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 Arguments
Applicant's arguments filed 12/22/2025 pertaining to the rejection of independent claims 1, 17 and 18 have been fully considered but they are not persuasive.
Regarding claims 1, 17 and 18, Applicant contends that none of either Selmon, Cottone or Manouchehr expressly disclose or adequately suggest the limitations of “a proximal end of the reentry support comprises a plurality of proximally extending ribs” on the grounds that the ribs of Manouchehr, as incorporated into the device of Selmon around each of the plurality of guidewire exit ports to provide support therefore, are not located at a proximal end of a reentry support but rather at a central portion of the “support region” surrounding each of the exit ports (218).
While the examiner concedes that the exit ports of Manouchehr appear to be located at a central portion of the catheter (as opposed to a distal tip thereof), the Examiner contends that, the rib structures of Manouchehr, when incorporated into the device of Selmon, are located at a “proximal end of the reentry support” that is formed of the catheter body portion within which the guidewire exit ports are disposed. As illustrated in Examiner’s Diagram of Fig. 3D below, the “support region” of the catheter may be defined as the distal portion thereof, within which the guide wire opening (22) is disposed. As the claims do not establish detailed delineation of the various regions of the catheter body, the “Proximal Portion” of the support region may be identified as shown in Examiner’s Diagram of Fig. 3D of Selmon below. In the resulting combination, the ribs of Manouchehr, once incorporated into the device of Selmon, would be disposed along a proximal end of the support region, regardless of their position within the device of Manouchehr due to the difference in location for the guide wire openings between the two devices. As the structure of the ribs in providing greater structural support does not appear to be location-dependent, due to the location of the guide wire openings within Selmon, the ribs would therefore be held to be within the proximal region of said support region.
PNG
media_image1.png
784
749
media_image1.png
Greyscale
Examiner’s Diagram of Fig. 3D
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 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.
Claim 1-2, 20-21 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1)(previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record).
Regarding claim 1, Selmon discloses:
A method of crossing an occlusion in a vascular lumen, comprising the steps of:
advancing a guidewire (guidewire 10, see Fig. 3A) from the vascular lumen through an intima, into a subintimal space, and distally beyond the occlusion (see Figs. 3A-3B showing wherein the guidewire is advanced from the vascular lumen, through the intima and distally beyond the occlusion; see also Para. [0056]-[0057] mentioning wherein the guidewire punctures through the vessel wall into the subintimal space and is advanced beyond the occlusion);
advancing a reentry catheter (catheter 20, see Fig. 3D) having an elongate tubular body (see Fig. 3D) with a single lumen extending therethrough (see Para. [0059]-[0060] mentioning wherein the catheter is advanced over the guidewire (i.e., wherein the guidewire is disposed within a lumen of the catheter)) and a reentry support (portion of the catheter body within which opening is disposed, see Figs. 3A-3E) extending through a reentry zone (see Fig. 3D showing wherein the catheter comprises a “reentry zone” in the region of lateral opening 22) thereof over the guidewire and beyond the occlusion (see Figs. 3B-3D and Para. [0059]-[0060]) such that at least one exit port (lateral port 22, see Fig. 3D) in the reentry zone, which are in communication with the single lumen (see Figs. 3D-3E and Para. [0059]-[0060] and [0090] mentioning wherein the lateral port is in communication with the lumen of the catheter containing the guidewire to allow the guidewire to reenter the vascular space distally of the occlusion), accessible by the guidewire (see Figs. 3D-3E and Para. [0059]-[0060] and [0090]), and arranged along a side wall of the reentry catheter (see Fig. 3D), is rotationally aligned with the vascular lumen (see Figs. 3D-3E and Para. [0059]-[0060] mentioning wherein the guidewire may be advanced through the lateral port (aligned with the vascular lumen) distally of the occlusion to reenter the vascular space); and
advancing the guidewire through the at least one exit port to puncture the intima and reenter the vascular lumen (see Para. [0060] and Figs. 3D-3E);
wherein the elongate tubular body comprises:
a braid layer (see Para. [0078]-[0079] and [0085] mentioning wherein the catheter shaft is formed from braided wire of varying degrees of flexibility; see Para. [0072] mentioning wherein alternative embodiments of the catheter and/or reentry system are configured to be used in the reentry procedure shown in Figs. 3A-3E and the constructions thereof are understood to be applicable to the catheter shown in Figs. 3E-3E unless otherwise stated).
However, Selmon does not expressly disclose:
wherein the reentry catheter comprises a plurality (i.e., more than one) of exit ports defined within the reentry zone;
wherein a different one of the plurality of exit ports is aligned with the vascular lumen depending upon a rotational orientation of the reentry catheter within the subintimal space;
a reentry support extending through said reentry zone; and
wherein:
a proximal end of the reentry support comprises a plurality of proximally extending ribs, and the elongate tubular body comprises:
a coil layer; and
wherein the braid layer at least partially overlays the coil layer, overlaps the proximal end of the reentry support, and is received by the plurality of proximally extending ribs.
In the same field of endeavor, namely surgical reentry catheters, Cottone teaches wherein a reentry catheter (catheter device 1, see Fig. 2A) may comprise a plurality of guidewire ports (exit ports 6 and 7, see Fig. 2A and Para. [0080]-[0081], [0108] and [0110]), wherein one or more guidewire exit ports may be provided along the reentry catheter to be utilized during reentry of a guidewire from within the reentry catheter into a vessel lumen to increase the likelihood of having at least one of the plurality of exit ports be facing the vessel lumen during orientation of the catheter (see Para. [0080]-[0081], [0108] and [0110]). The mention of “at least one side/exit port” does not limit the total potential exit ports to the “two” shown in Fig. 2A but rather may include any number to increase the likelihood of having at least one side port facing the lumen.
