DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation-in-part of application No. 18/822,319, filed on September 2, 2024, which is a continuation of application No. 18/081,298, filed on December 14, 2022, now Patent No. 12,178,468, which is a continuation of application No. 16/840,715, filed on April 6, 2020, now Pat. No. 11,596,436, which claimed priority of provisional application No. 63/619,920, filed on January 11, 2024.
Examiner notes that the limitation of “an outer tube coaxially disposed over the inner tube, a proximal portion of the outer tube being coupled to the proximal driving and control assembly, a distal portion of the outer tube being attached to the keystone portions, such that axial movement of the outer tube relative to the inner tube is operative to selectively open and close the first and second beaks” (claim 1, lines 10-13) and “a portion of the outer tube comprises at least one of changes in material thicknesses, density and laser cuts that form voids in a material of the outer tube over at least a portion of a length of the outer tube to vary at least one of a flexibility and an ability to transmit torque of at least the portion of the outer tube.” (claim 1, lines 18-21) are not in the application No. 18/822,319, application No. 18/081,298, and application No. 16/840,715 and so are only afforded the filing date of the provisional application, which is January 11, 2024.
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) 1-2, 5, 10, 12, 14-16, 18 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vetter et al. (US 2019/0365360, hereinafter “Vetter”).
Referring to claim 1, Vetter disclose a tissue excisional device (FIGS. 1-7 and 9B-13, FIG. 4 is reproduced and annotated below), comprising:
a proximal driving and control assembly (FIG. 16 shows handle 12 includes driving and control assembly, paras. [0034], [0039] and [0061]; para. [0034]: “Driving assembly or assemblies (hereafter, collectively “driving assembly” for ease of reference) for beaks may be controllable at the handle end of the device (e.g., outside the body) and can be quite sophisticated, reusable and electronically optimized for torque, rotational speed (rpm) and frequency (in the cases of translation, angular changes and oscillation motions).”);
a distal work element 13 (FIG. 2, which is reproduced and annotated below, paras. [0040] or FIG. 9B) formed from a single tube of material (para. [0040]) comprising cuts that define voids, the voids and remaining tube material defining a backbone portion (the backbone portions 1, 2 as shown in FIG. 4 and the portion near lead lines 292B as shown FIG. 3 have been interpreted a “a backbone portion,” para. [0025]), movable keystone portions (actuation tab 469 as shown in FIGS. 2 and 11); first and second beaks (452, 454 as shown in FIG. 2 or 524, 522 as shown in FIG. 9B) and tendons (468, 470 as shown in FIG. 2, para. [0040] or FIG. 15) extending between the movable keystone portions and the first and second beaks (“FIGS. 2 and 3 show details of components of a work element, according to one embodiment. Attention is drawn to the proximal end of a work element 13. Therein, a body portion 428 of a work element 13 may be mechanically coupled to tendon actuating element 469 at the proximal end of a work element. Note that a tendon actuating element 469 is already coupled to a body portion 428 through tendons 468, 470, toward the distal end of a work element 13.” (para. [0040]));
PNG
media_image1.png
404
685
media_image1.png
Greyscale
an inner tube (FIGS. 4-6, para. [0043]: “A proximal sheath 300, as shown in FIG. 4 may comprise a number of fenestrations or slots 304 that run through the wall of a proximal sheath 300, from an outer surface to an interior lumen thereof. The distal portion of a proximal sheath 300 may be configured to fit over and attach to the proximal end of a monolithic beak assembly 13 of FIGS. 2 and 3.” FIGS. 9B-11 shows inner tube 530, para. [0050]), the inner tube defining a longitudinal axis, a proximal portion of the inner tube being coupled to the proximal driving and control assembly, a distal portion of the inner tube being attached to the backbone portion (FIG. 11 shows inner tube 530 is continuous from the backbone portion near lead lines 588, para. [0050]: “Such a configuration may be advantageous in allowing for beak actuation wherein the proximally extended body portion 530 of the inner monolithic work element tube may be, for example, over 3 feet in length and flexible over its length as may commonly be associated with vascular intervention devices.”);
