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 .
Election/Restrictions
The Applicant’s election without traverse of Group II and Species B in the reply filed on 10/23/2025 is acknowledged.
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
Claims 34, 38, and 42 are objected to because of the following informalities:
in claim 34, line 15: “a proximal end” should be “the proximal end”;
in claim 34, line 16: “a proximal end” should be “the proximal end”;
in claim 34, line 16: “manoeuvring unit” should be “maneuvering unit”
in claim 34, line 24: “a rotational speed” should be “the rotational speed”;
in claim 38, line 1: “the interior or outer surface” should be “the interior surface or an outer surface”
in claim 42, line 1: the comma after “comprises” should be deleted or replaced with a colon;
in claim 42, line 2: “a proximal end” should be “the proximal end”; and
in claim 42, line 2: “a motor” should be “the motor”.
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 and 36-42 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 of the hollow tube” in line 7, but it is not clear if this recitation is the same as, related to, or different from the distal end of base member of claim 34, line 5. The relationship between these recitations should be made clear. If they are different, there is insufficient antecedent basis for “the distal end of the hollow tube” in claim 34.
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 line 3, the distal end of base member in line 5, or “the distal end of the hollow tube” in line 7. Clarification is required.
Claim 34 recites “a biopsy” in line 9, “a tissue sample” in line 17, and “a tissue sample” in line 23, but it is not clear if these recitations are the same as, related to, or different from each other and/or “a biopsy” in line 1. The relationship among these recitations should be made clear.
Claim 34 recites “a distal end of the biopsy instrument” in line 17 and “the distal end of the biopsy instrument” in line 21, but it is not clear if these recitations are referring to the distal end of the tubular member in line 3, the distal end of base member in line 5, and/or “the distal end of the hollow tube” in line 7. It would seem that “a distal end of the biopsy instrument” in line 17 should be one of these three recitations, but the claim does not make that clear. Clarification is required.
Claim 34 recites “preferably with the distal end of the base member being positioned inside the outer elongated hollow tubular member” in lines 18-19, but it renders the claim indefinite because it is unclear whether the limitations following “preferably” are part of the claimed invention.
Claim 34 recites “a hollow elongated tubular sample acquiring portion” in lines 30-31, but it is not clear if this recitation is the same as, related to, or different from “a sample acquiring portion of the elongated hollow tube” of claim 34, line 26. The relationship between these two recitations should be clear. If they are different, there is insufficient antecedent basis for “the smooth interior surface” of “the sampling acquiring portion” of claim 34, lines 34-35.
Claim 34 recites “a distal portion of the elongated hollow tube” in line 31, but it is not clear if this recitation is the same as, related to, or different from “a distal end portion of the base member “ of claim 34, line 6 since the hollow tube is at the distal end of the base member. Clarification is required.
Claim 34 recites “the retraction of the elongated hollow tube” in lines 32-33, but it is not clear if this recitation is the same as, related to, or different from the retracting of the distal end of the base member out of the tissue of claim 34, line 28 since the hollow tube is at the distal end of the base member. Clarification is required. If they are different, there is insufficient antecedent basis for “the retraction of the elongated hollow tube” in claim 34.
Claims 36-42 are rejected by virtue of their dependence from claim 34.
Claim 40 is generally indefinite since it appears to repeat previously recited limitation from claim 34 from which it depends. For example, the following underlined portions of claim 40 are already present in claim 34:
40. The method of claim 34, wherein the smooth interior surface is smooth to such an extent that when a reference biopsy is to be acquired, the cutting edge and the distal end of the elongated hollow tube is configured to be advanced along the central geometrical axis into a tissue while being rotated by being motor driven at its proximal end at a rotational speed of at least 13,000 rpm and thereby cut 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 the sample acquiring portion of the elongated hollow tube with a circumferential outer surface of the core at least partly abutting the smooth interior surface of the sample acquiring portion,
whereafter the elongated hollow tube is retracted from the tissue while being rotated at a rotational speed of at least 13,000 rpm by being motor driven at its proximal end whereby the core of the tissue is detached from the tissue by a pulling force due to the retraction of the elongated hollow tube 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.