Since Cottone discloses wherein increasing the number of guidewire exit ports increases the likelihood of having an exit port facing the vessel lumen during reentry of a catheter into the vessel lumen, the number of exit ports is viewed to be a “result-effective variable” and may be optimized as a matter of obviousness to increase the likelihood of having said at least one exit port facing the vessel lumen, no matter the orientation of the reentry catheter. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the exterior surface of the catheter of Selmon to include three opposing pairs of exit ports arranged along the reentry zone thereof as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the same field of endeavor, namely surgical catheters comprising one or more guidewire exit ports disposed along the length thereof, Manouchehr teaches wherein a catheter (cannula 200, see Fig. 7 and Para. [0034] mentioning wherein the cannula is a “catheter”), comprises an elongate body formed from an internal support coil (coils 208, see Fig. 7) overlaid by an outer top layer (coating 214, see Para. [0010] and [0059]), wherein the internal coil layer provides flexibility and strength to the catheter while preventing kinking during surgery (see Para. [0043]). Manouchehr further teaches wherein the catheter comprises a plurality of exit ports (see Figs 7-8 and Para. [0057]) disposed along the length thereof, wherein the catheter further comprises a reentry support (region of the catheter body comprising holes 218, see Fig. 7) having a plurality of proximally-extending ribs (sheath 213, see Examiner’s Diagram of Manouchehr Fig. 7 below indicating a plurality of “ribs”) disposed over the length of the body comprising the exit ports (see Figs. 7-8) to provide reinforcing strength to the regions of the catheter interrupted by the one or more exit ports (see Para. [0009]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Selmon to include an underlying coil layer beneath the outer braid forming the catheter body as taught and suggested by Manouchehr to, in this case, provide increased flexibility and strength to the catheter while preventing kinking during surgery (see Manouchehr Para. [0043]). It would have also been obvious to one of ordinary skill in the art to have modified the catheter of Selmon to include reinforcing rings around each of the guidewire exit ports of Selmon, as taught and suggested by Manouchehr to, in this case, provide reinforced strength to the catheter around each guidewire exit port to strength this area of weakened material (see Manouchehr Para. [0009]). The resulting configuration would have the braided catheter of Selmon overlapping and received by the internal coil layer and reinforcing ring disposed therein, as incorporated from the teachings of Manouchehr.
PNG
media_image2.png
710
627
media_image2.png
Greyscale
Examiner’s Diagram of Manouchehr Fig. 7
Regarding claim 2, the combination of Selmon, Cottone and Manouchehr disclose the method of claim 1, Selmon further discloses the step of retracting the reentry catheter leaving the guidewire extending into the vascular lumen distally of the occlusion (see Para. [0052] and [0124]).
Regarding claim 20, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, while Selmon, as modified by Cottone, discloses three pairs of radially-opposing guidewire exit ports as a matter of routine optimization, the combination does not expressly disclose wherein each opposing pair of exit ports is rotationally offset from an adjacent pair of opposing exit ports within a range of about 10 degrees to about 60 degrees, inclusive.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pairs of radially-opposing guidewire exit ports to be offset from adjacent pairs of radially-opposing exit ports within a range of between 10-60 degrees, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Selmon et al. would not operate differently with the claimed guide exit port offset and since only one pair of ports can be at the same axial location at the same time, newly added guidewire exit ports would inherently need to be offset from one-another to enable them to be included on the device. Further, Applicant places no criticality on the range claimed, indicating simply that the range is “preferably” within the 10-60 degrees but also provides several alternatives without an express benefit disclosed to distinguish the range of between 10 to 60 degrees from any other angular offset amount (see Specification Para. [0060]).
Regarding claim 21, the combination of Selmon, Cottone and Manouchehr disclose the method of claim 1, Selmon further discloses wherein a diameter of the single lumen extending through the reentry catheter is at least 120% of an outer diameter of the guidewire (see Para. [0073] mentioning wherein the catheter has a diameter of 0.012 inches and the guidewire has a diameter of 0.010 inches; Para. [0072] mentions that the alternative embodiments described are examples of potential arrangements or features of the catheter system described in Figs. 3A-3E and therefore, the recited diameters mentioned in Para. [0073] are seen to be applicable to the catheter and guidewire shown in Figs. 3A-3E unless otherwise stated).
Regarding claim 30, the combination of Selmon, Cottone and Manouchehr disclose the method of claim 1, Selmon, as modified by Cottone, further discloses wherein the plurality of exit ports comprises at least three opposing pairs of exit ports (as incorporated into the device of Selmon by the routine-optimization teachings of Cottone as recited in the rejection of Claim 1 above), and a first exit port of each of the three opposing pairs of exit ports are arranged in a first helix, and a second exit port of each of the three opposing pairs of exit ports are arranged in a second helix (with the inclusion of three opposing pairs of exit ports into the catheter of Selmon, as taught and suggested by Cottone, two helix configuration can be drawn between adjacent and opposing, longitudinally-spaced, pairs of exit ports).
Regarding claim 31, the combination of Selmon, Cottone and Manouchehr disclose the method of claim 30, Selmon, as modified by Cottone, further discloses wherein the first helix and the second helix are intertwined (should two helix formation be drawn between each adjacent and opposing, longitudinally-spaced, pairs of exit ports, the two helix formation would be intertwined as the two helix configuration would span the circumference of the catheter of Selmon).
