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 .
Specification
The disclosure is objected to because of the following informalities: Line 62: .
Appropriate correction is required.
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 1-15 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.
Regarding claim 1, the term “certain length” in claim 1 is a relative term which renders the claim indefinite. The term “certain length” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how the "certain length" of the protective case would be determined. Dependent claims 2-15 are likewise rejected.
Additionally, in Claims 3 and 14, both dependent on Claim 1, the length of the protective case is described as "adjustable", which deviates from the supposed "certain length" and is still not clearly defined.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C.
102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by
Park et al. (KR20200123338A) "Park", via attached translation (Stent Delivery Device (Park)).
Regarding Claim 1, Park discloses a stent delivery device (stent delivery device 10, FIG. 1) comprising: a protective case (body portion 200, FIG. 1) configured to have a certain length (par. [0030]) and have an inner space through which a guide wire passes (guide hole 220, guide wire 30, pars. [0033] and [0047], FIGS. 1, 2, 4);
a mover (handle portion 300, FIG. 1) configured to have an inner surface facing an outer surface of the protective case, be movable along the longitudinal direction of the protective case, and be penetrated at both ends (pars. [0034] and [0036]);
and a sheath connector (connection pipe 120, FIG. 2) configured to be connected to the mover to be linked to the mover, thereby being movable in the inner space of the protective case, through which the guide wire passes, and allow a control wire for contracting and expanding the stent connected to the guide wire to enter and exit (par. [0034], FIG. 2).
Regarding Claim 2, Park discloses the stent delivery device of claim 1, further comprising: a first cap (shaft fixing member 550, FIG. 2) configured to be detachably coupled to a trailing end of the protective case, allow the guide wire and the control wire to pass through and enter and exit, and at the same time prevent the mover from being separated from the trailing end of the protective case (par. [0043], FIG. 2);
and a second cap (head portion 600, FIG. 1) configured to be detachably coupled to a leading end of the protective case (par. [0030], FIG. 1).
Regarding Claim 4, the stent delivery device of claim 1, wherein the protective case further comprises: a housing (housing 100, FIG. 1) configured to be penetrated through both ends (par [0029], FIG. 1);
an inspection slot (first and second holes 111 and 112, FIG. 2) configured to be cut into the outer surface of the housing along the longitudinal direction of the housing (par. [0029], FIG. 2);
a first coupling step (at space 540, FIG. 2) configured to be formed stepwise at the trailing end of the housing (par. [0042], FIG. 2);
and a second coupling step (where force is applied at pressing grooves 350 and 360, FIGS. 1 and 2) configured to be formed stepwise at the leading end of the housing, wherein the guide wire can enter and exit through the first coupling step and the housing (par. [0053], FIGS. 1 and 2).
Regarding Claim 5, the stent delivery device of claim 1, further comprising: a first cap (head portion 600 may also serve as first cap) configured to be detachably coupled to one end of the protective case, allow the guide wire and the control wire to pass through and enter and exit, and at the same time prevent the mover from being separated from one end of the protective case (par. [0030], FIG. 1);
and a stopper (stopper 210, FIG. 1) configured to contact a front end of the first cap, contacting or spaced apart from the front end of the mover with respect to the trailing end of the fixed mover, and be detachable from the outer surface of the protective case (par. [0030], FIG. 1).
Regarding Claim 14, the stent delivery device of claim 4, wherein the housing further comprises a plurality of units (connector 120 and house advancing member 110, FIG. 2) configured to detachably coupled between the trailing end of the housing where the first coupling step (space 540, FIG. 2) is formed and the leading end of the housing where the second coupling step (where force is applied at pressing grooves 350 and 360, FIGS. 1 and 2) is formed and be arranged in a line between the first coupling step and the second coupling step (pars. [0008] and [0029], FIG. 2),
wherein both ends of each of the plurality of units are detachable from each other, and wherein the overall length of the protective case is adjustable by adding or subtracting the number of the plurality of units (par. [0029], FIG. 2).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR20200123338A) "Park" in view of Kim et al. (KR20220167974A) "Kim", via attached translations (Stent Delivery Device (Park)) and (Catheter for securing intravascular passage and Method for manufacturing the catheter (Kim)).
Regarding Claim 3, Park does not disclose a protective case that is adjustable in length. However, Kim discloses a stent delivery catheter (par. [0029]), wherein the protective case (case 11, par. [0024], FIG. 1) is adjustable in length (par. [0006]). 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 structure disclosed by Park to include a protective case with an adjustable length in order to provide better operational precision for the overall catheter structure (Kim, par. [0006]).
Claim(s) 7-9, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR20200123338A) "Park" in view of Inoue (US20070005122A1) "Inoue" via attached translation (Stent Delivery Device (Park)).
