises a spherical substrate (ball 30) which is located in a socket (Figure 4, socket 32, 35) and wherein there is a holding layer between the substrate (40) and the socket (Figure 4, Col. 5, lines 17-21 disclose the spherical ball being held in the cavity against lands 58 which form a holding layer for the ball within the socket).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Yeshurun to comprise the lands and grooves of Dornbusch within the socket, since Dornbusch teaches that such a configuration allows for precise metering of a product flowing from the socket during use while preventing excessive play in the spherical application element during use (Col. 5, lines 17-21).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of Ignon et al. (US 10,179,229).
Regarding claim 12, Yeshurun discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the use of a plurality of balls and a plurality of sockets.
Ignon et al. (henceforth Ignon) teaches a skin application member (e.g., 600B, Figure 6B) which comprises a plurality of roller ball substrates (644B) on a treatment surface (Figure 6B; Col. 15, lines 40-59 disclose the plurality of roller balls as contacting the treatment site and facilitating the delivery of fluids thereto).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the single ball device of Yeshurun to comprise a plurality of spherical substrates on the treatment end, since Ignon teaches that such a configuration is known in the art of skin applicator devices for engaging a treatment area to deliver fluids thereto. Such a modification could allow for treatment over a larger area via increased surface area contact, or provide for more precise delivery via multiple, smaller spherical substrate balls during use.
Claim(s) 17 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of Traverso et al. (US 2013/0165772).
Regarding claim 17, Yeshurun discloses the claimed invention substantially as set forth above for claim 1, but does not explicitly disclose the density of the microneedles on the substrate being greater than or equal to 1/dm2.
Traverso et al. (henceforth Traverso) teaches a microneedle device wherein the microneedles have a density of greater than or equal to 1/dm2 (100 cm2; ¶ [0048] discloses the microneedle or device can be spherical; ¶ [0065] discloses that the number of microneedles or density of the needles on the substrate is greater than or equal to 1/dm2; the citation provides a variety of densities including about 100/cm2 or greater as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to form the spherical microneedle applicator or Yeshurun having the needle density of greater than or equal to 100/cm2 as taught by Traverso, since Traverso teaches that it is known to provide microneedles of this density range depending on the end use. Since the density is known, it would have been obvious to utilize such a value depending on the size of the spherical substrate and the treatment area designed for it to be used on.
Regarding claim 28, Traverso teaches the density as claimed in claim 17 along with the statement that the density is dependent upon the design parameters of the device during use (and therefore teaches the general concept of applying needle density to a microneedle substrate). Claim 28 sets forth a number of variables for optimizing the microneedle density during design of the device. However, Traverso, as set forth above for claim 17, teaches a number of ranges of microneedle density which are greater than, or equal to, the required density of claim 17. Therefore, Traverso explicitly teaches a density which is claimed to function for the instant device, and by this function, satisfies the equation of claim 28, or else the claimed density of claim 17 would not be applicable. The design parameters of claim 28 would still need to result in a density of greater than or equal to 1/mm2 (as set forth in claim 17 and on page 21 of the filed disclosure). Because Traverso teaches the explicit density value, the cited combination is considered to teach that optimizing for the density using the equation of claim 28 is known so as to arrive at the density which is anticipated by Traverso. If Applicant wishes to explicitly claim, and require, disclosure of the individual variables being used during design or manufacture, the claim should be drafted as a method of making the device which specifically requires the claimed variables to be contemplated in order to achieve the claimed density.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeshurun in view of McGrath (US 3,745,548).
Regarding claim 19, Yeshurun discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the use of a vibration element.
McGrath teaches (Figure 1) a fluid dispensing vibrator apparatus which comprises a plurality of roller ball applicators and a vibration element (Col. 2, line 58-Col. 3, line 12 disclose the use of the ball applicators to deliver a measured quantity of substance to be applied to the site and further teaches the use of a vibration element 32 for vibrating the site during treatment).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Yeshurun to comprise the vibration element of McGrath, since McGrath teaches that it is known to use vibration in roller ball treatment applications to provide massage to the target site along, or independently, to a delivered treatment substance. McGrath points to increased ease of application and separate, vibration-only utility, for the device during use. Therefore, one of ordinary skill would have found it obvious to apply a vibration element to the applicator of Yeshurun to achieve these disclosed functions.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights