DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 10/24/2025 has been entered. Claim 21 has been canceled. Claims 1-9, 11-19, and 22 remain pending in the application.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
Applicant argues the modification of Shohat to have “a circular cross section in the axial plane when in its inflated state” would render it unsuitable for or unable to dissect tissue in a controlled manner and would thus render Shohat unsatisfactory for its intended purpose.
Examiner respectfully disagrees. The intended purpose of Shohat is an expandable tissue dissecting device and not exclusively to a directionally controllable inflatable bladder, i.e. a bladder controlled to be substantially planar ([0002]). Shohat teaches the inflatable bladder optionally dissects tissue by uniform, centered, and controlled lateral expansion ([0146]). Shohat further teaches the final shape of the bladder is optionally predefined according to anatomic considerations ([0151]). Moreover, Shohat teaches the shape of final inflation of the bladder (balloon) is optionally substantially planar ([0163]). Since Shohat teaches wherein the final shape of the balloon is optionally planar and wherein the final shape may optionally be defined according to anatomic considerations, final shapes of the balloon other than planar, i.e. spherical as taught by Sirimanne, may be had while not rendering Shohat unsatisfactory for its intended purpose of tissue dissection. Therefore, the modification of Shohat to have “a circular cross section in the axial plane when in its inflated state” as taught by Sirimanne is proper.
Applicant’s arguments with respect to claims 8 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Newly cited reference Tilson (US20090299401) is now being relied upon for teaching “at least one radiopaque and ultrasonically visible marker element imbedded in a wall of the balloon”.
Applicant states further, on page 8 of Remarks filed 10/24/2025, that “Claim 21 has been amended to recite that ‘the bioabsorbable balloon has a circular cross section in the axial plane throughout in its entire inflated state’”.
Examiner respectfully disagrees, as claim 21 appears to be canceled according to the claims filed with the Remarks, dated 10/24/2025. Accordingly, the examiner will be treating claim 21 as canceled.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
“in the axial plane” should be corrected to:
“in an axial plane”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195). Shohat is cited in the IDS filed 10/22/2024.
Regarding claim 1, Shohat teaches a biopsy marker delivery device, comprising:
a catheter shaft having a lumen, a proximal tube portion, and a distal tube portion ([0082], [0088], [0240], [0246], wherein the guide being a catheter having a proximal end, a distal end, and possessing a lumen comprises a catheter shaft having a lumen, proximal tube portion, and distal tube portion); and
a bioabsorbable balloon (10) fixedly connected to the distal tube portion to define a balloon assembly (Figs. 1B-1D, [0081-0082], [0154], [0167], [0220-0221], [0237-0240], “To enable biodegradation, device 10 is constructed from polymers which are biocompatible and bioabsorbable…”, “In some embodiments of the invention the plug is detachably connected to a distal end of a catheter…”), the bioabsorbable balloon (10) configured for fluid communication with the lumen of the catheter shaft ([0239-0241], [0246]).
However, Shohat fails to teach wherein the proximal tube portion is joined to the distal tube portion by a frangible link and wherein the balloon assembly is configured to be separated from the proximal tube portion of the catheter shaft by breaking the frangible link.
In an analogous balloon catheter field of endeavor, Squire teaches such a feature. Squire teaches a catheter (10) having an elongate shaft (12) and a balloon member (25) attached at a distal portion (20) of the elongate shaft (12) (Fig. 1, [0078]). Squire further teaches wherein the elongate shaft (12) includes a frangible link (24) (Fig. 1, [0080]). As shown in figure 1 of Squire, the elongate shaft (12) comprises a proximal tube portion and a distal tube portion separated by the frangible link (24) (Fig. 1). Squire teaches wherein the frangible link is configured to detach the balloon (24) from the catheter shaft (12) when breaking ([0080], [0085], [0095], [0097], [0099], [0101], [0103]). Squire therefore teaches joining of a proximal tube portion and distal tube portion with a frangible link (24) and wherein a balloon assembly (25) is configured to be separated from the proximal tube portion by breaking the frangible link (24).
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 invention of Shohat to have the catheter shaft further include a frangible link at its distal end as taught by Squire (Fig. 1, [0078], [0080], [0085], [0095]). The frangible link provides for a method for detaching the balloon via breaking as recognized by Squire ([0004], [0080], [0085]). Having multiple methods to detach the balloon may improve robustness and reliability of the device.
However, the modified combination noted above fails to teach wherein the distal tube portion has a one-way valve located in the lumen and wherein the bioabsorbable balloon being configured for fluid communication with the lumen of the catheter shaft is at a location distal to the one-way valve of the distal tube portion of the catheter shaft.
