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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Election/Restrictions
Applicant's election with traverse of claims 1-18 in the reply filed on 3/9/26 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because the method claims require different search techniques even when they are classified in the same area as the apparatus.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “: i) at least a first wire that is helically wound to form an outer coil so that adjacent helical windings of the at least first wire are in contact with one another [Par. 0036 and Fig. 7]; and ii) at least a second wire that is helically wound to form an inner coil so that adjacent helical windings of the at least second wire are in contact with one another; iii) the outer col surrounding the inner coil.” First “col” is a typographical error and should be “coil.” Second, the “and” is located in the middle of the series, which is confusing. It should be moved to just before the last element in the series (iii), or a wherein clause to be used before (iii).
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 1-5, 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “loosely wound.” The metes and bounds of the claim are unclear because it is unclear what, for example, pitch constitutes a loose winding.
Claim 17 recites “the proximal-most end portion tubular shaft distal portion.” The meaning of this is unclear and/or it lacks antecedent basis. A proximal-most end portion of a tubular shaft distal portion is previously recited, and it is assumed this is that this refers to.
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) 1-3, 5-9, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. [US 2018/0055535 A1, hereinafter “Tada”] in view of To et al. [US 8361094 B2, hereinafter “To”].
Re. claim 1. Tada discloses: A medical device [Figs. 1-10] that removes an object in a body lumen [Par. 0002], the medical device comprising:
a drive shaft [21] that is rotatable [Par. 0036];
a cutter [40] that is rotationally driven by the drive shaft [Par. 0034]and is able to cut the object [Par. 0041];
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an outer tubular shaft [30] that rotatably accommodates the drive shaft [Par. 0033];
a conveyance coil [26] that is loosely wound [See 112(b). This term is not well defined. However, relative to coil 27, coil 26 is loosely wound]; and
the conveyance coil being fixed to the drive shaft only at a distal end section of the conveyance coil [Par. 0041: “only one of the distal side and the proximal side of the first conveying body 26 may be fixed to the driven tube 21.” Here, the embodiment cited is that where only the distal side 26B of the coil 26 is fixed to the drive shaft 21].
The invention of Tada differs from the claimed invention in that Tada discloses the coil being wrapped around an interior of the drive shaft, not an exterior. However, To teaches, a medical device for removing an object in a body lumen, the conveyance coil [118, Fig. 3] is disposed to wrap around an outer periphery of the drive shaft [114]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Tada by adding an additional conveyance coil identical to the one above to the exterior of the drive shaft such that the conveyance coil is disposed to wrap around an outer periphery of the drive shaft, as taught by To, because this results in a shaft which is “automatically reinforc[ed]” by the coil and has maximized “torsional strength and stiffness, as well as column strength for "pushability", and minimize bending stiffness for flexibility. Such features are important for navigation of the catheter through tortuous vessels,” [To, Col. 7 lines 55-68. Note that To contemplates conveying coils on both the interior and exterior of the drive shaft. See Fig. 5B].
Re. claim 2. Tada discloses: The medical device according to Claim 1, wherein, during rotation, the conveyance coil extends along an axial direction, and the drive shaft extends along the axial direction [left-right in Fig. 2].
Re. claim 3. Tada discloses: The medical device according to Claim 1, wherein the conveyance coil is fixed to the drive shaft only at a distal end of the conveyance coil [Par. 0041: “only one of the distal side and the proximal side of the first conveying body 26 may be fixed to the driven tube 21.” Here, the embodiment cited is that where only the distal side (end, Fig. 7) of the coil 26B is fixed to the drive shaft 21].
Re. claim 5. Tada discloses: The medical device according to Claim 1, wherein a coil proximal end located at a proximal end of the conveyance coil has a curved surface [see Fig. 7. Proximal end 26C has a surface which is curved in a cylindrical shape].
