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 .
Priority
The present application is a continuation of U.S. Application Serial No. 17/366,669, filed July 2, 2021, issued as U.S. Patent No. 1,211,4887, which is a continuation of U.S. Application Serial No. 15/970,748, which was filed May 3, 2018, issued as U.S. Patent No. 11,051,842 on July 6, 2021, which claims the benefit of, and priority to, U.S. Provisional Application Serial No. 62/500,867, which was filed May 3, 2017, and U.S. Patent Application Serial No. 62/500,879, which was filed May 3, 2017.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an actuator…configured to selectively actuate the motor to drive rotation of the elongate body and tissue-removing element” in claim 12 (“The handle 40 supports an actuator 42 (e.g., a lever, a button, a dial, a switch, or other device) configured for selectively actuating a motor 43 disposed in the handle to drive rotation of the outer layer 12, and tissue-removing element 20 mounted at the distal end of the outer layer.” (para. [0020] of the publication) and “an advancer mounted on the handle…for moving the elongated body relative to the handle” in claim 13 (FIG. 1 shows advancer 45 is a lever or a stick coupled to motor 43).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 14 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lucas (US 2006/0253145, hereinafter “Lucas”).
Referring to claim 14, a tissue-removing catheter for removing tissue in a body lumen (Figs. 1 and 4-7. Fig. 1 is reproduced below), the tissue- removing catheter comprising:
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an elongate body 180 (Figs. 1 and 3, para. [0027]) having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen (FIGS. 3-5);
a tissue-removing element 185 (Figs. 1 and 3, para. [0041]: “tined catheter 180 has connected at its distal end the plurality of radially expandable tines 185 formed therefrom”) mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; and
an inner liner (balloon-tipped catheter 170, Figs. 3 and 7, para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25”) received within the elongate body and movable relative to the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational and torsional forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter (paras. [0038]-[0041] disclose balloon catheter 170 is remained stationary with balloon 175 is inflated and engaged with the inner surface of the blood vessel while the tines 185 and catheter 180 is rotated to remove the clot 25. Thus, Lucas inherently disclose rotational and torsional forces from elongate body are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter).
Referring to claim 18, Lucas discloses a method of removing tissue in a body lumen (FIGS. 1-5, paras. [0034] and [0038]-[0040]. FIGS. 4-5, which are reproduced below), the method comprising:
advancing a tissue-removing catheter 180 (Figs. 1 and 3, para. [0027]) over a guidewire 160 (FIG. 2, para. [0034]) in the body lumen to position a distal end of the catheter adjacent the tissue (FIG. 3) and a proximal end portion of the catheter outside of the body lumen, the catheter comprising an elongate body and a tissue removing element mounted on a distal end portion of the elongate body, and an inner liner (balloon catheter 170, para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25.”) disposed within the elongate body, the inner liner defining a guidewire lumen in which the guidewire is disposed during the advancement of the catheter;
actuating a motor to rotate the elongate body and tissue-removing element of the catheter to remove the tissue (paras. [0038], para. [0039]: “Further illustrated is the radially rotatory displacement of tines 185 in a preferred clockwise movement, allowing tines 185 to degrade the clot 25 by macerating, cutting, shearing and mechanical agitation and displacement. Further seen in FIG. 4 is balloon 175 in the inflated condition.”); and
isolating the guidewire from the elongate body and tissue-removing element with the inner liner (para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25.”) so that rotational and torsional forces are not transferred from the rotating elongate body 180 and tissue-removing element 185 to the guidewire 160 during rotation of the elongate body and tissue-removing element (paras. [0038]-[0041] disclose balloon catheter 170 is remained stationary with balloon 175 is inflated and engaged with the inner surface of the blood vessel while the tines 185 and catheter 180 is rotated to remove the clot 25. Thus, Lucas inherently disclose rotational and torsional forces from elongate body are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter).
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Referring to claim 19, Lucas discloses a method of claim 18, further comprising advancing the inner liner (balloon catheter 170) through the body lumen to move the inner liner relative to the elongate body 180 (FIGS. 2-3, para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25.”).