an outer tube coaxially disposed over the inner tube, a proximal portion of the outer tube being coupled to the proximal driving and control assembly, a distal portion of the outer tube being attached to the keystone portions, such that axial movement of the outer tube relative to the inner tube is operative to selectively open and close the first and second beaks (sheath 320 as shown in FIG. 6-7, para. [0044]: “Other attachment technologies may also be used, as appropriate. Once a distal sheath 320 is spot welded in place, it will rotate in synchronicity with a beak assembly 13 and proximal sheath 300, but will be able to move axially relative to proximal sheath 300, according to one embodiment. Such axial movement between distal and proximal sheaths will positively open and/or close a beak or beaks of monolithic beak assembly 13, as previously discussed.” Outer tube 531 as shown in FIGS. 9B-11, para. [0050]: “In this figure, a collar 532 may be comprised of three sub-elements, 532a, 532b and 532c, the most distal of which (532a) may be attached to, for example, a body portion 528 of a work element, the middle collar (532b) attached to a co-axially placed outer tube 531, and the most proximal collar (532c) attached to the tendon actuation tab 526. If the outer tube is rotated in relation to the work element, the sinusoidal or other form of wave around the periphery of the adjacent-most distal collar and middle collar will provide relative axial motion between the body portion 528 of the work element and the tendon actuation tab 526 of the work element, thus actuating the beak tip(s) without allowing the beak tips to twist in relation to one another… It should also be noted that if the outer tube 531 is pulled axially in a proximal direction while the work element 13 is stationary, then the middle collar 532b will pull the proximal collar 532c in a proximal direction as well, resulting in the beaks closing. Similarly, if the body portion 528 is pushed distally while the outer tube 531 is stationary, the beaks will also close. Such a configuration allows the beaks to be actuated either as a result of differential rotation of the body portion 528 and outer tube 531, or by relative axial motion between those two structures.”);
a portion of the inner tube comprises at least one of changes in material thicknesses, density and laser cuts that form voids in a material of the inner tube over at least a portion of a length of the inner tube to vary at least one of a flexibility and an ability to transmit torque of at least the portion of the inner tube (“flexible helical portion 582” as disclosed in paragraph [0054] and shown in FIG. 11).
a portion of the outer tube comprises at least one of changes in material thicknesses, density and laser cuts that form voids in a material of the outer tube over at least a portion of a length of the outer tube to vary at least one of a flexibility and an ability to transmit torque of at least the portion of the outer tube (flexible helical portion 585 as disclosed paragraph [0054] and shown in FIG. 11).
Referring to claim 2, Vetter discloses the tissue excisional device of claim 1, wherein the distal work element 13 is rigid (Vetter discloses work element 13 is configured to cut tissue and the work element is made from a stainless steel hypo tube (para. [0037]: “According to one embodiment, a tube may comprise a stainless-steel hypodermic tubing (“hypo tube”). Such a stainless hypo tube, according to one embodiment, may be provided with (e.g., laser) cuts to define a monolithic distal assembly that defines beaks, a living hinge that attaches the beak(s) to the generally tubular body of the device or that homogeneously spans between the beak(s) and the generally tubular body of the device.”)).
Referring to claim 5, Vetter discloses the tissue excisional device of claim 1, wherein a distal portion of the inner tube forms a first inner tube flange connector and a facing second inner tube flange connector, each of the first and second inner tube flange connectors being connected to respective portions of the backbone portion (see FIG. 2, which is reproduced and annotated above).
Referring to claim 10, Vetter discloses the tissue excisional device of claim 1, wherein the laser cuts of the portion of the inner tube form a discontinuous spiral pattern at a predetermined pitch such that the portion of the inner tube is configured to flex while maintaining the ability of the portion of the inner tube to transmit torque (FIG. 13, which is reproduced below, para. [0056]).
PNG
media_image2.png
378
567
media_image2.png
Greyscale
Referring to claim 12, Vetter discloses the tissue excisional device of claim 10, wherein the discontinuous spiral pattern of the portion of the inner tube comprises void patterns having a repeated axial separation that defines the predetermined pitch (FIG. 13, which is reproduced below, para. [0056]).
Referring to claim 14, Vetter discloses the tissue excisional device of claim 1, wherein the portion of the inner tube comprises an inner tube long flexible section 582 (FIG. 11) disposed between a proximal rigid section of the inner tube and an inner tube distal rigid tip, and wherein the portion of the outer tube comprises an outer tube long flexible section 585 (FIG. 11) disposed between a proximal rigid section of the outer tube and an outer tube distal rigid tip.
