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 .
Drawings
The drawings are objected to for the following reasons:
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "230" and "232" have both been used to designate “the wire”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” has been used to designate both “the clip introduction device” (Fig. 1) and “the clip device” (Fig. 3).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “240b” has been used to designate both “the second part” and “the modification” (see Figs. 14,15).
The drawings are objected to because Fig. 16 has two arrows showing a section that is magnified on “Fig. 16”; however, the Examiner believes that the arrows should be labeled as “Fig. 17”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200f” has been used to designate both “the modification” and the distal end of the “handle body” (see Figs. 27 and 29).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 4, 8, 15, 16, 17, and 19 are objected to because of the following informalities:
Claim 4 recites “an inner diameter” in line 4, although the line is understood by the Examiner to mean “the inner diameter” as the “inner diameter” was previously defined, the Examiner suggests the line be amended to read “the inner diameter” for the purpose of maintaining consistent language throughout the claims;
Claim 8 recites “accomodate” and “stete” which appear to be a typographical errors, therefore the Examiner suggests the lines be amended to read “accommodate” and “state”;
Claim 15 recites “wherein, in which”, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read “wherein, in a state in which”;
Claim 16 recites “a friction between the stopper and a friction the first part and between the stopper and …”, although the line does not rise to the level of being indefinite as the line is understood by the Examiner, based on Applicant’s disclosure, to mean “a friction between the stopper and the first part and a friction between the stopper and…”, the Examiner suggests the line be amended to read “a friction between the stopper and the first part and a friction between the stopper and…” for the purpose of maintaining consistent language throughout the claims;
Claim 17 recites “harderness” which is not grammatically correct, therefore the Examiner suggests the line be amended to read “hardness;
Claim 19 recites “a longitudinal direction” in line 9, although the line is understood by the Examiner to mean “the longitudinal direction” as the “longitudinal direction” was previously defined, the Examiner suggests the line be amended to read “the longitudinal direction” for the purpose of maintaining consistent language throughout the claims;
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 14, 15, 17 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 14, the phrase "friction between the second part and the handle" renders the claim indefinite because “the second part” is a part of handle and it is unclear if Applicant is intending the friction to be between the second part and some other portion of the handle (i.e., the first part) or if Applicant is intending for the friction to be generated between the second part and the stopper.
Regarding claim 17, the phrase "a middle layer….has a hardness than the inner layer and the outer layer" renders the claim indefinite because it is unclear if Applicant is intending for the hardness to have a hardness greater than, less than, or equal to the hardness of the inner layer and the outer layer. For the purpose of examination, the Examiner will read the claim to mean “less than”, wherein the middle layer has a hardness less than both the inner and outer layer”.
Claim 15 is rejected for being dependent on an indefinite claim.
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, 2, 4 – 12 and 19 – 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaneko et al (US 2009/0112225 A1).
Regarding claims 1 and 2, Kaneko discloses a medical device (endoscopic instrument 10) (abstract, paragraphs [0026 – 0027], and Figs. 1 – 7) comprising:
a sheath (sheath 11) extending in a longitudinal direction (paragraph [0027 – 0029] and Fig. 7);
a treatment portion (incision wire 12) disposed at a distal end of the sheath (sheath 11) (paragraph [0030] and Figs. 1 and 7);
a wire (wire 13) inserted into the sheath (sheath 11) and to which the treatment portion is fixed (paragraphs [0026 – 0038] and Fig. 7);
a handle (maneuvering section 14) disposed at a proximal end of the sheath (sheath 11) and to which the wire is fixed (fixed via rod 24) (paragraphs [0027], [0031], [0038], and Fig. 7); and
a transmission member (endoscope insertion section 1a) disposed on an outer periphery of the sheath (sheath 11) and extending from the handle to the distal end (Fig. 1), [claim 2] transmission member (endoscope insertion section 1a) is formed in a cylindrical shape through which the sheath is inserted (Fig. 1),
wherein the treatment portion (wire 12), the wire (wire 13), the handle (maneuvering section 14), and the transmission member (endoscope insertion section 1a) are rotatable in a circumferential direction with respect to the longitudinal direction relative to the sheath (sheath 11) (Examiner’s note: as stated in paragraphs [0036 – 0038] and shown in Fig. 7 the wire 13 (i.e., the wire) and the rotative operative section 23, which is a part of the maneuvering section 14 (i.e., the handle) are rotatable relative to the sheath 11, as the sheath 11 is fixed to the casing 22. Additionally, the instrument 10, which includes the sheath 11, is rotatable relative to the endoscope 1 (i.e., the transmission member) when the instrument 10 is not inserted into the endoscope 1 (i.e., the transmission member). Therefore, Kaneko discloses the limitations as claimed).
