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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 34 is objected to because of the following informalities:
in claim 34, line 17: “a distal end” should be “the distal end”;
in claim 34, line 24: “a rotational speed” should be “the rotational speed”;
in claim 34, line 28: “a rotational speed” should be “the rotational speed”.
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 34, 36, 38-39, and 41 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 34 recites “the distal end” in line 8, but it is not clear if this recitation is referring to the distal end of the tubular member in lines 3-4, the distal end of base member in line 5, or “a distal end of the elongated hollow tube” in lines 7-8. Clarification is required.
Claims 36, 38-39, and 41 are rejected by virtue of their dependence from claim 34.
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.
Claims 34, 38-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0038202 (Klein)(previously cited), in view of U.S. Patent Application Publication No. 2014/0142464 (Harms)(previously cited).
With respect to the various citations to the embodiments of Klein, Klein teaches, “It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention.” (paragraph 0469 of Klein). Therefore, to the extent that it can be argued that all the features taught by Klein are not provided in a single embodiment, Klein explicitly states that the features of any embodiment can be provided in any other embodiment in any suitable subcombination. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Klein.
Klein teaches a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of the distal end of the hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately or one motor portion is used for rotation and another motor portion is used for advancement, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (connecting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein to the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein),
activating the motor such that rotation at a rotational speed is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
Klein teaches that the rotation speed of the sampling portion by the motor during the sampling procedure can be between 100-12,000 RPM or a larger speed (paragraph 0242 of Klein). Klein teaches that the speed of rotation and advancement depends upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size (paragraphs 0010-0011, 0036, 0057-0058, 0119-0123, 0156, 0184-0185, 0188, and 0243 of Klein). Harms teaches that speeds of up to 90,000 RPM can be used (paragraphs 0026-0027 of Harms). In particular, Harms teaches that high rates of speed up to as much as 90,000 RPM may be used (paragraph 0026 of Klein). Klein and Harms therefore suggest that the rotation speed of the sampling portion by the motor during the sampling procedure can be varied depend upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. As such, the rotation speed of the sampling portion by the motor during the sampling procedure is a results-effective variable that would have been optimized through routine experimentation based on the factors of tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the rotation speed of the sampling portion by the motor during the sampling procedure, using the values of 100 RPM of Klein, 12,000 RPM of Klein, and 90,000 RPM of Harms as starting points, so as to obtain suitable samples with respect to tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. Thus, the rotation speed of the sampling portion by the motor before and during the sampling procedure being between 13,000 RPM and 25,000 RPM would have been obvious.
With respect to claim 34, the combination teaches or suggests a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein ),
activating the motor such that rotation at a rotational speed of between 13,000 and 25,000 rpm is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed of between 13,000 and 25,000 rpm thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member at a rotational speed of between 13,000 and 25,000 rpm with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein; the rotation range being obvious by the above discussed optimization),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
With respect to claim 38, the combination teaches or suggests that the interior surface or an outer surface of the sample acquiring portion is liquid tight (claim 13 of Klein; the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein have surfaces that are solid and therefore liquid tight).
With respect to claim 39, the combination teaches or suggests that the distally facing circular cutting edge is shaped and the smooth interior surface connects to the cutting edge such that the smooth interior surface extends, as seen along the central geometrical axis, to a most distal part of the cutting edge (see the interior surfaces of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 and the shear section 122, 455, 608, 616, 626, 636, 646 656, 712, 804, 1018, 1026 of Klein).
With respect to claim 41, the combination teaches or suggests that the base member comprises an inner elongated hollow tubular member extending from the proximal end to the distal end of the base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein is such a tubular member).
Claims 34, 38-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Klein, in view of U.S. Patent Application Publication No. 2006/0122535 (Daum).
With respect to the various citations to the embodiments of Klein, Klein teaches, “It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention.” (paragraph 0469 of Klein). Therefore, to the extent that it can be argued that all the features taught by Klein are not provided in a single embodiment, Klein explicitly states that the features of any embodiment can be provided in any other embodiment in any suitable subcombination. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Klein.
