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 .
Response to Amendment
In response to the amendment filed 1/5/2025, claims 1-11 are pending.
The previous drawing objections and 35 U.S.C. 112 rejections are obviated and hereby withdrawn.
Response to Arguments
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the arguments do not apply to any of the new combination of references being used in the current rejection. Applicant has amended the claims, thus changing the scope and requiring additional consideration. A new grounds of rejections is set forth below citing McWeeney et al (US 2012/0116248) to teach the features regarding the contact of the screw portion. The feature of a screw portion extending in a direction intersecting the axial direction of the device and in contact with the outer peripheral surface of the element it is locking is generally well known, see other references cited under the “Pertinent Art” section.
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.
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) 1-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinkham et al (US 2012/0226101) in view of McWeeney et al (US 2012/0116248) and Tseuda (US 2017/0266391).
Claim 1. Tinkham et al discloses a puncture device comprising:
a puncture needle (103) ([011]); and
an operation part (Fig. 1) that moves the puncture needle in an axial direction and is attachable to and detachable from an ultrasonic endoscope ([0011], [0017], [0018]),
wherein the operation part includes a gripping member (102) that is connected to the puncture needle ([0018]), a first member (104) that is connected to the gripping member and is movable relative to the gripping member in the axial direction ([0012]), and a restricting member (122) that restricts a relative movable distance between the first member and the gripping member ([0016]);
wherein the restricting member (122) includes a movable member (132) that is attached to an outer peripheral surface of the first member (104) to be movable along the axial direction with respect to the first member ([0016]), and a first rotational movement member (128) that is rotationally movable with respect to the movable member ([0016] discusses mechanism 122 is formed substantially similarly to mechanism 120; wherein [0014] discusses details of the rotational movement member 128), and
the first rotational movement member comprises a vertical rotating portion (Fig. 3, inside the center of the first rotational movement member 128) extending in a direction intersecting the axial direction.
Tinkham et al discloses rotation of the first rotational movement member (128) is able to move one or more arms (which are not shown and extend from a part of the knob 128 and is located between the ring 124 and the outer surface of the distal portion 106). The arms are sized so that, when the knob 128 is rotated to a first orientation, the arms are located within a space formed between a larger diameter portion of the non-circular inner surface of the ring 124 and the distal portion 106 so that the ring 124 is loosely held around the distal portion 106. Rotation of the knob 128 to a second orientation moves the arms into a smaller space between a reduced diameter portion of the non-circular inner surface of the ring 124 and the distal portion 106 so that the ring 124 is pressed tightly against the distal portion 106 locking the positions of the distal portion 106 and the central portion 104 ([0014]). Tinkham fails to disclose the first vertical portion of the rotational movement member comprises a screw portion and is in contact with the outer peripheral surface of the first member. However, in the same field of endeavor, McWeeney et al teaches a needle biopsy device having a restricting member including a movable member (33) (akin to Tinkham’s movable member 132) that is attached to an outer peripheral surface of a first member (10b) (akin to Tinkham’s first member 104) to be movable along the axial direction with respect to the first member, and a first rotational movement member (12) (akin to the first rotational movement member 128 of Tinkham et al) which comprises a screw portion (vertical portion in Figs. 5, 7, 8) extending in a direction (vertical direction) intersecting the axial direction (longitudinal direction of the device) and in contact (e.g. tightened, can be seen tightened against and making contact with element 10b in Fig. 7 as element 10b is disposed within locking ring 33) with the outer peripheral surface of the first member (10b) in order to rotate to thereby restrict movement between the movable member and the first member ([0069]). Therefore, since both Tinkham et al and McWeeney et al are directed to movement restriction mechanisms via a movable member and a first rotational movement member, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one mechanism (the arms of Tinkham et al) with another (the contacting screw of McWeeney et al) to achieve the predictable result of holding the movable member in place relative to the first member.