Referring to claim 15, Vetter discloses the tissue excisional device of claim 14, wherein the inner tube distal rigid tip is connected to the backbone portion (FIG. 11 shows the inner tube attached to the portion 528 of working tip 13), and wherein the outer tube distal rigid tip is connected to the keystone portions (para. [0054]: “An outer tube 584 may also feature a flexible element 585, a spot weld or glue hole 587 which may be matched to weld point 589 of an inner tube, and spot weld or glue holes 586 which may be matched to weld points 588 of an inner tube of a work element.”).
Referring to claim 16, Vetter discloses the tissue excisional device of claim 15, wherein the inner tube distal rigid tip is attached to the backbone portion (FIG. 11 shows the inner tube attached to the portion 528 of working tip 13) at a first fastening point, and wherein the outer tube distal rigid tip is attached to the keystone portions at second fastening points (para. [0054]: “An outer tube 584 may also feature a flexible element 585, a spot weld or glue hole 587 which may be matched to weld point 589 of an inner tube, and spot weld or glue holes 586 which may be matched to weld points 588 of an inner tube of a work element.” FIG. 11 shows weld point 589 is located at the proximal portion of keystone (actuation tab 469)).
Referring to claim 18, Vetter discloses the tissue excisional device of claim 14, wherein the inner tube long flexible section and the outer tube long flexible section are each configured to rotate and transmit axial forces to the distal work element through a tortuous path (paras. [0003] and [0033]).
Referring to claim 25, Vetter discloses the tissue excisional device of claim 1, wherein at least one of the inner tube and the outer tube comprises a step-up in inside diameter proximal of an attachment point to the distal work element to define an expansion chamber configured to reduce compression or friction on a cored tissue sample transported proximally through the tissue excisional device (FIG. 8, para. [0054]).
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) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 2019/0365360) as applied to claim 1 above.
Referring to claim 11, Vetter discloses the tissue excisional device of claim 1, wherein the portion of the outer tube comprises the laser cuts (FIG. 11). Vetter fails to disclose wherein the laser cuts of the portion of the outer tube form a discontinuous spiral pattern at a predetermined pitch such that the portion of the outer tube is configured to flex while maintaining the ability of the portion of the outer tube to transmit torque. However, Vetter discloses the laser cuts of the portion of the inner tube form a discontinuous spiral pattern at a predetermined pitch such that the portion of the inner tube is configured to flex while maintaining the ability of the portion of the inner tube to transmit torque (FIG. 13, para. [0056]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have made the flexible portion of the outer tube similar to the embodiment as shown in FIG. 11 so that it too would have the same advantage.
Referring to claim 13, the modified device of Vetter discloses the tissue excisional device of claim 11, wherein the discontinuous spiral pattern of the portion of the outer tube comprises void patterns having a repeated axial separation that defines the predetermined pitch (see FIG. 13, which is reproduced above).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 2019/0365360) as applied to claims 1 and 14 above in view of Ferrera et al. (US 2011/0160757, hereinafter “Ferrera”).
Referring to claim 17, Vetter disclose the tissue excisional device of claim 14 but fails to disclose wherein at least one of the inner tube long flexible section and the outer tube long flexible section is more flexible at a distal region thereof than at a proximal region thereof.
Referring again to claim 17, Ferrera discloses a catheter device, which is made from a hypotube, for insertion into a blood vessel includes a laser cut portion to provide flexibility to allow the catheter to access through the tortuous vessels (“a distal portion (e.g., at least approximately the distal 35 cm) of the variable stiffness hypotube can be more flexible to allow for access through the tortuous vessels of the cerebral vasculature (e.g., to get above the carotid siphon (as shown in FIG. 35) and/or past the C1/C2 vertebral arteries).” (para. [0190])). Ferrera discloses the flexible portion L (FIG. 7A, which is reproduced below) can gradually decrease in stiffness from a proximal end to a distal end or can decrease in step-wire fashion by changing the variable-pitch of the helical cut (paras. [0190]-[0191], “The elongate member 505 can gradually decrease in stiffness from the proximal end to the distal end or can decrease in step-wise fashion. With reference to FIG. 7A, region L illustrates a laser cut transition region of the variable-pitch hypotube.” (para. 0190]))
PNG
media_image3.png
238
586
media_image3.png
Greyscale
Still referring to claim 17, in view of Ferrera’s teaching, 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 flexible portion of the inner tube or inner and out tubes of Vetter according to the teaching of Ferrera so that it too would have the same advantage.