Regarding claim 4, Kaneko discloses wherein an outer diameter of the handle (maneuvering section 14) is larger than an inner diameter of an endoscope channel through which the treatment portion (wire 12) can be inserted, and an outer diameter of the transmission member (endoscope insertion section 1a) is smaller than an inner diameter of the endoscope channel (Examiner’s note: it should be understood that endoscopes come in a wide variety of sizes, and the above limitation is an intended use which only requires the structure to be capable of being inserted into an endoscope channel, wherein the endoscope has an inner diameter as claimed; with that said, the outer diameter of the maneuvering section 14 is larger than a smaller inner diameter endoscope channel through which the transmission member can be inserted. Additionally, it should be understood that the transmission member (i.e., endoscope insertion section 1a) can be placed within a larger endoscope, wherein the transmission member (i.e., the endoscope insertion section 1a) has an outer diameter smaller than the inner diameter of the endoscope).
Regarding claim 5, Kaneko discloses wherein a length of the transmission member (endoscope insertion section 1a) is longer than a length of the handle (maneuvering section 14) in the longitudinal direction (Fig. 1).
Regarding claim 6, Kaneko discloses wherein a length of the transmission member (endoscope insertion section 1a) is shorter than a length of the sheath (sheath 11) in the longitudinal direction (Fig. 1).
Regarding claim 7, Kaneko discloses wherein a length from a distal end of the treatment portion to a distal end of the transmission member in the longitudinal direction is shorter than a length of an endoscope channel through which the treatment portion can be inserted (Examiner’s note: the length between a distal end of the endoscope insertion section 1a (i.e., the transmission member) to the distal end of the wire 12 (i.e., the treatment portion) is shown in Fig. 1. And it should be understood that the endoscope is not positively recited, and that the endoscope insertion section 1a (i.e., the transmission section) is capable of being inserted into a larger endoscope that has a channel with a length larger than the length between the two distal ends. Therefore, Kaneko discloses the device as claimed).
Regarding claim 8, Kaneko discloses wherein the distal end of the transmission member is accommodated in the endoscope channel in a state in which the treatment portion is inserted into the endoscope channel and protruding from a distal end of the endoscope channel (Examiner’s note: the preceding limitation is an intended use limitation as the endoscope channel is only functionally recited; with that said, the transmission member (i.e., endoscope insertion section 1a) is capable of being inserted into a larger endoscope channel such that the transmission member (i.e., the endoscope channel 1a) is within the larger endoscope channel and protruding from the distal end thereof when the treatment portion is inserted therein).
Regarding claim 9, Kaneko discloses wherein a length from a distal end of the transmission member to a forceps port of an endoscope channel is 30 cm or less in a state in which the treatment portion is inserted into the endoscope channel and protruding from a distal end of the endoscope channel (Examiner’s note: the preceding limitation is an intended use limitation as the endoscope channel is only functionally recited; with that said, the transmission member (i.e., endoscope insertion section 1a) is capable of being inserted into a larger endoscope, the length between a distal end of the transmission member (i.e., the endoscope 1a) to a forceps port of said endoscope channel can be between 30cm or less if the transmission member (i.e., the endoscope 1a) is inserted therein to have that length).
Regarding claim 10, Kaneko discloses wherein the handle includes a first part (sliding-operation section 21) connected to the transmission member (endoscope insertion section 1a) and rotatable in conjunction with the transmission member (endoscope insertion section 1a) (Examiner’s note: as shown in Fig. 1, the endoscope insertion section 1a is indirectly connected to the sliding-operation section 21 (i.e., the first part) when the device 10 is inserted; additionally, the sliding-operation section 21 and the endoscope insertion section 1a (i.e., the transmission member) are rotatable together because the entire system is rotatable as a single unit; and the claims do not require wherein the rotation of one causes the rotation of the other), and a second part (rotative operation section 20) connected to be rotatable relative to the first part (sliding-operation section 21) (Examiner’s note: the rotating member 23 of the rotative operation section 20 (i.e., the second part) is rotatable relative to the sliding operation section 21 (i.e., the first part)).