Tinkham et al further fails to disclose an outer peripheral surface of the gripping member (102) includes a pair of first planes that are arranged in a first direction and are disposed to face each other, and a pair of second planes that are arranged in a second direction intersecting the first direction and are disposed to face each other. However, Tinkham does disclose the shape of the gripping member is not critical as it may be formed with a non-circular cross-sectional shape without deviating from the scope of the invention as opposed to being cylindrical ([0012]). In the same field of endeavor of endoscopic needles, Tseuda teaches a puncture device having an operation part having a plurality of members (61, 62) (equivalent to the manipulative parts of Tinkham et al, including elements 102, 104 and 106), wherein the outer peripheral surfaces of the members (61, 62) may be cylindrical or square tubular ([0057]). Therefore, since both Tinkham et al and Tseuda are directed to operating parts of an endoscopic needle and Tinkham et al explicitly states the cylindrical shape of its gripping part is not required, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known shape (cylindrical tubular of Tinkham) with another (square tubular Tseuda) to achieve the predictable result of providing a graspable shape for manipulation of an endoscopic needle. It is the Examiner’s position that it would have been well within the purview of one of ordinary skill in the art to select the desired shape for use based on the teachings of the prior art. Tinkham et al as modified with Tseuda would result in the outer peripheral surface of the gripping member (102) including a pair of first planes (top and bottom side planes) that are arranged in a first direction and are disposed to face each other, and a pair of second planes (left and right side planes) that are arranged in a second direction intersecting the first direction and are disposed to face each other as a square by definition includes four parallel sides of equal lengths at four right angles which would result in the claimed plane configuration.
Claim 2. The combination discloses the invention substantially as claimed above, wherein Tseuda further discloses the first direction and the second direction are orthogonal to each other ([0057]; i.e. a square as defined includes four orthogonal angles and therefore the first and second direction are orthogonal to each other).
Claim 3. The combination discloses the invention substantially as claimed above, wherein Tinkham et al further discloses the gripping member (102) has a tubular shape (Fig. 3), the first member (104) is inserted into a distal end side of the gripping member (102) (Fig. 3; [0011], [0013]). The combination fails to disclose an outer peripheral surface of the first member has a shape including a plane parallel to at least one of the pair of first planes or the pair of second planes.
However, Tseuda teaches a puncture device having an operation part having a plurality of members (61, 62) (equivalent to the manipulative parts of Tinkham et al, including elements 102, 104 and 106), wherein the outer peripheral surfaces of the members (61, 62) may be cylindrical or square tubular ([0057]). Therefore, since both Tinkham et al and Tseuda are directed to operating parts of an endoscopic needle, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known shape (cylindrical tubular of Tinkham as seen in Fig. 2) with another (square tubular Tseuda) to achieve the predictable result of providing a graspable shape for manipulation of an endoscopic needle. It is the Examiner’s position that it would have been well within the purview of one of ordinary skill in the art to select the desired shape for use based on the teachings of the prior art. Tinkham et al as modified with Tseuda would result in the outer peripheral surface of the first member (104) having a shape including a plane parallel to at least one of the pair of first planes or the pair of second planes as both the first member (104) and gripping member (102) would have a square tubular cross-sectional shape and the first member is oriented in a manner to fit into the distal side of the gripping member (Tinkham et al: [0011], [0016]).
Claim 4. The combination discloses the invention substantially as claimed above, wherein as modified with the square tubular shape of Tseuda, the device of Tinkham et al would result in the outer peripheral surface of the first member (104) having a shape including planes parallel to each of the pair of first planes and to each of the pair of second planes as both the first member (104) and gripping member (102) would have a square tubular cross-sectional shape and the first member is oriented in a manner to fit into the distal side of the gripping member (Tinkham et al: [0011], [0016]).
Claim 5. The combination discloses the invention substantially as claimed above, wherein Tinkham et al further discloses the operation part includes a second member (106) that is connected to the first member (104) and is movable relative to the first member in the axial direction ([0011], [0014], [0015]), and a fixing member (120) that fixes a relative position between the first member and the second member to any of a plurality of positions ([0014], [0015]). The combination fails to disclose an outer peripheral surface of the second member has a shape including a plane parallel to each of the pair of first planes and the pair of second planes.
However, Tseuda teaches a puncture device having an operation part having a plurality of members (61, 62) (equivalent to the manipulative parts of Tinkham et al, including elements 102, 104 and 106), wherein the outer peripheral surfaces of the members (61, 62) may be cylindrical or square tubular ([0057]). Therefore, since both Tinkham et al and Tseuda are directed to operating parts of an endoscopic needle, it would have been obvious to one of ordinary skill in the art before the effective filing date to substitute one known shape (cylindrical tubular of Tinkham as seen in Fig. 2) with another (square tubular Tseuda) to achieve the predictable result of providing a graspable shape for manipulation of an endoscopic needle. It is the Examiner’s position that it would have been well within the purview of one of ordinary skill in the art to select the desired shape for use. Tinkham et al as modified with Tseuda would result in the outer peripheral surface of the second member (106) having a shape including a plane parallel to each of the pair of first planes and the pair of second planes as both the first member (104) and gripping member (102) would have a square tubular cross-sectional shape and the first member is oriented in a manner to fit into the distal side of the gripping member (Tinkham et al: [0011], [0016]).
