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 § 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 2-6 and 8-20 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.
Claim 2 discloses the limitation " typically” in line 2. This expression "typically " defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 3 discloses the limitation "preferably" in line 1. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 4 discloses the limitation "preferably" in lines 5-8. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 5 discloses the limitation "typically" in line 1. This expression " typically " defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 6 discloses the limitations "preferably" and “optionally” in lines 9-11. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 8 discloses the limitation "preferably" in lines 4-5. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 9 discloses the limitation "preferably" in lines 2-4 and 6. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 10 discloses the limitation "preferably" in line 3. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 11 discloses the limitation "preferably" in lines 2-3 and 5. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 12 discloses the limitation "preferably" in line 3. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 17 discloses the limitation "preferably" in lines 3, 5 and 8. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 18 discloses the limitation "preferably" in lines 3-4. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim 19 discloses the limitation "preferably" in lines 3, 9, 12, 16, 21, 22, 24, 25 and 28. This expression "preferably" defines different scopes and therefore rendering the claim unclear and indefinite.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 6 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghareeb US 2005/0143757.
Regarding claim 1, Ghareeb discloses a ligator for deploying ligation bands (paragraph 0001), the ligator comprising a band deployment device (figure 2) having a plurality of seats spaced apart in an axial direction (figures 8a-9c, grooves may be defined by ridges 24, 30 on first and second tubes or inner and outer parts), each seat being configured to receive a respective ligation band 18 (figure 9a), the band deployment device comprising an inner part (inner tube 20, figure 20, paragraph 0024) and an outer part (outer tube 22, figure 5, paragraph 0024) each being configured to provide parts of said seats (figures 8a, 9a, grooves may be defined by ridges 24, 30 on first and second tubes or inner and outer parts), the inner and outer parts being capable of relative reciprocating movement in said axial direction between a non-deploying state and a deploying state (figures 9a-9c, paragraphs 0011, 0027 shows retracted position and extended position or deploying state with reciprocal movement), wherein said seats include a foremost seat located at a free end of said deployment device (figures 8a-9c, distal or free end having ridges or fingers 24, 28, foremost seat at the most distal end) from which a foremost one of said ligation bands 18 is deployed during use in response to operation of said deployment device from the non-deploying state to the deploying state (figure 9b, paragraph 0029 foremost band 18a is pushed off the free end to be deployed), and wherein at least said foremost seat includes a ramp that is inclined away from said axial direction in a forward direction towards the free end of the deployment device (figure 9a-9b, foremost band 18a ride up over ridges 30 aligned in a forward direction toward the free end).
Regarding claim 2, Ghareeb discloses wherein the ramp of the foremost seat is provided by the inner part 20 of the deployment device (foremost seat 24, figures 3, 8b), typically by the respective seat parts of the inner part (figure 8b, distal free end of the device seats formed by ridges 24, 30).
Regarding claim 3, Ghareeb discloses wherein the foremost seat, preferably the ramp of the foremost seat, has first and second portions, each portion having a different angle of inclination with respect to the axial direction (for example, figure 8b, ramp portion and perpendicular portions have different angles of inclination).
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Regarding claim 6, Ghareeb discloses wherein a plurality of recessed tracks are formed in the exterior of the inner part 20 (paragraph 0023, recessed tracks 26, figure 3), the tracks being spaced apart, preferably evenly spaced apart (paragraph 0023, tracks circumferentially at 90 degree intervals, figure 4), around the outer periphery of the inner part (figure 5), each track extending in the axial direction (figure 5, paragraph 0023, slots parallel to the axis of tube), and wherein a respective raised portion of the inner part is defined between adjacent tracks (raised portions or ridges 24 between ridges 24, figure 3), each raised portion extending in the axial direction (figure 3, along longitudinal axis between ridges 26), and wherein the outer part 22 comprises a plurality of spaced apart, parallel fingers 28 that extend in the axial direction (figure 5), the inner and outer parts being configured to fit together such that each finger fits into a respective track (figure 8a), and each raised portion fits into a respective gap between adjacent fingers (figures 8a-9c), and wherein each finger 28 is movable along the respective track (figures 8a-9c, reciprocally movable relative to one another to move band 18 toward free end), and wherein, preferably, an outer surface of each raised portion includes a respective part of each of said seats (figures 8a-8c, raised portion of 24 forms seats to hold bands 18), and/or wherein, preferably, an outer surface of each finger includes a respective part of at least one of the seats (figures 8a-8c, raised portion of 24 forms seats to hold bands 18), optionally a respective part of all of the seats or a respective part of each seat except the foremost seat (figures 8a-8c, raised portions of 24 forms a part of all seats to hold bands 18).
