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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/11/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-14 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.
In regard to claim 1, the limitation “configured to inject an inject material accommodated therein at an end thereof” (emphasis added by examiner) renders the claim indefinite. It is unclear what structures “therein” and “thereof” refer to. It is plausible to either associate them with the material inject tip, the handpiece, or some other non-identified structure.
The dependent claims are rejected by virtue of their dependency on the rejected independent claim.
In regard to claim 5, there is no antecedent basis for “the liquid”. The applicant should consider amending the limitation to “the liquid state inject material”.
In further regard to claim 5, it is unclear what “an outside” is referencing. Claim 1 previously recites that the laser beam is generated by a laser beam generator. The instant limitation alters that limitation in that the laser beam is emitted from “an outside”. It is unclear if the “outside” is another structure or space or direction. The applicant should consider replacing it with “the laser beam emitted from the laser beam generator”.
In regard to claim 6, the use of the word “may” renders the claim indefinite. It is unclear if the limitations following “may” are required or not because of the conditional nature of the term “may”. The applicant should consider changing from “may comprise” to “comprises”.
In further regard to claim 6, “an inject material” should read “the liquid state inject material” to provide proper antecedent reference.
In regard to claim 7, “the inject material” should read “the liquid state inject material” to provide proper antecedent reference.
In further regard to claim 7, it is unclear “thereof” references. Applicant is encouraged to recite the structure.
In regard to claims 8-9, 10 and 14, “the inject material” should read “the liquid state inject material” to provide proper antecedent reference.
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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kolorpen LTD. (WO 2016/181377; hereafter Kolorpen) in view of Marchitto et al. (US 6,389,313; hereafter Marchitto) and further in view of Hein (US 2,671,447).
In regard to claim 1, Kolorpen discloses a material inject device (see Fig. 1) comprising: a main body (40) comprising a power supply (50) (see par. [0090]-[0091]); a handpiece (12) comprising a laser beam generator (14) configured to generate a laser beam with power received from the power supply (see par. [0069]); and a material inject tip (26) mounted to the handpiece (see Fig. 1), and configured to inject an inject material accommodated therein at an end thereof as internal pressure is increased by the laser beam emitted from the laser beam generator (see par. [0065], [0067], [0073]), wherein the laser beam generator generates the laser beam at a repetition rate of 15 to 25 Hz so that the inject material is injected to penetrate into skin through a skin surface (see par. [0054] and [0084]). The applicant has not disclosed that the recited range works to exclusion and/or produces better results than the broader disclosed range of up to 1000 Hz of Kolorpen and therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to use the recited range since an overlapping range is known in the art to produce useful results and the recited range can be chosen based on the particular application.
Furthermore, in a similar art, Marchitto teaches that the use of a laser operated at a repetition rate of about 20 Hz and a wavelength of 1064 nm is known in the art to produce suitable results (see col. 10, line 44-48).
Kolorpen fails to expressly teach wherein the material inject tip is detachably mounted to the handpiece.
In a similar art, Hein teaches a handpiece body (5) with a tip piece (12, 15) detachably mounted to the body (5) (see col. 2, line 45- col. 3, line 7). The detachable allows for the nozzle to be sterilized and remounted to the device (see col. 2, line 45- col. 3, line 7).
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 device of Kolorpen with the detachable tip of Hein in order to provide a detachable tip that allowed for sterilization and/or replacement of a used nozzle.
In regard to claim 2, the combination teaches wherein the laser beam generator is configured to generate the laser beam having a wavelength of 532 nm, 1064 nm, 2900 nm or 2940 nm (see col. 10, line 44-48 of Marchitto).
In regard to claim 3, Kolorpen discloses wherein the inject material is in a liquid state (see par. [0065]).
In regard to claim 4, Kolorpen discloses wherein the material inject tip comprises an inject nozzle formed with an injecting hole having an inner diameter of 50 to 500 pm (see par. [0073]-[0118]).
Claim(s) 5-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kolorpen in view of Marchitto and Hein and further in view of JSKBIOMED INC (KR-20190049097; hereafter JSKBIOMED).
In regard to claim 5, the combination fails to teach wherein the material inject tip comprises: a pressure chamber configured to accommodate the liquid therein; a window provided at one side of the pressure chamber, and configured to allow the laser beam emitted from an outside to pass therethrough and reach the liquid accommodated in the pressure chamber; and a membrane unit provided one side of the pressure chamber, and configured to seal the pressure chamber and be transformed by pressure generated as the liquid is irradiated with the laser beam.
