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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first joint member has a stent storage region in which the stent is stored” in claim 17 and 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Examiner notes that the drawings show the first outer tube member 1 comprising a stent storage region E1, but there is no disclosure or drawings showing the first joint member having a stent storage region.
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 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 11 is 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.
Claim 11 recites “the stent” in line 2. There is insufficient antecedent basis for this limitation in the claims.
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(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ichimura et al. (US 2022/0175564) in view of Hayakawa (WO 2020/184553 – see translation attached).
Regarding claim 1, Ichimura et al. discloses a delivery device (1, FIG 1-2, [0031]) comprising: a first outer tube member (10, FIG 1-2); an inner tube member (80, FIG 2) that is inserted into the first outer tube member (FIG 2); a second outer tube member (30) that is positioned at a proximal side with respect to the first outer tube member (FIG 2) and is connected to the inner tube member ([0035, 0074]); a pulling member (20, FIG 2, [0034]) that is inserted into the second outer tube member ([0034]) and is connected to the first outer tube member ([0034]); a first joint member (11) in which a second hole (See lumen of 11, FIG 2) configured to allow the inner tube member to advance and retract (FIG 2, 80 is slidable within 11) is formed; and a fixing member (12) that fixes the first joint member to the first outer tube member to each other ([0041, 0050]).
Ichimura et al. further discloses the pulling member (20) is fixed to first joint member (11, FIG 2, [0046-0047]) and discloses many different means by which 20 can be joined to 11 but is silent regarding first joint member 11 having a first hole for fixing the pulling member 20 therein.
However, Hayakawa teaches a delivery device (10, FIG 1) having a means for attaching a pulling member (100, FIG 4) to a first joint member (90/92, [0040]) wherein the first joint member comprises a first hole for fixing the pulling member therein (FIG 5A shows there is a hole formed in the adhesive 92 which received the pulling member 100) and wherein said first joint member also has a second hole for receiving an inner tube member (40/42, FIG 5A, wherein the hole is formed between 90 and the adhesive 92).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first joint member of Ichimura to comprise a first hole for fixing the pulling member therein, as taught by Hayakawa, for the purpose of utilizing a connection means commonly known in the art for permanently affixing a pull member to a joint member, therefore achieving the predictable result of transferring a retraction force applied on the pulling member to the first joint member and thus the first outer tube member.
Regarding claim 2, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 1. Ichimura further discloses the fixing member (12) is positioned at a radial direction outer side of the first joint member (FIG 2 shows 12 is radially outside of 11, [0050]), and covers the entire circumference of an outer circumferential surface of the first joint member to fix the first outer tube member and the first joint member to each other (FIG 2, [0050]).
Ichimura is silent regarding the fixing member being positioned at a radially direction outer side of the first outer tube member and covering the entire outer circumferential surface of the first outer tube member.
Ichimura contemplates an alternative arrangement of the fixing member wherein the fixing member is positioned radially outward of the first outer tube member ([0050] discloses “the connection tube 12 may be disposed outward of the proximal side of the tubular member that forms the outer tube 10”) and uses the radially inward or outward arrangement of the fixing member relative to the first outer tube member and relative to the first joint member interchangeably ([0050] discloses both arrangements are possible).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the fixing member being positioned at a radially direction outer side of the first outer tube member, as taught by the alternative arrangement in Ichimura, for the purpose of substituting a configuration commonly known in the art to be an equivalent arrangement, thereby achieving the predictable result of securely joining the first outer tube member to the first joint member.
Regarding claim 3, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 2. Ichimura further discloses an end surface of the first outer tube member (Proximal end of 10 seen in FIG 2) and an end surface of the first joint member (Distal end of 11 seen in FIG 2) are disposed to come into contact with each other on the radial direction inner side of the fixing member (In the device as modified such that 10 is radially inward of 12, the claimed ends of the first outer tube member and the first joint member would be in contact).
Regarding claim 4, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 2. Ichimura further discloses a surface of the first joint member is formed of a resin having a heat-fusing property ([0049] discloses 11 being formed of a polyimide-based resin).
Ichimura is silent regarding a surface of the fixing member and a surface of the first outer tube member being formed of the same resin having a heat-fusing property, and wherein the fixing member, the first outer tube member, and the first joint member are fixed to each other by heat fusing.
However, Ichimura discloses heat fusing the first outer tube member (10) to another member using a heat-shrinkable resin tube ([0046]) as a method for “easily and firmly connecting” two members. Ichimura further reaches attaching tube 30 and tube 80 using a heat-meltable tubular members ([0072-0073]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the adhesive connection taught by Ichimura with the heat shrink tubular connection taught by the alternative embodiments, for the purpose of achieving the predictable result of reliably and securely connecting the first outer tube member to the first joint member using the fixing member, thereby increasing the fixing strength therebetween compared to only having an adhesive connection. In the device as modified it is understood that a surface of the fixing member and a surface of the first outer tube member are formed of the same resin having a heat-fusing property as the fixing member in order to achieve the attachment.