Claim 6. The combination discloses the invention substantially as claimed above, wherein Tinkham et al discloses the first member (104) has a tubular shape (Figs. 2, 3), and the second member (106) is inserted into a distal end side of the first member (Figs. 1-3; [0011], [0014], [0015]).
Claim 7. The combination discloses the invention substantially as claimed above, wherein Tinkham et al discloses a distal end part (108) of the second member is mountable in a treatment tool introduction hole of the ultrasonic endoscope ([0011], [0017], [0018]), and an outer diameter of the distal end part is larger than an inner diameter of the first member (Figs. 1-3).
Claim 10. The combination discloses the invention substantially as claimed above, wherein Tseuda discloses a length of each of the pair of first planes and a length of each of the pair of second planes coincide with each other in a state of being viewed in the axial direction ([0057], a square by definition includes four parallel sides of equal lengths at four right angles and would therefore have coinciding lengths1.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinkham et al in view of McWeeney et al and Tseuda et al as applied to claims 1 and 5 above, and further in view of Mata (US 2002/0042613).
Claim 8. The combination discloses the invention substantially as claimed above, wherein but fails to disclose an outer peripheral surface of the first rotational movement member has a shape including a pair of third planes that are arranged in a third direction and are disposed to face each other, and a pair of fourth planes that are arranged in a fourth direction intersecting the third direction and are disposed to face each other.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely using a rotational screw to come into contact with an elongate member to thereby hold the elongate member in place, Mata teaches a restricting member of a medical device, including a rotational movement member (81) having a shape (square) including a pair of third planes (left and right side planes) that are arranged in a third direction (left and right direction) and are disposed to face each other, and a pair of fourth planes (front and back side planes) that are arranged in a fourth direction (front and back direction) intersecting the third direction and are disposed to face each other (Fig. 6; [0034]; a square by definition includes four parallel sides of equal lengths at four right angles which would result in the claimed plane configuration and intersection of direction due to the orthogonal angles). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the first rotational movement member (128) in the combination to have such a shape, and thus planes, as claimed to provide a suitable shape for gripping and applying torque to rotate the first rotational movement member.
Claim 9. The combination discloses the invention substantially as claimed above, wherein Tinkham et al discloses the operation part includes a fixing member (120) includes a second rotational movement member (128) that is rotationally movable about a rotational movement shaft (a direction perpendicular to the x-axis and y-axis, extending along the z-axis, up and down, in Fig. 3)2 extending in a direction intersecting the axial direction ([0014]). The combination fails to disclose a shape of an outer peripheral surface of the second rotational movement member is a shape including a pair of fifth planes that are arranged in a fifth direction intersecting the rotational movement shaft and are disposed to face each other, and a pair of sixth planes that are arranged in a sixth direction intersecting the fifth direction and are disposed to face each other.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely using a rotational screw to come into contact with an elongate member to thereby hold the elongate member in place, Mata teaches a restricting member of a medical device, including a rotational movement member (81) having a shape (square) including a pair of fifth planes (left and right side planes) that are arranged in a fifth direction (left and right direction) and are disposed to face each other, and a pair of sixth planes (front and back side planes) that are arranged in a sixth direction (front and back direction) intersecting the fifth direction and are disposed to face each other (Fig. 6; [0034]; a square by definition includes four parallel sides of equal lengths at four right angles which would result in the claimed plane configuration and intersection of direction due to the orthogonal angles). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the second rotational movement member (128) in the combination to have such a shape, and thus planes, as claimed to provide a suitable shape for gripping and applying torque to rotate the second rotational movement member.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinkham et al in view of McWeeney et al and Mata.
