Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
This is in response to the preliminary amendment filed 03/27/2024.
Allowable Subject Matter
Claims 86 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 86 recites wherein the system has multiple deceleration thresholds comprising the maximum threshold (D.sub.MAX) and at least one lower threshold (D.sub.1, D.sub.2), wherein the system comprises an algorithm that is configured to record a number of times the z-actuator exceeds either or both thresholds, and to enter an alert state in which use of the system is stopped until further action of an operator is performed, or to enter an alert state in which use of the system can continue, but the operator is notified of the exceeding of the threshold.
The Office agrees the art of record fails to teach of suggest these features.
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) 78, 79, 82-84, 88-95, 97-99 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2020/0038051 (Austen)
Regarding claims 78, 79, 82, 83, 88 Austen discloses as shown in Figure 4A, 4B, a system for producing a cosmetic effect in skin tissue of a patient, the system comprising: a treatment module (three needles 120) comprising at least one coring element (needle 120, see paragraph [0044]) capable of removing a portion of skin tissue when the coring element is inserted into and withdrawn from the skin tissue; and an actuation assembly (reciprocating arrangement 420, see paragraph [0058]) operably attached to the treatment module and configured to translate the treatment module in one or more directions relative to a surface of the skin tissue, wherein the actuation assembly comprises a z-actuator (reciprocating member, see paragraph [0058]) that is capable of advancing the at least one coring element into the skin, wherein the system is capable of performing a microcoring procedure that provides a cosmetic effect to the patient, and wherein the system includes a limit on depth of travel of the z-actuator (housing 430 limits travel of substrate 130 , see paragraph [0058]) of to limit depth of penetration of the at least one coring element into the skin, wherein the limit on depth of travel is a limit depth of travel of a translating component of the z-actuator that translates along a z-axis, wherein the system is capable so that a titration or other iterative adjustment procedure is capable of being performed by an operator, in which the depth of penetration is adjusted, wherein the system is capable of decelerating the z-actuator as the at least one coring element is approaching a target depth if the reciprocating arrangement was manually turned off (it would necessary decelerate the z-actuator) as the at least one coring element is approaching a target depth, wherein ranges of positions of the translating component of the z-actuator range from a −z.sub.max to z.sub.max, with a rise time, t.sub.r, wherein the translating component of the actuator has a velocity, v, and a maximum velocity, v.sub.max, and an acceleration, a, and wherein the acceleration a of the translating component of the actuator is capable of being controlled to approximate a smooth continuous function. see paragraph [0058].
Regarding claim 84, Austen discloses wherein the system is capable of monitoring deceleration of a translating component of the z-actuator by monitoring the deceleration of the associated coring element and to adjust the depth of penetration. See paragraph [0060].
Regrading claim 89, Austen discloses at least one treatment device (template or tattoo device, see paragraph [0083]), wherein the at least one treatment device is void of any surface, projection, or other mechanical stop that is contacted by the treatment module during advancement of the at least one coring element in a microcoring procedure.
Regarding claims 90, 91 Austen discloses wherein the system is configured to monitor deceleration of the z-actuator. See paragraph [0060].
Regarding claim 92, Austen discloses wherein the system is capable of preventing further use until inspection by an operator is performed, wherein, the treatment module is replaced or confirmation of no damage is provided by the operator, if it is turned manually and not turned manually back on until inspection by an operator is performed, wherein, the treatment module is replaced or confirmation of no damage is provided by the operator. see paragraph [0058].
Regarding claim 93, Austen discloses wherein the at least one coring element comprises at least three coring elements, wherein, the at least three coring elements are located at a separation distance of no more than 7 mm, 6 mm, 5 mm, or 4 mm. see paragraph [0053] and Figure 4B.
Regarding claim 94, Austen discloses wherein the at least one coring element comprises an outer diameter of between 0.0203″ and 0.0500” (.3 mm - .8 mm disclosed which is .011 in - .3 in.). see paragraph [0012].
Regarding claim 95, Austen discloses wherein the at least one coring element comprises an inner diameter of between 0.0103″ and 0.0207″ ″ (.14 mm - .84 mm disclosed which converts to .0055 in - .033 in). see paragraph [0012].
Regarding claim 98, Austen discloses a receiving portion (portion which receives substrate 130 and disclosed handle 410) including a handle, wherein the treatment module is configured to operably attach to the receiving portion. See Figure 4b and paragraphs [0058], [0060].
Regarding claim 97, Austen discloses comprising multiple treatment modules (multiple sets of three needles, see paragraph [0052]), wherein each treatment module comprises at least one coring element configured to remove a portion of skin tissue when the coring element is inserted into and withdrawn from the skin tissue, and wherein each treatment module is configured to be operably attached to the actuation assembly.