Regarding claim 5, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses a diameter of the first hole of the first joint member is smaller than a diameter of the second hole of the first joint member (Because 20 is substantially smaller in diameter than 80, and the first and second holes are sized to receive each element respectively).
Regarding claim 6, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 1. Ichimura further discloses a second joint member (71, FIG 2, [0074-0075]) in which a first hole configured to fix the second outer tube member therein and a second hole configured to fix the inner tube member therein are formed ([0074] discloses 71 fixes the traction member housing tube 30 and the guide wire tube 80 to each other. As seen in the cross section of 71 in FIG 2, there are two holes which receive 80 and 30).
Regarding claim 7, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 6. Ichimura further discloses the first hole of the second joint member is configured to allow the pulling member to be inserted thereinto and allows the pulling member to advance and retract (30 is received within the first hole, and pulling member 20 is freely slidable within 30).
Regarding claim 8, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 6. Ichimura further discloses the second hole of the second joint member has a size that allows a guide wire for guiding the delivery device to be inserted thereinto and allows the guide wire to advance and retract (The second hole receives 80, which comprises a lumen to allow a guidewire to pass therethrough, [0034]).
Regarding claim 9, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 6. Ichimura further discloses the second joint member has a first end in which the inner tube member is fixed therein (Proximal end wherein 80 is fixed via frictional contact) and a second end in which the second outer tube member is fixed therein (Distal end wherein 30 is fixed via frictional contact).
Ichimura shows the first hole and the second hole as being equal diameters along their lengths and therefore is silent regarding a diameter of the first hole is larger at the second end than at the first end, and wherein a diameter of the second hole is larger at the first end than at the second end.
However, it would have been an obvious matter of design choice to alter the diameters of each hole along their length according, in order to allow for a desired amount of flexibility and bending of the inner tube member and the second outer tube member within the holes and relative to each other. Therefore, altering the diameter of the first hole to be larger at the second end than at the first end, and the diameter of the second hole to be larger at the first end than at the second end would not have required an inventive step. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Regarding claim 10, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 1. Ichimura further discloses a second joint member (71, FIG 2, [0074-0075]) that is disposed at a proximal side of the delivery device with respect to the first joint member (FIG 2) and fixes the second outer tube member with the inner tube member ([0074] discloses 71 fixes the traction member housing tube 30 and the guide wire tube 80 to each other).
Regarding claim 11, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 10. Ichimura further disclose the first outer tube member has a stent storage region in which the stent is stored (See distal lumen of 10 in FIG 2 which houses stent 2), wherein the first joint member (11) has a second end at a proximal side of the delivery device (Proximal end of 11 which attached to 20, FIG 2), wherein the second joint member (71) has a first end at a distal side of the delivery device (Distal end of 71, FIG 2).
Ichimura discloses various relative lengths of the device, for example that the length of outer tube 10 is dependent on the length of the stent 2 being disposed in the lumen thereof ([0039]) and discloses other relative lengths of the device ([0060-0061, 0074, 0079]) but is silent regarding explicitly stating that a length from the second end of the first joint member to the first end of the second joint member is longer than a length of the stent storage region.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the length from the second end of the first joint member to the first end of the second joint member to be longer than a length of the stent storage region of the device of Ichimura since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ichimura would not operate differently with the claimed lengths and since the stent storage region only needs to be as long as the stent it is holding, the device would function appropriately having the length from the first joint member to the second joint member be longer.
Regarding claim 12, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 10. Ichimura further discloses the first outer tube member has a first end at a distal side of the delivery device (See annotated FIG 2 below), wherein the second joint member has a first end at a distal side of the delivery device (See annotated FIG 2 below), wherein the second outer tube member has a second end at a proximal side of the delivery device (The second end of second outer tube member 30 is located at the region of controller 4, FIG 1), and wherein, in a longitudinal direction of the delivery device, a length from the first end of the second joint member to the second end of the second outer tube member is longer than a length from the first end of the first outer tube member to the first end of the second joint member (As seen in FIG 1, the distance between the first end of the first outer tube member to the first end of the second joint member is short relative to a length form the second joint member to the proximal end of the device).
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Regarding claim 13, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 1. Ichimura further discloses a stent (2) that is stored between the first outer tube member and the inner tube member (FIG 2) and is released as the pulling member moves toward a proximal side with respect to the second outer tube member (Proximal retraction of 20 moves 10 backwards relative to the stent and second outer tube member 80, thereby releasing the stent, [0052 and 0079]).