Regarding claim 11, Kaneko discloses wherein the handle includes a handle body (maneuvering section 14), and a slider (slider 26) supported by the handle body (maneuvering section 14) and movable in the longitudinal direction, wherein the slider (slider 26) is disposed in the first part (sliding operation section 21) (Fig. 7).
Regarding claim 10, (alternate interpretation – changes italicized below) Kaneko discloses wherein the handle includes a first part (rotative operation section 20) connected to the transmission member (endoscope insertion section 1a) and rotatable in conjunction with the transmission member (endoscope insertion section 1a) (Examiner’s note: as shown in Fig. 1, the endoscope insertion section 1a is indirectly connected to the rotative operation section 20 (i.e., the first part) when the device 10 is inserted; additionally, the rotative operation section 20 and the endoscope insertion section 1a (i.e., the transmission member) are rotatable together because the entire system is rotatable as a single unit; and the claims do not require wherein the rotation of one causes the rotation of the other), and a second part (sliding-operation section 21) connected to be rotatable relative to the first part (rotative operation section 20) (Examiner’s note: the rotating member 23 of the rotative operation section 20 (i.e., the first part) is rotatable relative to the sliding operation section 21 (i.e., the second part)).
Regarding claim 12, (alternate interpretation) Kaneko discloses wherein the handle includes a handle body (maneuvering section 14), a slider (slider 26) supported by the handle body (maneuvering section 14) and movable in the longitudinal direction, wherein the slider (slider 26) is disposed in the second part (sliding-operation section 21).
Regarding claim 19, Kaneko discloses a medical device (endoscopic instrument 10) (abstract, paragraphs [0026 – 0027], and Figs. 1 – 7) comprising:
a sheath (sheath 11) extending in a longitudinal direction (paragraph [0027 – 0029] and Fig. 7);
a treatment portion (incision wire 12) disposed at a distal end of the sheath (sheath 11) (paragraph [0030] and Figs. 1 and 7);
a wire (wire 13) inserted into the sheath (sheath 11) and to which the treatment portion is fixed (paragraphs [0026 – 0038] and Fig. 7);
a handle (maneuvering section 14) disposed at a proximal end of the sheath (sheath 11) and to which the wire is fixed (fixed via rod 24) (paragraphs [0027], [0031], [0038], and Fig. 7); and
the treatment portion (incision wire 12), the wire (wire 13), the handle (maneuvering section 14), and the sheath (sheath 11) are rotatable in a circumferential direction relative to a longitudinal direction in conjunction with each other (Examiner’s note: the entire device can be rotated such that all of the parts above are rotated in conjunction with each other).
Regarding claim 20, Kaneko discloses comprising a grip (endoscope 1) connected to the sheath (sheath 11) (Fig. 1), wherein the grip is slidable on the sheath (sheath 11) and has an outer diameter larger than an outer diameter of the sheath (paragraph [0027] and Fig. 1).
Claims 1, 2, 4, 10 – 14, and 19 – 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al (US 2007/0112359 A1).
Regarding claims 1 and 2, Kimura discloses a medical device (clip introduction device 10) (abstract, paragraphs [0044 – 0046], and Figs. 1 – 3, 20 – 25) comprising:
a sheath (introduction tube 20) extending in a longitudinal direction (paragraph [0046] and Fig. 1);
a treatment portion (hook portion 31 and hook a clip unit 60) disposed at a distal end of the sheath (introduction tube 20) (paragraph [0054] and Figs. 21 - 25);
a wire (wire 32) inserted into the sheath (sheath 11) and to which the treatment portion is fixed (paragraph [0055] and Figs. 1 – 3, 20 – 25);
a handle (operating portion 40) disposed at a proximal end of the sheath (introduction tube 20) and to which the wire is fixed (paragraphs [0065 – 0067], and Fig. 2); and
a transmission member (endoscope insertion forceps channel 95a) disposed on an outer periphery of the sheath (introduction tube 20) and extending from the handle to the distal end (paragraph [0141] and Figs. 21-25) (Examiner’s note: the endoscope insertion forceps channel 95a (i.e., the transmission member) will extends from the handle, when the clip introduction device is inserted into the endoscope 95), [claim 2] transmission member (endoscope insertion forceps channel 95a) is formed in a cylindrical shape through which the sheath is inserted (Figs. 21, 22),
wherein the treatment portion (hook portion 31 and hook a clip unit 60), the wire (wire 32), the handle (operating portion 40), and the transmission member (endoscope insertion forceps channel 95a) are rotatable in a circumferential direction with respect to the longitudinal direction relative to the sheath (introduction tube 20) (Examiner’s note: as stated in paragraph [0167] hook portion 31 and hook a clip unit 60 are rotated via the operating portion 40 / rotation grip 41b and the wire 32 relative to the introduction tube 20 (i.e., the sheath). Additionally, endoscope forceps channel 95a (i.e., the transmission member) is rotatable relative to the introduction tube 20 (i.e., the sheath) at least when the two components are separated from each other. Therefore, Kaneko discloses the limitations as claimed).