It is not clear what the above underlined portions are meant to convey since they appear to be redundant. Also, the above underlined portions recite various limitations that have indefinite articles in front of them, but are also very similar to previously recited limitations. For example, the above underlined portions include: “a tissue” in line 3, “a rotational speed of at least 13,000 rpm” in line 4, “a core of the tissue” in lines 4-5, “a circumferential outer surface of the core” in lines 6-7, “a rotational speed of at least 13,000 rpm” in lines 8-9, “a pulling force” in line 10, “an adhesive force” in lines 10-11, and “an interface” in line 11. Are these truly new limitations or are they referring to the previously recited recitations of claim 34. These issues render claim 40 indefinite.
Claim 42 recites “the connector being capable of transferring the movement along the central geometrical axis and said rotation and torque” in lines 2-3, which is so grammatically awkward that its meaning is not clear. Indeed, it appears that text is missing from this limitation.
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 and 37-42 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0038202 (Klein), in view of U.S. Patent Application Publication No. 2014/0142464 (Harms).
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 an outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein or the coating of PTFE and/or HDPE in paragraph 0372 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 biopsy 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, 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 a 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 a proximal end of the outer elongated hollow tubular member to the manoeuvring unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the biopsy instrument to a position where a tissue sample is to be acquired, preferably 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 biopsy instrument (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 a 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 a hollow elongated tubular sample acquiring portion being provided at a distal portion of the elongated hollow tube (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 elongated hollow tube 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). Harms teaches that speeds of up to 90,000 RPM can be used (paragraphs 0026-0027 of Harms). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a rotation speed of 90,000 RPM for the rotation speed of the sampling portion by the motor during the sampling procedure of Klein since Klein teaches that larger values of 12,000 RPM can be used and Harms teaches one such value
Alternatively, 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, 0119-0122, 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). Klein and Harms therefore suggests 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 range of up to 90,000 RPM of Harms as a starting point, 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 of at least 13,000 RPM (as recited in claim 34) or between 13,000 rpm and 25,000 rpm (as recited in claim 37) 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 an outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein or the coating of PTFE and/or HDPE in paragraph 0372 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 biopsy 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, 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 a 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 a proximal end of the outer elongated hollow tubular member to the manoeuvring unit (paragraphs 0230, 0239, 0246, 0250, 0316-0317, 0321-0328 of Klein),
moving a distal end of the biopsy instrument to a position where a tissue sample is to be acquired, preferably 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 at least 13,000 rpm is transferred to the distal end of the biopsy instrument (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 of at least 13,000 rpm being obvious as suggested by Harms and/or optimization),
advancing the elongated hollow tube with the distally facing circular cutting edge into the tissue from which a 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 at least 13,000 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 of at least 13,000 rpm being obvious as suggested by Harms and/or 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 least at 13,000 rpm with a circumferential outer surface of the core at least partly abutting a smooth interior surface of a hollow elongated tubular sample acquiring portion being provided at a distal portion of the elongated hollow tube (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 of at least 13,000 rpm being obvious as suggested by Harms and/or optimization),
wherein the core of the tissue is detached from the tissue by a pulling force due to the retraction of the elongated hollow tube 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 37, the combination teaches or suggests that the rotational speed is between 13,000 rpm and 25,000 rpm (the rotation between 13,000 rpm and 25,000 rpm being obvious as suggested by Harms and/or optimization).
With respect to claim 38, the combination teaches or suggests that the interior or 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 40, the combination teaches or suggests that the smooth interior surface is smooth to such an extent that when a reference biopsy is to be acquired, the cutting edge and the distal end of the elongated hollow tube is configured to be advanced along the central geometrical axis into a tissue while being rotated by being motor driven at its proximal end at a rotational speed of at least 13,000 rpm and thereby cut 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 the sample acquiring portion of the elongated hollow tube with a circumferential outer surface of the core at least partly abutting the smooth interior surface of the sample acquiring portion (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 of at least 13,000 rpm being obvious as suggested by Harms and/or optimization), whereafter the elongated hollow tube is retracted from the tissue while being rotated at a rotational speed of at least 13,000 rpm by being motor driven at its proximal end (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 of at least 13,000 rpm being obvious as suggested by Harms and/or optimization) whereby the core of the tissue is detached from the tissue by a pulling force due to the retraction of the elongated hollow tube 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 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 PEEK and/or PEBAX and/or other materials of the sleeve 801 is the inner elongated hollow tubular member while the coating of PTFE and/or HDPE is the outer elongated hollow tube tubular member; paragraph 0372 of Klein).
