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 .
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu et al. (US KR 20200018886 A, English translation is being used for referring to the specification).
Regarding claim 1, Ryu teaches a procedure tool module (figure 1) for a vascular intervention procedure device, wherein the procedure tool module (figure 1) is coupled to a platform 43, which transfers at least one of a catheter 25, a guide wire 25a, a micro catheter, and a micro guide wire used for a vascular intervention procedure in a front and rear direction (page 9, lines 16-30) and generates rotation power (page 9, line 33-page 10, line 6) for rotating the at least one of the catheter, the guide wire, the micro catheter, and the micro guide wire about a rotation axis (axis along which element 23 rotates) of the front and rear direction,
wherein the procedure tool module (figure 1) supports a procedure tool 25, 25a which is one of the catheter 25, the guide wire 25a, the micro catheter, and the micro guide wire,
wherein the procedure tool module (figure 1) comprises:
a module housing (housing of elements 10 and 20 combined) configured to be separably coupled to the platform (element 10 could be separated from element 43 in the same manner element 10 is connected to element 43); and
a driven gear 23 disposed in the module housing to be rotatable about the rotation axis (axis along which element 23 rotates), coupled to the procedure tool, and configured to be driven by the rotation power from the platform in a state where the module housing is coupled to the platform and to rotate the procedure tool about the rotation axis (page 9, line 33-page 10, line 6), and
wherein a portion of the procedure tool (page 5) is disposed so as to extend frontward from a central portion (central portion of element 23) of the driven gear.
Regarding claim 2, Ryu teaches wherein the module housing (housing formed by elements 10 and 20 combined) includes an accommodating portion 12 (hollow portion inside element 10) configured to accommodate the driven gear 23 and a portion of the procedure tool 25, 25a,
wherein the accommodating portion 12 has an opening portion (see “OP” in figure 2 below) formed in a radially outward direction (direction towards outward from element 25a) of the rotation axis, and a front slit (see “FS” in figure 2 below) communicating with the opening portion (see “OP” in figure 2 below) and formed to extend from the opening portion up to a front end (end where “FS” in figure 2 below is present) of the module housing (housing formed by elements 10 and 20 combined), and
wherein the driven gear 23 and the procedure tool 25a, 25 are configured to be separable (page 4, lines 28-30) from the accommodating portion 12 through the opening portion and the front slit (see “FS” in figure 2 below) in the radially outward direction (element 20 could be inserted into element 12 or moved out from element 12 from element “OP” in figure 2 below when element 20 is not engaging element 11 even if the movement is little to separate element 20 from element 10).
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Regarding claim 3, Ryu teaches wherein the module housing (housing formed by elements 10 and 20 combined) includes a housing cover 21 configured to be separably coupled (see figure 2) to the accommodating portion 12 so as to open and close the opening portion (see “OP” in figure 2 above) of the accommodating portion, and
wherein the driven gear 23 and the procedure tool 25, 25a are configured to be separable from the accommodating portion 12 in the radially outward direction (if element 21 is inserted from “OP” without engaging element 11 then element 21 would also move out from “OP” thereby removing elements 23 and 25, 25a) in a state where the housing cover 21 is removed from the accommodating portion.
Regarding claim 16, Ryu teaches wherein the procedure tool is the catheter 25 and wherein the procedure tool module further comprises a front guide module 44 disposed in a front guide section (section between element “FF” in figure 1 below and element “F” in figure 1 below) between a front end (see “F” in figure 1 below, examiner construes element “F” as being part of element 43) of the platform and a front end of the module housing (housing of elements 10 and 20 combined) and configured to guide and support transfer of the procedure tool 25 in the front and rear direction.