Re. claim 6. Tada discloses: A medical device [Figs. 1-10] operable to remove an object in a body lumen [Par. 0002], the medical device comprising:
a rotatable [Par. 0036] drive shaft [21] that extends in an axial direction [left-right in Fig. 2] and that has a distal end portion [where cutter 40 is attached], the rotatable drive shaft having an outer periphery [its outer diameter]
a cutter [40] connected to the drive shaft so that rotation of the drive shaft results in rotation of the cutter [Par. 0034], the cutter being located at the distal end portion of the drive shaft [Fig. 2, as defined] and being configured to cut the object when the cutter is brought into contact with the object while rotating [Par. 0041];
an outer tubular shaft [30] having an interior in which is located the drive shaft, the outer tubular shaft having an inner periphery [inner diameter of tube] facing the outer periphery of the drive shaft so that a spaced exists between the inner periphery of the outer tubular shaft and the outer periphery of the drive shaft [Par. 0033. Because the drive shaft is rotatable inside the outer tubular shaft, a space necessarily exists];
an opening [25] through which is conveyable a part of the object cut by the cutter and liquid in the body lumen, so that the part of the object cut by the cutter and the liquid can enter by way of the opening [Par. 0008, 0035];
a conveyance coil [26] helically wound around a drive shaft so that axially adjacent windings of the conveyance coil are axially spaced apart from one another [Fig. 7], the conveyance coil having a distal end portion terminating at a distal-most end of the conveyance coil and a proximal end portion terminating at a proximal-most end of the conveyance coil [Fig. 2];
and at least a part of the distal end portion of the conveyance coil being fixed to the drive shaft so that rotation of the drive shaft results in rotation of the conveyance coil so that the conveyance coil conveys the part of the object cut by the cutter and the liquid in the axial direction [Par. 0008], an entirety of the proximal end portion of the conveyance coil being a non-fixed portion of the conveyance coil that is not fixed to the drive shaft so that the drive shaft is movable relative to the non-fixed portion of the conveyance coil [Par. 0041: “only one of the distal side and the proximal side of the first conveying body 26 may be fixed to the driven tube 21.” Here, the embodiment cited is that where only the distal side 26Bof the coil 26 is fixed to the drive shaft 21].
The invention of Tada differs from the claimed invention in that Tada discloses the coil being wrapped around an interior of the drive shaft, not an exterior, and thus fails to teach the opening in communication with the space between the outer shaft and drive shaft, the conveyance coil being located in the space. However, To teaches, a medical device for removing an object in a body lumen, the conveyance coil [118, Fig. 3] is disposed to wrap around an outer periphery of the drive shaft [114], and a space being located between the drive shaft and outer shaft [120, Fig. 1A-B], the opening in communication with the space between the outer shaft and drive shaft, the conveyance coil being located in the space. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of Tada by adding an additional conveyance coil identical to the one above to the exterior of the drive shaft such that the conveyance coil is disposed to wrap around an outer periphery of the drive shaft, as taught by To, because this results in a shaft which is “automatically reinforc[ed]” by the coil and has maximized “torsional strength and stiffness, as well as column strength for "pushability", and minimize bending stiffness for flexibility. Such features are important for navigation of the catheter through tortuous vessels,” [To, Col. 7 lines 55-68. Note that To contemplates conveying coils on both the interior and exterior of the drive shaft. See Fig. 5B]. This addition defines the above “space” as a conveying space, since material is conveyed through it, the conveyance coil being located in the space, and the opening through which the material is drawn is therefore in communication with the space between the outer shaft and the drive shaft as claimed. See To Col 9 lines 19-23.
Re. claim 7. Tada discloses: The medical device according to Claim 6, wherein the opening [25] is a distal end opening located at a distal end of the outer tubular shaft and proximal of a proximal end of the cutter [40] [see Fig. 2].