Regarding claim 32, the combination of Selmon, Cottone and Manouchehr disclose the method of claim 1, Selmon, as modified by Cottone and Manouchehr, further discloses wherein each rib of the plurality of proximally extending ribs includes a respective circumferential segment disposed at a proximal end of the respective rib (see Manouchehr Fig. 7 showing wherein the “ribs” are circumferential structures extending around the catheter body), each respective circumferential segment being spaced circumferentially from, and circumferentially discontinuous with, each of the other respective circumferential segments (as the lateral openings of Selmon, incorporated from the teachings of Cottone, are axially-separated from one-another (see Cottone Fig. 2A), combined with the interpreted resulting configuration, as stated in the rejection of claim 1, as having a separate reinforcing ring around “each of the plurality of openings”, each rib of Manouchehr would be circumferentially separated apart from and discontinuous with adjacent ribs), and the circumferential segments being configured to create an interference fit (as the rib of Manouchehr, when incorporated into the device of Selmon, is disposed under the braided layer of Selmon, the resulting combination would provide an “interference fit” so as to prevent the underlying rib from sliding relative to the braided layer during use).
Claim 3-4 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1) (previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record), further in view of Alvarez (US 2013/0006173 A1) (previously of record).
Regarding claim 3, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 2.
However, while Selmon discloses wherein the guidewire may be left in place to allow further procedures to utilize the guidewire for further procedures including but not limited to: Angioplasty balloon catheters, rotational atherectomy catheters, directional atherectomy catheters, and stent-placement catheters (see Para. [0052]), Selmon does not expressly disclose the step of advancing a balloon catheter over the guidewire and expanding the balloon in the subintimal space.
In the same field of endeavor, namely crossing vessel occlusions, Alvarez teaches crossing a total vessel occlusion via a guidewire (guidewire 602, see Fig. 6A) that is inserted into a subintimal layer of the vessel (see Fig. 6A) followed by a catheter (catheter 100, see Fig. 6B) that is inserted over the guidewire (see Fig. 6B) that are passed distally of the occlusion (see Fig. 6C). At which time, the guidewire is reintroduced into the vessel true lumen distal of the occlusion (see Fig. 6E-6F), followed by a retraction of the catheter, leaving the guidewire behind (see Figs 6G-6H, see also Para. [0074]) to allow further procedures known in the art to utilize said guidewire (see Para. [0074]).
Alvarez provides an example of a following procedure comprising steps of advancing a balloon catheter over the guidewire and expanding a balloon in the subintimal space (see Alvarez Para. [0074] mentioning wherein after the guidewire has reentered the vessel lumen, other procedures known in the art such as percutaneous balloon angioplasty is performed to restore blood flow wherein a balloon catheter may be used to dilate the subintimal space).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Selmon to include the method step of advancing a balloon catheter over the guidewire and expanding the balloon in the subintimal space disclosed by Alvarez as a known subsequent method of use for the guidewire as disclosed by both Selmon (see Para. [0052]) and Alvarez (see Para. [0074]). It is noted that stent-delivery catheters and balloon catheters are also disclosed by Selmon to be utilized for further procedures after the vessel occlusion had been crossed with the aid of the guidewire left in place (see Selmon Para. [0052]).
Regarding claim 4, the combination of Selmon, Cottone, Manouchehr and Alvarez disclose the method of claim 3, Selmon, as modified by Alvarez, further discloses the step of expanding a stent in the subintimal space to maintain patency of a neolumen that permits perfusion around the occlusion (see Alvarez Para. [0074] mentioning wherein after the guidewire has reentered the vessel lumen, other procedures known in the art such as balloon angioplasty and stenting procedures are performed, noting that stents may be expanded via balloon catheters). It is noted that stent-delivery catheters and balloon catheters are also disclosed by Selmon to be utilized for further procedures after the vessel occlusion had been crossed with the aid of the guidewire left in place (see Selmon Para. [0052]).
Regarding claim 22, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, none of the combination expressly discloses wherein a diameter of the single lumen extending through the reentry catheter is at least 200% of an outer diameter of the guidewire.
In the same field of endeavor, namely catheter systems for crossing total vascular occlusions, Alvarez teaches a guidewire (602, see Figs. 6A-6G) and a catheter (100, see Fig. 6B) that are used to cross a total vascular occlusion (see Figs. 6A-6G), wherein the diameter of a single lumen extending through the reentry catheter is at least 200% of an outer diameter of the guidewire (see Para. [0033] mentioning wherein the catheter lumen can house guidewire having a diameter from 0.01-0.04 inches, implying that if the guidewire has a diameter of 0.01 inches, the diameter of the lumen would be greater than 200% the diameter of the guidewire)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the inner diameter of the lumen of the catheter of Selmon to be at least 200% of the outer diameter of the guidewire as disclosed by Alvarez as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0072]-[0073] indicating the diameter “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1) (previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record), further in view of Alvarez (US 2013/0006173 A1) (previously of record), as applied to claim 4, further in view of Makower (US 6709444 B1)(previously of record).
Regarding claim 5, the combination of Selmon, Cottone, Manouchehr and Alvarez disclose all limitations of the method of claim 4. Both Selmon and Alvarez further disclose wherein after the guidewire has reentered the vessel lumen, other procedures known in the art such as balloon angioplasty and stenting procedures may be performed (see Selmon Para. [0052], and Alvarez Para. [0074])
However, the none of either Selmon, Cottone or Alvarez expressly discloses wherein the stent is expanded by the balloon.