While Shohat fails to teach such a feature, Shohat does teach a one-way valve located in a port (14) of the balloon (10) ([0154], [0220-0221], [0238-0240], [0247], [0259]). 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 invention of Shohat to place the one-way valve in the lumen of the distal tube portion. The position or particular placement of the one-way valve being in the distal tube portion rather than the port of the balloon would not have modified the operation of the device and is therefore an obvious matter of design choice. Moreover, the bioabsorbable balloon would predictably be configured for fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve as a result of the modification. See MPEP § 2144.04 (VI) C., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
However, the modified combination noted above fails to teach a breast biopsy marker delivery device, and wherein the bioabsorbable balloon and the distal tube portion define a breast biopsy marker configured shaped, in the inflated state to apply pressure to and fill a breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
In an analogous biopsy marker field of endeavor, Burbank teaches such a feature. Burbank teaches breast biopsy marker delivery devices (24; 54, 55) and corresponding markers (50) (Figs. 3-10, [0002], [0092], [0094], [0096], [0099]). Burbank teaches wherein the marker (50c) may comprise a bioabsorbable balloon (Fig. 10c, [0022], [0102], [0129-0131]). Moreover, Burbank teaches wherein the balloon (50c) may be released in a breast biopsy site (BC) (Fig. 10c, [0022], [0130]). Burbank teaches wherein the balloon is inflated within the breast biopsy cavity (BC) and teaches wherein the balloon may be detectably by either ultrasound or x-ray ([0129-0131]). As shown in figure 10c, the balloon 50c fills and thus applies pressure to the breast biopsy cavity (BC). Burbank therefore teaches a breast biopsy marker delivery device and wherein a biopsy marker is shaped, in the inflated state to apply pressure to and fill the breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
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 invention of Shohat to have the device be configured and shaped for breast biopsy as taught by Burbank (Figs. 3-10, [0002], [0022], [0092], [0094], [0096], [0099], [0102], [0129-131]). Configuring and shaping the device for breast biopsy may aid in the diagnosis and treatment of breast cancer, one of the most common cancer suffered by women in the US as recognized by Burbank ([0005-0006]). A breast biopsy marker may also aid a surgeon in finding the location in the breast from where tumor tissue has been taken during a biopsy procedure to further aid in removing an entire tumor as further recognized by Burbank ([0008]). Modifying Shohat in view of Squire with the teachings of Burbank to configure the device for breast biopsy would predictably result wherein the biopsy marker delivery device is a breast biopsy marker delivery device and wherein the marker comprising a balloon and a distal tube attached thereto define a breast biopsy marker shaped, in the inflated state to apply pressure to and fill the breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
However, the modified combination noted above fails to teach wherein the bioabsorbable balloon has a circular cross section in the axial plane when in its inflated state.
In an analogous breast biopsy marking device field of endeavor, Sirimanne teaches such a feature. Sirimanne teaches an implantable device configured for marking breast tissue during a biopsy procedure (Abstract). Sirimanne teaches the device (100) has a generally spherical body (102) (Figs. 1A & 2A-2B, [0029], [0089], [0104], [0106]). Sirimanne teaches the marker (110) may be a sphere (150) or hollow sphere (152) (Figs. 2A-2B, [0104], [0106]).
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 invention of Shohat to have the marker be spherical as taught by Sirimanne (Figs. 1A & 2A-2B, [0029], [0089], [0104], [0106]). A biopsy marker may be any shape including spherical as recognized by Sirimanne ([0089]). Sirimanne teaches wherein the particular shape of the marker may be chosen to match the biopsy cavity in which the marker is placed ([0089]); by making the marker be spherical, it may help match the shape of the biopsy cavity, i.e. a breast biopsy cavity. Shohat similarly teaches wherein the shape of the balloon may be defined according to anatomic considerations ([0151]). Shohat further teaches wherein the balloon having a substantially planar shape while inflated is optional ([0163]). Shohat in view of Burbank teaches wherein the balloon comprises a breast biopsy marker. Therefore Shohat in view of Burbank modified by the teachings of Sirimanne to have the marker have spherical body would predictably result in the balloon comprising the marker to have a circular cross section in an axial plane when inflated.
Regarding claim 2, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
Shohat further teaches the bioabsorbable balloon (10) having a deflated state and an inflated state (Abstract, [0019-0025], [0044], [0063], [0078], [0147-0148]), and comprising a gel material configured to be inserted into the bioabsorbable balloon (10) through the one-way valve of the distal tube portion of the catheter shaft to effect the inflated state of the bioabsorbable balloon (10) ([0239-0240], [0246], “The guide can be a thin catheter or a blunt tip needle (cannula), of about 1-10 mm in diameter, optionally 2-3 mm in diameter, optionally a 16 French catheter. The guide possess a lumen through which a bladder-expanding fluid (or rigid element) can be conducted from a device such as a syringe (in the case of fluid) to bladder 12”, [0247], “Such self-sealing can be effected by a one-way valve incorporated into port 14, by viscosity of a bladder expanding liquid (e.g. one that forms a gel)”, [0336-0337]).