Claim(s) 1-2, 5, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 2016/0166240, hereinafter “Vetter”).
Referring to claim 1, Vetter discloses a tissue excisional device (FIGS. 1-7, FIG. 4 is reproduced and annotated below), comprising:
PNG
media_image4.png
408
597
media_image4.png
Greyscale
a proximal driving and control assembly (FIG. 6 shows handle 12 includes driving and control assembly, paras. [0041] and [0043]-[0045]);
a distal work element 13 (see the annotated figure above) formed from a single tube of material (paras. [0026] and [0031]) comprising cuts that define voids, the voids and remaining tube material defining a backbone portion (the backbone portions 1, 2 and the portion near lead lines 588 as shown in FIG. 4, para. [0025]), movable keystone portions (actuation tab 469 as shown in FIGS. 2A and 4. Paragraph [0031] discloses “travel limiter structures”. In paragraph [0130] of the publication of the application discloses “travel limiting structures such as keystone-shaped, or tendon actuation element 16 (hereinafter referred to as the “keystone” element)”); first and second beaks (452, 454 as shown in FIG. 2A or 652, 654 as shown in FIG. 4. FIG. 4 is reproduced and annotated below) and tendons (468, 470 as shown in FIG. 2A, para. [0025]: “tendons 470 connected to the beaks”) extending between the movable keystone portions and the first and second beaks (“Therein, a body portion 428 of a work element 13 may be mechanically coupled to tendon actuating tab 469 at the proximal end of work element 13. Note that a tendon actuating tab 469, from the embodiment of FIGS. 2A and 2B, is already coupled to a body portion 428 through tendons 468, 470, toward the distal end of a work element 13. That is, an entire work element 13 may be formed of a single homogeneous piece of material—such as from a single hollow tube that is (for example) laser-cut to form the structures shown in FIGS. 2A and 2B. Two beaks are shown. It is to be understood, however, that such need not be the case, as a work element 13 may comprise multiple beaks or a single beak that acts against a non-moveable part, such as a fixed trough-shaped distal portion of a distal sheath or against a fixed, opposing beak that is part of a work element 13 itself.” (para. [0026]));
an inner tube (FIGS. 3-4, para. [0032]: “The work element 13 may be mechanically coupled to a proximal sheath 584 as an extension of the tubular structure.”), the inner tube defining a longitudinal axis, a proximal portion of the inner tube being coupled to the proximal driving and control assembly, a distal portion of the inner tube being attached to the backbone portion (para. [0032]: “Significantly, the attachment of the proximal sheath 584 to both the body portion 428 and to tendon actuating tabs 469 of the work element 13 results in substantially equal torque being imposed on the constituent elements of a work element under rotation, thereby maintaining the structural integrity of the work element 13as it is used and as first and second articulable beaks 602, 604 cut through variably dense, fibrous and/or vascularized tissues.”);
an outer tube coaxially disposed over the inner tube, a proximal portion of the outer tube being coupled to the proximal driving and control assembly, a distal portion of the outer tube being attached to the keystone portions, such that axial movement of the outer tube relative to the inner tube is operative to selectively open and close the first and second beaks (para. [0033]: “An outer sheath, if desired, may be added but is not visible in this view.” And para. [0041]: “Also shown in this figure are two circular dogs, one of which, dog element 16, acts as a thrust bearing, allowing rotation. Dog element 16, in the implementation shown in FIG. 6, is connected to the tendon actuation tab 469 of the work element 10 if the work element is a single tube (as shown in FIG. 2A), or on the outer tube (which if present may act on the tendon actuation tab where the work element is composed of an inner and outer tube, according to embodiments).”);
a portion of the inner tube comprises at least one of changes in material thicknesses, density and laser cuts that form voids in a material of the inner tube over at least a portion of a length of the inner tube to vary at least one of a flexibility and an ability to transmit torque of at least the portion of the inner tube (“flexible extension element 582” as disclosed paragraph [0033] and shown in FIG. 4).