Regarding claim 4, Kimura discloses wherein an outer diameter of the handle (operating portion 40) is larger than an inner diameter of an endoscope channel through which the treatment portion can be inserted (hook portion 31 and hook a clip unit 60), and an outer diameter of the transmission member (endoscope insertion forceps channel 95a) is smaller than an inner diameter of the endoscope channel (Examiner’s note: it should be understood that endoscopes come in a wide variety of sizes, and the above limitation is an intended use which only requires the structure to be capable of being inserted into an endoscope channel, wherein the endoscope has the inner and outer diameters as claimed; with that said, the outer diameter of the operating portion 40 can be larger than the inner diameter of an endoscope channel through which the endoscope insertion forceps channel 95a (i.e., the transmission portion) can be inserted. Additionally, it should be understood that the transmission member (endoscope insertion forceps channel 95a) can be placed within a larger endoscope such that the transmission member has an outer diameter smaller than the inner diameter of the endoscope).
Regarding claim 10, Kimura discloses wherein the handle includes a first part (slider 42 and operation pipe 33) connected to the transmission member (endoscope insertion forceps channel 95a) and rotatable in conjunction with the transmission member (endoscope insertion forceps channel 95a) (Examiner’s note: endoscope insertion forceps channel 95a is indirectly connected to the slider 42 and operation pipe 33 (i.e., the first part) when the device is inserted into the endoscope; additionally, the slider 42 and operation pipe 33 and the endoscope insertion forceps channel 95a (i.e., the transmission member) are rotatable together as a whole, as the entire system is rotatable as a single unit; and the claims do not require wherein the rotation of one causes the rotation of the other), and a second part (rotary grip 41b) connected to be rotatable relative to the first part (slider 42 and operation pipe 33) (paragraphs [0174 – 0175]).
Regarding claim 11, Kimura discloses wherein the handle includes a handle body (handle body 41), and a slider (slider 42) supported by the handle body (handle body 41) and movable in the longitudinal direction (paragraph [0178] and Figs. 1,2), wherein the slider (slider 42) is disposed in the first part (slider 42 and operation pipe 33).
Regarding claim 10, (alternate interpretation – changes italicized below) Kimura discloses a first part (rotary grip 41b) connected to the transmission member (endoscope insertion forceps channel 95a) and rotatable in conjunction with the transmission member (endoscope insertion forceps channel 95a) (Examiner’s note: endoscope insertion forceps channel 95a is indirectly connected to the rotary grip 41b (i.e., the first part) when the device is inserted into the endoscope; additionally, the rotary grip 41b and the endoscope insertion forceps channel 95a (i.e., the transmission member) are rotatable together as a whole, as the entire system is rotatable as a single unit; and the claims do not require wherein the rotation of one causes the rotation of the other), and a second part (slider 42 and operation pipe 33) connected to be rotatable relative to the first part (rotary grip 41) (paragraphs [0174 – 0175]).
Regarding claim 12, (alternate interpretation) Kimura discloses wherein the handle includes a handle body (handle body 41), a slider (slider 42) supported by the handle body (handle body 41) and movable in the longitudinal direction (paragraph [0178] and Figs. 1,2), wherein the slider (slider 42) is disposed in the second part (slider 42 and operation pipe 33).
Regarding claim 13, Kimura discloses wherein the handle includes a stopper (O-ring 44) between the first part (slider 42 and operation pipe 33) and the second part (rotary grip 41b) (paragraph [0173] and Fig. 2), configured to restrict a relative rotation between the first part and the second part (paragraph [0173] and [0174]).
