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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 27, 2026, has been entered.
Response to Amendment
The amendments filled March 27, 2026, 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 and are persuasive. However, upon further consideration a new ground of rejection is made.
The new prior art of record Deberadine US 20140128842 A1 clearly teaches a link between the injection device identifying if the correct medication vial is added and using that information to administer or not administer if the incorrect medication is use or there is another problem such as incorrect temperature or incorrect dosing. While the instant application has the identification tag reader preventing the vacuum thereby not delivering the incorrect medication the concept is the same as the device of Deberadine also prevents delivery of the wrong medication.
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 Deberadine US 20140128842 A1.
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 while the handpiece is being handled and manipulated during use, wherein the identification tag comprises information about the container and wherein vacuum from the vacuum source is maintained inactive 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.
Deberadine teaches a skin treatment system (abstract- a system for delivering medication to the skin; thereby, being able to treat the skin) comprising: a main body portion (or pen -20/ 50, and [0093]/[0124]); a tip (or needle 24/ 51, and [0091]/). The pen includes an identification tag reader (or medicament detector 36 [0093] or cartridge identifier 60 [0124]) which reads a bar code or RF-ID tag on the cartridge ([0093]/ [0124]). A controller is couped to the cartridge identifier [0125] which determines if the correct vial is added to the pen. The controller determines if the wrong cartridge is added, and the enabler/ preventer 63 works to allow for the medication to be enabled or prevented depending on if the correct medication container is added [0142].
Additionally, per claims 19 and 25 Deberadine teaches a control module operatively coupled to the identification tag reader and configured to process information of the identification tag detected by the identification tag reader ([0142]).
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 Deberadine to the device of Ignon to prevent user errors such as placing the wrong medication or incorrect concentration (Deberadine [0142]) and preventing the device to operate if the wrong medication is present to avoid harm.
Regarding claim 12, 22 and 28, as modified above Deberadine additionally discloses wherein the identification tag of the container comprises a RFID chip, and wherein the identification tag reader comprises a RFID reader ([0124] discloses an RFID - tag maybe used).
Regarding claim 13, as modified above Deberadineadditionally discloses wherein the identification tag of the container comprises a barcode, and wherein the identification tag reader comprises a barcode reader. ([0124] 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 Deberadine 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 (Deberadine additionally discloses the controller 62 processes the information from the code and processes the information based on the given directions noted in the code [0125] and the controller is housed within the device figure 7- see 62 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 Deberadine US 20140128842 A1 and in further view of Caputo et al. US 2004/0051368 A1 (hereafter referred to as Caputo).
Regarding claim 15, Ignon and Deberadinefail 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 Deberadine (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 Deberadine to include expiration date to prevent to delivery of expired medication.
Regarding claim 21 and 27, Ignon and Deberadine 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 Deberadine (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 Deberadine 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
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
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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