In the same field of endeavor, namely reentry catheters for crossing total vessel occlusions, Makower teaches a stenting procedure wherein a catheter is traversed over a guidewire within the subintimal space (see Figs. 5A-5F), wherein after the guidewire has reentered the vessel lumen distal of the occlusion (see Fig. 5D), a catheter (catheter 206, see Fig. 5E) having a stent (stent 208, see Fig. 5E) placed thereon is expanded by a balloon the catheter (See Col. 11, Lines 31-45) so that the stent firmly coapts with the intima of the artery and a mid-portion of the stent, providing a scaffold which maintains the sub-intimal tract in an open condition capable of carrying blood past the obstruction (see Col. 11, Lines 35-45).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stenting procedure as disclosed by Selmon to include inflation of the stent by a balloon catheter as taught and suggested by Makower to, in this case, have the stent firmly coapt with the intima of the artery and a mid-portion of the stent, thereby providing a scaffold which maintains the sub-intimal tract in an open condition capable of carrying blood past the obstruction (see Makower Col. 11, Lines 35-45).
Claim 6-7, 17-18 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1) (previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record), further in view of Sparks (US 20020103459 A1)(previously of record), in further view of Yang (US 2019/0336727 A1) (previously of record).
Regarding claim 6, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, the combination does not expressly disclose the step of applying vacuum to the single lumen extending through the reentry catheter to draw subintimal tissue against the side wall of the reentry catheter by way of the plurality of exit ports.
In the same field of endeavor, namely reentry catheter device and methods for entering subintimal cavities, Sparks teaches a method of applying a vacuum to ports at the distal end of a catheter to “invaginate” subintimal tissue within a distal portion of the catheter (see Para. [0140], [0149], [0151], [0154], [0162] and [0171]-[0173]), thereby securing the catheter to the subintimal wall of the vessel and additionally reducing risk to surrounding vascular tissue and inadvertent perforation of the vessel wall to the pericardial space by invaginating the sub-intimal tissue (see Para. [0140]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the method of Selmon to include the step of applying a vacuum suction to the distal ports of the catheter as disclosed by Sparks to, in this case, lock the sub-intimal tissue on the surface of the catheter (see Sparks Para. [0188]).
However, the combination of Selmon and Sparks does not disclose wherein the vacuum is applied to the single lumen of the device.
In the same field of endeavor, namely catheters inserted over a guidewire that utilize a vacuum for treating thrombosis within the vasculature through a single lumen, Yang teaches a catheter (see Fig. 1-2) that applies a vacuum within the vasculature (see Para. [0113]-[0114]), wherein the guidewire and vacuum are applied through a single lumen (see Para. [0074] mentioning wherein the catheter has only a single central lumen) .
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter lumen of Selmon, as modified by Sparks to only utilize a single lumen for both the vacuum and guidewire, as previously stated to be the case in by Selmon as taught and suggested by Yang to, in this case, allow the catheter to be made smaller and more easily manufacturable by reducing the number of lumens needed by applying the vacuum through the single main lumen.
Regarding claim 7, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, the combination does not expressly disclose the step of applying vacuum to the single lumen extending through the reentry catheter to draw subintimal tissue against the wide wall of the reentry catheter by way of the plurality of exit ports, and aspirate hematoma from the target site subintimal space by way of the plurality of exit ports.
In the same field of endeavor, namely surgical reentry catheters that travel through subintimal spaces to traverse occlusions, Sparks teaches a method step of applying a vacuum to the catheter while in a subintimal space, thereby securing the catheter to the subintimal tissue (see Para. [0140], [0149], [0151], [0154], [0162] and [0171]-[0173]), the method further discloses that upon reentry into the true vessel lumen, the vacuum is still applied and aspirates blood from the vessel true lumen (see Para. [0151]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Selmon to include the step of applying a vacuum suction to the distal ports of the catheter as disclosed by Sparks to, in this case, lock the sub-intimal tissue on the surface of the catheter (see Sparks Para. [0188]) as well as to aspirate blood from the vessel true lumen after reentry into said true lumen (see Sparks Para. [0151]).
However, the combination of Selmon and Sparks does not expressly disclose wherein the vacuum is applied to the single lumen of Selmon.
In the same field of endeavor, namely catheters inserted over a guidewire that utilize a vacuum for treating thrombosis within the vasculature through a single lumen, Yang teaches a catheter (see Fig. 1-2) that applies a vacuum within the vasculature (see Para. [0113]-[0114]), wherein the guidewire and vacuum are applied through a single lumen (see Para. [0074] mentioning wherein the catheter has only a single central lumen) to allow the catheter to be readily modified to incorporate) additional structures as needed (see Para. [0074])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter lumen of Selmon as modified by Cottone and Sparks to only utilize a single lumen for both the vacuum and guidewire, as previously stated to be the case in by Selmon and taught and suggested by Yang, to, in this case, allow the catheter to be made smaller and more easily manufacturable by reducing the number of lumens needed to apply the vacuum through the single lumen.