Re. claim 8. Tada discloses: The medical device according to Claim 6, wherein the conveyance coil is helically wound around an intermediate portion of the drive shaft so that one portion of the drive shaft extends distally beyond the distal-most end of the conveyance coil and an other portion of the drive shaft extends proximally beyond the proximal-most end of the conveyance coil [Annotated Fig. 2].
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Re. claim 9. Tada discloses: The medical device according to Claim 6, wherein the drive shaft is comprised of at least one wire that is helically wound in a coil so that adjacent helical windings of the at least one wire are in contact with one another [Par. 0036 and Fig. 7].
Re. claim 18. Tada discloses the apparatus set forth above but fails to explicitly disclose a handle. However, To teaches a handle “handle,” Col. 5 line 58], the drive shaft including a proximal portion operatively connected to a drive unit that, when operated, rotates the drive shaft, the drive unit being located in the handle [Col. 5 lines 55-61]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus to include a handle with a drive unit in it in order to allow a user to operate the device bay hand.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of To, as applied to claim 1, and further in view of Shturman et al. [US 20030139689 A1, hereinafter “Shturman”].
Re. claim 4. Tada discloses: The medical device according to Claim 1, wherein the drive shaft includes a multi-wire coil comprised of plural wound wire materials [portion 21A being formed of wires, Par. 0036 and Fig. 7], but fails to teach the claimed integrated portion.
However, Shturman teaches, in a medical device, a shaft formed of coiled wire [22, Fig. 45]] including an integrated portion [25] in which a plurality of the wire materials arranged in a circumferential direction over an entire circumference are melted and integrated with one another [when welded, Par. 0121], and the distal end section of the conveyance coil being fixed to the integrated portion [Fig. 45, distal end of 24]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tada to form an integrated portion as taught by Sturman in order to ensure the drive shaft and outer coil are “coaxially stabilized” so that they “cannot shift relative to one another in an axial direction,” Shturman Par. 0121]
Re. claim 10. Tada discloses: Re. claim 10. The medical device according to Claim 6, the at least a part of the distal end portion of the conveyance coil being fixed to a portion of the drive shaft [see claim 6 above] but fails to teach the annular integrated portion as claimed.
However, Shturman teaches, in a medical device, the shaft [22] includes an annular integrated portion [25] in which adjacent windings of the at least one wire are joined together by melting [when welded, Par. 0121], the at least a part of the distal end portion of the conveyance coil being fixed to the annular integrated portion of the drive shaft [Fig. 45, distal end of 24]. . It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tada to form an integrated portion as taught by Sturman in order to ensure the drive shaft and outer coil are “coaxially stabilized” so that they “cannot shift relative to one another in an axial direction,” Shturman Par. 0121]
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of To, as applied to claim 6, and further in view of McKenzie (US 5108411 A).
Re. claim 11. Tada discloses: the medical device according to Claim 6, wherein the drive shaft is comprised of: i) at least a first wire that is helically wound to form an outer coil so that adjacent helical windings of the at least first wire are in contact with one another [Par. 0036 and Fig. 7]; but fails to teach the second wire.
However, McKenzie teaches, in a drive shaft [14] for a medical device, a first [44, Fig. 2] and ii) at least a second [46] wire that is helically wound to form an inner coil so that adjacent helical windings of the at least second wire are in contact with one another [Fig. 2]; iii) the outer coil surrounding the inner coil [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tada by forming the drive shaft to comprise, in addition to the first wire, a second wire which is an inner wire surrounded by the outer coil as taught by McKenzie because this configuration allows for a ” very high torsional modulus of elasticity may be achieved, while the flexural modulus of elasticity is decreased because of the flexible nature of the coil structures,” McKenzie Col. 6 lines 9-12.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of To, as applied to claim 6, and further in view of Takemoto [US 20180078282 A1].
Re. claim 12. Tada discloses: The medical device according to Claim 6, but fails to teach the outer tubular shaft comprising an inner and outer layer.
