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 .
A complete action on the merits of pending claims 1-14 appears herein.
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 distal end part of the transmission rod having a fist shape must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 12 and 14 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 11 and 13 respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 objected to because of the following informalities:
Regarding claim 1, the phrase “rotatably connected one ends thereof” should read --rotatably connected on ends thereof--
Regarding claim 1, the phrase “a forward and backward movement transmission rod to move” should read-- a forward and backward movement transmission rod configured to move--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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 1 recites the limitation “a sheath with flexibility inserted into and removed from an endoscope channel.” The wording of this limitation renders the claim unclear as to if the sheath or the flexibility is inserted/removed from an endoscope channel. For the purpose of examination, the limitation is interpreted as referring to the sheath being inserted/removed from the endoscope channel. Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation “an operation unit disposed in a proximal end part of the sheath, having a liquid injection port injecting a treatment liquid into the sheath and operating the operation wire.” The wording of this limitation renders the claim unclear as to if the operation unit or the injection port are operating the operation wire. For the purpose of examination, the limitation is interpreted as referring to the operation unit being responsible for the operating of the operation wire. Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation “a front side from opposite positions to the distal end of the tube part.” The wording of this limitation renders the claim unclear as to what the “opposite positions” are opposite relative to. (e.g. opposite the front side, opposite each other, or opposite the distal end of the tube part.) For the purpose of examination, the limitation is interpreted as referring to the arm parts being positioned on opposite positions from each other, and extending to a front side to the distal end of the tube part. Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation “side surfaces of the driving links and/or the opening and closing links.” This limitation renders the claim unclear as to if both the side surfaces of the driving links and the opening and closing links are required or of only one is required by the claim language. For the purpose of examination, the limitation “side surfaces of the driving links and/or the opening and closing links” is interpreted as “side surfaces of the driving links or the opening and closing links.” Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation "both side edge parts." There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation “both side edge parts” is interpreted as “a first and second side edge parts.” Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation "the distal end side." There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation “the distal end side” is interpreted as “a distal end side.” Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claim 1 recites the limitation “a through hole inserting and guiding the forward and backward movement transmission rod.” This limitation renders the claim unclear as to how a hole can insert anything. For the purpose of examination, the limitation “a through hole inserting and guiding the forward and backward movement transmission rod” is interpreted as “through hole receiving and guiding the forward and backward movement transmission rod.” Claims 2-14 are rejected due to their respective dependencies on claim 1.
Claims 4, 11, and 12 recite the limitation “the driving link and/or the opening and closing link” in the third line of the claims. This limitation renders the claim unclear as to if both the driving link and the opening/closing link are required or if only one is required. For the purpose of examination, the limitation “the driving link and/or the opening and closing link” is interpreted as “the driving link or the opening and closing link.” Claim 9 is rejected due to its dependency on claim 4.
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.
Claim(s) 1-3 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Maslanka (US 4,646,751) in view of Kaneko (US 2003/0187349 A1).
Regarding claim 1, Maslanka teaches
a sheath with flexibility inserted into and removed from an endoscope channel; (Fig. 1, Char. 13: cable jacket)
an operation wire disposed within the sheath (Fig. 1, Char. 17: operating cable) to be able to advance and retreat; (Col. 2, Lines 28-37)
an operation unit disposed in a proximal end part of the sheath, (Fig. 2) having a liquid injection port injecting a treatment liquid into the sheath (Fig. 1-2, Char. 33: fluid inlet tube; Col. 3, Lines 3-18) and operating the operation wire; (Col. 2, Lines 28-37)
a treatment unit support member (Fig. 1, Char. 23 and 25) having a tube part connected to a distal end part of the sheath (Fig. 1, Char. 23: pincer mounting collar) and a pair of arm parts extending to a front side from opposite positions to the distal end of the tube part; (Fig. 1: Pincer mounting (25) appears to have two arm portions at least extending distally from pincer mounting collar (25) given that lever arms (31) extend radially past pincer mounting collar (25); As best understood by examiner in light of the numerous 112b rejections discussed above, and looking to Applicant’s Fig. 10 of the present drawings, it appears the arm portions of pincer mounting collar (25) meet this limitation.)