With respect to claim 42, the combination teaches or suggests that the method further comprises, connecting 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) at a proximal end thereof to 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) via a connector (the gear of paragraph 0240 of Klein; the transmission of paragraph 0243 of Klein), the connector being capable of transferring the movement along the central geometrical axis and said rotation and torque (paragraphs 0240 and 0243 of Klein).
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).
The combination teaches or suggests 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 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34 and 37-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,408,898 (the reference patent), in view of Klein, and further in view of Harms.
Claim 10 of the reference includes all the features of claim 34 of the present application except the claimed outer elongated hollow tube tubular member, the base member being arranged inside the outer elongated hollow tubular member, and the base member being independently rotationally and translationally movable relative to the outer elongated hollow tubular member.
Klein teaches a method of acquiring a biopsy, comprising: providing a biopsy instrument comprising an outer elongated hollow tube tubular member (the elongated sleeve 118, 475, 582, 801, and 1614 of Klein or the coating of PTFE and/or HDPE in paragraph 0372 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 and moves within the outer elongated hollow tube tubular member. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such an outer tubular member so as to provide protection to the base member during insertion and retraction from the tissue.
Klein teaches that 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, 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). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such independent rotational and advancement control so as to provide better control of the sampling portion in specific circumstances related to tissue placement and tissue type.
Harms teaches that speeds of up to 90,000 RPM can be used (paragraphs 0026-0027 of Harms). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a rotation speed of 90,000 RPM for the rotation speed of the sampling portion by the motor during the sampling procedure since values of rotation are required and Harms teaches such values.
Alternatively, 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, 0119-0122, 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). Klein and Harms therefore suggests 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 range of up to 90,000 RPM of Harms as a starting point, 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 of at least 13,000 RPM (as recited in claim 34) or between 13,000 rpm and 25,000 rpm (as recited in claim 37) would have been obvious.
In view of the above, claim 10 of the reference patent (as modified) contains all the features of claims 34, 37, and 40.
With respect to claim 38 of the present, Klein teaches or suggests that the interior or 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). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such liquid-tightness so as to retain the integrity of the sample upon retraction.
With respect to claim 39, Klein 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). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such features since a cutting edge and interior surface is required and Klein teaches such suitable structures.
With respect to claim 41, Klein 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 PEEK and/or PEBAX and/or other materials of the sleeve 801 is the inner elongated hollow tubular member while the coating of PTFE and/or HDPE is the outer elongated hollow tube tubular member; paragraph 0372 of Klein). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such inner and outer tubular members so as to provide protection to the base member during insertion and retraction from the tissue.
With respect to claim 42, Klein teaches the connection of the sampling portion 108, 450, 602, 612, 620, 630, 640, 650, 660, 670, 680, 690, 702, 802, 1011, 1014, 1022, 1622 of Klein at a proximal end thereof to a motor (paragraphs 0010, 0057, 0199-0200, 0240-0243, 0245, 0297, 0331, 0386-0389, 0391-0392, and 0396-0399 of Klein) via a connector (the gear of paragraph 0240 of Klein; the transmission of paragraph 0243 of Klein), the connector being capable of transferring the movement along the central geometrical axis and said rotation and torque (paragraphs 0240 and 0243 of Klein). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such an arrangement between the elongated hollow tube and the motor since it provides the necessary transmission aspects between the two structures as required in the claim.
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,408,898 (the reference patent), in view of Klein, and further in view of Harms, and further in view of Prow.
Claim 10 of the reference patent (as modified) contains all the features of claim 34 including an elongated hollow tube having a distally facing circular cutting edge defining a mouth of the distal end of the hollow tube. Specific surface roughness numbers are not recited. 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 elongated hollow tube and the cutting edge 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 elongated hollow tube and the cutting edge 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 elongated hollow tube and the cutting edge, 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.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791