Regarding claim 17, Ghareeb discloses wherein operation of said deployment device from the non-deploying state to the deploying state involves movement of said outer part 22 relative to said inner part 20 in said forward direction (figures 9a-9c, outer part with fingers 28 moves in the forward direction to deploy the band), and wherein, preferably, said outer part is configured to push the foremost ligation band up and off the ramp of the foremost seat by said movement in the forward direction (figure 9b), and/or wherein, preferably, said movement in the forward direction is by a distance corresponding to a pitch between adjacent seats (bands move between seats, figures 9a-9c, until pushed off the free end), and wherein, preferably the configuration is such that during operation of said deployment device from the non-deploying state to the deploying state said outer part, preferably the seat parts of the outer part, is configured to move the or each band seated on said outer part in the forward direction to align the or each band with an adjacent forwardly located seat of the deployment device (figure 9a-9c). Examiner further notes the limitations including the language “preferably” or “typically” are not positively claimed and are not explicitly required by the prior art.
Regarding claim 18, Ghareeb discloses wherein operation of said deployment device from the deploying state to the non-deploying state involves movement of said outer part 22 relative to said inner part 20 in a rearward direction opposite to said forward direction (figures 9a outer part is extended, figure 9c moves rearward direction opposite to the forward direction or free end), and wherein, preferably, said inner part, preferably the respective seat parts of said inner part, is configured to engage with the or each band 18 carried by the deployment device when the outer part moves in said rearward direction in order to stop the or each band from moving rearwardly with the outer part and so cause the or each band to be seated in an adjacent forwardly located seat of the deployment device (bands along seats figure 9c, after put in retracted position). Examiner further notes the limitations including the language “preferably” or “typically” are not positively claimed and are not explicitly required by the prior art.
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(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghareeb US 2005/0143757.
Regarding claim 4, Ghareeb discloses wherein the second portion is located forwardly of the first portion such that, in response to operation of the deployment device from the non-deploying state to the deploying state, the foremost band is pushed along the first portion and subsequently pushed up the second portion, and wherein the angle of inclination of the first portion is shallower than the angle of inclination of the second portion (paragraph 0029, bands 18 are pushed up and over the ramp portion having a shallower angle relative to the longitudinal axis, the second portion being perpendicular or having a larger angle to the longitudinal axis and advanced along the device until being pushed off the end), and wherein, preferably, the first portion is inclined with respect to the axial direction at an angle of 1°-10°, preferably 5°-10°, and most preferably 7°-9°, and/or wherein, preferably, the second portion is inclined with respect to the axial direction at an angle of 10°-25°, preferably 15°-20°, and most preferably 16°-18°, and/or wherein, typically, each of said first and second portions is planar (figure 5, ramp portion and perpendicular end are planar). The inclined angle of the first portion of the ramp may be about 15 degrees in the direction towards the free end (paragraph 0023), the second portion being about 90 degrees perpendicular from the device axis (figure 5), and further although ridges or seats may have a sawtooth cross section, other shaped cross sections may be realized to advance the bands step by step in a similar manner (paragraph 0030). Examiner further notes that the claim does not explicitly disclose the inclines having the specific claimed angles, as the claim may only require the non preferable configuration. Further, it would have been an obvious matter of design choice to provide a shape sufficient for advancing the bands distally off the device (paragraph 0030), since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 5, Ghareeb discloses wherein the foremost seat, typically the ramp of said foremost seat, has an upper end from which said foremost one of said ligation bands is deployed during use (figure 9c, band 18a deployed over foremost seat), but fails to explicitly disclose said upper end being rounded.
Ghareeb discloses that although ridges or seats may have a sawtooth cross section, other shaped cross sections may be realized to advance the bands step by step in a similar manner (paragraph 0030).