Regarding claim 17, Selmon discloses:
A method of crossing an occlusion in a vascular lumen, comprising the steps of:
advancing a guidewire (guidewire 10, see Fig. 3A) from the vascular lumen through an intima, into a subintimal space, and distally beyond the occlusion (see Figs. 3A-3B showing wherein the guidewire is advanced from the vascular lumen, through the intima and distally beyond the occlusion see also Para. [0056]-[0057] mentioning wherein the guidewire punctures through the vessel wall into the subintimal space and is advanced beyond the occlusion);
advancing a reentry catheter (catheter 20, see Fig. 3D) having an elongate tubular body (see Fig. 3D) with a single lumen extending therethrough (see Para. [0059]-[0060] mentioning wherein the catheter is advanced over the guidewire (i.e., wherein the guidewire is disposed within a lumen of the catheter)) and a reentry support (portion of the catheter body within which opening 22 is disposed, see Figs. 3A-3E) extending through a reentry zone (see Fig. 3D showing wherein the catheter comprises a “reentry zone” in the region of lateral opening 22) thereof over the guidewire and beyond the occlusion (see Figs. 3B-3D and Para. [0059]-[0060]) such that at least one exit port (lateral port 22, see Fig. 3D) in the reentry zone, which are in communication with the single lumen (see Figs. 3D-3E and Para. [0059]-[0060] and [0090] mentioning wherein the lateral port is in communication with the lumen of the catheter containing the guidewire to allow the guidewire to reenter the vascular space distally of the occlusion), accessible by the guidewire (see Figs. 3D-3E and Para. [0059]-[0060] and [0090]), on a side wall of the reentry catheter (see Fig. 3D), is rotationally aligned with the vascular lumen (see Figs. 3D-3E and Para. [0059]-[0060] mentioning wherein the guidewire may be advanced through the lateral port (aligned with the vascular lumen) distally of the occlusion to reenter the vascular space) such that after retracting a distal portion of the guidewire into the single lumen, a distal tip of the guidewire is positioned to puncture through an intima and into the vascular lumen upon exiting the at least one of the plurality of exit ports (see Para. [0060] and Figs. 3C-3E); and
wherein the elongate tubular body comprises:
a braid layer (see Para. [0078]-[0079] and [0085] mentioning wherein the catheter shaft is formed from braided wire of varying degrees of flexibility; see Para. [0072] mentioning wherein alternative embodiments of the catheter and/or reentry system are configured to be used in the reentry procedure shown in Figs. 3A-3E and the constructions thereof are understood to be applicable to the catheter shown in Figs. 3E-3E unless otherwise stated).
However, Selmon does not expressly disclose wherein the reentry catheter comprises a plurality (i.e., more than one) of radially offset exit ports defined within the reentry zone, wherein a different one of the plurality of exit ports is aligned with the vascular lumen depending upon a rotational orientation of the reentry catheter within the subintimal space;
A reentry support extending through said reentry zone; and
applying vacuum to the plurality of exit ports by way of the single lumen, and aspirating blood or hematoma from the subintimal space;
wherein:
a proximal end of the reentry support comprises a plurality of proximally extending ribs, and the elongate tubular body comprises:
a coil laver; and
wherein the braid layer at least partially overlays the coil layer, overlaps the proximal end of the reentry support, and is received by the plurality of proximally extending ribs.
In the same field of endeavor, namely surgical reentry catheters, Cottone teaches wherein a reentry catheter (catheter device 1, see Fig. 2A) may comprise a plurality of guidewire ports (exit ports 6 and 7, see Fig. 2A and Para. [0080]-[0081], [0108] and [0110]), wherein one or more guidewire exit ports may be provided along the reentry catheter to be utilized during reentry of a guidewire from within the reentry catheter into a vessel lumen to increase the likelihood of having at least one of the plurality of exit ports be facing the vessel lumen during orientation of the catheter (see Para. [0080]-[0081], [0108] and [0110]). The mention of “at least one side/exit port” does not limit the total potential exit ports to the “two” shown in Fig. 2A but rather may include any number to increase the likelihood of having at least one side port facing the lumen.
Since Cottone discloses wherein increasing the number of guidewire exit ports increases the likelihood of having an exit port facing the vessel lumen during reentry of a catheter into the vessel lumen, the number of exit ports is viewed to be a “result-effective variable” and may be optimized as a matter of obviousness to increase the likelihood of having said at least one exit port facing the vessel lumen, no matter the orientation of the reentry catheter. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the exterior surface of the catheter of Selmon to include three opposing pairs of exit ports arranged along the reentry zone thereof as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the same field of endeavor, namely surgical catheters comprising one or more guidewire exit ports disposed along the length thereof, Manouchehr teaches wherein a catheter (cannula 200, see Fig. 7 and Para. [0034] mentioning wherein the cannula is a “catheter”), comprises an elongate body formed from an internal support coil (coils 208, see Fig. 7) overlaid by an outer top layer (coating 214, see Para. [0010] and [0059]), wherein the internal coil layer provides flexibility and strength to the catheter while preventing kinking during surgery (see Para. [0043]). Manouchehr further teaches wherein the catheter comprises a plurality of exit ports (see Figs 7-8 and Para. [0057]) disposed along the length thereof, wherein the catheter further comprises a reentry support having a plurality of proximally-extending ribs (sheath 213, see Examiner’s Diagram of Manouchehr Fig. 7 below indicating a plurality of “ribs”) disposed over the length of the body comprising the exit ports (see Figs. 7-8) to provide reinforcing strength to the regions of the catheter interrupted by the one or more exit ports (see Para. [0009]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Selmon to include an underlying coil layer beneath the outer braid forming the catheter body as taught and suggested by Manouchehr to, in this case, provide increased flexibility and strength to the catheter while preventing kinking during surgery (see Manouchehr Para. [0043]). It would have also been obvious to one of ordinary skill in the art to have modified the catheter of Selmon to include reinforcing rings around each of the guidewire exit ports of Selmon, as taught and suggested by Manouchehr to, in this case, provide reinforced strength to the catheter around each guidewire exit port to strength this area of weakened material (see Manouchehr Para. [0009]). The resulting configuration would have the braided catheter of Selmon overlapping and received by the internal coil layer and reinforcing ring disposed therein, as incorporated from the teachings of Manouchehr.
