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 .
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on 04/28/26 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 500. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 1 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 claim 1, the limitation "an injection port formed on a rear side through which a chemical solution is injected" is a recitation of a method step and renders the claim indefinite. As per MPEP 2173.05(p)(ll), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed. The “is injected” of the limitation should say something like through which a chemical solution “is configured to be injected” or “is capable of being injected”.
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.
Claims 1-3, 5-6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101656660 B1) in view of Roh (KR 20150018336 A).
Regarding claim 1, Kim discloses a multi-needle module for skin treatment (p. 5, [0019], lines 1-3, needle module for a skin procedure). Kim is silent to a multi-needle module for skin treatment, which is connected to a syringe and mounted on an injection device. However, Roh teaches multi-needle module for skin treatment (Roh, p. 2, lines 10-12, multi-needle module for skin treatment), which is connected to a syringe (Roh, Fig. 9 syringe 3) and mounted on an injection device (Roh, Fig. 9 injection body 5’). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of a multi-needle module for skin treatment of Kim with the teachings of connecting the multi-needle module for skin treatment to a syringe and mounting it on an injection device as taught by Roh as the multi-needle module for skin treatment of Kim has an injection tube (Kim, Fig. 3a drug injection pipe 72) which can be connected to a syringe that can push the external drug (Kim, p. 11, [0041], lines 1-3, external drug) to where “the drug injection pipe 72 is a space for receiving an external drug, and communicates with the drug passage 71 as described above to supply the drug to the drug flow path 71” (Kim, p. 11, [0041], lines 1-3). Additionally, the multi-needle module of Kim has a flange (see Kim, ‘Modified Fig. 3b’ below, flange) which would provide a surface for gripping or latching onto and for preventing the multi-needle module of Kim from being pushed too far into an injection device.
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The first modified device of Kim discloses multi-needle module for skin treatment, which is connected to a syringe and mounted on an injection device and comprises: an upper body (see Kim, ‘Modified Fig. 3a’ below, upper body), a lower body (see Kim, ‘Modified Fig. 3a’ below, lower body), a connection part (see Kim, ‘Modified Fig. 3b’ above, connection part), and needles (Kim, Fig. 3a drug injection needles 60), wherein the upper body (see Kim, ‘Modified Fig. 3a’ below, upper body) is open on front (see Kim, ‘Modified Fig. 3a’ below, open upper body front side) and rear sides (see Kim, ‘Modified Fig. 3b’ above, open upper body rear side), and includes a side wall (see Kim, ‘Modified Fig. 3a’ below, upper body side wall), a plurality of needle pipes (Kim, Fig. 3a guider 11) formed therein, through which the needles (Kim, Fig. 3a drug injection needles 60) penetrates, and an insertion end (see Kim, ‘Modified Fig. 3b’ above, insertion end) formed on an outer periphery of the rear opening (see Kim, ‘Modified Fig. 3b’ above, open upper body rear side), the lower body (see Kim, ‘Modified Fig. 3a’ below, lower body) includes an opening formed on a front side (see Kim, ‘Modified Fig. 3a’ below, open lower body front side), side walls (see Kim, ‘Modified Fig. 3a’ below, lower body side walls) formed so as to define a space inside (see Kim, ‘Modified Fig. 3a’ below, space inside), an inlet hole (Kim, Fig. 3a distribution flow path 71) formed in the bottom, an injection port (Kim, Fig. 3a drug injection pipe 72) formed on a rear side (see Kim, ‘Modified Fig. 3b’ above, open lower body rear side), through which a chemical solution (Kim, p. 11, [0041], lines 1-3, external drug) is injected, a stepped portion (see Kim, ‘Modified Fig. 3a’ below, stepped portion) formed on an inner peripheral surface of the front opening (see Kim, ‘Modified Fig. 3a’ below, open lower body front side), and one or more injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) formed on the rear side (see Kim, ‘Modified Fig. 3b’ above, open lower body rear side), the insertion end (see ‘Modified Fig. 3a’ below, insertion end) of the upper body (see ‘Modified Fig. 3a’ below, upper body) is fitted into the fitting groove (see Kim, ‘Modified Fig. 3a’, fitting groove) of the lower body (see Kim, ‘Modified Fig. 3a’ below, lower body), so that the insertion end (see Kim, ‘Modified Fig. 3a’ below, insertion