Therefore, it would have been an obvious matter of design choice to provide a shape sufficient for advancing the bands distally off the device (paragraph 0030) such as a shape with the upper end being rounded, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghareeb US 2005/0143757 in view of Mears US 6136009.
Regarding claims 7-15, Ghareeb discloses a ligator essentially as claimed as discussed above, but fails to disclose wherein one or more rolling-element bearing is provided between the inner and outer parts of the deployment device to facilitate said relative reciprocating movement, wherein one or more rolling-element bearing is provided between the inner and outer parts of the deployment device to facilitate said relative reciprocating movement, and wherein at least one rolling-element bearing is provided between at least one finger, preferably each finger, and the corresponding track, and wherein, preferably, a plurality of rolling-element bearings are provided between each finger and the corresponding track, the rolling-element bearings being spaced apart in the axial direction, wherein a first rolling-element bearing is provided at a relatively forward location of the respective finger, preferably at a forward portion, for example a forward half, of the finger that includes its free end, and wherein, preferably, the first rolling-element bearing is rearwardly spaced apart from the free end of the respective finger, and wherein, preferably, the first rolling-element bearing is located in register with, or substantially in register with, a foremost seat part formed in the respective finger, preferably being in line with, or substantially in line with, an abutment surface of the foremost seat part and/or a base of a respective ramp of the foremost seat part, wherein, when the deployment device is in the non-deploying state, the first rolling-element bearing is aligned or substantially aligned with the seat adjacent said foremost seat, preferably with an abutment surface of the seat adjacent said foremost seat part and/or a base of a respective ramp of the seat adjacent said foremost seat, wherein a second rolling-element bearing is provided at a relatively rearward location of the respective finger, preferably at a rearward portion, for example a rearward half, of the finger, and wherein, preferably, the second rolling-element bearing is located in register with, or substantially in register with, a rearmost seat part formed in the respective finger, preferably in line with, or substantially in line with, an abutment surface of the rearmost seat part and/or a base of a ramp of the rearmost seat part, wherein, when the deployment device is in the non-deploying state, the second rolling-element bearing is aligned or substantially aligned with the rearmost seat, preferably with an abutment surface of the rearmost seat and/or a base of a respective ramp of the rearmost seat, wherein the, or each, rolling-element bearing is rotatably located in a respective socket provided in an underside of the respective finger, wherein an elongate recess for receiving the, or each, respective rolling-element bearing is provided in an upper face of the respective track, wherein the, or each, rolling-element bearing is rotatably located in a respective socket provided in an underside of the respective finger, and wherein the underside of the finger is in engagement with the upper face of the respective track, with the, or each, rolling-element bearing being contained within the respective socket and the recess.
Mears discloses wherein one or more rolling-element bearing is provided between the inner and outer parts of the deployment device to facilitate said relative reciprocating movement (column 6, lines 14-17, rolling diaphragm, figure 6 for reciprocal movement, outer part 104 comprises reciprocating movement with inner member 16 ) , wherein one or more rolling-element bearing is provided between the inner and outer parts of the deployment device to facilitate said relative reciprocating movement, and wherein at least one rolling-element bearing is provided between at least one finger, preferably each finger, and the corresponding track, and wherein, preferably, a plurality of rolling-element bearings are provided between each finger and the corresponding track, the rolling-element bearings being spaced apart in the axial direction, wherein a first rolling-element bearing is provided at a relatively forward location of the respective finger, preferably at a forward portion, for example a forward half, of the finger that includes its free end, and wherein, preferably, the first rolling-element bearing is rearwardly spaced apart from the free end of the respective finger, and wherein, preferably, the first rolling-element bearing is located in register with, or substantially in register with, a foremost seat part formed in the respective finger, preferably being in line with, or substantially in line with, an abutment surface of the foremost seat part and/or a base of a respective ramp of the foremost seat part, wherein, when the deployment device is in the non-deploying state, the first rolling-element bearing is aligned or substantially aligned with the seat adjacent said foremost seat, preferably with an abutment surface of the seat adjacent said foremost seat part and/or a base of a respective ramp of the seat adjacent said foremost seat, wherein a second rolling-element bearing is provided at a relatively rearward location of the respective finger, preferably at a rearward portion, for example a rearward half, of the finger, and wherein, preferably, the second rolling-element bearing is located in register with, or substantially in register with, a rearmost seat part formed in the respective finger, preferably in line with, or substantially in line with, an abutment surface of the rearmost seat part and/or a base of a ramp of the rearmost seat part, wherein, when the deployment device is in the non-deploying state, the second rolling-element bearing is aligned or substantially aligned with the rearmost seat, preferably with an abutment surface of the rearmost seat and/or a base of a respective ramp of the rearmost seat, wherein the, or each, rolling-element bearing is rotatably located in a respective socket provided in an underside of the respective finger, wherein an elongate recess for receiving the, or each, respective rolling-element bearing is provided in an upper face of the respective track, wherein the, or each, rolling-element bearing is rotatably located in a respective socket provided in an underside of the respective finger, and wherein the underside of the finger is in engagement with the upper face of the respective track, with the, or each, rolling-element bearing being contained within the respective socket and the recess. Examiner notes the claim languages including “preferably” is not positively claimed and not required by the prior art, for example, the claim does not require the roll element bearing being a ball bearing at the relative positioning with the fingers or the respective tracks.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Ghareeb with a rolling element, as taught by Mears, as a known substitute in the prior art for providing reciprocal movement between an inner and outer part for the delivery of ligation bands.