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Regarding claim 19, Ryu teaches a vascular intervention procedure device (figure 1) comprising: a platform 43 for transferring at least one of a catheter 25, a guide wire 25a, a micro catheter, and a micro guide wire, which are used for a vascular intervention procedure device, in a front and rear direction (page 9, lines 16-30), and generating rotation power (page 9, line 33-page 10, line 6) for rotating the at least one of the catheter 25, the guide wire 25a, the micro catheter and the micro guide wire about a rotation axis (axis along which element 23 rotates) of the front and rear direction; and
a procedure tool module 10, 20 coupled to a platform 43 and supporting a procedure tool which is one of a catheter 25, a guide wire 25a, a micro catheter, and a micro guide wire,
wherein the procedure tool module (figure 1) comprises:
a module housing (housing of elements 10 and 20 combined) configured to be separably coupled to the platform (element 10 could be separated from element 43 in the same manner element 10 is connected to element 43); and
a driven gear 23 disposed in the module housing to be rotatable about the rotation axis (axis along which element 23 rotates), coupled to the procedure tool, and configured to be driven by the rotation power from the platform in a state where the module housing is coupled to the platform and to rotate the procedure tool about the rotation axis (page 9, line 33-page 10, line 6), and
wherein a portion of the procedure tool (page 5) is disposed so as to extend frontward from a central portion (central portion of element 23) of the driven gear.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (US KR 20200018886 A) in view of Falb et al. (US 2016/0271368 A1).
Regarding claim 4, Ryu discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Ryu further discloses wherein the procedure tool 25, 25a is the catheter 25 or the micro catheter, wherein the driven gear 23, the procedure tool 25, and another procedure tool 25a inserted into the procedure tool 25 are configured to be separable from the accommodating portion 12 through the opening portion (see “OP” in figure 2 above), the front slit (see “FS” in figure 2 above) in the radially outward direction.
Ryu is silent regarding wherein the module housing has a rear slit formed to extend from the opening portion up to a rear end and wherein the driven gear, the procedure tool and another procedure tool are configured to be separable from the accommodating portion through the rear slit in the radially outward direction.
However, Falb teaches a design of a robotic catheter system (figure 1) wherein the module housing 244 (figure 4) has a rear slit (see “RS” in figure 2 below) formed to extend from the opening portion (see “O” in figure 2 below) up to a rear end and (end where element “RS” in figure 2 below is present) wherein the driven gear 241, the procedure tool 228 are configured to be separable from the accommodating portion (portion in element 244 that accommodates elements 228, 241 and 233) through the rear slit in the radially outward direction (upward direction) for the purpose of using an alternative well-known configuration for separably connecting the gear and the procedure tool into the housing (figure 2, paragraph 0054).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection mechanism of the driven gear and the procedure tool (including another procedure tool) of Ryu to incorporate wherein the module housing has a rear slit formed to extend from the opening portion up to a rear end and wherein the driven gear, the procedure tool and another procedure tool are configured to be separable from the accommodating portion through the rear slit in the radially outward direction as taught by Falb for the purpose of using an alternative well-known configuration for separably connecting the gear and the procedure tool into the housing (figure 2, paragraph 0054).
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Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (US KR 20200018886 A) in view of Wenderow et al. (US 2010/0069833 A1).
Regarding claim 5, Ryu discloses the claimed invention substantially as claimed as set forth above in claim 1. Ryu is silent regarding the module housing includes a coupling portion configured to be separably fitted to the platform.
However, Wenderow teaches a design of a catheter system (figure 2A) wherein the module housing 42, 44 includes a coupling portion 46 configured to be separably fitted to the platform 22 for the purpose of allowing to separate the component when needed for any purpose including sterility (paragraph 0049, lines 9-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the module housing of Ryu to incorporate the module housing includes a coupling portion configured to be separably fitted to the platform as taught by Wenderow for the purpose of allowing to separate the component when needed for any purpose including sterility (paragraph 0049, lines 9-11).
Regarding claim 6, Ryu discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Ryu is silent regarding wherein the coupling portion is formed in a transverse direction orthogonal to the front and rear direction and is configured to be fitted to the platform in the transverse direction.
However, Wenderow teaches wherein the coupling portion 46 is formed in a transverse direction (element 46 extends in transverse direction orthogonal to longitudinal axis of the element 164) orthogonal to the front and rear direction and is configured to be fitted to the platform in the transverse direction (see figure 3A) for the purpose of allowing to separate the component when needed for any purpose including sterility (paragraph 0049, lines 9-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the module housing of Ryu to incorporate wherein the coupling portion is formed in a transverse direction orthogonal to the front and rear direction and is configured to be fitted to the platform in the transverse direction as taught by Wenderow for the purpose of allowing to separate the component when needed for any purpose including sterility (paragraph 0049, lines 9-11).