Referring Claim 20, Lucas discloses a method of claim 18, further comprising advancing the elongate body 180 and tissue-removing element 185 through the body lumen to move the elongate body and tissue-removing element relative to the inner liner (balloon catheter 170) (FIGS. 4-5, which are reproduced above show catheter 180 and tines 185 is advancing forward with respect to inner liner (balloon catheter 170) to clear occlusive material 25).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4, 6-8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas (US 2006/0253145, hereinafter “Lucas”) in view of Jeffrey et al. (US 2007/0282367, hereinafter “Jeffrey”).
Referring to claim 1, Lucas discloses a tissue-removing catheter for removing tissue in a body lumen (Figs. 1 and 4-7. Fig. 1 is reproduced below), the tissue-removing catheter comprising:
an elongate body 180 (Figs. 1 and 3, para. [0027]) having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen (FIGS. 3-5);
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a tissue-removing element 185 (Figs. 1 and 3, para. [0041]: “tined catheter 180 has connected at its distal end the plurality of radially expandable tines 185 formed therefrom”) mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen;
an inner liner received within the elongate body, the inner liner defining a guidewire lumen (balloon catheter 170, Figs. 3 and 7, para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25”), the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen (paras. [0038]-[0041] disclose balloon catheter 170 is remained stationary with balloon 175 is inflated and engaged with the inner surface of the blood vessel while the tines 185 and catheter 180 is rotated to remove the clot 25. Thus, Lucas inherently disclose rotational and torsional forces from elongate body are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter).
Lucas discloses the invention substantially as claimed except for disclosing an atraumatic tip disposed on a distal end portion of the balloon catheter 170 (inner liner), the atraumatic tip being separate from the inner liner and attached to the inner liner.
However, Jeffrey discloses a balloon catheter for treating a blockage in a blood vessel (para. [0003]). The balloon catheter includes a highly flexible and soft tip member at the distal end portion of the catheter to navigate safely through tortuous blood vessel without damaging the vessel (Figs. 2A-8, Fig. 5 is reproduced below, paras. [0008] and [0054]. [0008]: “Preferably, the distal tip member is softer than the catheter shaft to provide improved trackability and maneuverability and to decrease the risk of damage to the patient's vessels during advancement therein.”).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a highly flexible and soft tip member as suggested by Jeffrey to the distal end portion of the catheter 170 of Lucas to provide the advantage of allowing the catheter to navigate safely through tortuous blood vessel without damaging the vessel.
Referring to claim 2, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip defines a soft, low profile distal end to facilitate delivery of the inner liner through the body lumen (Fig. 5, which is reproduced above, of Jeffrey reference shows that the soft tip 518 has a tapered configuration to define a low profile distal end).
Referring to claim 4, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1, wherein the inner liner includes an inner layer, an outer layer, and an intermediate layer disposed between the inner and outer layers. In paragraph [0028] Jeffrey discloses the outer and inner catheter of the balloon catheter can be a multilayered polymeric tube that includes metallic or nonmetallic braiding within or between layers of the tube. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made the elongate body of the balloon catheter 170 from a multilayered polymeric tubes that includes metallic or nonmetallic braiding within or between layers of the tube to improve flexibility and torqueability to the catheter.
Referring to claim 6, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1, wherein a distal end of the inner liner extends distally of the tissue-removing element (Lucas: Figs. 1 and 4-5 show distal end of balloon catheter 170 extends distally of tissue removing element 185.).
Referring to claim 7, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 6, wherein the guidewire lumen extends through the distal end of the inner liner (Lucas: para. [0038]: “In addition, a balloon-tipped catheter 170 is advanced over the guidewire through the lumen of tined catheter 180 and advanced distally so that the reversibly expandable balloon member 175 comes to rest in a position proximal to the thrombus 25”).
Referring to claim 8, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a tapered distal end (Jeffrey: see Fig. 5, which is reproduced above).
Referring to claim 10, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1, further comprising a handle 120 (Lucas: Fig. 1) mounted on to the proximal end portion of the elongate body 180 and operable to cause rotation of the elongate body (Lucas: para. [0027]).