Regarding claim 16, Ghareeb discloses a ligator essentially as claimed, but fails to disclose wherein there are 5 fingers.
Mears teaches a ligation device for delivery of ligation bands (column 5-7), the device comprising 5 fingers (figure 7d) placed circumferentially around the device for deploying the ligation band 110 (figure 7e). It would have been an obvious matter of design choice to modify the Ghareeb, to have five fingers, since applicant has not disclosed that having 4 or 5 or 6 fingers placed around the device cirfumerentially solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality of having 5 fingers, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghareeb US 2005/0143757 in view of Basu et al. US 2021/0007749.
Regarding claims 19 and 20, Ghareeb discloses a ligator essentially as claimed but fails to further disclose a probe, the deployment device being provided at a free end of the probe, and an operating device typically comprising a trigger, and wherein, preferably, the probe comprises an inner tube located coaxially within an outer tube, the inner and outer tubes being capable of reciprocating movement with respect to each other in the axial direction, and wherein the inner part of the deployment device is coupled to an end of the inner tube, and the outer part of the deployment device is coupled to a corresponding end of the outer tube such that relative reciprocating movement between the inner and outer tubes causes corresponding relative reciprocating movement between the inner and outer parts, and wherein, preferably, the operating device is coupled to the probe such that operation of the operating device causes relative reciprocating movement between the inner and outer tubes and corresponding relative reciprocating movement between the inner and outer parts, the coupling between the operating device and the probe preferably being such that operation of the operating device from a first state to a second state causes the deployment device to be operated from the non-deploying state to the deploying state, and operation of the operating device from the second state to the first state causes the deployment device to be operated from the deploying state to the non-deploying state, and wherein, preferably, the deployment device includes a cavity with an open mouth at the free end of the deployment device, the ligator further including a suction system for drawing tissue, or other objects, into the cavity, and wherein the suction system may include, or be connectable to, a suction source, the deployment device typically including a through-aperture and/or channel to allow air to be drawn into the probe, in particular into the inner tube, via the mouth and cavity, and wherein, preferably, the suction system is operable to selectively create suction force at the mouth, the suction system preferably configured not to apply suction force at the mouth when the deployment device is in the non-deploying state, and to apply suction force at the mouth when the deployment device is in the deploying state, and wherein, preferably, the suction system is activated by the operating device, preferably such that, when the operating device is in its first state, the suction system is disabled such that suction force is not applied at the mouth, and when the operating device is in its second state the suction system is enabled such that suction force is applied at the mouth, and wherein, preferably, when the operating device is in an intermediate state between the first state and the second state, the suction system is enabled such that suction force is applied at the mouth, wherein the inner tube includes an aperture through which air may be drawn when the aperture is exposed, the probe being configured such that, depending on the relative axial position of the inner and outer tubes, the aperture is either exposed or not exposed, the arrangement being such that when the deployment device is in the non-deploying state the aperture is exposed, and when the deployment device is in the deploying state the aperture is not exposed, and wherein when the suction system is activated a suction force is applied to the inner tube downstream of the aperture such that, when the aperture is exposed, the suction force draws air into the inner tube through the aperture thereby preventing the suction force from being transferred to the deployment device, and when the aperture is not exposed the suction force does not draw air into the inner tube through the aperture such that the suction force is transferred to the deployment device.
