DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Arguments
In view of the amendment filed June 12, 2026, claims 1, 12, 14 and 18 have been amended.
The amendment to independent claims 14 and 18 overcome the rejection of claims 14 and 18-20 under 35 U.S.C. § 102 as being anticipated by Lucas (US 2006/0253145). Therefore, the rejection is hereby withdrawn.
The amendment to independent claim 1 overcome the rejection of claims 1-2, 6, 6-8 and 10-12 under 35 U.S.C. § 103 as being unpatentable over Lucas in view of Jeffrey et al. (US 2007/0282367). Therefore, the rejection is hereby withdrawn.
As to prior art rejections applicant’s argument filed June 12, 2026 have been fully considered and persuasive. Examiner acknowledges that Lucas reference fails to disclose new limitation in claims 1, 14 and 18.
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 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 Thomas (US 2012/0203163, hereinafter “Thomas”).
Referring to claim 14, a tissue-removing catheter 10 for removing tissue in a body lumen (Figs. 1-5. Figs. 1-2 are reproduced below), the tissue- removing catheter comprising:
PNG
media_image1.png
433
647
media_image1.png
Greyscale
an elongate body 14 (Figs. 1-2, para. [0022]) 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 (Fig. 3);
a tissue-removing element 32 (Fig. 1, para. [0025]: “As shown in FIG. 1, the distal portion 28 of the cutting catheter 14 may include serrated teeth 32 that can engage and break up a clot or occlusion when rotated in a clockwise/counterclockwise manner or in a forward/backward motion with regard to the cross-section of the vessel and the outer catheter 12.”) 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 16 (Figs. 1-3, para. [0024]: “The bypass catheter 16 is disposed within the cutting catheter 14 and is movable, rotatable, or slidable within the cutting catheter 14.”) received within the elongate body and movable relative to the elongate body, the inner liner being radially spaced apart from the elongate body to define a perfusion space there between (Fig. 2 shows a perfusion space between outer surface of bypass catheter 16 and inner surface of cutting catheter 14, para. [0033]: “It should be noted that while the bypass catheter 16, the cutting catheter 14, and outer catheter 12, are navigated through the body and positioned at the site of the occlusion, pressurized (at approximately 300 mm Hg) and/or heparinized saline is pumped through all of the lumen of the catheters 12, 14, and 16.”), 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. [0024]-[0025] disclose bypass catheter 16 and cutting catheter 14 can be movable, rotatable or slidable with respect with each other. Thus, Thomas inherently disclose rotational and torsional forces from cutting catheter 14 are not transferred from the cutting catheter to the interior of the guidewire lumen of bypass catheter 16 when the cutting catheter is rotated during operation of removing obstruction 40).
Referring to claim 18, Thomas discloses a method of removing tissue in a body lumen (Figs. 1-5, para. [0034]-[0038] and [0040]-[0046], Figs. 1-2 are reproduced above), the method comprising:
advancing a tissue-removing catheter 14 (Fig. 3, para. [0034]-[0038] and [0040]-[0046]) over a guidewire 18 (FIG. 4, para. [0034]) in the body lumen to position a distal end of the catheter adjacent the tissue (FIG. 4) and a proximal end portion of the catheter outside of the body lumen, the catheter comprising an elongate body and a tissue removing element 32 mounted on a distal end portion of the elongate body, and an inner liner 16 disposed within the elongate body and radially spaced apart therefrom, the inner liner defining a perfusion space between the inner liner and the elongate body 14 and a guidewire lumen in which the guidewire 18 is disposed during the advancement of the catheter (Figs. 1-2, which are reproduced above. Fig. 2 shows a perfusion space between outer surface of bypass catheter 16 and inner surface of cutting catheter 14, para. [0033]: “It should be noted that while the bypass catheter 16, the cutting catheter 14, and outer catheter 12, are navigated through the body and positioned at the site of the occlusion, pressurized (at approximately 300 mm Hg) and/or heparinized saline is pumped through all of the lumen of the catheters 12, 14, and 16.”);
actuating a motor to rotate the elongate body and tissue-removing element of the catheter to remove the tissue (paras. [0025]: “The rotational or forward/backward motions are generally imparted manually by the fingers of the operating surgeon under fluoroscopic visualization, or by an electrical motor outside the patient's body (not shown).”); and
isolating the guidewire 18 from the elongate body 14 and tissue-removing element 32 with the inner liner 16 so that rotational and torsional forces are not transferred from the rotating elongate body 14 and tissue-removing element 32 to the guidewire 18 during rotation of the elongate body and tissue-removing element (paras. [0024]-[0025] disclose bypass catheter 16 and cutting catheter 14 can be movable, rotatable or slidable with respect with each other. Thus, Thomas inherently disclose rotational and torsional forces from cutting catheter 14 are not transferred from the cutting catheter to the interior of the guidewire lumen of bypass catheter 16 when the cutting catheter is rotated during operation of removing obstruction 40).