Regarding Claim 7, Park discloses the stent delivery device of claim 5, wherein the stopper (stopper 210) comprises a main body (stopper 210 and more specifically stopper 212) configured to be in contact with a surface of a front end of the mover (See Fig. 1 and Annotated Fig. 5, below), but does not disclose: and engaging cutout and a handle. However, Inoue discloses:
an engaging cutout (recessed par of main body 61 is cutout, FIG. 7) configured to be formed by incision from one edge of the main body (main body 61, FIG. 7) toward the other edge of the main body (main body 61 and 72, FIGS. 7 and 8) and have an inner edge facing the outer surface of the protective case (FIGS. 7 and 8, pars. [0051] and [0055]);
and a handle (flaps 73, par. [0055]) configured to protrude from the other edge of the main body and be provided to be graspable (FIG. 8, par. [0055]). 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 structure disclosed by Park to include an engaging cutout and handle in order to be more secured to the protective case and in some cases promote the expulsion of bile in the stenotic area when a stenosis develops in a bile duct (pars. [0004], [0051] and [0055]).
Regarding Claim 8, Park does not disclose recessed sides of the engaging cutout and sides that are coupled and seated in the engaging grooves on the outer edges of the inspection slot. However, Inoue discloses:
a stent delivery catheter (Abstract), wherein each of opposite sides of the inner edge of the engaging cutout is recessed on the outer surface of the protective case and is coupled and seated in engaging grooves (grooves 86 and 95, FIG. 8) disposed on the outer edges of both sides of the inspection slot (slits 90, FIGS. 7 and 8, par. [0055]). 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 structure disclosed by Park to include recessed sides of the engaging cutout and sides that are coupled and seated in the engaging grooves on the outer edges of the inspection slot in order to removably hold the stent, allowing greater control of the stent (Inoue, par. [0057]).
Regarding Claim 9, Park does not disclose a stopper comprising a reinforcing rib and a hook configured to protrude. However, Inoue discloses:
the stent delivery device catheter (Abstract), wherein the stopper (pushing member 24, FIG. 8) further comprises: a reinforcing rib (rib 85, FIG. 8) configured to protrude along the edge of the main body (main body 72, FIG. 8, par. [0057]);
and a hook (flaps 73, FIG. 8) configured to protrude from both sides of the entrance of the inner edge of the engaging cutout to face each other, be recessed on the outer surface of the protective case and be engaged and fixed in engaging grooves disposed on the outer edges of both sides of the inspection slot (FIGS. 7 and 8, par. [0055]). 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 structure disclosed by Park to include a reinforcing rib and a hook configured to protrude in order to maintain the central strength of the stent and to protect and secure the stent (Inoue, pars. [0004], [0057] and [0061]).
Regarding Claim 12, Park discloses the stent delivery device of claim 1, wherein the sheath connector (connection pipe 120) comprises: a main tube (first tube 400, FIG. 4) configured to be movable along the inner space of the protective case and have both ends through which the guide wire passes for entry and exit (FIG. 4. par. [0047]), but does not disclose a flushing port configured to protrude and be exposed through a tube through-hole. However, Inoue discloses:
and a flushing port (conduit 9, FIG. 5) configured to protrude inclinedly from an outer circumferential surface of the main tube (main tube 61, part of conduit system with protruding flaps 63 and 64, FIG. 7), be exposed through a tube through-hole (main body contains tube through-hole as well as lateral hole 62, FIG. 7, par. [0051]) by passing through the outer surface of the mover and communicate with the inner space of the main tube to enable entry and exit of the control wire, wherein the flushing port is exposed through an inspection slot cut into the outer surface of the protective case along the length direction of the protective case (FIGS. 7 and 8, par. [0051]). 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 structure disclosed by Park to include a flushing port configured to protrude and be exposed through a tube through-hole in order to provide an organized path for the stent and to ensure the stent remains secure (Inoue, par. [0004]).
Regarding Claim 13, Park further discloses: the stent delivery device of claim 12, wherein the sheath connector further comprises: an O-ring (fixing part 311, FIG. 3) configured to be embedded in the main tube and through which the guide wire passes (FIG. 3, par. [0035]);
and an O-ring cover (first tube fixing member 310, FIG. 3) configured to be embedded in the main tube, through which the guide wire passes, and disposed between the O-ring and the leading end of the main tube (FIG. 3, par. [0035]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the structure disclosed by the first embodiment of Park to include an O-ring and an O-ring cover embedded in the main tube in order to surround and fix the main tube within the mover (handle portion 300) (par. [0035]).