Vetter discloses the invention substantially as claimed except for disclosing a portion of the outer tube comprises at least one of changes in material thicknesses, density and laser cuts that form voids in a material of the outer tube over at least a portion of a length of the outer tube to vary at least one of a flexibility and an ability to transmit torque of at least the portion of the outer tube. Examiner notes that Vetter already discloses that the inner tube 584 includes changes in density and laser cuts 582 that form voids in the material of the inner tube to improve flexibility at the distal portion of the inner tube. Thus, 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 flexible tension to the outer tube so that it too would have the same advantage.
Referring to claim 2, the modified device of Vetter discloses the tissue excisional device of claim 1, wherein the distal work element 13 is rigid (Vetter discloses work element 13 is configured to cut tissue and the work element is made from a stainless steel hypo tube (para. [0008], para. [0033]: “As noted above, the work element 13 and the extension element 582 may be formed of, or cut from, a single piece of material such as, for example, a stainless steel hypo tube.” and para. [0050]: “As shown therein, Block B171 calls for providing a device that comprising a work element configured to cut tissue and that is formed from a single tube of material defining a lumen.”).
Referring to claim 5, the modified device of Vetter discloses the tissue excisional device of claim 1, wherein a distal portion of the inner tube forms a first inner tube flange connector and a facing second inner tube flange connector, each of the first and second inner tube flange connectors being connected to respective portions of the backbone portion (see FIG. 4, which is reproduced and annotated above).
Referring to claim 19, the modified device of Vetter discloses the tissue excisional device of claim 1, wherein the proximal driving and control assembly comprises a first dog element fixed to the inner tube and a second dog element fixed to the outer tube, the first and second dog elements being configured to permit axial sliding of the inner tube and the outer tube while keeping the inner tube and the outer tube rotating together (para. [0041]: “The thrust bearings or dogs 16 and 17 may be fixed to their respective elements of the work element 13 by adhesive or other appropriate fixation mechanism. Dog element 17 serves as a thrust bearing allowing rotational and axial movement and is attached either to the body portion of the work element 13 in a single tube work element embodiment, or to the inner tube of the work element, if present, according to embodiments. It should be noted that each of the dog elements 16, 17 comprises an extended half shaft of semi-circular or other form that work in concert to ensure that any rotation of the thrust bearings is coordinated while allowing axial motion, one relative to the other.”).
PNG
media_image5.png
372
626
media_image5.png
Greyscale
Referring to claim 20, the modified device of Vetter discloses the tissue excisional device of claim 19, wherein the first and second dog elements 16, 17 (FIG. 6, para. [0041]) comprise telescoping partial tube-shaped dogs (FIG. 6, para. [0041]) configured to slide past one another to telescope the inner tube and the outer tube while keeping rotations of the inner tube and the outer tube together to reduce torsional stresses. (para. [0041]: “It should be noted that each of the dog elements 16, 17 comprises an extended half shaft of semi-circular or other form that work in concert to ensure that any rotation of the thrust bearings is coordinated while allowing axial motion, one relative to the other.”).
Referring to claim 21, the modified device of Vetter discloses the tissue excisional device of claim 1, further comprising an outer sleeve disposed over the outer tube, wherein the inner tube, the outer tube and the outer sleeve are flexible along at least part of their respective lengths and steerable to follow a tortuous pathway while maintaining rotation and force transmission to operate the first and second beaks (para. [0035]: “According to one embodiment, a guiding element may be provided coaxial with, in tandem with or adjacent to the long axis of elements of the device, such as the work element 13. Alternatively, the guiding element may be a completely separate or separable entity, such as a removable outer sheath, with or without a scoopula-shaped distal portion that may function as a locating tube. Such a locating tube may be pre-placed by an operator skilled in imaging and targeting and fixed in place near or within the target tissue. After placement and fixation, an operator may then proceed by advancing the device 10 over a previously precisely placed and anchored guiding element to the target tissue site.” (emphasis added)).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 2016/0166240) in view of To et al. (US 2009/0018565, hereinafter “To”).