Klein teaches a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of the distal end of the hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately or one motor portion is used for rotation and another motor portion is used for advancement, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (connecting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein to the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein),
activating the motor such that rotation at a rotational speed is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
Klein teaches that the rotation speed of the sampling portion by the motor during the sampling procedure can be between 100-12,000 RPM or a larger speed (paragraph 0242 of Klein). Klein teaches that the speed of rotation and advancement depends upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size (paragraphs 0010-0011, 0036, 0057-0058, 0119-0123, 0156, 0184-0185, 0188, and 0243 of Klein). Daum teaches that speeds of up to 6 RPM to 600,000 RPM can be used for cutting tubes (paragraphs 0021 and 0023 and claim 4 of Daum). Klein and Daum therefore suggest that the rotation speed of the sampling portion by the motor during the sampling procedure can be varied depend upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. As such, the rotation speed of the sampling portion by the motor during the sampling procedure is a results-effective variable that would have been optimized through routine experimentation based on the factors of tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the rotation speed of the sampling portion by the motor during the sampling procedure, using the values of 6 RPM of Daum, 100 RPM of Klein, 12,000 RPM of Klein, and 600,000 RPM of Daum as starting points, so as to obtain suitable samples with respect to tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. Thus, the rotation speed of the sampling portion by the motor before and during the sampling procedure being between 13,000 RPM and 25,000 RPM would have been obvious.
With respect to claim 34, the combination teaches or suggests a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein ),
activating the motor such that rotation at a rotational speed of between 13,000 and 25,000 rpm is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed of between 13,000 and 25,000 rpm thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member at a rotational speed of between 13,000 and 25,000 rpm with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein; the rotation range being obvious by the above discussed optimization),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
With respect to claim 38, the combination teaches or suggests that the interior surface or an outer surface of the sample acquiring portion is liquid tight (claim 13 of Klein; the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein have surfaces that are solid and therefore liquid tight).
With respect to claim 39, the combination teaches or suggests that the distally facing circular cutting edge is shaped and the smooth interior surface connects to the cutting edge such that the smooth interior surface extends, as seen along the central geometrical axis, to a most distal part of the cutting edge (see the interior surfaces of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 and the shear section 122, 455, 608, 616, 626, 636, 646 656, 712, 804, 1018, 1026 of Klein).
With respect to claim 41, the combination teaches or suggests that the base member comprises an inner elongated hollow tubular member extending from the proximal end to the distal end of the base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein is such a tubular member).
Claims 34, 38-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Klein, in view of U.S. Patent Application Publication No. 2008/0208230 (Chin).
With respect to the various citations to the embodiments of Klein, Klein teaches, “It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention.” (paragraph 0469 of Klein). Therefore, to the extent that it can be argued that all the features taught by Klein are not provided in a single embodiment, Klein explicitly states that the features of any embodiment can be provided in any other embodiment in any suitable subcombination. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Klein.
Klein teaches a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of the distal end of the hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately or one motor portion is used for rotation and another motor portion is used for advancement, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (connecting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein to the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein),
activating the motor such that rotation at a rotational speed is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
Klein teaches that the rotation speed of the sampling portion by the motor during the sampling procedure can be between 100-12,000 RPM or a larger speed (paragraph 0242 of Klein). Klein teaches that the speed of rotation and advancement depends upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size (paragraphs 0010-0011, 0036, 0057-0058, 0119-0123, 0156, 0184-0185, 0188, and 0243 of Klein). Chin teaches that speeds between 5000 to 20,000 RPM can be used for a core sampler in which the sample is retained in the sampler (paragraphs 0014, 0040, and 0096-0097 of Chin). Klein and Chin therefore suggest that the rotation speed of the sampling portion by the motor during the sampling procedure can be varied depend upon tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. As such, the rotation speed of the sampling portion by the motor during the sampling procedure is a results-effective variable that would have been optimized through routine experimentation based on the factors of tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the rotation speed of the sampling portion by the motor during the sampling procedure, using the values of 100 RPM of Klein, 5000 RPM of Chin, 12,000 RPM of Klein, and 20,000 RPM of Chin as starting points, so as to obtain suitable samples with respect to tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size.
Thus, the rotation speed of the sampling portion by the motor before and during the sampling procedure being between 13,000 RPM and 25,000 RPM would have been obvious.