In the same field of endeavor, namely surgical reentry catheters that travel through subintimal spaces to traverse occlusions, Sparks teaches a method step of applying a vacuum to the catheter while in a subintimal space, thereby securing the catheter to the subintimal tissue (see Para. [0140], [0149], [0151], [0154], [0162] and [0171]-[0173]), the method further discloses that upon reentry into the true vessel lumen, the vacuum is still applied and aspirates blood from the vessel true lumen (see Para. [0151]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Selmon to include the step of applying a vacuum suction to the distal ports of the catheter as disclosed by Sparks to, in this case, lock the sub-intimal tissue on the surface of the catheter (see Sparks Para. [0188]) as well as to aspirate blood from the vessel true lumen after reentry into said true lumen (see Sparks Para. [0151]).
However, the combination of Selmon and Sparks does not expressly disclose wherein the vacuum is applied to the single lumen of Selmon.
In the same field of endeavor, namely catheters inserted over a guidewire that utilize a vacuum for treating thrombosis within the vasculature through a single lumen, Yang teaches a catheter (see Fig. 1-2) that applies a vacuum within the vasculature (see Para. [0113]-[0114]), wherein the guidewire and vacuum are applied through a single lumen (see Para. [0074] mentioning wherein the catheter has only a single central lumen) to allow the catheter to be readily modified to incorporate) additional structures as needed (see Para. [0074])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter lumen of Selmon as modified by Cottone and Sparks to only utilize a single lumen for both the vacuum and guidewire, as previously stated to be the case in by Selmon and taught and suggested by Yang, to, in this case, allow the catheter to be made smaller and more easily manufacturable by reducing the number of lumens needed to apply the vacuum through the single lumen.
PNG
media_image2.png
710
627
media_image2.png
Greyscale
Examiner’s Diagram of Manouchehr Fig. 7
Regarding claim 18, Selmon discloses:
A method of reentering a vascular lumen from a subintimal space, comprising the steps of:
advancing a guidewire (guidewire 10, see Fig. 3A) from the vascular lumen through an intima and into the subintimal space (see Figs. 3A-3B showing wherein the guidewire is advanced from the vascular lumen, through the intima and distally beyond the occlusion; see also Para. [0056]-[0057] mentioning wherein the guidewire punctures through the vessel wall into the subintimal space and is advanced beyond the occlusion);
advancing a reentry catheter (catheter 20, see Fig. 3D) having an elongate tubular body (see Fig. 3D) with a single lumen extending therethrough (see Para. [0059]-[0060] mentioning wherein the catheter is advanced over the guidewire (i.e., wherein the guidewire is disposed within a lumen of the catheter)) and a reentry support (portion of the catheter body within which opening 22 is disposed) extending through a reentry zone thereof (see Fig. 3D showing wherein the catheter comprises a “reentry zone” in the region of lateral opening 22) over the guidewire such that at least one exit port (lateral port 22, see Fig. 3D) in the reentry zone, which are in communication with the single lumen (see Figs. 3D-3E and Para. [0059]-[0060] and [0090] mentioning wherein the lateral port is in communication with the lumen of the catheter containing the guidewire to allow the guidewire to reenter the vascular space distally of the occlusion), accessible by the guidewire (see Figs. 3D-3E and Para. [0059]-[0060] and [0090]) on a side wall of the reentry catheter (see Fig. 3D), is rotationally aligned with the vascular lumen (see Figs. 3D-3E and Para. [0059]-[0060] mentioning wherein the guidewire may be advanced through the lateral port (aligned with the vascular lumen) distally of the occlusion to reenter the vascular space);
wherein:
the elongate tubular body comprises a braid layer (see Para. [0078]-[0079] and [0085] mentioning wherein the catheter shaft is formed from braided wire of varying degrees of flexibility; see Para. [0072] mentioning wherein alternative embodiments of the catheter and/or reentry system are configured to be used in the reentry procedure shown in Figs. 3A-3E and the constructions thereof are understood to be applicable to the catheter shown in Figs. 3E-3E unless otherwise stated).
However, Selmon does not expressly disclose wherein the reentry catheter comprises a plurality (i.e., more than one) of radially-offset exit ports defined within the reentry zone, wherein a different one of the plurality of exit ports is aligned with the vascular lumen depending upon a rotational orientation of the reentry catheter within the subintimal space;
A reentry support extending through said reentry zone; and
wherein:
a proximal end of the reentry support comprises a plurality of proximally extending ribs, and the elongate tubular body comprises:
a coil layer; and
wherein the braid laver at least partially overlays the coil laver, overlaps the proximal end of the reentry support, and is received by the plurality of proximally extending ribs; and
applying vacuum to the plurality of exit ports by way of the single lumen to stabilize tissue between the reentry catheter and the vascular lumen; and
during the applying vacuum step, advancing a wire from the at least one exit port of the reentry catheter, puncturing through the tissue, and into the vascular lumen.