Referring to claim 19, Thomas discloses a method of claim 18, further comprising advancing the inner liner 16 through the body lumen to move the inner liner relative to the elongate body 14 (Figs. 3-4).
Referring Claim 20, Thomas discloses a method of claim 18, further comprising advancing the elongate body 14 and tissue-removing element 32 through the body lumen to move the elongate body and tissue-removing element relative to the inner liner 16 (Figs. 4-5).
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) 1-3, 6-8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2012/0203163, hereinafter “Thomas”) in view of Montague et al. (US 2008/0319462, hereinafter “Montague”).
Referring to claim 1, Lucas discloses a tissue-removing catheter 10 for removing tissue in a body lumen (Figs. 1-6. Figs. 1-2 are reproduced below), the tissue-removing catheter comprising:
PNG
media_image1.png
433
647
media_image1.png
Greyscale
an elongate body 14 (Figs. 1-2, para. [0022]) 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. 4-5);
a tissue-removing element 32 (Fig. 1, para. [0025]: “As shown in FIG. 1, the distal portion 28 of the cutting catheter 14 may include serrated teeth 32 that can engage and break up a clot or occlusion when rotated in a clockwise/counterclockwise manner or in a forward/backward motion with regard to the cross-section of the vessel and the outer catheter 12.”) 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 16 (para. [0024]: “The bypass catheter 16 is disposed within the cutting catheter 14 and is movable, rotatable, or slidable within the cutting catheter 14.”) received within the elongate body and radially spaced apart therefrom to define a perfusion space, the inner liner defining a guidewire lumen (Figs. 1-3, Fig. 2 shows a perfusion space between outer surface of bypass catheter 16 and inner surface of cutting catheter 14, para. [0033]: “It should be noted that while the bypass catheter 16, the cutting catheter 14, and outer catheter 12, are navigated through the body and positioned at the site of the occlusion, pressurized (at approximately 300 mm Hg) and/or heparinized saline is pumped through all of the lumen of the catheters 12, 14, and 16.”)), 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. [0024]-[0025] disclose bypass catheter 16 and cutting catheter 14 can be movable, rotatable or slidable with respect with each other. Thus, Thomas inherently disclose rotational and torsional forces from cutting catheter 14 are not transferred from the cutting catheter to the interior of the guidewire lumen of bypass catheter 16 when the cutting catheter is rotated during operation of removing obstruction 40).
Thomas discloses the invention substantially as claimed except for disclosing an atraumatic tip disposed on a distal end portion of the bypass catheter 16 (“inner liner” as recited in the claim), the atraumatic tip being separate from the inner liner and attached to the inner liner.
However, Montague discloses a catheter system for treating a blockage in a blood vessel (Fig. 6, para. [0052]). Montague discloses guidewire catheter 100 includes a highly flexible and soft tip member at the distal end portion of the catheter to facilitate movement of the sheath and guidewire through an occluded lesion with less trauma (para. [0052]: “However, with reference now to FIG. 6, an alternate embodiment of the sheath 100 may comprise a soft, resilient and flexible atraumatic tip 140, having an axial length L and that may comprise soft plastic or soft rubber to facilitate steering the sheath 100 and accompanying guide wire 15 through vasculature with improved atraumatic results. The atraumatic tip 140 is shown comprising a taper which, in addition to facilitating steering the sheath 100 and guide wire 15 through vasculature, may further facilitate movement of the sheath 100 and guide wire 15 through an occluded lesion with less trauma than a sheath 100 without tip 140. Alternatively, the atraumatic tip 140 may not require a taper, instead utilizing soft plastic and/or thinner walls to create the desired resilience and flexibility.”).
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 Montague to the distal end portion of the bypass catheter 16 of Thomas to provide the advantage of allowing the catheter to navigate safely through tortuous blood vessel and through occluded lesion (see Fig. 4 of Thomas reference. The figure show the distal tip of bypass catheter 16 is passed through the occluded lesion) without damaging the vessel.
Referring to claim 2, Thomas/Montague 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 16 through the body lumen (Fig. 6 of Montague reference shows that the soft tip 140 has a tapered configuration to define a low profile distal end).