end) is in close contact with the stepped portion (see Kim, ‘Modified Fig. 3a’ below, stepped portion), the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part) is inserted between the upper body (see Kim, ‘Modified Fig. 3a’ below, upper body) and the lower body (see Kim, ‘Modified Fig. 3a’ below, lower body), and includes a plurality of insertion holders (Kim, Fig. 3a insulating cap 41) and needle holes (see Kim, ‘Modified Fig. 3a’ below, needle holes) formed on a front side (see Kim, ‘Modified Fig. 3a’ below, front side), the front side (see Kim, ‘Modified Fig. 4a’ below, connection part front side) of the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part) and a rear end (see Kim, ‘Modified Fig. 4a’ below, upper body rear end) of the upper body (see Kim, ‘Modified Fig. 3a’ below, upper body) are spaced apart from each other to define a receiving space (see Kim, ‘Modified Fig. 3a’ below, receiving space), and adhesive F (not explicitly mentioned in Kim although fixing is mentioned in Kim, p. 10, [0038], lines 1-7) injected into the injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) is filled in the receiving space (see Kim, ‘Modified Fig. 3a’ below, receiving space) to adhesively fix the upper body (see Kim, ‘Modified Fig. 3a’ below, upper body), the lower body (see Kim, ‘Modified Fig. 3a’ below, lower body), the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part), and the needles (Kim, Fig. 3a drug injection needles 60) into an integrated structure at once (see how the recited components come together in Kim, ‘Modified Fig. 3a’, to become an integrated structure during a single assembly event for a functional multi-needle module for skin treatment). The limitation “adhesive F injected into the injection holes is filled in the receiving space to adhesively fix the upper body, the lower body, the connection part, and the needles into an integrated structure at once.” is being treated as a as a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to the applicant to show an unobvious difference.
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The first modified device of Kim does not explicitly mention adhesive F. However, Roh teaches adhesive F (Roh, Fig. 4 adhesive 5). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the first modified device of Kim teaching the structure of injection holes, receiving space, upper body, lower body, connection part, and needles that become an integrated structure at once to include receiving an adhesive F, as taught by Roh, through that already present structure in the first modified device of Kim for fixing the components, as the first modified device of Kim discloses “the groove 73 of the hub 70 is formed in a shape in which an edge portion of the hub 70 is recessed in a semicircular shape, and the groove 73 communicates with the groove 52 formed in the channel 50” (p. 11, [0042], lines 1-3). With all of the structure from the different components including the pathways within them communicating with each other, the adhesive could easily be injected through the injection holes, filled in the receiving space and spread between the components for adhesive fixing to create the desired result. Additionally, the first modified device of Kim discloses “the drug injection needle 60 passes through the insulating cap 41 of the holder 40, and the rear end of the drug injection needle 60 passes through the channel 50 and is fixed. In more detail, the rear end portion of the drug injection needle 60 is fixed through the insertion protrusion 51 of the channel 50, and since the rear end portion of the drug injection needle 60 is located inside the drug flow path 71 of the hub 70, the drug supplied to the drug flow path 71 is supplied to the flow path formed inside the drug injection needle 60” (Kim, p. 10, [0038], lines 1-7). The fixing mechanism not explicitly mentioned in [0038] could predictably be the adhesive to achieve the desired fixing results.
Regarding claim 2, the second modified device of Kim discloses the needle pipes (Kim, Fig. 3a guider 11) include needle holes (see Kim, ‘Modified Fig. 3a’ above, needle holes) formed on front ends (see Kim, ‘Modified Fig. 3a’ above, open upper body front side) so that the needles (Kim, Fig. 3a drug injection needles 60) can be inserted therein, and needle through holes (Kim, Fig. 3a through holes 22) formed on rear ends in communication with the needle holes (see Kim, ‘Modified Fig. 3a’ above, needle holes), and the needle through holes (Kim, Fig. 3a through holes 22) are connected to lattice walls (Kim, Fig. 3a electrode plate 20), and filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) are formed between the lattice walls (Kim, Fig. 3a electrode plate 20) to be filled with the adhesive (Roh, Fig. 4 adhesive 5).