In a similar art, JSKBIOMED discloses wherein the material inject tip (see Fig. 1) comprises: a pressure chamber (100) configured to accommodate the liquid therein; a window (110) provided at one side of the pressure chamber, and configured to allow the laser beam emitted from an outside to pass therethrough and reach the liquid accommodated in the pressure chamber; and a membrane unit (300) provided one side of the pressure chamber, and configured to seal the pressure chamber and be transformed by pressure generated as the liquid is irradiated with the laser beam (see par. [0039]-[0047] and [0068]). The JSKBIOMED configuration provides an art-recognized alternate means for using a laser to deliver substances to the body.
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 combination with the configuration of JSKBIOMED because substituting an alternate means (means for pressurizing a delivery substance) to provide a predictable result (substance delivery to the patient) is considered well within the skill of the ordinary artisan.
In regard to claim 6, the combination teaches wherein the material inject tip may comprise an inject material accommodating chamber (see element 24 of Kolorpen and element 210 of JSKBIOMED) configured to accommodate an inject material, configured to accommodate tattoo dye, and configured for fluid communication with the membrane unit (functional language; the chambers of these devices hold the delivery substance).
In regard to claim 7, the combination teaches wherein the material inject tip further comprises an inject material supply unit (see “reservoir 32” of Kolorpen and “syringe 10” of JSKBIOMED) detachably mounted to one side of the inject material accommodating chamber to supply the inject material to the inject material accommodating chamber, and the inject material accommodating chamber comprises a channel (see “conduit 43” of Kolorpen and “drug solution side port 240” for fluid communication with the inject material supply unit at one side thereof.
In regard to claim 8, the combination teaches wherein the inject material accommodating chamber further comprises a first valve (see “unidirectional valve 36” of Kolorpen and “supply section flow prevention valve 500” of JSKBIOMED) configured to set whether to allow the inject material to flow from the inject material supply unit toward the inject material accommodating space.
In regard to claim 9, the combination teaches wherein the first valve (see “supply section flow prevention valve 500” of JSKBIOMED) comprises an opening/closing portion (520) configured to seal an opening of the channel at a side of the inject material accommodating chamber, and the opening/closing portion comprises an elastic material to be transformed by difference between the internal pressure of the inject material accommodating chamber and the internal pressure of the channel (“The supply zone prevention valve 500 of the present invention is formed of a material having elasticity”).
In regard to claim 11, the combination teaches further comprising a second valve (see “nozzle backflow prevention valve 400” of JSKBIOMED) provided inside the inject material accommodating chamber, and configured to set whether to allow the inject material to flow toward the inject nozzle.
In regard to claim 12, the combination teaches wherein the second valve comprises a one-way valve (see “nozzle backflow prevention valve 400” of JSKBIOMED).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kolorpen in view of Marchitto and Hein and JSKBIOMED in further view of Peterson et al. (US 5,098,405; hereafter Peterson).
In regard to claim 10, the combination fails to teach wherein the inject material accommodating chamber is internally formed with a cylindrical space, the first valve has a hollow shape and comprise an outer circumferential surface to come into close contact with an inner surface of the cylindrical space of the inject material accommodating chamber, and the opening/closing portion is configured to be transformed toward a central axis of the hollow.
In a similar art of providing a one-way valve in a fluid channel, Peterson discloses wherein the inject material accommodating chamber (13) is internally formed with a cylindrical space (shown in Fig. 1), the first valve (10) has a hollow shape (see Fig. 2) and comprise an outer circumferential surface (19) to come into close contact with an inner surface of the cylindrical space of the inject material accommodating chamber (see Fig. 2), and the opening/closing portion is configured to be transformed toward a central axis of the hollow (see Figs. 2-3). Peterson shows an equivalent means for mounting a one-way valve in a fluid delivery channel.
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 combination with the features of Peterson because substituting an alternate means (means for mounting/securing a one-way valve) to provide a predictable result (providing a working one-way valve) is considered well within the skill of the ordinary artisan.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kolorpen in view of Marchitto and Hein and JSKBIOMED in further view of Rosenberg (US 3,572,375).
In regard to claims 13-14, the combination fails to teach wherein the inject material accommodating chamber further comprises a stopper configured to press the second valve toward the inject nozzle so that the second valve can be locked in the inject material accommodating chamber and wherein the stopper is internally formed with a hollow to allow the inject material to move from an inside of the inject material accommodating chamber to the inject nozzle.
In a similar art of providing a one-way valve in a fluid channel, Rosenberg discloses a stopper (64) configured to press the second valve (61) toward the inject nozzle (4) so that the second valve can be locked in the inject material accommodating chamber (67) and wherein the stopper is internally formed with a hollow (72) to allow the inject material to move from an inside of the inject material accommodating chamber to the inject nozzle (see Fig. 4). Rosenberg shows an equivalent means for mounting a one-way valve in a fluid delivery channel.
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 combination with the features of Rosenberg because substituting an alternate means (means for mounting/securing a one-way valve) to provide a predictable result (providing a working one-way valve) is considered well within the skill of the ordinary artisan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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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.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783