Examiner notes the claim languages including “preferably” or “typically” is not positively claimed and not required by the prior art, for example, the claim does not require the trigger, or the probe comprising an inner and outer tube.
Basu et al. teaches a ligation band device for deploying ligation bands, further disclose a probe 102 having an inner tube 196 and outer tube 104 coaxially reciprocating within the outer tube in the axial direction (figure 2), the deployment device being provided at a free end of the probe (at distal end, deployment device or deployment sleeve 118), and an operating device (108, figure 2) comprising a trigger (thumb ring 108, figure 2), and wherein the inner part of the deployment device is coupled to an end of the inner tube (deployment device 118 at the distal end coupled within the device, figure 3), and the outer part of the deployment device is coupled to a corresponding end of the outer tube such that relative reciprocating movement between the inner and outer tubes causes corresponding relative reciprocating movement between the inner and outer parts (deployment device 118 at the distal end coupled within the device to both inner and outer parts, figure 8), and wherein, preferably, the operating device is coupled to the probe such that operation of the operating device causes relative reciprocating movement between the inner and outer tubes and corresponding relative reciprocating movement between the inner and outer parts (with reciprocating movement by moving trigger 108, figure 8), the coupling between the operating device and the probe preferably being such that operation of the operating device from a first state to a second state causes the deployment device to be operated from the non-deploying state to the deploying state (figure 8), and operation of the operating device from the second state to the first state causes the deployment device to be operated from the deploying state to the non-deploying state, and wherein, preferably, the deployment device includes a cavity with an open mouth at the free end of the deployment device (for attachment to a vacuum port, paragraph 0013), the ligator further including a suction system for drawing tissue, or other objects, into the cavity, and wherein the suction system may include, or be connectable to, a suction source, the deployment device typically including a through-aperture and/or channel to allow air to be drawn into the probe (paragraph 0013, through vacuum port), in particular into the inner tube, via the mouth and cavity, and wherein, preferably, the suction system is operable to selectively create suction force at the mouth (through vacuum port, paragraph 0013), the suction system preferably configured not to apply suction force at the mouth when the deployment device is in the non-deploying state (paragraph 0013, configured to not apply suction by turning off or detaching the suction hose), and to apply suction force at the mouth when the deployment device is in the deploying state (paragraph 0013) configured to apply suction when , and wherein, preferably, the suction system is activated by the operating device, preferably such that, when the operating device is in its first state, the suction system is disabled such that suction force is not applied at the mouth (configured to detach or turn off suction, paragraph 0070), and when the operating device is in its second state the suction system is enabled such that suction force is applied at the mouth, and wherein, preferably, when the operating device is in an intermediate state between the first state and the second state, the suction system is enabled such that suction force is applied at the mouth (paragraph 0070, suction is configured to be turned off or detached as desired), wherein the inner tube includes an aperture through which air may be drawn when the aperture is exposed (through vacuum port, paragraph 0013), the probe being configured such that, depending on the relative axial position of the inner and outer tubes, the aperture is either exposed or not exposed, the arrangement being such that when the deployment device is in the non-deploying state the aperture is exposed, and when the deployment device is in the deploying state the aperture is not exposed, and wherein when the suction system is activated a suction force is applied to the inner tube downstream of the aperture such that, when the aperture is exposed, the suction force draws air into the inner tube through the aperture thereby preventing the suction force from being transferred to the deployment device, and when the aperture is not exposed the suction force does not draw air into the inner tube through the aperture such that the suction force is transferred to the deployment device (paragraph 0070, suction hose attached to vacuum port and is configured to provide suction or not as desired for the procedure or between procedures).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Ghareeb with a probe, the deployment device being provided at a free end of the probe, and an operating device, as taught by Basu et al. with a plunger probe for reciprocating the inner and outer parts and allow for suction through an aperture to draw the tissue toward the device for reciprocating movement for pushing and deployment of the ligation band off the device (paragraph 0051).
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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