Referring to claim 11, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 10, further comprising a motor in the handle, the motor operatively engaging the elongate body for driving rotation of the elongate body and tissue-removing element mounted on the elongate body (Lucas: para. [0027]: “Activation mechanism 125 is depicted mounted in handle housing 120 and allows an operator to start the thrombectomy device motor housed in the handle 120, which in turn rotates tines 185 along with catheter 180 from which the tines 185 are formed.”).
Referring to claim 12, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 11, further comprising an actuator positioned on the handle and configured to selectively actuate the motor to drive rotation of the elongate body and tissue-removing element (Lucas: para. [0027]: “Activation mechanism 125 is depicted mounted in handle housing 120 and allows an operator to start the thrombectomy device motor housed in the handle 120, which in turn rotates tines 185 along with catheter 180 from which the tines 185 are formed.”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas in view of Jeffrey et al. as applied to claim 1 and further in view of Foreman et al. (US 6,478,807, hereinafter “Foreman”).
Referring to claim 3, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1. Examiner notes that Lucas device and Jeffrey device are for treating a blockage in a blood vessel. Lucas/Jeffrey fails to disclose wherein the atraumatic tip has a maximum outer diameter of about 0.02 inches (0.6 mm).
Referring again to claim 3, however, in the same field of endeavor, which is a balloon catheter for treating blockage in a blood vessel, Foreman discloses it is well known that the size of a catheter for insertion into coronary artery to treat a blockage is about 0.02 inches in diameter (col. 7, ln. 26-31). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have selected the balloon catheter of Lucas with a 0.02 inches in diameter to remove a blockage in coronary artery. The modification would expand the utility of the device of Lucas, therefore, expand the market share of the device of Lucas. Attention is directed to Fig. 5 of Jeffrey reference, examiner notes that when the diameter of outer catheter is 0.02 inches, the tip 518 as shown in Fig. 5 would be about 0.02 inches or smaller.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas in view of Jeffrey et al. as applied to claims 4 and 1 above and further in view of Preissman et al. (US 5,728,063).
Referring to claim 5, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 4 but fails to disclose wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide.
Referring again to claim 5, examiner notes that in paragraph [0028] Jeffrey disclose the outer and inner catheter can be a multilayered polymeric tube that includes metallic or nonmetallic braiding within or between layers of the tube. However, Preissman discloses (Figs. 1 and 4) a high torque balloon catheter includes an outer catheter 5 (Fig. 1) or 104 (Fig. 4), an inner catheter 16 (Fig. 1) or 102 (Fig. 4) and a balloon 8 (Fig. 1) or 106 (Fig. 4) attached to the distal end of the outer catheter and the distal end of the inner catheter. Preissman discloses the catheter includes an inner layer, intermediate layer and an outer layer, wherein the inner layer comprises Polytetrafluorethylene (PTFE) (col. 7, ln. 1-10), the intermediate layer comprises stainless steel (col. 7, ln 15-21), and the outer layer comprises polyimide (col. 7, ln. 54-60) and wherein each layer extends from proximal end to distal end of the catheter body to improve pushability and torqueability of the catheter through tortuous blood vessel (col. 1, ln 65 to col. 2, ln 12).
Referring still to claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application, to have made the modified catheter of Lucas according Preissman suggestions to improve pushability and torqueability of the catheter to allow the surgeon to navigate the catheter through tortuous blood vessel.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas in view of Jeffrey et al. as applied to claim 1 above and further in view of Hiblar et al. (US 6,800,083, hereinafter “Hublar”).
Referring to claim 9, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 1 but fails to disclose wherein the tissue-removing element comprises an abrasive burr. However, in the same field of endeavor, which is an atherectomy device, Hiblar discloses tissue-removing element 110 (Figs. 1A-1C) includes a plurality of segments or arms (Fig. 1C) and each segment or arm has an abrasive portion 16 on the forward surface 114. Hiblar discloses the advantages of having abrasive portion only on the forward surface is for avoiding or minimizing undesirable contact between the abrasive portion and the vessel wall and to enhancing ablative action at the location of the hardened occlusion (col. 5, ln. 13-25).
Referring again to claim 9, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute the tines 182 with the tissue-removing element 110 of Hiblar so that it too would have the same advantages. In alternative, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to add abrasive material to tines 182 to effectively removing hardened occlusion.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas in view of Jeffrey et al. as applied to claim 1 above and further in view of Farr (US 5,019,089, hereinafter “Farr”).