However, Takemoto teaches, in a shaft for a medical device, wherein the outer tubular shaft [4 and 5, Fig. 2] is comprised of an inner layer [4] and an outer layer[5] , the inner layer being radially inwardly of the outer layer [Fig. 2], the inner layer having an outer surface and the outer layer having an inner surface, the outer surface of the inner layer and the inner surface of the outer layer facing one another and being spaced apart from one another so that a lumen exist between the outer surface of the inner layer and the inner surface of the outer layer [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Tada such that the outer tubular shaft is formed of two layers with a lumen between them as taught by Takemoto because this configuration allows for the use of outer tubes with different properties, here a braided inner layer for transmitting torsional torque [Takemoto Par. 0016] and an outermost layer which has a smooth surface, improving insertability [Takemoto Par. 0017].
Re. claim 13. Takemoto further teaches the outer layer includes at least one through hole [7, Fig. 2] that opens into the lumen between the outer surface of the inner layer and the inner surface of the outer layer [Par. 0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the above apparatus to further include a through hole in the outer layer as taught by Takemoto such that “the space in which the braided tube 4 is disposed is prevented from expanding even when the pressure is decreased by vacuum suction, and rupturing of the outer tube 5 can be reliably prevented” [Takemoto Par. 0025]
Re. claim 14. Tada discloses: the outer tubular shaft extends distally beyond the distal-most end of the conveyance coil and extends proximally beyond a proximal-most end of the conveyance coil [Fig. 2]. Takemoto teaches the inner layer extending along the entire outer tubular shaft, and therefore the combined Tada-Takemoto teaches the inner layer extends distally beyond the distal-most end of the conveyance coil as claimed.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of To, as applied to claim 6, and further in view of Smith [US 4917085 A].
Re. claim 15. Tada discloses: The medical device according to Claim 6, wherein the drive shaft is comprised of at least one wire that is helically wound as a drive shaft coil so that adjacent helical windings of the at least one wire are in contact with one another [Par. 0036 and Fig. 7] , but fails to teach a distal protecting tubular body. However, Smith teaches, in a drive shaft, the drive shaft also including a distal protecting tubular body [72, Fig. 6] covering an outer peripheral surface of a distal portion of the drive shaft coil [74]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tada by adding a distal protecting tubular body as taught by Smith in order to further reinforce the shaft and improve the ability to transmit torque.
Regarding the distal protecting tubular body being spaced distally from the distal-most end of the conveyance coil, because Tada teaches the drive shaft extending distally beyond the conveyance coil, the above references as combined reasonably teach this limitation.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of To and Smith, as applied to claim 15, and further in view of Takemoto.
Re. claim 16, Tada fails to teach the outer tubular shaft comprising an inner and outer layer. However, Takemoto teaches, in a shaft for a medical device, wherein the outer tubular shaft [4 and 5, Fig. 2] is comprised of an inner layer [4] and an outer layer[5] , the inner layer having an outer surface and the outer layer having an inner surface, the outer surface of the inner layer and the inner surface of the outer layer facing one another and being spaced apart from one another so that a lumen exist between the outer surface of the inner layer and the inner surface of the outer layer [Fig. 2]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Tada such that the outer tubular shaft is formed of two layers with a lumen between them as taught by Takemoto because this configuration allows for the use of outer tubes with different properties, here a braided inner layer for transmitting torsional torque [Takemoto Par. 0016] and an outermost layer which has a smooth surface, improving insertability [Takemoto Par. 0017].
the outer tubular shaft also comprising a tubular shaft distal portion [indicated portion 6, Annotated Fig. 1] having a proximal-most end portion that axially overlaps with and is fixed to a distal-most end portion of the inner layer [Annotated Fig. 1], the distal protecting tubular body [equivalent 2] having an outer surface that faces an inner surface of the tubular shaft distal portion [Fig. 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Tada to include the tubular shaft distal portion as taught by Takemoto in order to allow the ends to be fixed to one another.
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Allowable Subject Matter
Claim 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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