Regarding claim 14, Ichimura et al. discloses endoscope system (medical tubular body delivery device 1 plus the endoscope taught in [0003]) comprising: a delivery device (1, FIG 1-2, [0031]) comprising: a first outer tube member (10, FIG 1-2); an inner tube member (80, FIG 2) that is inserted into the first outer tube member (FIG 2); a second outer tube member (30) that is positioned at a proximal side with respect to the first outer tube member (FIG 2) and is connected to the inner tube member ([0035, 0074]); a pulling member (20, FIG 2, [0034]) that is inserted into the second outer tube member ([0034]) and is connected to the first outer tube member ([0034]); a first joint member (11) in which a second hole (See lumen of 11, FIG 2) configured to allow the inner tube member to advance and retract (FIG 2, 80 is slidable within 11) is formed; and a fixing member (12) that fixes the first joint member to the first outer tube member to each other ([0041, 0050]); and an endoscope having a treatment instrument channel configured to allow the delivery device to advance and retract ([0004] discloses use of delivery device 1 with an endoscope, wherein a guidewire is delivered through a channel of the endoscope and the delivery device is delivered over the guidewire, therefore also through the channel of the endoscope).
Ichimura et al. further discloses the pulling member (20) is fixed to first joint member (11, FIG 2, [0046-0047]) and discloses many different means by which 20 can be joined to 11 but is silent regarding first joint member 11 having a first hole for fixing the pulling member 20 therein.
However, Hayakawa teaches a delivery device (10, FIG 1) having a means for attaching a pulling member (100, FIG 4) to a first joint member (90/92, [0040]) wherein the first joint member comprises a first hole for fixing the pulling member therein (FIG 5A shows there is a hole formed in the adhesive 92 which received the pulling member 100) and wherein said first joint member also has a second hole for receiving an inner tube member (40/42, FIG 5A, wherein the hole is formed between 90 and the adhesive 92).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first joint member of Ichimura to comprise a first hole for fixing the pulling member therein, as taught by Hayakawa, for the purpose of utilizing a connection means commonly known in the art for permanently affixing a pull member to a joint member, therefore achieving the predictable result of transferring a retraction force applied on the pulling member to the first joint member and thus the first outer tube member.
Regarding claim 15, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 14. Ichimura further discloses a second joint member (71, FIG 2, [0074-0075]) that is disposed at a proximal side of the delivery device with respect to the first joint member (FIG 2) and fixes the second outer tube member with the inner tube member ([0074] discloses 71 fixes the traction member housing tube 30 and the guide wire tube 80 to each other).
Regarding claim 16, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 15. Ichimura further discloses a stent (2) that is stored between the first outer tube member and the inner tube member (FIG 2) and is released as the pulling member moves toward a proximal side with respect to the second outer tube member (Proximal retraction of 20 moves 10 backwards relative to the stent and second outer tube member 80, thereby releasing the stent, [0052 and 0079]).
Regarding claim 17, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 16. Ichimura further discloses the first joint member (Interpreted to mean the first outer tube in view of the specification of the present invention, see drawing objection above) has a stent storage region in which the stent is stored (See distal lumen of 10 in FIG 2 which houses stent 2), and wherein the first joint member and the second joint member are configured to be positioned in the treatment instrument channel in a state in which the entire stent storage region protrudes from a distal side of the endoscope in the treatment instrument channel (When delivered to the treatment site using an endoscope, only the stent storage region which holds and deploys the stent need protrude from the distal end of the endoscope. Therefore, it is configured such that proximal elements of the delivery device including the first and second joint members be positioned within the channel during use).
Regarding claim 18, Ichimura/Hayakawa disclose the invention substantially as claimed, as set forth above for claim 16. Ichimura further disclose the first outer tube member has a first end at a distal side of the delivery device (Distal end of 10, FIG 2), wherein the second joint member has a first end at a distal side of the device (Distal end of 71, FIG 2), wherein the first joint member (Interpreted to mean the first outer tube in view of the specification of the present invention, see drawing objection above) has a stent storage region in which the stent is stored (See distal lumen of 10 in FIG 2 which houses stent 2).
Ichimura discloses various relative lengths of the device, for example that the length of outer tube 10 is dependent on the length of the stent 2 being disposed in the lumen thereof ([0039]) and discloses other relative lengths of the device ([0060-0061, 0074, 0079]) but is silent regarding explicitly stating that a length from the first end of the second joint member to a forceps port of the endoscope is longer than a length from the first end of the first outer tube member to the first end of the second joint member in a state in which the entire stent storage region protrudes from a distal side of the endoscope in the treatment instrument channel.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the length from the first end of the second joint member to a forceps port of the endoscope is longer than a length from the first end of the first outer tube member to the first end of the second joint member in a state in which the entire stent storage region protrudes from a distal side of the endoscope in the treatment instrument channel of the device of Ichimura since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Ichimura would not operate differently with the claimed lengths and since the length of the operating end of the device should be relatively short compared to the region of the device which navigates to the treatment site, the device would function appropriately having the lengths.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771