a link mechanism constructed by a pair of opening and closing links which are rotatably connected one ends thereof by a first connection shaft (Attached “Annotated Maslanka Fig 1” below: The pin connecting the portions labelled “Third Link” and “Fourth Link”) in crossing parts intersecting in an overlapping manner, and a pair of driving links which are rotatably connected one ends thereof to the other ends of the pair of opening and closing links respectively by a second connection shaft (Attached “Annotated Maslanka Fig 1” below: The pin connecting the portions labelled “Third Link” and “First Link”) and a third connection shaft (Attached “Annotated Maslanka Fig 1” below: The pin connecting the portions labelled “Second” and “Fourth Link”) in an overlapping manner, and are rotatably connected the other ends thereof by a fourth connection shaft (Attached “Annotated Maslanka Fig 1” below: The pin connecting the portions labelled “First Link” and “Second Link”) in an overlapping manner, in which side surfaces of the driving links and/or the opening and closing links overlapping both side edge parts of the pair of arm parts of the treatment unit support member are in contact while rubbing, (Attached “Annotated Maslanka Fig 1” below: As best understood by examiner in light of the numerous 112b rejections discussed above, and looking to Applicant’s Fig. 11 in the present drawings, this claim limitation appears to be met by the link structure depicted in Maslanka.) a position of the first connection shaft being fixed to the arm part; (Fig. 1: Pivot (27) would be fixed to pincer mounting (25) to prevent the entire structure formed by both jaw members (29) and lever arms (31) from merely translating within pincer mounting (25) with translation of operating cable (17) instead of opening/closing the jaw members (29))
a pair of treatment pieces adapted to extend in a distal end direction from the one ends of the pair of opening and closing links of the link mechanism, and forming a treatment unit performing treatment of an affected area in a living body by a change between a closed state and an open state of the distal end side; (Attached “Annotated Maslanka Fig 1” below: The portions of jaws (29) labelled “Treatment Piece A” and “Treatment Piece B”) and
a forward and backward movement transmission rod to move the fourth connection shaft forward and backward by a forward and backward action force of the operation wire, (Attached “Annotated Maslanka Fig 1” below: The part labelled “Transmission Rod”)
wherein an inner concave wall having a through hole inserting and guiding the forward and backward movement transmission rod is formed in the tube part, (Fig. 1: The inner surface of pincer mounting collar (23) defining the lumen housing operating cable (17) and disposed within outside plastic covering (15) would be considered an inner concave wall; Said lumen housing operating cable (17) would be considered a through hole inserting and guiding operating cable (17)) and the through hole has a liquid supply part allowing the treatment liquid supplied through an inner side of the sheath to flow out to the inner surface of the pair of arm parts, (Col. 3, Lines 5-17) and
wherein the arm part has a treatment liquid supply path which jets the treatment liquid flowed out of the pair of concave surface parts, in a gap between the inner surface of the pair of arm parts and a side surface of the link mechanism. (Col. 3, Lines 5-17: As best understood by examiner, the cleaning solution would travel through the lumen housing operating cable (17), and wash/cover the link mechanism and jaw members disposed between the arm portions of pincer mounting (25))
Annotated Maslanka Fig. 1
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Maslanka, as applied to claim 1 above, is silent regarding the sheath being inserted into and removed from an endoscope channel; and wherein in the treatment unit support member, a concave surface part is formed in an inner surface of the pair of arm parts, the concave surface part being formed into a concave shape in a cross section which is vertical to a longitudinal direction,
However, absent a statement of criticality AND unexpected results, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Maslanka to make the inner surfaces of the arm parts of the pincer mounting (25) of Maslanka of whatever form or shape was desired or expedient, including having a concave shape in a cross section which is vertical to a longitudinal direction. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Modified Maslanka, as applied to claim 1 above, is silent regarding the sheath being inserted into and removed from an endoscope channel.