With respect to claim 34, the combination teaches or suggests a method of acquiring a biopsy, comprising:
providing a biopsy instrument comprising a flexible outer elongated hollow tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein) which extends from a proximal end to a distal end along a central geometrical axis, and a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube, the elongated hollow tube at the distal end being intended to be at least partly inserted into a tissue from which a tissue sample is to be obtained (the tissue insertion disclosed in step 206, step 422, FIGS. 4B-4D, FIG. 7, paragraphs 0191 of Klein), wherein the base member is arranged inside the outer elongated hollow tubular member (paragraphs 0164, 0190, 0231, 0250, 0255, 0258, 0286, 0292, 0299, 0316, and 0328 of Klein; see FIGS. 1A, 16A, and 17A-17L of Klein) and is independently rotationally and translationally movable relative to the outer elongated hollow tubular member (the user selects independently the rotation velocity and the axial advancement velocity or the rotation velocity and the axial advancement velocity are determined separately, thus teaching that the base member is independently rotationally and translationally movable; paragraphs 0036-0042, 0122-0123, 0184-0185, 0189, 0231, and 0243 of Klein. Also, the advancement and rotations steps are different steps (see steps 206 and 208, steps 422 and 426, and paragraphs 0295-0297 of Klein);
providing a maneuvering unit (the handle, the control unit, the driving unit 104, and the motor of Klein) having a motor (the motor of Klein; paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, 0396-0399 of Klein),
connecting the proximal end of the base member to the motor (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein),
connecting the proximal end of the outer elongated hollow tubular member to the maneuvering unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the elongated hollow tube to a position where the tissue sample is to be acquired, with the distal end of the base member being positioned inside the outer elongated hollow tubular member (the moving of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein into position; step 206, step 422, and paragraphs 0232, 0254-0255, 0295-0297 of Klein ),
activating the motor such that rotation at a rotational speed of between 13,000 and 25,000 rpm is transferred to the distal end of the base member (activating the motor to rotate the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 208, step 426, and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which the tissue sample is to be obtained, while the distal end of the base member is being rotated by the motor at a rotational speed of between 13,000 and 25,000 rpm thereby cutting a core of the tissue which, due to the advancement of the elongated hollow tube, enters relative to the elongated hollow tube through the mouth into a sample acquiring portion of the elongated hollow tube (taking the sample using the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; step 210, step 426, FIGS. 4B-4D and 7; and paragraphs 0005, 0041, 0055, 0084, 0126, 0183, 0242, 0256, 0268-0269, 0297, and 0331 of Klein; the rotation range being obvious by the above discussed optimization); and
retracting the distal end of the base member out of the tissue while continuing to rotate the distal end of the base member at a rotational speed of between 13,000 and 25,000 rpm with a circumferential outer surface of the core at least partly abutting a smooth interior surface of the sample acquiring portion (retracting the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein while rotating with the tissue sample abutting inside of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein; the rotation range being obvious by the above discussed optimization),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the base member and due to an adhesive force formed at an interface between the smooth interior surface and the circumferential outer surface of the core which force keeps the core inside the sample acquiring portion having the smooth interior surface (the tissue sample being removed from the tissue by forces due to friction, tensile, tearing, retraction, and shearing; paragraphs 0022, 0049-0050, 0100, 0134-0135, 0182, 0196, 0209, 0236, 0254, 0270, 0298-0299, 0309-0310, 0312, 0314 of Klein).
With respect to claim 38, the combination teaches or suggests that the interior surface or an outer surface of the sample acquiring portion is liquid tight (claim 13 of Klein; the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein have surfaces that are solid and therefore liquid tight).
With respect to claim 39, the combination teaches or suggests that the distally facing circular cutting edge is shaped and the smooth interior surface connects to the cutting edge such that the smooth interior surface extends, as seen along the central geometrical axis, to a most distal part of the cutting edge (see the interior surfaces of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 690, 702, 802, 1011, 1014, 1022, 1622 and the shear section 122, 455, 608, 616, 626, 636, 646 656, 712, 804, 1018, 1026 of Klein).