Claim(s) 10, 11, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR20200123338A) "Park", via attached translation (Stent Delivery Device (Park)).
Regarding Claim 10, the first embodiment of Park discloses the stent delivery device (stent delivery device 10) of claim 1, wherein the mover (handle portion 300) comprises a first divided part (portion of connection pipe 120 inserted within handle portion 300, FIGS. 1 and 2) configured to occupy one-half of an inner surface facing the outer surface of the protective case (FIGS. 1 and 2, par. [0034]);
a second divided part (section of body portion 200 inserted within handle portion 300, FIGS. 1 and 2) configured to occupy the other half of the inner surface facing the outer surface of the protective case so as to have an inner surface facing the outer surface of the protective case by being coupled with the first divided part (FIGS. 1 and 2, par. [0034]), but does not disclose a tip protruding slope portion and a sheath connector that is movable along the protective case. However, another embodiment of Park discloses:
and a tip protruding slope portion (See Annotated Fig. 5, below) configured to be formed along the edge of the leading end of each of the first divided part and the second divided part so that separation from the protective case is prevented by a second cap detachably coupled to the leading end of the protective case (See Annotated Fig. 5, pars. [0031] and [0034]),
wherein the sheath connector is movable along the protective case together with the first divided part and the second divided part while being in communication with each other through a coupling part of the first divided part and the second divided part (See Annotated Fig. 5, FIGS. 1 and 2, par [0034]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the structure disclosed by the first embodiment of Park to include a tip protruding slope portion and a sheath connector that is movable along the protective case in order to secure the stent structures and provide the most useful positioning for the mover (handle position 300, par. [0034]).
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Regarding Claim 11, the first embodiment of Park does not disclose a mover with a cut through-hole. However, another embodiment of Park discloses: the stent delivery device (stent delivery device 10) of claim 10, wherein the mover (handle portion 300) further comprises a tube through-hole (first tube 400, FIGS. 3 and 4) which is cut at the coupling part of the first divided part and the second divided part to communicate with a flushing port of the sheath connector (FIGS. 3 and 4, par. [0047]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the structure disclosed by the first embodiment of Park to include a mover with a tube through-hole cut at the coupling part of the first divided part and the second divided part to communicate with a flushing port of the sheath connector in order to initiate a secure process of installing the stent (par. [0047]).
Regarding Claim 15, the first embodiment of Park does not disclose a second engaging flange that protrudes. However, another embodiment of Park discloses the stent delivery device of claim 2, further comprising a second engaging flange (end of stopper 212 facing head portion 600, FIG. 2) configured to protrude along the edge of the trailing end of the second cap (head portion 600, FIG. 2) to prevent the leading end of the mover from escaping from the protective case (FIG. 2, pars. [0031] and [0044]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the structure disclosed by the first embodiment of Park to include a second engaging flange configured to protrude along the edge of the trailing end of the second cap in order to fix the second cap (head portion 600) to the structure, which thus helps secure the stent (par. [0044]).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR20200123338A) "Park" in view of Kim et al. (KR20220167974A) "Kim" in further view of Inoue (US20070005122A1) "Inoue", via attached translations (Stent Delivery Device (Park)) and (Catheter for securing intravascular passage and Method for manufacturing the catheter (Kim)).
Regarding Claim 6, Park discloses a stent delivery device (stent delivery device 10) further comprising: inspection slot (guide hole 220, FIG. 2) configured to be cut into an outer surface of the protective case along the longitudinal direction of the protective case (FIG. 2, par. [0033]), but does not disclose a first engaging flange protruding along the first cap and recessed grooves. However, Kim discloses:
a stent delivery catheter (par. [0029]), further comprising: a first engaging flange (connector body 15, FIG. 1) protruding along the edge of the front end of the first cap (sealing cap 19, FIG. 1) to prevent the trailing end of the mover (operation dial 12, FIG. 1) from being separated from the protective case (case 11, par. [0024], FIG. 1), but does not disclose recessed grooves on the outer surface of the protective case. However, Inoue discloses:
recessed grooves (grooves 86 and 95, FIG. 8) configured to be formed on the outer surface of the protective case (protective case 70, FIG. 8) to be disposed on the outer edges of both sides of the inspection slot (slits 90, FIG. 8), and in which the stopper (pushing member 24, FIG. 8) is coupled and seated (FIG. 8, par. [0060]- [0061]). 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 structure disclosed by Park to include a first engaging flange protruding along the edge of the front end of the first cap and recessed grooves configured to be formed on the outer surface of the protective case in order to provide a guide passage for the catheter and prevent liquid from falling back into the catheter (Kim, pars. [0028]- [0029]), and to removably hold the stent, allowing greater control of the stent (Inoue, par. [0057]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700