Kaneko, in a similar field of endeavor, teaches an endoscope configured for viewing a treatment location; (Fig. 1 and Par. [0047]) wherein said endoscope has a lumen (Fig. 1, Char. 2a: forceps opening) configured for housing a treatment tool inserted into and removed from said lumen. (Fig. 1 and Par. [0048])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Maslanka, as applied to claim 1 above, to incorporate the teachings of Kaneko, and configure the device of Maslanka to be inserted into and removed from an endoscope channel, wherein said endoscope comprises cameras and visual sensors to visualize the target treatment zone. Doing so would allow for the user to easily see the treatment zone and would protect the device of Maslanka from causing/receiving accidental damage during insertion/navigation to/from the treatment zone.
Regarding claim 2, the combination of Maslanka/Kaneko, as applied to claim 1 above, teaches the treatment liquid supply path is formed in such a manner that the treatment liquid is wider than a diameter of the first connection shaft and the treatment liquid flows straightly in both sides of the first connection shaft. (Maslanka: Col. 3, Lines 5-17 and Fig. 1: The liquid would coat the forceps during the washing step, making said liquid wider than the portions of the forceps being washed; The arm portions of pincer mounting (25) would cause the fluid to flow “straightly” at least in that said arms would prevent flow in the radial direction past said arm portions.)
Regarding claim 3, the combination of Maslanka/Kaneko, as applied to claim 2 above, teaches the concave surface part is a concave surface which is formed in each of opposite surfaces of the pair of arm parts in such a manner that a center of curvature conforms to an extended center line of the operation wire, (Absent a statement otherwise, one or ordinary skill in the art would expect operating cable (17) of Maslanka to be disposed in the center of the catheter, as shown in Fig. 1 of Maslanka; Furthermore, one of ordinary skill in the art would expect the curved arm portions of pincer mounting (25) to be centered around operating cable (17) in the Maslanka/Kaneko combination applied to claim 1 above.)
The combination of Maslanka/Kaneko, as applied to claim 2 above, is silent regarding a planar side surface part in an outer side of the crossing part of the opening and closing link is in slide contact with both side edge parts via the concave surface part in the opposite surfaces of the arm part in the same side.
However, it has been held that an “obvious to try” rationale when choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is a support for a conclusion of obviousness which is consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham, if the following findings can be established: (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem; (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem; (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. See MPEP § 2143(I)(E).
In the instant case, and as per (1), there is a need to minimize the risk of tissue/debris from entering the inner working mechanisms of electrosurgical devices and damaging, clogging, or otherwise interfering with the normal operation of said electrosurgical devices during use. As per (2), one of ordinary skill in the art would recognize that the spacing in the radial direction between the arm portions of the pincer mounting (25) of Maslanka and links forming the lever arms (31) of Maslanka can only be selected from the following options: (A) wherein the arm portions of the pincer mounting (25) of Maslanka and links forming the lever arms (31) of Maslanka are in contact with each other during actuation of said lever arms; or (B) wherein arm portions of the pincer mounting (25) of Maslanka and links forming the lever arms (31) of Maslanka are not in contact with each other during actuation of said lever arms”. As per (3), one of ordinary skill in the art would recognize that modifying the prior art based on the finite number of predictable solutions outlined herein can be done without changing the principles of operation of the prior art, and without changing the intended purpose of the prior art. As such, one of ordinary skill in the art would have a reasonable expectation of success when modifying the prior art. As per (4), by configuring the links forming the lever arms (31) of Maslanka to be in contact with the arm portions forming the pincer mounting (25) of Maslanka, the number of openings through which tissue debris can travel into the device and potentially clog/jam or otherwise interfere with the functionality of said device is minimized.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Maslanka/Kaneko, as applied to claim 2 above, by having the links forming the lever arms (31) of Maslanka be configured in sliding contact with the arms forming pincer mounting (25) of Maslanka, as a matter of trying a finite number of predictable solutions, in order to minimize the number of openings through which tissue debris can travel into the device and potentially clog/jam or otherwise interfere with the functionality of said device.
Regarding claims 6-8, the combination of Maslanka/Kaneko, as applied to claims 3 above, is silent regarding the liquid supply part is formed into an oval shape which is longer in the facing direction of the pair of arm parts.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the liquid supply part in the combination of Maslanka/Kaneko, as applied to claim 3 above, of whatever form or shape was desired or expedient, including an oval shape which is longer in the facing direction of the pair of arm parts. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 4, 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Maslanka (US 4,646,751) in view of Kaneko (US 2003/0187349 A1), as applied to claims 1 and 2 respectively above, and further in view of Kidooka (US 2004/0186348 A1).