Claim 11. Tinkham et al discloses a puncture device comprising:
a puncture needle (103) ([011]); and
an operation part (Fig. 1) that moves the puncture needle in an axial direction and is attachable to and detachable from an ultrasonic endoscope ([0011], [0017], [0018]),
wherein the operation part includes a gripping member (102) that is connected to the puncture needle ([0018]), a first member (104) that is connected to the gripping member and is movable relative to the gripping member in the axial direction ([0012]), and a restricting member (122) that restricts a relative movable distance between the first member and the gripping member ([0016]),
the restricting member (122) includes a movable member (132) that is attached to an outer peripheral surface of the first member (104) to be movable along the axial direction with respect to the first member ([0016]), and a first rotational movement member (128) that is rotationally movable with respect to the movable member ([0016] discusses mechanism 122 is formed substantially similarly to mechanism 120; wherein [0014] discusses details of the rotational movement member 128); and
the first rotational movement member comprises a vertical rotating portion (Fig. 3, inside the center of the first rotational movement member 128) extending in a direction intersecting the axial direction.
Tinkham et al discloses rotation of the first rotational movement member (128) is able to move one or more arms (which are not shown and extend from a part of the knob 128 and is located between the ring 124 and the outer surface of the distal portion 106). The arms are sized so that, when the knob 128 is rotated to a first orientation, the arms are located within a space formed between a larger diameter portion of the non-circular inner surface of the ring 124 and the distal portion 106 so that the ring 124 is loosely held around the distal portion 106. Rotation of the knob 128 to a second orientation moves the arms into a smaller space between a reduced diameter portion of the non-circular inner surface of the ring 124 and the distal portion 106 so that the ring 124 is pressed tightly against the distal portion 106 locking the positions of the distal portion 106 and the central portion 104 ([0014]). Tinkham fails to disclose the first vertical portion of the rotational movement member comprises a screw portion and is in contact with the outer peripheral surface of the first member. However, in the same field of endeavor, McWeeney et al teaches a needle biopsy device having a restricting member including a movable member (33) (akin to Tinkham’s movable member 132) that is attached to an outer peripheral surface of a first member (10b) (akin to Tinkham’s first member 104) to be movable along the axial direction with respect to the first member, and a first rotational movement member (12) (akin to the first rotational movement member 128 of Tinkham et al) which comprises a screw portion (vertical portion in Figs. 5, 7, 8) extending in a direction (vertical direction) intersecting the axial direction (longitudinal direction of the device) and in contact (e.g. tightened, can be seen tightened against and making contact with element 10b in Fig. 7 as element 10b is disposed within locking ring 33) with the outer peripheral surface of the first member (10b) in order to rotate to thereby restrict movement between the movable member and the first member ([0069]). Therefore, since both Tinkham et al and McWeeney et al are directed to movement restriction mechanisms via a movable member and a first rotational movement member, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one mechanism (the arms of Tinkham et al) with another (the contacting screw of McWeeney et al) to achieve the predictable result of holding the movable member in place relative to the first member.
Tinkham et al further fails to disclose an outer peripheral surface of the first rotational movement member includes a pair first of planes that are arranged in a first direction and disposed to face each other, and a pair of second planes that are arranged in a second direction intersecting the first direction and that are disposed to face each other.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely using a rotational screw to come into contact with an elongate member to thereby hold the elongate member in place, Mata teaches a restricting member of a medical device, including a rotational movement member (81) having a shape (square) having an outer peripheral surface including a pair of first planes (left and right side planes) that are arranged in a first direction and disposed to face each other, and a pair of second planes (front and back side planes) that are arranged in a second direction intersecting the first direction and that are disposed to face each other (Fig. 6; [0034]; a square by definition includes four parallel sides of equal lengths at four right angles which would result in the claimed plane configuration and intersection of direction due to the orthogonal angles). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the first rotational movement member (128) of Tinkham et al to have such a shape, and thus planes, as claimed to provide a suitable shape for gripping and applying torque to rotate the first rotational movement member.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ouchi (US 20010005778) and Ravikumar et al (KR 20090013169) each disclose surgical instruments using a screw making contact with another element to thereby tighten and lock the element in place. This feature is therefore old and well known in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1 As defined by Applicant in [0041] of the published application (“Two lengths being substantially the same means that the two lengths coincide with each other, excluding tolerances in difference.”)
2 Applicant uses the term “shaft” to refer to an axis as noted in [0058] of the published application and therefore the term will be given the same interpretation in the claim (“The outer peripheral surface 320 of the second rotational movement member 32 has preferably a quadrangle or a shape in which corner portions of the quadrangle are chamfered in a plan view along a direction of the rotational movement shaft (a direction perpendicular to the fifth direction D5 and the sixth direction D6))”.