With respect to claim 41, the combination teaches or suggests that the base member comprises an inner elongated hollow tubular member extending from the proximal end to the distal end of the base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein is such a tubular member).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Klein, in view of Harms, and further in view of U.S. Patent Application Publication No. 2015/0112225 (Prow)(previously cited).
The combination teaches or suggests a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube. The shear sections and sampling portions of Klein are shown to be smooth. However, specific surface roughness numbers are not disclosed. Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the sampling portion and the shear section of Klein to have a surface roughness of greater than 1 micron since a surface roughness is implicitly needed and Prow teaches such a surface roughness.
Alternatively, Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). This suggests that the surface roughness is subject to change depending upon the types of tissue and desired retention of the sample. As such, the surface roughness of the sampling portion and the shear section of Klein is a results-effective variable that would have been optimized through routine experimentation based on the types of tissue and desired retention of the sample. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the surface roughness of the sampling portion and the shear section of Klein, using the values of Prow as a starting point, so as to obtain the desired types of tissue and desired retention of the sample. Thus, the feature of “wherein the smooth inner surface extends to a most distal part of the cutting edge and wherein the smooth inner surface has a surface roughness with an Ra value of less than 1.5 µm when formed of steel or less than 6 µm when formed of a polymer-based material” would have been obvious.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Klein, in view of Daum, and further in view of Prow.
The combination teaches or suggests a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube. The shear sections and sampling portions of Klein are shown to be smooth. However, specific surface roughness numbers are not disclosed. Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the sampling portion and the shear section of Klein to have a surface roughness of greater than 1 micron since a surface roughness is implicitly needed and Prow teaches such a surface roughness.
Alternatively, Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). This suggests that the surface roughness is subject to change depending upon the types of tissue and desired retention of the sample. As such, the surface roughness of the sampling portion and the shear section of Klein is a results-effective variable that would have been optimized through routine experimentation based on the types of tissue and desired retention of the sample. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the surface roughness of the sampling portion and the shear section of Klein, using the values of Prow as a starting point, so as to obtain the desired types of tissue and desired retention of the sample. Thus, the feature of “wherein the smooth inner surface extends to a most distal part of the cutting edge and wherein the smooth inner surface has a surface roughness with an Ra value of less than 1.5 µm when formed of steel or less than 6 µm when formed of a polymer-based material” would have been obvious.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Klein, in view of Chin, and further in view of Prow.
The combination teaches or suggests a flexible base member (the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein) which extends from a proximal end to a distal end along the central geometrical axis, wherein at least a distal end portion of the base member is shaped as an elongated hollow tube having a distally facing circular cutting edge (the shear section 122, 455, 608, 616, 626, 636, 646 656, 684, 712, 804, 1018, 1026 of Klein) defining a mouth of a distal end of the elongated hollow tube. The shear sections and sampling portions of Klein are shown to be smooth. However, specific surface roughness numbers are not disclosed. Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the sampling portion and the shear section of Klein to have a surface roughness of greater than 1 micron since a surface roughness is implicitly needed and Prow teaches such a surface roughness.
Alternatively, Prow teaches that sample retaining structures can have a surface roughness of greater than 1 micron and less than 25 microns (paragraph 0037 of Prow). This suggests that the surface roughness is subject to change depending upon the types of tissue and desired retention of the sample. As such, the surface roughness of the sampling portion and the shear section of Klein is a results-effective variable that would have been optimized through routine experimentation based on the types of tissue and desired retention of the sample. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the surface roughness of the sampling portion and the shear section of Klein, using the values of Prow as a starting point, so as to obtain the desired types of tissue and desired retention of the sample. Thus, the feature of “wherein the smooth inner surface extends to a most distal part of the cutting edge and wherein the smooth inner surface has a surface roughness with an Ra value of less than 1.5 µm when formed of steel or less than 6 µm when formed of a polymer-based material” would have been obvious.
Response to Arguments
The Applicant’s arguments filed 5/5/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 5/5/2026, the previous claim objections have been withdrawn. However, there are new grounds of claim objections that were necessitated by the claim amendments filed on 5/5/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 5/5/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn with the exception to indefiniteness rejection based on “the distal end” in claim 34, line 8. The Applicant did not address this indefiniteness rejection by amendment or argument. The Examiner cannot find a reason to withdraw the rejection.