Referring to claim 3, Thomas/Montague discloses 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) (para. [0062]: “Referring, for example, to the embodiment shown in FIG. 6, the bypass catheter 116 may have a length from 150 cm to about 300 cm and may have an external diameter from 0.62 mm to 0.95 mm.”).
Referring to claim 6, Thomas/Montague 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 (Thomas: Figs. 2-4 show distal end of bypass catheter16 extends distally of tissue removing element 32 of cutting catheter 14.).
Referring to claim 7, Thomas/Montague discloses a tissue-removing catheter as set forth in claim 6, wherein the guidewire lumen extends through the distal end of the inner liner (Thomas: Figs. 3-4).
Referring to claim 8, Thomas/Montague discloses a tissue-removing catheter as set forth in claim 1, wherein the atraumatic tip has a tapered distal end (Montague: see Fig. 6).
Referring to claim 10, Thomas/Montague discloses 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 180 and operable to cause rotation of the elongate body. (Thomas inherently discloses a handle for storing motor and for the surgeon to manipulate the catheters (paras. [0025]: “The rotational or forward/backward motions are generally imparted manually by the fingers of the operating surgeon under fluoroscopic visualization, or by an electrical motor outside the patient's body (not shown).”)).
Referring to claim 11, Thomas/Montague 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 (Thomas inherently discloses a handle for storing motor and for the surgeon to manipulate the catheters (paras. [0025]: “The rotational or forward/backward motions are generally imparted manually by the fingers of the operating surgeon under fluoroscopic visualization, or by an electrical motor outside the patient's body (not shown).”)).
Referring to claim 12, Thomas/Montague discloses a tissue-removing catheter as set forth in claim 11, wherein the perfusion space is configured to permit the perfusion of a fluid therethrough to cool the elongate body as the tissue-removing element is rotated by the elongate body within the body lumen. (Thomas: para. [0033]: “It should be noted that while the bypass catheter 16, the cutting catheter 14, and outer catheter 12, are navigated through the body and positioned at the site of the occlusion, pressurized (at approximately 300 mm Hg) and/or heparinized saline is pumped through all of the lumen of the catheters 12, 14, and 16.”) and para. [0051]: “In this embodiment, the heparinized pressured saline component of the solution is cooled before it is introduced into the revascularization catheter system 10, either by itself or in combination with the oxygen-carrying compound (usually blood).”).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas in view of Montague et al. as applied to claim 1 above and further in view of Preissman et al. (US 5,728,063).
Referring to claims 4-5, Thomas/Montague discloses a tissue-removing catheter as set forth in claim 1, wherein the inner liner 16 includes a combination of metal and polymeric material (para. [0030]: “The outer catheter 12, cutting catheter 14, and the bypass catheter 16 may all be made of a metallic material, such as stainless steel or titanium, a plastic or polymeric material, or a combination of the two. Other suitable materials are also contemplated.”). Thomas/Montague fails to disclose the inner liner includes an inner layer, an outer layer, and an intermediate layer disposed between the inner and outer layers (claim 4) and wherein the inner layer comprises Polytetrafluorethylene (PTFE), the intermediate layer comprises stainless steel, and the outer layer comprises polyimide (claim 5).
Referring again to claims 4-5, 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 4-5, 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 the catheters of Thomas 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 Thomas in view of Montague et al. as applied to claim 1 above and further in view of Dahm et al. (US 2015/0209066, hereinafter “Dahm”).
Referring to claim 9, Thomas/Montague 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, Dahm discloses tissue-removing element (Fig. 1A) includes teeth or a continuous but abrasive surface for removing matter (para. [0056]: “The distal end 82 can be configured to engage and disrupt the occlusion 20 to enhance access through the stenosis 20. The distal end 82 preferably is stiffer than the elongate body 84 at locations proximal of the distal end 82. The end 82 includes an occlusion clearing implement 94, which can be one or more teeth, a continuous but abrasive surface for removing matter”).
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 serrated feature of Thomas with the abrasive feature of Dahm since it has been held that substitution of one known element for another to obtain predictable result is old and well known in the art (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas in view of Montague et al. as applied to claim 1 above and further in view of Farr (US 5,019,089, hereinafter “Farr”).
Referring to claim 13, Thomas/Montague 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 Thomas to allow the motor, gears and the drive shaft 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 Thomas in view of Preissman et al. (US 5,728,063).
Referring to claims 15-17, Thomas discloses a tissue-removing catheter as set forth in claim 14 but fails to disclose the inner liner (bypass catheter 16) 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 bypass catheter 16 of Thomas according Preissman suggestions to improve pushability and torqueability of the catheter to allow the surgeon to navigate the catheter through tortuous blood vessel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
Prosecution Insights