Regarding claim 14, Kimura discloses wherein the stopper (O-ring 44) is a friction member configured to generate friction between the first part (slider 42 and operation pipe 33) and the stopper (O-ring), and generate friction between the second part and the handle (Examiner’s note: the preceding limitations are intended use which require only that the structure of the prior art be capable of functioning as intended, with that said, the O-ring is capable of generating friction as claimed).
Regarding claim 19, Kimura discloses a medical device (clip introduction device 10) (abstract, paragraphs [0044 – 0046], and Figs. 1 – 3, 20 – 25) comprising:
a sheath (introduction tube 20) extending in a longitudinal direction (paragraph [0046] and Fig. 1);
a treatment portion (hook portion 31 and hook a clip unit 60) disposed at a distal end of the sheath (introduction tube 20) (paragraph [0054] and Figs. 21 - 25);
a wire (wire 32) inserted into the sheath (sheath 11) and to which the treatment portion is fixed (paragraph [0055] and Figs. 1 – 3, 20 – 25);
a handle (operating portion 40) disposed at a proximal end of the sheath (introduction tube 20) and to which the wire is fixed (paragraphs [0065 – 0067], and Fig. 2); and
the treatment portion (hook portion 31 and hook a clip unit 60), the wire (wire 32), the handle (operating portion 40), and the sheath (introduction tube 40) are rotatable in a circumferential direction relative to a longitudinal direction in conjunction with each other (Examiner’s note: the entire device can be rotated such that all of the parts above are rotated in conjunction with each other).
Regarding claim 20, Kimura discloses comprising a grip (endoscope 95) connected to the sheath (introduction tube 20) (Figs. 21, 22), wherein the grip is slidable on the sheath (introduction tube 20) (paragraph [0146]) and has an outer diameter larger than an outer diameter of the sheath (introduction tube 20) (Fig. 22).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al (US 2009/0112225 A1) as applied to claim 1 above, and further in view of Honda et al (US 2009/0105536 A1).
Regarding claims 1 and 2, (alternate interpretation – changes italicized below) Kaneko discloses a medical device (endoscopic instrument 10) (abstract, paragraphs [0026 – 0027], and Figs. 1 – 7) comprising:
a sheath (sheath 11) extending in a longitudinal direction (paragraph [0027 – 0029] and Fig. 7);
a treatment portion (incision wire 12) disposed at a distal end of the sheath (sheath 11) (paragraph [0030] and Figs. 1 and 7);
a wire (wire 13) inserted into the sheath (sheath 11) and to which the treatment portion is fixed (paragraphs [0026 – 0038] and Fig. 7);
a handle (maneuvering section 14) disposed at a proximal end of the sheath (sheath 11) and to which the wire is fixed (fixed via rod 24) (paragraphs [0027], [0031], [0038], and Fig. 7); and
wherein the treatment portion (wire 12), the wire (wire 13), and the handle (maneuvering section 14), are rotatable in a circumferential direction with respect to the longitudinal direction relative to the sheath (sheath 11) (Examiner’s note: as stated in paragraphs [0036 – 0038] and shown in Fig. 7 the wire 13 (i.e., the wire) and the rotative operative section 23, which is a part of the maneuvering section 14 (i.e., the handle) are rotatable relative to the sheath 11, as the sheath 11 is fixed to the casing 22).
However, Kaneko is silent regarding (i) [claims 1 and 2] a transmission member, formed in a cylindrical shape, disposed on an outer periphery of the sheath and extending from the handle to the distal end, (ii) [claim 1] the transmission member rotatable relative to the sheath, and (iii) [claim 18] wherein the transmission member can transition between a contracted state having a first length in the longitudinal direction and an extended state having a second length in the longitudinal direction that is longer than the first length.