Prior art rejection
The Applicant asserts:
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This argument is not persuasive. Paragraph 0242 of Klein clearly teaches:
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From the above, Klein makes it clear that the enumerated rotation speeds (the range of 100-12,000 RPM, the specific value of 300 RPM, the specific value of 600 RPM, and the specific value of 800 RPM) are examples “[a]ccording to some exemplary embodiments”. Klein is then suggesting that other embodiments may use different rotation speeds other than those enumerated, including outside the range of 100-12,000 RPM. Also, the expression “or any intermediate, smaller or larger speed” is reasonably interpretated to mean any intermediate speed in the range of 100-12,000 RPM, a speed smaller than the range of 100-12,000 RPM, or any speed larger than the range of 100-12,000 RPM. This reading of this expression is consistent with the fact that the enumerated rotation speeds (100-12,000 RPM, 300 RPM, 600 RPM, and 800 RPM) are examples “[a]ccording to some exemplary embodiments”. Although any intermediate speed may refer to any value between the enumerated examples, there is nothing in the text to suggest that the smaller and larger speeds must be contained within the range of 100-12,000 RPM.
Additionally, paragraph 0256 of Klein teaches
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From the above, Klein makes it clear that the enumerated rotation speeds (the range of 100 RPM or greater (as indicated by the expression “at least 100 RPM”), the specific value of 300 RPM, the specific value of 600 RPM, and the specific value of 1000 RPM) are examples according to “some embodiments”. Klein is then suggesting that other embodiments may use different rotation speeds other than those enumerated. Also, the expression “or any intermediate, smaller or larger value” is reasonably interpretated to mean any intermediate speed between the values of 100-1000 RPM, a speed smaller than the range of 100-1000 RPM, or any speed larger than the range of 100-1000 RPM. This reading of this expression is consistent with the fact that the enumerated rotation speeds (300 RPM, 600 RPM, and 1000 RPM) are examples according to “some embodiments”. Although any intermediate speed may refer to any value between the enumerated examples, there is nothing in the text to suggest that the larger speeds must be lower than 1000 RPM.
The Applicant asserts:
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This argument is not persuasive. Paragraph 0264 of Klein clearly teaches:
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From the above, Klein makes it clear that the rotation speeds is set to be smaller than R4 “[i]n some embodiments”. Klein is then suggesting that other embodiments may use different rotation speeds other than those smaller than R4. Rotation speed values of larger than R4 are contemplated, but Klein teaches that such a speed may cause damage to tissue warm-up “[i]n some embodiments”. This teaching connotes that, in other embodiments, rotation speed values of larger than R4 would not cause damage to tissue warm-up. Thus, the teachings of Klein do not preclude rotation speeds greater than R4.
The Applicant asserts:
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The Applicant also discusses the advantages of the claimed method in the last three paragraphs of page 6 of the Remarks filed on 5/5/2026. These arguments are not persuasive. Klein teaches, and therefore, suggests rotation speeds of 12,000 RPM or greater since the text of Klein says so. Klein, as modified by Harms, teaches or suggests the other steps of the claims method. As such, the combination renders the claimed method obvious. The advantages provided by the Applicant do not make the method of claim 34 non-obvious over the combination of Klein and Harms.
The Applicant asserts:
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These arguments are not persuasive. Harms is relied upon to show values of rotation speed greater than 12,000 RPM in the same context as that in Klein. The combination of Klein and Harms does not necessarily result in a rotation speed of 90,000 RPM though optimization, but merely the candidate rotation speeds can range from 100-90,000 RPM. The final rotation speed would be the result of routine experimentation based on the factors of tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the rotation speed of the sampling portion by the motor during the sampling procedure, using the values of 100 RPM of Klein, 12,000 RPM of Klein, and 90,000 RPM of Harms as starting points, so as to obtain suitable samples with respect to tissue type and/or tissue properties, such as target tissue composition, target tissue density and/or target tissue size.
The Applicant asserts:
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This argument is not persuasive. The combination results in the claimed combination, as outline above in the rejection.
Double patenting rejections
In view of the terminal disclaimer filed on 5/5/2026, the double patenting rejections based on U.S. Patent No. 12,408,898 have been withdrawn.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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