Referring to claim 13, Lucas/Jeffrey discloses a tissue-removing catheter as set forth in claim 10, but fails to disclose the tissue-removing catheter further comprising an advancer mounted on the handle and operatively coupled to the elongate body for moving the elongate body relative to the handle. However, in the same field of endeavor, which is a tissue-removing catheter, Farr discloses motor (not shown) and drive shaft 30, which is attached to the motor, can be translated incrementally with respect to a housing of the catheter to allow the cutter 28, which is at the distal end of the drive shaft, to move beyond the distal end of sheath 20 (Figures 8A-8B) to remove long obstructive tissue. Figures 9A-9C show housing 12 includes a longitudinal groove or channel 34 to allow advancer (36, 38, 40), which is coupled to motor and drive shaft 30, to move the motor and drive 30 along a longitudinal axis of sheath 20 to allow the cutter 28 to treat a long occlusion in blood vessel.
Referring again to claim 13, therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the handle of Lucas to allow the motor, gears and the drive shaft 180 to move along the longitudinal axis of the housing to treat long occlusion without moving the handle.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lucas in view of Preissman et al. (US 5,728,063).
Referring to claims 15-17, Lucas discloses a tissue-removing catheter as set forth in claim 14 but fails to disclose the inner liner (balloon catheter 170) comprises a plurality of layers each extending from a proximal end of the inner liner to a distal end of the inner liner (claim 15), wherein the inner liner includes an inner layer, an outer layer, and an intermediate layer disposed between the inner and outer layers (claim 16), and wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide (claim 17).
Referring again to claims 15-17, however, Preissman discloses (Figs. 1 and 4) a high torque balloon catheter includes an outer catheter 5 (Fig. 1) or 104 (Fig. 4), an inner catheter 16 (Fig. 1) or 102 (Fig. 4) and a balloon 8 (Fig. 1) or 106 (Fig. 4) attached to the distal end of the outer catheter and the distal end of the inner catheter. Preissman discloses the catheter includes an inner layer, intermediate layer and an outer layer, wherein the inner layer comprises Polytetrafluorethylene (PTFE) (col. 7, ln. 1-10), the intermediate layer comprises stainless steel (col. 7, ln 15-21), and the outer layer comprises polyimide (col. 7, ln. 54-60) and wherein each layer extends from proximal end to distal end of the catheter body to improve pushability and torqueability of the catheter through tortuous blood vessel (col. 1, ln 65 to col. 2, ln 12).
Referring still to claims 15-17, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application, to have made the balloon catheter 170 (interpreted as inner liner) of Lucas according Preissman suggestions to improve pushability and torqueability of the catheter to allow the surgeon to navigate the catheter through tortuous blood vessel.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,114,887 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claims 1-14 of the patent application can be found in claims 1-13 of the patent.
The claims match-up with respect to one another as listed below:
U.S. Application 18/915,056
U.S. Patent No. 12,114,887
Claim 1. A tissue-removing catheter for removing tissue in a body lumen, the tissue- removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; an inner liner received within the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen; and an atraumatic tip disposed on a distal end portion of the inner liner, the atraumatic tip being separate from the inner liner and attached to the inner liner.
Examiner notes that claim 1 of the patent discloses all limitation in claim 1 of the application and much more (see underlined portion in claim 1 of the patent). Claim 1 of the patent is more specific than claim 1 of the application. The more specific anticipates the broader.
Claim 1. A tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; an inner liner received within the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen; and an atraumatic tip disposed on a distal end portion of the inner liner, the atraumatic tip being separate from the inner liner and attached to the inner liner,
the atraumatic tip having an outer cross-sectional dimension that increases from a proximal end of the atraumatic tip to an intermediate location on the atraumatic tip and decreases from the intermediate location to a distal end of the atraumatic tip, an outer dimension of the atraumatic tip at the distal end being substantially the same as an outer dimension of the atraumatic tip at the proximal end; wherein the inner liner is free of a balloon disposed on a distal end margin of the inner liner.
Claim 2. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip defines a soft, low profile distal end to facilitate delivery of the inner liner through the body lumen.