As to the above, Honda teaches, in the same field of endeavor, a medical device (endoscope treatment system 1) (abstract, paragraph [0027], and Fig. 1) comprising a sheath (elongated sheath 2b), a treatment portion (collecting portion 2a) at the distal end of the sheath (elongated sheath 2b), a wire (operation wire – discussed in paragraph [0035]) within the sheath (elongated sheath 2b), a handle (handle 2c) (paragraphs [0035 – 0037] and Fig. 1, 6), and a transmission member (connecting tube 50) formed in a cylindrical shape, disposed on an outer periphery of the sheath and extending from the handle to the distal end (paragraph [0050] and Fig. 6), wherein the transmission member (connecting tube 50) rotatable relative to the sheath (Examiner’s note: because the connecting tube 50 and the sheath 2b are separate structures there is nothing that prevents one from rotating relative to the other; therefore, the connecting tube 50 (i.e., the transmission member) is rotatable relative to the sheath), and wherein the transmission member (connecting tube 50) can transition between a contracted state having a first length in the longitudinal direction and an extended state having a second length in the longitudinal direction that is longer than the first length (paragraphs [0050 – 0051] and Figs. 4 – 5). Honda further teaches, in paragraph [0050], the transmission member (connecting tube 50) is useful for preventing the sheath (sheath 2b) from contacting unclear areas.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Kaneko to incorporate the transmission member, as taught by Honda, for the purpose of preventing the sheath from contacting unclear areas (paragraph [0050] – Honda).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al (US 2009/0112225 A1)
Regarding claim 3, as discussed above, Kaneko discloses the medical device of claim 1. Additionally, Kaneko discloses wherein the handle (maneuvering section 14) includes a handle body (maneuvering section 14), and a slider (sliding operation section 21) supported by the handle body and movable in the longitudinal direction (paragraphs [0036], [0039], and Fig. 7), the wire (wire 13) is connected to the slider and movable in the longitudinal direction in conjunction with the slider (paragraphs [0036], [0039], and Fig. 7), and the transmission member (endoscope insertion section 1a) is bendable along the sheath (Examiner’s note: as shown in Fig. 1, the endoscope 1 (i.e., the transmission member) is bendable along the sheath). Furthermore, Kaneko makes obvious wherein the transmission member (endoscopic channel 1a) has a higher flexibility than the handle for the purpose of being able to bend / flex the transmission member (endoscopic channel 1a) in order to traverse through the contours the vasculature.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al (US 2009/0112225 A1) as applied to claim 1 above, and further in view of Matsushita et al (US 2002/0010386 A1).
Regarding claim 17, as discussed above, Kaneko discloses the medical device of claim 1. Additionally, Kaneko makes obvious wherein the transmission member (endoscopic channel 1a) has a higher flexibility than the handle for the purpose of being able to bend / flex the transmission member (endoscopic channel 1a) in order to traverse through the contours the vasculature.
However, Kaneko is silent regarding wherein (i) the transmission member includes an inner layer, an outer layer, and a middle layer that is disposed radially between the inner layer and the outer layer and has a hardness less than the inner layer and the outer layer.
As to the above, Matsushita teaches, in a similar field of endeavor, namely flexible outer tubing through which a medical device is inserted through, a flexible tube for an endoscope (which is equated to transmission member / endoscopic channel 1a of Kaneko) comprising an inner layer and outer layer (layers 31 and 32) and a middle layer (intermediate layer 33) radially between the inner and outer layers with a hardness less than the inner layer and outer layers (paragraphs [0090 – 0091], [0094 – 0096], [0338 – 0353]) for the purpose of providing a flexible tubing with excellent operability of insertion, resistance to chemicals, and durability (paragraph [0011]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the transmission member of Kaneko to incorporate an inner, outer, and intermediate layers, wherein the intermediate layer has a hardness less than that of the inner and outer layers, based on the teachings of Matsushita, for the purpose of providing a flexible tubing with excellent operability of insertion, resistance to chemicals, and durability (paragraph [0011] – Matsushita).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al (US 2007/0112359 A1).
Regarding claim 16, as discussed above, Kimura discloses the medical device of claim 13.
However, Kimura is silent regarding (i) wherein a friction between the stopper and a friction between the stopper and the second part are greater than 10 mN-m. (see the objection for claim 16, for an explanation on the changed language).
As to the above, there is no evidence of record that establishes that changing the frictional threshold would result in a difference in function of the Kimura device. Further, a person having ordinary skill in the art, being faced with modifying the frictional force of Kimura, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed frictional threshold. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the friction “may” be within the claimed range, and offering other acceptable ranges (specification at para. [0128]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frictional force threshold to be greater than 10mN-m as an obvious matter of design choice within the skill of the art.
Allowable Subject Matter
Claim 15 is 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Griego et al (US 2002/0010485 A1) teaches a sheath, a wire, a handle, a treatment member, and a transmission member, wherein the wire, treatment member, handle, and transmission member are rotatable relative to the sheath.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Andrew Restaino/Primary Examiner, Art Unit 3771
Prosecution Insights