Regarding claim 3, the second modified device of Kim discloses the upper body (see Kim, ‘Modified Fig. 3a’ above, upper body) includes needle through holes (Kim, Fig. 3a through holes 22) formed on the rear ends the needle pipes (Kim, Fig. 3a guider 11), the needle through holes (Kim, Fig. 3a through holes 22) are connected to lattice walls (Kim, Fig. 3a electrode plate 20), and filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) are formed between the lattice walls (Kim, Fig. 3a electrode plate 20) to be filled with the adhesive (Roh, Fig. 4 adhesive 5), the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part) includes a plate-shaped base (Kim, Fig. 3a holder 40) and insertion holders (Kim, Fig. 3a insulating cap) protruding from an outer surface of the base (Kim, Fig. 3a holder 40), the insertion holders (Kim, Fig. 3a insulating cap) are inserted into the filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves), and ends of the insertion holders (Kim, Fig. 3a insulating cap) are supported in contact with the ends of the filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) and the adhesive F (Roh, Fig. 4 adhesive 5) introduced into the injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) is filled in the receiving space (see Kim, ‘Modified Fig. 3a’ above, receiving space) and spaces between the filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) and the insertion holders (Kim, Fig. 3a insulating cap) so as to adhesively fix the upper body (see Kim, ‘Modified Fig. 3a’ above, upper body), the lower body (see Kim, ‘Modified Fig. 3a’ above, lower body), the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part), and the needles (Fig. 3a drug injection needles 60) into an integrated structure at once (see how the recited components come together in Kim, ‘Modified Fig. 3a’ above, to become an integrated structure during a single assembly event for a functional multi-needle module for skin treatment).
Regarding claim 5, the second modified device of Kim discloses the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part) includes a base that is formed in a plate shape (Kim, Fig. 3a holder 40) and that includes a support part (Kim, Fig. 3a channel 50) protruding to form a stepped portion (Kim, see ‘Modified Fig. 3b’ above, stepped portion), and insertion holders (Kim, Fig. 3a insulating cap) protruding from an outer surface of the base (Kim, Fig. 3a holder 40).
Regarding claim 6, the second modified device of Kim discloses the insertion holders (Kim, Fig. 3a insulating cap) include holder support members (see supporting structure and function in Kim, Fig. 3a high frequency needles 30) formed outside the insertion holders (Kim, Fig. 3a insulating cap).
Regarding claim 8, the second modified device of Kim discloses the injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) include first and second injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole), each formed on the rear side (see Kim, ‘Modified Fig. 3a’ above, lower body) of lower body (see Kim, ‘Modified Fig. 3a’ above, lower body) to have a positional deviation.
Regarding claim 9, the second modified device of Kim discloses the lower body (see Kim, ‘Modified Fig. 3b’ above, lower body) includes adhesive injection pipes (see Kim, ‘Modified Fig. 3a’ above, injection pipe) formed therein and including discharge ports (see Kim, ‘Modified Fig. 3b’ above, discharge port) which communicate with the injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) and through which the adhesive F (Roh, Fig. 4 adhesive 5) is moved, the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part) includes grooves (see Kim, Fig. 3a grooves 52) connected to the adhesive injection pipes (see Kim, ‘Modified Fig. 3a’ above, injection pipe) to form pipes (see Kim, ‘Modified Fig. 3a’ above, injection pipe), the upper body (see Kim, ‘Modified Fig. 3a’ above, upper body) includes filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) formed so as to be filled with the adhesive F (Roh, Fig. 4 adhesive 5) discharged into the grooves (see Kim, Fig. 3a grooves 52), and the adhesive F (Roh, Fig. 4 adhesive 5) introduced into the injection holes (see Kim, ‘Modified Fig. 3b’ above, injection hole) is moved to the adhesive injection pipes (see Kim, ‘Modified Fig. 3a’ above, injection pipe) and the grooves (see Kim, Fig. 3a grooves 52) and fills the receiving space 100a (see Kim, ‘Modified Fig. 3a’ above, receiving space) and the filling grooves (see Kim, ‘Modified Fig. 4a’ above, filling grooves) so as to adhesively fix the upper body (see Kim, ‘Modified Fig. 3a’ above, upper body), the lower body (see Kim, ‘Modified Fig. 3a’ above, upper body), the connection part (see Kim, ‘Modified Fig. 3b’ above, connection part), and the needles (Kim, Fig. 3a drug injection needles 60) into an integrated structure at once (see how the recited components come together in Kim, ‘Modified Fig. 3a’ above, to become an integrated structure during a single assembly event for a functional multi-needle module for skin treatment). The limitation “adhesive F injected into the injection holes is filled in the receiving space to adhesively fix the upper body, the lower body, the connection part, and the needles into an integrated structure at once.” is being treated as a as a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, the burden is shifted to the applicant to show an unobvious difference.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101656660 B1) in view of Roh (KR 20150018336 A) and further in view of Bang (KR 2012/0044612 A).