Claim 2. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip defines a soft, low profile distal end to facilitate delivery of the inner liner through the body lumen.
Claim 3. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a maximum outer diameter of about 0.02 inches (0.6 mm).
Claim 3. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a maximum outer diameter of about 0.02 inches (0.6 mm).
Claim 4. A tissue-removing catheter as set forth in claim 1, wherein the inner liner includes an inner layer, an outer layer, and an intermediate layer disposed between the inner and outer layers.
Claim 4. A tissue-removing catheter as set forth in claim 1, wherein the inner liner includes an inner layer, an outer layer, and an intermediate layer disposed between the inner and outer layers.
Claim 5. A tissue-removing catheter as set forth in claim 4, wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide.
Claim 5. A tissue-removing catheter as set forth in claim 4, wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide.
Claim 6. A tissue-removing catheter as set forth in claim 1, wherein a distal end of the inner liner extends distally of the tissue-removing element.
Claim 6. A tissue-removing catheter as set forth in claim 1, wherein a distal end of the inner liner extends distally of the tissue-removing element.
Claim 7. A tissue-removing catheter as set forth in claim 6, wherein the guidewire lumen extends through the distal end of the inner liner.
Claim 7. A tissue-removing catheter as set forth in claim 6, wherein the guidewire lumen extends through the distal end of the inner liner.
Claim 8. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a tapered distal end.
Claim 8. A tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a tapered distal end.
Claim 9. A tissue-removing catheter as set forth in claim 1, wherein the tissue-removing element comprises an abrasive burr.
Claim 9. A tissue-removing catheter as set forth in claim 1, wherein the tissue-removing element comprises an abrasive burr.
Claim 10. A tissue-removing catheter as set forth in claim 1, further comprising a handle mounted on to the proximal end portion of the elongate body and operable to cause rotation of the elongate body.
Claim 10. A tissue-removing catheter as set forth in claim 1, further comprising a handle mounted on to the proximal end portion of the elongate body and operable to cause rotation of the elongate body.
Claim 11. A tissue-removing catheter as set forth in claim 10, further comprising a motor in the handle, the motor operatively engaging the elongate body for driving rotation of the elongate body and tissue-removing element mounted on the elongate body.
Claim 11. A tissue-removing catheter as set forth in claim 10, further comprising a motor in the handle, the motor operatively engaging the elongate body for driving rotation of the elongate body and tissue-removing element mounted on the elongate body.
Claim 12. A tissue-removing catheter as set forth in claim 11, further comprising an actuator positioned on the handle and configured to selectively actuate the motor to drive rotation of the elongate body and tissue-removing element.
Claim 12. A tissue-removing catheter as set forth in claim 11, further comprising an actuator positioned on the handle and configured to selectively actuate the motor to drive rotation of the elongate body and tissue-removing element, wherein the actuator comprises one of a lever, a button, a dial, or a switch.
Claim 13. A tissue-removing catheter as set forth in claim 10, further comprising an advancer mounted on the handle and operatively coupled to the elongate body for moving the elongate body relative to the handle.
Claim 13. A tissue-removing catheter as set forth in claim 10, further comprising an advancer mounted on the handle and operatively coupled to the elongate body for moving the elongate body relative to the handle.
Claim 14. A tissue-removing catheter for removing tissue in a body lumen, the tissue- removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; and an inner liner received within the elongate body and movable relative to the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational and torsional forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter.
Examiner notes that claim 1 of the patent discloses all limitation in claim 14 of the application and much more (see underlined portion in claim 1 of the patent). Claim 1 of the patent is more specific than claim 1 of the application. The more specific anticipates the broader.
Claim 1. A tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; an inner liner received within the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during removal of tissue from the body lumen;
and an atraumatic tip disposed on a distal end portion of the inner liner, the atraumatic tip being separate from the inner liner and attached to the inner liner,
the atraumatic tip having an outer cross-sectional dimension that increases from a proximal end of the atraumatic tip to an intermediate location on the atraumatic tip and decreases from the intermediate location to a distal end of the atraumatic tip, an outer dimension of the atraumatic tip at the distal end being substantially the same as an outer dimension of the atraumatic tip at the proximal end; wherein the inner liner is free of a balloon disposed on a distal end margin of the inner liner.