In the same field of endeavor, namely surgical reentry catheters, Cottone teaches wherein a reentry catheter (catheter device 1, see Fig. 2A) may comprise a plurality of guidewire ports (exit ports 6 and 7, see Fig. 2A and Para. [0080]-[0081], [0108] and [0110]), wherein one or more guidewire exit ports may be provided along the reentry catheter to be utilized during reentry of a guidewire from within the reentry catheter into a vessel lumen to increase the likelihood of having at least one of the plurality of exit ports be facing the vessel lumen during orientation of the catheter (see Para. [0080]-[0081], [0108] and [0110]). The mention of “at least one side/exit port” does not limit the total potential exit ports to the “two” shown in Fig. 2A but rather may include any number to increase the likelihood of having at least one side port facing the lumen.
Since Cottone discloses wherein increasing the number of guidewire exit ports increases the likelihood of having an exit port facing the vessel lumen during reentry of a catheter into the vessel lumen, the number of exit ports is viewed to be a “result-effective variable” and may be optimized as a matter of obviousness to increase the likelihood of having said at least one exit port facing the vessel lumen, no matter the orientation of the reentry catheter. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the exterior surface of the catheter of Selmon to include three opposing pairs of exit ports arranged along the reentry zone thereof as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the same field of endeavor, namely surgical catheters comprising one or more guidewire exit ports disposed along the length thereof, Manouchehr teaches wherein a catheter (cannula 200, see Fig. 7 and Para. [0034] mentioning wherein the cannula is a “catheter”), comprises an elongate body formed from an internal support coil (coils 208, see Fig. 7) overlaid by an outer top layer (coating 214, see Para. [0010] and [0059]), wherein the internal coil layer provides flexibility and strength to the catheter while preventing kinking during surgery (see Para. [0043]). Manouchehr further teaches wherein the catheter comprises a plurality of exit ports (see Figs 7-8 and Para. [0057]) disposed along the length thereof, wherein the catheter further comprises a reentry support having a plurality of proximally-extending ribs (sheath 213, see Examiner’s Diagram of Manouchehr Fig. 7 below indicating a plurality of “ribs”) disposed over the length of the body comprising the exit ports (see Figs. 7-8) to provide reinforcing strength to the regions of the catheter interrupted by the one or more exit ports (see Para. [0009]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Selmon to include an underlying coil layer beneath the outer braid forming the catheter body as taught and suggested by Manouchehr to, in this case, provide increased flexibility and strength to the catheter while preventing kinking during surgery (see Manouchehr Para. [0043]). It would have also been obvious to one of ordinary skill in the art to have modified the catheter of Selmon to include reinforcing rings around each of the guidewire exit ports of Selmon, as taught and suggested by Manouchehr to, in this case, provide reinforced strength to the catheter around each guidewire exit port to strength this area of weakened material (see Manouchehr Para. [0009]). The resulting configuration would have the braided catheter of Selmon overlapping and received by the internal coil layer and reinforcing ring disposed therein, as incorporated from the teachings of Manouchehr.
In the same field of endeavor, namely reentry catheter device and methods for entering subintimal cavities, Sparks teaches a method of applying a vacuum to ports at the distal end of a catheter to “invaginate” subintimal tissue within a distal portion of the catheter (see Para. [0140], [0149], [0151], [0154], [0162] and [0171]-[0173]), thereby securing the catheter to the subintimal wall of the vessel and additionally reducing risk to surrounding vascular tissue and inadvertent perforation of the vessel wall to the pericardial space by invaginating the sub-intimal tissue (see Para. [0140]); the method further discloses that upon reentry into the true vessel lumen, the vacuum is still applied and aspirates blood from the vessel true lumen (see Para. [0151]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the method of Selmon to include the step of applying a vacuum suction to the distal ports of the catheter as disclosed by Sparks to, in this case, lock the sub-intimal tissue on the surface of the catheter (see Sparks Para. [0188]), as well as to then aspirate blood from the vessel true lumen after reentry into said true lumen (see Sparks Para. [0151]).
However, the combination of Selmon and Sparks does not disclose wherein the vacuum is applied to the single lumen of the device.
In the same field of endeavor, namely catheters inserted over a guidewire that utilize a vacuum for treating thrombosis within the vasculature through a single lumen, Yang teaches a catheter (see Fig. 1-2) that applies a vacuum within the vasculature (see Para. [0113]-[0114]), wherein the guidewire and vacuum are applied through a single lumen (see Para. [0074] mentioning wherein the catheter has only a single central lumen).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter lumen of Selmon, as modified by Sparks to only utilize a single lumen for both the vacuum and guidewire, as previously stated to be the case in by Selmon as taught and suggested by Yang to, in this case, allow the catheter to be made smaller and more easily manufacturable by reducing the number of lumens needed by applying the vacuum through the single main lumen.
PNG
media_image2.png
710
627
media_image2.png
Greyscale
Examiner’s Diagram of Manouchehr Fig. 7
Regarding claim 26, the combination of Selmon, Cottone, Manouchehr, Sparks and Yang disclose the method of claim 6, Selmon, as modified by Cottone, further discloses wherein drawing subintimal tissue against the side wall of the reentry catheter by way of the plurality of exit ports includes securing subintimal tissue against the side wall of the reentry catheter from opposing sides of the reentry catheter (as there is only a single lumen within the catheter of Selmon, any suction applied to one port facing the vessel lumen would also be applied to the opposing port as incorporated from Cottone into the device of Selmon).