Regarding claims 4, 11, and 12, the combination of Maslanka/Kaneko, as applied to claims 1 and 2 respectively above, is silent regarding the arm part is provided with a stopper which is disposed at a position preventing movement of the driving link and/or the opening and closing link caused by the forward and backward action of the forward and backward movement transmission rod.
Kidooka, in a similar field of endeavor, teaches a forceps device comprising an arm part provided with a stopper which is disposed at a position preventing movement of a first and second link past a certain point. (Fig. 2: The proximal portion of fore end member (2) would operating wires (8) from extending past a certain point after contacting said proximal portion)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Maslanka/Kaneko, as applied to claims 1 and 2 respectively above, to incorporate the teachings of Kidooka, and configure the pincer mounting (25) of Maslanka to include the proximal stopper of Kidooka which is disposed at a position preventing movement of the driving link and/or the opening and closing link caused by the forward and backward action of the forward and backward movement transmission rod. Doing so would ensure the jaws (29) of Maslanka remain within a predefined limit suitable for operation without damage to the device due to over extending the jaws (29).
Regarding claim 9, the combination of Maslanka/Kaneko/Kidooka, as applied to claims 4 above, is silent regarding the liquid supply part is formed into an oval shape which is longer in the facing direction of the pair of arm parts.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the liquid supply part in the combination of Maslanka/Kaneko/Kidooka, as applied to claim 4 above, of whatever form or shape was desired or expedient, including an oval shape which is longer in the facing direction of the pair of arm parts. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 5, 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Maslanka (US 4,646,751) in view of Kaneko (US 2003/0187349 A1), as applied to claims 1 and 3 respectively above, and further in view of Wang (US 2008/0161792 A1).
Regarding claims 5, 13, and 14, the combination of Maslanka/Kaneko, as applied to claims 1 and 3 respectively above, teaches the forward and backward movement transmission rod is in a distal end of the forward and backward movement transmission rod passing through the cylinder tube part. (Attached “Annotated Maslanka Fig. 1” below: The portion labelled “Transmission Rod” is disposed at least partially within mincer mounting collar (23))
Annotated Maslanka Fig. 1
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The combination of Maslanka/Kaneko, as applied to claims 1 and 3 respectively above, is silent regarding the forward and backward movement transmission rod is provided with a distal end part having a greater diameter than a shorter diameter of the liquid supply part and formed into a fist shape.
Wang, in a similar field of endeavor, teaches an irrigation catheter comprising a push/pull rod (Fig. 7a-b, Char. 770: actuating push/pull wire (770)) with a distal valve component disposed at a distal end of said push/pull rod; (Fig. 7a-b, Char. 708: valve element) wherein the valve component has a greater diameter than a shorter diameter of the liquid supply lumen. (Fig. 7a-b)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Maslanka/Kaneko, as applied to claims 1 and 3 respectively above, to incorporate the teachings of Wang, and configure the portion labelled “Transmission Rod” in attached “Annotated Maslanka Fig. 1” above to have a diameter greater than a shorter diameter of the liquid supply lumen, such that the transmission rod acts as a valve, closing off fluid supply when retracted to the proximal most position. Doing so would minimize the risk of accidentally delivering fluid through the device and injecting fluid to the treatment zone.
The combination of Maslanka/Kaneko/Wang, as applied to claims 5, 13, and 14 above, is silent regarding the distal end part of the transmission rod being formed into a fist shape.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the transmission rod in the Maslanka/Kaneko/Wang combination as applied to claims 5, 13, and 14 above, of whatever form or shape was desired or expedient, including a fist shape. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 10, the combination of Maslanka/Kaneko/Wang, as applied to claims 5 above, is silent regarding the liquid supply part is formed into an oval shape which is longer in the facing direction of the pair of arm parts.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the liquid supply part in the combination of Maslanka/Kaneko/Wang, as applied to claim 5 above, of whatever form or shape was desired or expedient, including an oval shape which is longer in the facing direction of the pair of arm parts. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./ Examiner, Art Unit 3794