Regarding claim 22, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
However, Shohat fails to teach wherein the bioabsorbable balloon is fixedly connected to the distal tube portion at a proximal end of the distal tube portion and a distal end of the distal tube portion.
In an analogous balloon catheter field of endeavor, Squire teaches such a feature. Squire teaches a catheter (10) having an elongate shaft (12) and a balloon member (25) attached at a distal portion (20) of the elongate shaft (12) (Fig. 1, [0078]). Squire further teaches wherein the balloon (25) may be bonded to the elongate shaft (12) at a proximal end (29) of the shaft and a distal end (30) of the shaft (Fig. 4B, [0090]). As shown in figure 4B, the balloon (25) is fixedly connected to a distal tube portion (20) at a proximal (29) and distal end (30) of the distal tube portion (20).
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 invention of Shohat to have the balloon be connected or bonded to proximal and distal ends of the distal tube as taught by Squire (Fig. 4B, [0090]). By having the distal tube extend through the balloon member and be open at the distal end and thus have the balloon be connected to a proximal and distal end of the distal tube, the catheter may be tracked over a guidewire which may extend through distal tube of the catheter as recognized by Squire ([0090]).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 1 above, and further in view of Hoffa (US20120078086) and Kontos (US5861005).
Regarding claim 3, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
However, Shohat fails to teach the proximal tube portion having a first end portion; the distal tube portion having a second end portion having a proximal end surface, and wherein the second end portion of the distal tube portion is positioned inside the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region, and such that the proximal end surface of the distal tube portion is proximally exposed in the lumen of the catheter shaft.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). As shown in figures 4A and 4B, the cannula (12) comprises a proximal tube portion having a first end portion and the tip member (20) comprises a distal tube portion having a second end portion having a proximal end surface, and wherein the second end portion of the distal tube portion is positioned inside the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region (Fig. 4A). Moreover, figure 4A shows wherein the proximal end surface of the tip member (20) is exposed to the lumen (18) of the shaft (12). Moreover, Hoffa teaches wherein the tip member (20) may be attached to the cannula (12) via a frangible coupling or by an adhesive ([0036]).
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 invention of Shohat to arrange for the distal tube portion of the marker to be inserted within the proximal tube portion of the shaft as taught by Hoffa (Figs. 1-6, [0029-0030], [0036]). In this arrangement, the marker may be releasably attached to the distal end of the marking device, be guided to the biopsy site, and be deployed as recognized by Hoffa ([0029-0030]).
However, the modified combination noted above fails to teach wherein the one-way valve is positioned inside the second end portion within a reduced diameter region of the second end portion.
In an analogous balloon catheter field of endeavor, Kontos teaches such a feature. Kontos teaches a balloon catheter (520) (Fig. 14, Column 6 lines 21-47). Kontos teaches wherein the balloon catheter includes an inflation port (151) which includes a check valve (152) (Fig. 14, Column 6 lines 42-47). As shown in figure 14, the check valve (152) is positioned within a reduced diameter region of an end portion (151) (Fig. 14).
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 invention of Shohat to include a check valve inside the balloon inflation port as taught by Kontos (Fig. 14, Column 6 lines 21-47). Shohat teaches wherein the balloon includes an inflation port (14) positioned adjacent the balloon (12) (Fig. 1B, [0238-0240]). Shohat teaches wherein the port (14) includes a one-way valve incorporated into it ([0247]). Modifying Shohat with the teachings of Kontos to include a check valve inside the port would predictably result wherein the check valve (152) is positioned in a reduced diameter region of the second end portion as shown in Kontos’s figure 14. The check valve as taught by Kontos may predictably and similarly allow for fluid to be added to the balloon for its inflation as recognized by Kontos (Fig. 14, Column 6 lines 42-47).
Regarding claim 4, Shohat in view of Squire, Burbank, Sirimanne, Hoffa, and Kontos teaches the invention as claimed above in claim 3.
However, Shohat fails to teach wherein the frangible link that joins the proximal tube portion to the distal tube portion is located at the overlap region.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Figure 4A shows wherein the cannula (12) comprising the proximal tube portion forms an overlap region with the marker (20) comprising the distal tube portion. Hoffa further teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036], wherein an adhesive would also comprise a frangible link). In the case that the attachment/frangible link is an adhesive, the adhesive/frangible link would predictably be located within the overlap region as the marker (20) is attached to the cannula (12) in the overlap region.