Regrading claim 99, Austen discloses wherein at least one coring element is capable of being in a locked state when the treatment module is not attached to the receiving portion, because needle 120 is disclosed as attached to substrate without a structure which would allow it to be removed. Is the position of the Office that this necessarily means that it is locked would be remained locked if the treatment module is not attached to the receiving portion.
Note: Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04 and 2143.03.
In this case, the Office’s position that the limitation of “when the treatment module is not attached to the receiving portion” is optional. If the treatment module is always attached to the receiving portion, the limitations following that do not apply.
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.
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.
Claim(s) 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2012/0226288 (Mays et al.)
Regarding claim 80, Austen fails to discloses a console that comprises a user interface configured to input the depth of penetration by an operator.
Mays et al. from the same field of endeavor teaches a similar system as shown in figure 4, where the system includes a console (computer, see paragraph [0158]) that comprises a user interface (interface for computer) capable of inputting the depth of penetration by an operator, for the purpose of remotely controlling the needle precisely using a computer. See paragraphs [0158], [0159].
It would have been obvious to one of ordinary skill in the art, before the effective fling date of the claimed invention to modify the system disclosed by Mays et al. to include the robotic arm and controller taught by Mays et al. such that it included a console that comprises a user interface configured to input the depth of penetration by an operator in order to remote controlling the needle precisely using a computer, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2011/0238038 (Sefi et al.)
Regarding claim 81, Austen fails to disclose wherein the depth of penetration is 3 mm, 4 mm, or 5 mm.
Sefi et al., from the same field of endeavor teaches a similar system where the depth penetration of a needle is 3 mm – 5 mm for the purpose of reaching a specific area of the skin. See paragraph [0063].
It would have been obvious to one of ordinary skill in the art, before the effective fling date of the claimed invention to modify the system disclosed by Mays et al. such that the depth of penetration is 3 mm, 4 mm, or 5 mm as taught by Sefi et al. in order to reach a specific area of the skin, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2004/0064098 (Cushieri et al.) as applied to claim 84 above, and further in view of U.S. Patent Publication Number 2002/0045861 (Tribe et al.)
Regarding claim 85, Austen discloses the system is configured to monitor the deceleration of the translating component of the z-actuator. See paragraph [0060].
Austen fails to disclose the system is configured if the monitored deceleration exceeds a maximum threshold (D.sub.MAX) to enter an alarm or other alert state.
Tribe, from a related field of endeavor teaches a similar system as shown in Figure 1, where the system is configured to monitor the deceleration of a translating component of an z-actuator, and, if the monitored deceleration exceeds a maximum threshold (D.sub.MAX) to enter an alarm or other alert state. See paragraph [0015].
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 system disclosed by Austen to include the alarm taught by Tribe in order to alert the user if the translating component slows down to quickly, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2004/0138688 (Giraud)
Regarding claim 87, Austen fails to disclose one or more algorithms configured to control the z-actuator via one or more sets of instruction.
Giraud, from a related field of endeavor teaches a similar system as shown in Figure 1, where the system includes one or more algorithms configured to control the z-actuator via one or more sets of instruction for the purpose of automatically adjusting the actuator. See paragraph [0059].
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 system disclosed by Austen to include the algorithm taught by Giraud in order to automatically adjust the actuator, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2007/0106306 (Bodduluri)
Regarding claim 96, Austen fails to disclose treatment module is configured to detach and operably attach to the actuation assembly.
Bodduluri, from the same field of endeavor teaches a similar system as shown in Figure 22, where treatment module is configured to detach and operably attach to the actuation assembly. See paragraph [0092].
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 system disclosed by Austen to disclose treatment module is configured to detach and operably attach to the actuation assembly as taught by Bodduluri in order to replace treatment module if it is broken or sterilize it in order to use it again, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 100, 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0038051 (Austen) in view of U.S. Patent Publication Number 2016/0135662 (Hatakeyama et al.)
Regarding claims 100, 101 Austen fails to disclose a sensor configured to produce a signal, wherein the system is configured to detect proper attachment of the treatment module to the receiving portion based on the signal, wherein comprises a magnetic sensor.
Hatakeyama et al., from a related field of endeavor teaches a similar system as shown in Figure 1, a sensor configured to produce a signal, wherein the system is configured to detect proper attachment of the treatment module to the receiving portion based on the signal, wherein comprises a magnetic sensor. See paragraph [0047].
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 system disclosed by Austen to include a sensor configured to produce a signal, wherein the system is configured to detect proper attachment of the treatment module to the receiving portion based on the signal, wherein comprises a magnetic sensor to confirm the needles are properly received in the receiving portion, a predictable use of known components with a reasonable expectation of success. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771