Regarding claim 27, the combination of Selmon, Cottone, Manouchehr, Sparks and Yang disclose the method of claim 7, Selmon, as modified by Sparks and Yang further discloses the step of applying vacuum to the single lumen extending through the reentry catheter to aspirate hematoma from the subintimal space through a catheter tip lumen positioned distally of the elongate body (see Selmon Fig. 3D showing wherein the lateral port is located in the distal tip of the elongate catheter body (noting that the catheter elongate body and the distal tip are distinguished from one-another in Examiner’s Diagram of Fig. 3D below), noting that any suction applied thereto would be drawing in biological material into a lumen that is distal of the catheter elongate body, see Sparks Para. [0151] and [0188]).
PNG
media_image3.png
607
609
media_image3.png
Greyscale
Examiner’s Diagram of Selmon Fig. 3D
Regarding claim 28, the combination of Selmon, Cottone, Manouchehr, Sparks and Yang disclose the method of claim 18, Selmon further discloses wherein advancing the wire from the at least one exit port of the reentry catheter, through the tissue, and into the vascular lumen includes advancement of the same guidewire used to enter the subintimal space from the vascular lumen (see Figs. 3A and 3E showing wherein the guidewire is used to both enter and exit the subintimal space, see also Para. [0057] and [0059]).
Claims 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1) (previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record), further in view of Ghodke (US 2013/0158578 A1).
Regarding claim 23, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, none of either Selmon, Cottone or Manouchehr expressly disclose the step of visualizing the rotational orientation of the reentry catheter within the subintimal space using a radiopaque ring, which surrounds the at least one exit port.
In the field of endeavor of surgical catheters comprising one or more exit ports along the length thereof, Ghodke teaches wherein a catheter (104, see Fig. 1A) may comprise ring-shaped radiopaque markers positioned along openings of an articulated portion of the catheter (see Para. [0047]) to be visualized under X-ray fluoroscopy during navigation to a target site (see Para. [0047]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Selmon, as modified by Cottone, to comprise a radiopaque ring surround each guidewire exit port along the length thereof, as taught and suggested by Godhke to, in this case, visualize the location of each guidewire exit port during navigation to a target site (i.e., through the subintimal space) (see Godhke Para. [0047]).
Regarding claim 24, the combination of Selmon, Cottone and Manouchehr disclose all of the limitations of the method of claim 1.
However, none of either Selmon, Cottone or Manouchehr expressly disclose the step of visualizing the rotational orientation of the reentry catheter within the subintimal space by viewing a plurality of radiopaque rings, each ring surrounding one of the plurality of exit ports, as an “O” or an “X”.
In the field of endeavor of surgical catheters comprising one or more exit ports along the length thereof, Ghodke teaches wherein a catheter (104, see Fig. 1A) may comprise ring-shaped radiopaque markers positioned along openings of an articulated portion of the catheter (see Para. [0047]) to be visualized under X-ray fluoroscopy during navigation to a target site (see Para. [0047]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the catheter of Selmon, as modified by Cottone, to comprise a radiopaque ring surround each guidewire exit port along the length thereof, as taught and suggested by Godhke to, in this case, visualize the location of each guidewire exit port during navigation to a target site (i.e., through the subintimal space) (see Godhke Para. [0047]).
Claim 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selmon (US 2006/0276749 A1) (previously of record) in view of Cottone (US 2016/0074627 A1)(previously of record), further in view of Manouchehr (US 2017/0021127 A1) (previously of record), further in view of Sparks (US 20020103459 A1)(previously of record), in further view of Yang (US 2019/0336727 A1) (previously of record), as applied to claim 18, further in view of Alvarez (US 2013/0006173 A1) (previously of record).
Regarding claim 29, the combination of Selmon, Cottone, Manouchehr, Sparks and Yang disclose all of the limitations of the method of claim 18.
However, Selmon does not expressly disclose wherein advancing the wire from the at least one exit port of the reentry catheter, puncturing through the tissue, and into the vascular lumen includes advancement of a second guidewire, which is distinct from the guidewire used to enter the subintimal space from the vascular lumen.
In the same field of endeavor, namely balloon catheter systems for crossing total vascular occlusions, Alvarez teaches a method comprising the steps of advancing a guidewire (602, see Fig. 6A) into a subintimal space (see Fig. 6A), followed by the step of advancing a catheter along the guidewire to a point beyond the occlusion (see Figs. 6B-6D). Alvarez then discloses the step of reentering the vessel true lumen via a reentry member (112, see Fig. 6E) to allow the guidewire to be reintroduced to the vessel true lumen (see Para. [0073]-[0074]). Such a reentry member comprises a sharp edge 156 that dissects the vessel wall from the subintimal space into the true vessel lumen. It is thought that the cutting action significantly reduces the force required to safely and accurately reenter the vessel lumen even in the presence of calcified tissue. This reentry force is suspected to be significantly lower than the forces required for known reentry devices (i.e., with a guidewire), which require lateral extension of the catheter. Moreover, the reentry device 112 includes an improved torsional control to support reentry forces (see Para. [0073])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the reentry step of Selmon to incorporate a reentry device as taught and suggested by Alvarez to be used to reentry the vessel true (as opposed to the guidewire 10) to, in this case, significantly reduce the force required to safely and accurately reenter the vessel lumen even in the presence of calcified tissue in addition to providing an improved torsional control to support reentry forces (see Alvarez Para. [0073]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 10342569 B2 to Kugler, US 6235000 B1 to Milo, US 11020141 B2 to Kugler and US 7179270 B2 to Makower disclose catheter device comprising either a supporting coil layer disposed therein and/or methods of crossing an occlusion through a subintimal layer of the vasculature with a catheter comprising at least one guide wire opening.
THIS ACTION IS MADE FINAL. 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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached on 5712724695. 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.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights