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 .
Priority
This application is a CON of application 16396956 which is a CON of application 15430209 which is a CON of application 14211290 which has priority to provisional application 61/791157 filed on March 15, 2013.
Response to Amendment
The amendments filled August 11, 2025, have been entered. Claims 11-15 and 19-30 are currently pending. Claims 11, 19, and 25 have been amended. Claims 16-18 have been canceled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 11-15 and 19-30 have been considered but are not persuasive.
Applicant argues the prior fails to teach the vacuum source fails to prevent the transfer of material from an incorrect vial. Respectfully, Lintern is only used to teach using a tag reader is known to make sure the correct drugs are used. Lintern is not used to teach the skin treatment handpiece only that tag readers to prevent incorrect medication delivery is known.
The Examiner appreciates the applicant list of the assignee’s patents and applications; at this time no double patenting rejections are being made.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 11-14, 19-20, 22-23, 25-26, and 28-29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ignon US 2003/0167032 A1 in view of Lintern et al. US 2013/0296807 A1 (hereafter referred to as Lintern).
Regarding claim 11, 19 and 25, Ignon discloses a skin treatment handpiece comprising (abstract):a main body portion (or handpiece, 122b, fig 12); a tip (or applicator, 153b fig 12) positioned along a distal end of the main body portion ([0056] and figure 12), the tip being configured to be translated over a skin surface during a skin treatment procedure using the handpiece (abstract, [0011] which discloses the device is used over a targeted skin area during treatment); a receiving area along the main body portion (area that holds cartridge 139, [0056]), the receiving area configured to receive a container (139, [0056]) containing a treatment material, wherein the treatment material is configured to be delivered to the tip and on a skin surface of a subject when the container is positioned in the receiving end (figure 8) and when the handpiece is in use [0056]; at least one fluid conduit placing an interior of the container in fluid communication with the tip once the container is positioned in the receiving area of main body portion (the fluid from the container flows through the tip thereby creating a fluid passage, [0056]);
at least one vacuum conduit configured to hydraulicly couple to a vacuum source and the tip to create suction at the tip when the vacuum source is activated ([0011] which discloses the vacuum pulls media out of the container and to the applicator); and
wherein the handpiece is configured to transfer treatment material from the container positioned in the receiving area when suction is created along the tip ([0011] which discloses the suction allows for the release of the material form the container); and
wherein the handpiece is configured so the tip can be translated over a skin surface during a skin treatment procedure ([0011] which notes the container held within the handpiece has an applicator tip for applying the material on the skin).
Ignon fails to disclose an identification tag reader, wherein the identification tag reader is configured to automatically detect and identify an identification tag of the container when the container is positioned within the receiving area of the main body portion of the handpiece, wherein the identification tag comprises information about the container and wherein the vacuum source is maintained closed or terminated to prevent transfer of treatment material from the container to the tip when the identification tag reader detects that the container inserted in the receiving area is not approved for an operation of the handpiece.
Lintern teaches a skin treatment handpiece (abstract- a handpiece for delivering medication; thereby, being able to treat the skin) comprising: a main body portion (or device -70 , figure 7 and [0056]); a tip positioned along a distal end of the main body portion (see annotated below, patient injection needle is element 80 [0056] ; a receiving area along the main body portion (or connector- 72, figure 7 and [0056]), the receiving area configured to receive a container (or vial- 100, figure 7 and [0056]) containing a treatment material ([0056]); at least one fluid passage or conduit placing an interior of the container in fluid communication with the tip once the container is positioned within the receiving area of main body portion ([0056] which notes a fluid connection between the vial and tip/ injection needle); and an identification tag reader ([0047] discloses a tag reader), wherein the identification tag reader is configured to automatically detect and identify an identification tag of the container when the container is positioned within the receiving area of the main body portion of the handpiece, wherein the identification tag comprises information about the container and stop if an incorrect vial is present ([0047 discloses a tag on vial is able to be read by the handpiece such that the handpiece is able to then prepare the solution as needed if the correct vial is present) per claims 11, 19 and 25.
Additionally, per claims 19 and 25 Lintern teaches a control module (33, [0047]) operatively coupled to the identification tag reader and configured to process information of the identification tag detected by the identification tag reader (the controller processes the information from the code and processes the information based on the given directions [0047] and the controller is housed within the device [0047] and figure 2- see 33 inside the device) and [0051] discloses the fluid will not be released if the controller prevents it). .
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added the identification tag reader component of Lintern to the device of Ignon to prevent user errors such as placing the wrong medication or incorrect concentration (Lintern [0047]).
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Regarding claim 12, 22 and 28, as modified above Lintern additionally discloses wherein the identification tag of the container comprises a RFID chip, and wherein the identification tag reader comprises a RFID reader ([0047] discloses an RFID - tag maybe used).
Regarding claim 13, as modified above Lintern additionally discloses wherein the identification tag of the container comprises a barcode, and wherein the identification tag reader comprises a barcode reader. ([0047] discloses a barcode maybe used).
Regarding claim 14, 23, and 29, Ignon additionally discloses wherein the receiving area of the main body portion comprises a recess, the recess being shaped, sized and configured to receive the container (see recessed area 224 which is configured to receive the vial 139 in figure 14 and ([0057]).
Regarding claim 20 and 26 as modified above Lintern additionally discloses wherein a control module operatively coupled to the handpiece is configured to process the information of the identification tag detected by the identification tag reader (Lintern additionally discloses the controller 33 processes the information from the code and processes the information based on the given directions noted in the code [0047] and the controller is housed within the device [0047] and figure 2- see 33 inside the device).
Claim(s) 15, 21, 24, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ignon US 2003/0167032 A1 in view of Lintern et al. US 2013/0296807 A1 (hereafter referred to as Lintern) and in further view of Caputo et al. US 2004/0051368 A1 (hereafter referred to as Caputo).
Regarding claim 15, Ignon and Lintern fail to disclose wherein information about the container associated with the identification tag of the container comprises information regarding contents of the container, an expiration date, a manufacturing date, and/or a lot number.
Caputo teaches a medical fluid delivery system thereby being in the same field of endeavor as Ignon and Lintern (abstract). Caputo teaches the medication has a RFID tag that is read by a device and then automatically programs the fluid flow rate to prevent user error [0010] and [0004]. The RFID can also contain information such as expiration date, lot number, and manufacturing date [0015] and [0028].
It would have been obvious to one of ordinary skill before the effective filing date of the invention to have added additional information to RFID tag of Lintern to include expiration date to prevent to delivery of expired medication.
Regarding claim 21 and 27, Ignon and Lintern fail to disclose wherein the control module is separate from the handpiece.
Caputo teaches a medical fluid delivery system thereby being in the same field of endeavor as Ignon and Lintern (abstract). Caputo teaches the medication has a RFID tag that is read by a device and then automatically programs the fluid flow rate to prevent user error [0010] and [0004]. Additionally, Caputo teaches the reader can be within the pump which accepts the vial for fluid delivery or a separate reader [0032].
It would have been obvious to one of ordinary skill before the effective filling date to have uncoupled the control module of Lintern as taught by Caputo since the device remains functionally equivalent i.e., the information and programing of the rates will still be performed. Given the limited number of options coupled or un-coupled it would have been obvious to try with a reasonable expectation of success per MPEP 2143.1.E. Uncoupling the controller can allow for a slimmer device that is easier to clean and less expensive due not needing parts that are small enough to fit in a handpiece, while coupling the device reduces connections and makes the device more portable by being a single unit instead of needing to remember multiple pieces.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781