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 .
Information Disclosure Statement
The information disclosure statement filed 4/7/23 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on 2/18/26 is acknowledged.
Applicant elected species I, a system with a needle bundle in a disposable cartridge, and no blades. Although Applicant amended claim 6 to depend from claim 1, because claim 6 recites blades, claim 6 does not read on the elected embodiment and claims 6-8 are withdrawn as being directed to a non-elected embodiment (note that the examiner does not find support in the specification for an embodiment which includes both blades and needles).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “senor” which should be “sensor.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5,9,14,16-18,20-21 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 1 recites “the first distance drive.” There is insufficient antecedent basis for this limitation in the claim. It is assumed this was intended to read “the depth drive.”
Claim Interpretation
Claim 16 recites “the needle bundle comprises a compact linear configuration.” The term “compact” is assumed to refer to a needle bundle in which the needles touch each other, as indicated in the specification, Fig. 17A.
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) 1, 14, 17, 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton [US 2016/0287281 A1] in view of Wang et al. [US 20080269666 A1, hereinafter “Wang”], Chiu et al. [US 20200384197 A1, hereinafter “Chiu”], Garnier [US 4381777 A], Juster [US 20220273029 A1], and Cafaro [US 5170525 A].
Re. claim 1, Knowlton discloses a system for use in the application and removal of tattoos [Par. 0340] and other skin treatments [Par. 0012], comprising:
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a handpiece [“control device,” Par. 0231; Annotated Fig. 75];
a disposable [Par. 0231] cartridge [“scalpet device,” Par. 0231, Annotated Fig. 75] couplable to the handpiece, the disposable cartridge comprising a needle bundle [array of needles, see Par. 0200] and
an oscillation drive [vibration input source, Fig. 75] configured to provide oscillatory motion to the needle bundle [Par. 0324];
the system configured to provide linear motion to the needle bundle [“downward axial force into skin,” Fig. 64];
a rotational drive [“drive system…configured to apply rotational force to the scalpet array,” Par. 0357] configured to provide rotational motion to the needle bundle [“rotational torque,” Par. 0284]; and
a drive shaft [Par. 0283], the system configured to independently translate oscillatory, linear, and rotational motion to the needle bundle [“Embodiments herein include the use of a vibration component or system to facilitate skin incising with rotation torque/axial force and to use vibration to facilitate skin incising with direct impaction without rotation,” Par. 0324].
The system of Knowlton differs from the claimed system in that Knowlton is silent regarding the flexible tubing, the system controller, and the details of the oscillation drive, depth drive, and rotational drive; and the drive shaft.
Regarding the flexible tubing: Wang teaches, in a needle array device, using a flexible tubing connection [Par. 0096] to deliver a drug/formulation such as substances for tattooing, cosmetics, etc. [Wang Pars. 0079], the tubing connection couplable to a fluid pump [Par. 0013] configured to dispense facilitating fluid to the needle bundle [Par. 0013]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Knowlton by adding a flexible tubing connection couplable to a pump to dispense fluid to the needle bundle as taught by Wang in order to dispense a therapeutic agent [Wang Par. 0014].
Regarding the system controller: Chiu teaches, in a fluid infusion system, a system controller [114] comprising a power input [112], a microprocessor [Par. 0198], and a graphics processing unit [Par. 0198], the system controller configured to control the operation of one or more drives [Par. 0198]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Knowlton by adding a system controller with power input, microprocessor, and GPI to control the operation of one or more drive as taught by Chiu in order to allow the system to be programmable.
Regarding the structure of the oscillation drive: Garnier teaches, in an oscillating needle system, an oscillation drive unit [11] comprising an oscillation drive frame [drive unit head, Col. 2 lines 46-47], an oscillation motor [micro-motor, Col. 2 line 47], and an eccentric crank [21]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Knowlton by replacing the oscillation drive of Knowlton with that of Garnier because this amounts to a simple substitution of one oscillation drive system known in the art for another with predictable results.
Regarding the depth drive: Juster teaches, in a medical device, a depth drive [Fig. 2, Par. 0026] comprising a block [32], a first motor [34], a gear train [36], a lead screw shaft [Par. 0026], and a sensor [force sensor, Par. 0029] configured to provide linear motion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Knowlton by adding a depth drive to impart the axial movement, as taught by Juster, because this amounts to a simple substation of one linear drive mechanism known in the art for another with predictable results [Juster Par. 0026], and wherein the sensor provides feedback on the force used, indicating position of the components [Juster Par 0029].
Regarding the structure of the rotational drive: Cafaro teaches, in a medical device with a rotary motion, a rotational drive comprising a motor, a drive rod, and a gear combination [“ the motor shaft of the DC motor is connected to a flexible drive rod which is connected, by a gear train arrangement, to rotatably drive the bristle means of the brush,” Col. 2 lines 20-25]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Knowlton by replacing the rotational drive of Knowlton with that of Cafaro because this amounts to a simple substitution of one rotational drive system known in the art for another with predictable results.
Regarding the drive shaft which translates the three types of motion to the needle bundle: Knowlton teaches all three types of motion, as set forth above, but is not clear regarding how the motion is transmitted. However, Knowlton teaches a drive shaft. And given the above teachings by the secondary references, using the drive shaft to translate the three types of motion to the needle bundle would have been obvious in order to reduce the number of parts needed [compared to a plurality of drive shaft or other motion transfer mechanisms].
Re. claims 14, 20, and 21, the above modified Knowlton teaches the three types of motion and the microprocessor. Configuring the above-modified systemn such that the microprocessor is configured to operate the oscillation drive, the depth drive, and the rotational drive individually and cooperatively would have been obvious to one of ordinary skill in the art because this allows the three drives to operate either together or independently, depending on the operation to be performed, and because the above inventions teach respective controllers for the drives, so configuring the one microcontroller to control each drive separately or together would have been obvious given the above teachings.
Re. claim 17, Knowlton discloses the needle bundle comprises a spaced linear configuration, the needle bundle configured to orient a group of needles spaced apart from one another without touching or overlapping needles [Fig. 75].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Vescovi [US 2018/0043146 A1].
Re. claim 2, the modified Knowlton discloses the apparatus set forth above but fails to teach a wrist controller. However, Vescovi teaches, in a tattoo system, a wrist controller [14] configured to adjust treatment parameters of the handpiece [Par. 0020]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Knowlton to add a wrist controller as taught by Vescovi in order to allow a user to quickly and easily configure the operations of the device.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Colton et al. [US 20110288575 A1, hereinafter “Colton”].
Re. claim 3, the modified Knowlton discloses the apparatus set forth above but fails to teach the foot controller. However, Colton teaches, in a tattoo system, a foot controller [foot pedal, Par. 0054] configured to start and stop operation of the system when the foot controller is engaged and disengaged [Par. 0054]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Knowlton to add a foot controller as taught by Colton in order to allow hands-free control of the system.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Lee [US 20190076636 A1].
Re. claim 4, the modified Knowlton discloses the apparatus set forth above but fails to teach the tablet controller. However, Lee teaches a tattoo system comprising a tablet controller [10, Par. 0018]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Knowlton to add a tablet controller as taught by Lee in order to allow the system to clearly display voltage and other quantities, and permit fine-tuned control including touch-free control of the device [Lee Par. 0019].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Bunting et al. [US 20130123746 A1, hereinafter “Bunting”].
Re. claim 5, the modified Knowlton discloses the apparatus set forth above but fails to teach the controller controlling flow initiation/stoppage and rate. However, Bunting teaches, in a tattoo removal system, the system controller is configured to control the initiation, flow rate, and stoppage of the facilitating fluid dispensed by the fluid pump [Par. 0047]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Knowlton to further configure the controller to control flow rate and starting/stoppage of the fluid dispensed by the fluid pump, as taught by Bunting, in order to allow a user to select a desired flow rate and prevent fluid overfilling the reservoir [Bunting Par. 0047].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Theiss et al. [US 6033421 A, hereinafter “Theiss”].
Re. claim 9, the modified Knowlton discloses the apparatus set forth above but fails to teach the drive shaft being flexible. However, Theiss teaches a drive shaft which sis flexible [Col. 2 lines 4-5]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Knowlton to form the drive shaft to be flexible, as taught by Theiss, because this amounts to a simple substitution of one drive shaft material [a flexible material] known in the art for another with predictable results.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Lawson et al. [US 6030404 A, hereinafter “Lawson”].
Re. claim 16, the modified Knowlton discloses the apparatus set forth above but fails to teach the needles being in a compact single layered arrangement. However, Lawson teaches, in a skin penetration apparatus, the needle bundle comprises a compact linear configuration, the needle bundle configured to orient a group of needles in a single layered arrangement [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Knowlton by configuring the needles to be oriented in a compact linear configuration, as taught by Lawson, because “needles assembled in this manner thus exhibit substantially uniform flexure resilience at all locations throughout the assembly as such assembly of needles is manually or mechanically manipulated to lift the skin simultaneously at multiple penetrations,” Lawson Col. 1 lines 48-52].
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton in view of Wang, Chiu, Garnier, Juster, and Cafaro, as applied to claim 1 above, and further in view of Tharp et al. [US 20180280675 A1, hereinafter “Tharp”]
Re. claim 18, the modified Knowlton discloses the apparatus set forth above but fails to teach the needles being in a staggered arrangement. However, Tharp teaches, in a needling device and drug applicator, wherein the needle bundle comprises a staggered configuration, the needle bundle configured to orient a group of needles in two or more rows with the needles in a first row offset spatially from the needles in a second row [Fig. 105]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Knowlton such that the needles are in a staggered configuration as taught by Tharp because this amounts to a simple rearrangement of parts [a shift of the second row so that the first and second rows are offset] and provides the added advantage of ensuring that a substance is provided at different locations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771