Referring to claims 22-23, the modified device of Vetter discloses the tissue excisional device of claim 21 but fails to disclose wherein the outer sleeve is configured to control an exposure length of a rigid length and a flexible length of at least one of the inner tube and the outer tube to provide directionality and to control a degree of deviation of the distal work element from a centerline axis of the outer sleeve. However, in the same field of endeavor, which is a catheter device for clearing a blockage in a blood vessel (abstract), To discloses (Figs. 26A-26C and 29A-29B) distal portion of outer sleeve can be controlled to facilitate the steering of the distal portion of the cutting catheter and the cutting catheter has a built-in bias configured to direct the distal work element off-axis as the distal cutter exits a distal end of the outer sleeve (“The length of the flexible distal portion 122 (or a predefined portion) may be controlled, i.e., adjusted by including a member 124 either inside or outside the catheter 120, or both inside and outside the catheter. The member 124 may comprise an axially adjustable sheath, wire, or guidewire, for example, the member 124 having a stiffness greater than the flexible distal portion. As seen in FIG. 26A, when the sheath 124 is advanced distally, its added stiffness reduces the flexibility of the flexible distal portion 122. When the sheath 124 is retracted proximally, the length of the flexible distal portion may be increased relative to the portion the sheath 124 was retracted (see FIG. 26B).” paras. [0262]-[0263]).
Referring again to claims 22-23, in view of To’s teaching 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 guiding element (outer sleeve as required in claim 21) according to To’s suggestion so that it too would have the advantage of allow the cutting element to rotate in an arcuate path (orbital path or a sweeping motion) to attack plaque on the side wall (Figs. 23G-23H) or plaque in a large diameter vessel (Figs. 22D-22E).
Referring to claim 25, the modified device of Vetter discloses the tissue excisional device of claim 1, wherein at least one of the inner tube and the outer tube comprises a step-up (the portion at lead line 332 as shown in FIG. 5) in inside diameter proximal of an attachment point to the distal work element to define an expansion chamber configured to reduce compression or friction on a cored tissue sample transported proximally through the tissue excisional device (FIG. 5, para. [0038]).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vetter et al. (US 2016/0166240, hereinafter “Vetter”) in view of Ferrera et al. (US 2011/0160757, hereinafter “Ferrera”).
Referring to claim 3, the modified device of Vetter discloses the tissue excisional device of claim 1, but fails to disclose wherein the portion of the inner tube is configured such that the changes in material thicknesses, density or laser cuts result in the inner tube having a gradient of flexibility from a proximal end of the portion of the inner tube to a distal end of the portion of the inner tube.
Referring again to claim 3, Ferrera discloses a catheter device, which is made from a hypotube, for insertion into a blood vessel includes a laser cut portion to provide flexibility to allow the catheter to access through the tortuous vessels (“a distal portion (e.g., at least approximately the distal 35 cm) of the variable stiffness hypotube can be more flexible to allow for access through the tortuous vessels of the cerebral vasculature (e.g., to get above the carotid siphon (as shown in FIG. 35) and/or past the C1/C2 vertebral arteries).” (para. [0190])). Ferrera discloses the flexible portion L (FIG. 7A, which is reproduced below) can gradually decrease in stiffness from the proximal end to the distal end or can decrease in step-wire fashion by changing the variable-pitch of the helical cut (paras. [0190]-[0191], “The elongate member 505 can gradually decrease in stiffness from the proximal end to the distal end or can decrease in step-wise fashion. With reference to FIG. 7A, region L illustrates a laser cut transition region of the variable-pitch hypotube.” (para. 0190]))
PNG
media_image3.png
238
586
media_image3.png
Greyscale
Still referring to claim 3, in view of Ferrera’s teaching, 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 flexible portion 582 of the inner tube 584 of Vetter according to the teaching of Ferrera so that it too would have the same advantage.
Referring to claim 4, the modified device of Vetter discloses the tissue excisional device of claim 1, wherein the portion of the outer tube is configured such that the changes in material thicknesses, density or laser cuts result in the outer tube having a gradient of flexibility from a proximal end of the portion of the outer tube to a distal end of the portion of the outer tube (see rejection of claim 3 above).
Allowable Subject Matter
Claims 6-9 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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