Regarding claim 4, the second modified device of Kim discloses the lower body includes distribution passages (Kim, Fig 3a channel 50) formed on the front side (see Kim, ‘Modified Fig 3a’, front side) communicating with the inlet hole (Kim, Fig. 3a distribution flow path 71), and an injection port (Kim, Fig. 3a drug injection pipe 72) formed on the rear side (see Kim, ‘Modified Fig. 3b’ above, open lower body rear side) communicating with the inlet hole (Kim, Fig. 3a distribution flow path 71), the injection port (Kim, Fig. 3a drug injection pipe 72) includes a passage (Fig 4a channel 50) formed inside, a flange (see Kim, ‘Modified Fig. 3b’ above, flange) formed on an outer peripheral surface (see outer peripheral surface of Kim, ‘Modified Fig. 3b’ above, drug injection port 72), and an upper injection port (see ‘Modified Fig. 3b’ above, upper injection port) and a lower injection port (see Kim, ‘Modified Fig. 3b’ above, lower injection port) based on the flange (see Kim, ‘Modified Fig. 3b’ above, flange), the lower injection port (see Kim, ‘Modified Fig. 3b’ above, lower injection port) has a port coupling hole (see Kim, ‘Modified Fig. 3b’ above, port coupling hole) formed at one end.
The second modified device of Kim does not explicitly mention the upper injection port (see Kim,‘Modified Fig. 3b’ above, upper injection port) includes a rotation prevention part. However, Bang teaches the upper injection port (see Bang,‘Modified Fig. 5’ below, upper injection port) includes a rotation prevention part (Bang, Fig. 5 rotary assembly 300). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of a multi-needle module for skin treatment of Kim with the teachings of using a rotation prevention part on the upper injection port as taught by Bang as the second modified device of Kim discloses “when the stopper 80 is installed on the outer surface of the holder 40, the holder 40 is not moved backward by the hook 12 fastened to the hook 43, and is not moved forward by the stopper 80. That is, in order to prevent the high frequency needle 30 and the drug injection needle 60 from moving forward or backward, the hook 12 is hooked on the hook 43 and the stopper 80 is installed” (Kim, p. 11, [0044], lines 1-6). The second modified device of Kim thereby recognizes the use of external structure features to control the relative positioning and movement of the module during assembly and use. Adding the rotation prevention part (Bang, Fig. 5 rotary assembly 300) on another external surface (see Kim,‘Modified Fig. 3b’ above, upper injection port) to control a different degree of freedom, rotation, in the relative positioning and movement of the module during assembly and use of the multi-needle module is a predictable result. Furthermore, the upper injection port of the second modified device of Kim (see Kim,‘Modified Fig. 3b’ above, upper injection port) and its adjacent flange (see Kim, ‘Modified Fig. 3b’ above, flange) provide an appropriate mounting location for the rotation prevention part, such that incorporating the feature would not interfere with the operation of the multi-needle module and would predictably engage the corresponding structure of an injection device.
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Regarding claim 7, the second modified device of Kim further modified by Bang discloses the rotation prevention part (Bang, Fig. 5 rotary assembly 300) includes, on both sides (see Bang, ‘Modified Fig. 5’ above, first side and second side) thereof, straight parts (see Bang, ‘Modified Fig. 5’ above, straight part) having vertical surfaces (see Bang, ‘Modified Fig. 5’ above, vertical surfaces).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-8591. The examiner can normally be reached Monday through Friday 6:30 AM to 3:00 PM.
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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