Claims 7, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (US KR 20200018886 A) in view of Weitzner et al. (US 2007/0060879 A1).
Regarding claim 7, Ryu discloses the claimed invention substantially as claimed, as set forth above in claim 1. Ryu discloses further comprising a guide module disposed in a guide section, which is a section extending frontward from the module housing or a section extending rearward from the module housing, and configured to guide and support transfer of a guided procedure tool, which is one among the catheter, the guide wire, the micro catheter, and the micro guide wire, in the front and rear direction.
However, Weitzner teaches a design of a coaxial catheter system (figure 3) comprising a guide module 60 disposed in a guide section (section of the system shown in figure 3 where element 3 is present), which is a section extending frontward from the module housing 50 or a section extending rearward from the module housing 50, and configured to guide and support transfer of a guided procedure tool 30, which is one among the catheter, the guide wire, the micro catheter, and the micro guide wire, in the front and rear direction for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the procedure tool module of Ryu to incorporate a guide module disposed in a guide section, which is a section extending frontward from the module housing or a section extending rearward from the module housing, and configured to guide and support transfer of a guided procedure tool, which is one among the catheter, the guide wire, the micro catheter, and the micro guide wire, in the front and rear direction as taught by Weitzner for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Regarding claim 17, Ryu discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 16. Ryu is silent regarding further comprising a rear guide module disposed in a rear guide section between a rear end of the module housing and a front end of another procedure tool module and configured to guide and support transfer of the another procedure tool which is inserted into the procedure tool, in the front and rear direction.
However, Weitzner teaches further comprising a rear guide module (module formed by components inside element 60) disposed in a rear guide section (section formed between end of element 60 furthest away from element 50 and end of element 50 closest to element 52 in figure 3) between a rear end (end of element 60 furthest away from element 50) of the module housing (housing of element 60) and a front end (end of element 50 closest to element 52) of another procedure tool module 50 and configured to guide and support transfer of the another procedure tool 20A which is inserted into the procedure tool 30A, in the front and rear direction for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the procedure tool module of Ryu to incorporate further comprising a rear guide module disposed in a rear guide section between a rear end of the module housing and a front end of another procedure tool module and configured to guide and support transfer of the another procedure tool which is inserted into the procedure tool, in the front and rear direction as taught by Weitzner for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Regarding claim 18, Ryu discloses the claimed invention substantially as claimed, as set forth above in claim 1. Ryu further discloses wherein the procedure tool is a catheter 25 or the micro catheter, but is silent regarding wherein the procedure tool module further comprises a rear guide module disposed in a rear guide section between a rear end of the module housing and a front end of another procedure tool module and configured to guide and support transfer of the another procedure tool which is inserted into the procedure tool, in the front and rear direction.
However, Weitzner teaches further comprising a rear guide module (module formed by components inside element 60) disposed in a rear guide section (section formed between end of element 60 furthest away from element 50 and end of element 50 closest to element 52 in figure 3) between a rear end (end of element 60 furthest away from element 50) of the module housing (housing of element 60) and a front end (end of element 50 closest to element 52) of another procedure tool module 50 and configured to guide and support transfer of the another procedure tool 20A which is inserted into the procedure tool 30A, in the front and rear direction for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the procedure tool module of Ryu to incorporate further comprising a rear guide module disposed in a rear guide section between a rear end of the module housing and a front end of another procedure tool module and configured to guide and support transfer of the another procedure tool which is inserted into the procedure tool, in the front and rear direction as taught by Weitzner for the purpose of individually controlling the catheters of plurality of coaxial catheter when using the coaxial catheters as needed in the medical procedure (paragraph 0044).
Allowable Subject Matter
Claims 8-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Ryu et al. (US KR 20200018886 A) in view of Weitzner et al. (US 2007/0060879 A1) discloses wherein the guide module includes a guide housing disposed at a front end or a rear end of the guide section, supporting members configured to be drawn into or drawn out from the guide housing so as to have a variable length in the guide section but is silent regarding a pair of supporting members configured to sandwich the guided procedure tool by being engaged with each other in combination with other claimed limitations of claim 8.
Claims 9-15 being dependent on claim 8 are also indicated allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Parihar et al. (US 2014/0276722 A1): teaches a design of a device to control the forward, reverse and rotational movement of the medical device using gears.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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