Claims 14 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 18-20, respectively, of U.S. Patent No. 11,051,842 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claims 14 and 18-20 of the patent application can be found in claims 15 and 18-20, respectively, of the patent.
The claims match-up with respect to one another as listed below:
U.S. Application 18/915,056
U.S. Patent No. 11,051,842
Claim 14. A tissue-removing catheter for removing tissue in a body lumen, the tissue- removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; and an inner liner received within the elongate body and movable relative to the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational and torsional forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter.
Examiner notes that claim 15 of the patent discloses all limitation in claim 14 of the application and much more (see underlined portion in claim 15 of the patent). Claim 15 of the patent is more specific than claim 14 of the application. The more specific anticipates the broader.
Claim 15. A tissue-removing catheter for removing tissue in a body lumen, the tissue-removing catheter comprising: an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis, the elongate body being sized and shaped to be received in the body lumen; a tissue-removing element mounted on the distal end portion of the elongate body, the tissue-removing element being configured to remove the tissue as the tissue-removing element is rotated by the elongate body within the body lumen; and an inner liner received within the elongate body and movable relative to the elongate body, the inner liner defining a guidewire lumen, the inner liner isolating an interior of the guidewire lumen from the elongate body and tissue-removing element such that rotational and torsional forces are not transferred from the elongate body and tissue-removing element to the interior of the guidewire lumen when the elongate body and tissue-removing element are rotated during operation of the tissue-removing catheter,
wherein a clearance between the inner liner and the elongate body prevents rotation of the inner liner caused by the rotation of the elongate body, and wherein the inner liner is free of radial openings in the inner liner.
Claim 18. A method of removing tissue in a body lumen, the method comprising: advancing a tissue-removing catheter over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and a proximal end portion of the catheter outside of the body lumen, the catheter comprising an elongate body and a tissue removing element mounted on a distal end portion of the elongate body, and an inner liner disposed within the elongate body, the inner liner defining a guidewire lumen in which the guidewire is disposed during the advancement of the catheter; actuating a motor to rotate the elongate body and tissue-removing element of the catheter to remove the tissue; and isolating the guidewire from the elongate body and tissue-removing element with the inner liner so that rotational and torsional forces are not transferred from the rotating elongate body and tissue-removing element to the guidewire during rotation of the elongate body and tissue-removing element.
Examiner notes that claim 18 of the patent discloses all limitation in claim 18 of the application and much more (see underlined portion in claim 18 of the patent). Claim 18 of the patent is more specific than claim 18 of the application. The more specific anticipates the broader.
Claim 18. A method of removing tissue in a body lumen, the method comprising: advancing a tissue-removing catheter over a guidewire in the body lumen to position a distal end of the catheter adjacent the tissue and a proximal end portion of the catheter outside of the body lumen, the catheter comprising an elongate body and a tissue removing element mounted on a distal end portion of the elongate body, and an inner liner disposed within the elongate body, the inner liner defining a guidewire lumen in which the guidewire is disposed during the advancement of the catheter; actuating a motor to rotate the elongate body and tissue-removing element of the catheter to remove the tissue; and isolating the guidewire from the elongate body and tissue-removing element with the inner liner so that rotational and torsional forces are not transferred from the rotating elongate body and tissue-removing element to the guidewire during rotation of the elongate body and tissue-removing element,
wherein a clearance between the inner liner and the elongate body prevents rotation of the inner liner caused by the rotation of the elongate body, and wherein the inner liner is free of radial openings in the inner liner.
Claim 19. A method of claim 18, further comprising advancing the inner liner through the body lumen to move the inner liner relative to the elongate body.
Claim 19. A method of claim 18, further comprising advancing the inner liner through the body lumen to move the inner liner relative to the elongate body.
Claim 20. A method of claim 18, further comprising advancing the elongate body and tissue-removing element through the body lumen to move the elongate body and tissue-removing element relative to the inner liner.
Claim 20. A method of claim 18, further comprising advancing the elongate body and tissue-removing element through the body lumen to move the elongate body and tissue-removing element relative to the inner liner.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771