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 invention of Shohat to attach the marker to the shaft of the catheter via an adhesive as taught by Hoffa ([0036]). By using an adhesive, the marker may be released when pushed by a stylet or push-rod as recognized by Hoffa ([0036]). Since the frangible link is an adhesive, the adhesive/frangible link would necessarily be located in the overlap region as that is where the proximal and distal tubes are in contact/attached.
Regarding claim 5, Shohat in view of Squire, Burbank, Sirimanne, Hoffa, and Kontos teaches the invention as claimed above in claim 3.
However, Shohat fails to teach wherein the frangible link that joins the proximal tube portion to the distal tube portion is connected to each of the proximal end surface of the second end portion of the distal tube portion and the proximal tube portion.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Figure 4A shows wherein the cannula (12) comprising the proximal tube portion forms an overlap region with the marker (20) comprising the distal tube portion. Hoffa further teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036], wherein an adhesive would also comprise a frangible link). In the case that the attachment/frangible link is an adhesive, the proximal end of the distal tube portion of the marker (20) including the proximal end surface would predictably be coated with said adhesive, resulting in the adhesive (frangible link) being connected to both the proximal end surface of the distal tube portion (20) and the proximal tube portion (12).
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 invention of Shohat to use a frangible link comprising an adhesive to couple the distal and proximal tubes as taught by Hoffa (Figs. 1-6, [0029-0030], [0036]). The adhesive may be adapted to release the marker when overcome by a predetermined force generated from a push-rod or stylet as recognized by Hoffa ([0036]). Those having ordinary skill in the art would recognize the marker may be secured to the distal end of the shaft in a number of ways, allowing for the marker to remain attached until the marker reaches the biopsy site and is acted upon by a push-rod as further recognized by Hoffa ([0036]). Shohat modified by the teachings of Hoffa would predictably result in coating a proximal end of the marker including the proximal end surface with an adhesive such that the marker including the proximal end surface and the proximal tube portion are connected via the adhesive.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 1 above, and further in view of Wales (US20210128140).
Regarding claim 6, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
However, Shohat fails to teach wherein the frangible link is a spot weld.
In an analogous elongate medical tool field of endeavor, Wales teaches such a feature. Wales teaches a medical device (700) including an elongate shaft (714), a sleeve (730), and a cutter (740) (Figs. 18-20, [0105-0106]). As shown in figures 18-20, the sleeve (730) comprises a proximal tube portion and the cutter (740) comprises a distal tube portion. Wales teaches the cutter (740) is releasably coupled to the sleeve (730) by a frangible link (744), the frangible link (744) being a spot weld ([0108]). Wales therefore teaches wherein a frangible link that joins a proximal tube portion with a distal tube portion may be a spot weld.
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 invention of Shohat to have the frangible link be a spot weld as taught by Wales (Figs. 18-20, [0105-0108]). The spot welded frangible link may hold two tube portions during delivery of the device to a location within the body and may be broken when desired as recognized by Wales ([0108]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 1 above, and further in view of Rebellino (US20220071732).
Regarding claim 7, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
However, Shohat fails to teach the invention comprising an elongate stylet configured for insertion into the lumen of the catheter shaft to break the frangible link to separate the proximal tube portion of the catheter shaft from the balloon assembly.
In an analogous breast biopsy marker field of endeavor, Rebellino teaches such a feature. Rebellino teaches a marker (100; 600) for breast biopsy (Fig. 8, Abstract, [0002-0003], [0051], [0081-0083]). Rebellino teaches a marker delivery device (650) including an outer cannula (662) and a push rod (668) comprising a stylet (Fig. 9, [0088]). Rebellino teaches the push rod (668) includes a plunger (670) for forcing the rod (668) distally in the cannula (662) to deploy the marker out of the cannula (662) (Fig. 9, [0088]). Rebellino teaches wherein the marker (600) is coupled to a tether (620) including a crimp or frangible link (622) (Figs. 9-11, [0086-0087]). Rebellino teaches the plunger (670) is pushed to translate the push rod (668) distally to cause the frangible link (622) to break, resulting in the deployment of the marker (600) (Figs. 10-11, [0096]). Rebellino therefore teaches an elongate stylet (push rod 668) configured for insertion into a lumen of a cannula shaft to break a frangible link to separate a proximal portion from a distal portion comprising a marker.
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 invention of Shohat to use a push rod or elongate stylet to break the frangible link as taught by Rebellino (Figs. 9-11, [0096]). Using the frangible link (622) and stylet (668), a marker (600) may be guided to and deployed at a biopsy site as recognized by Rebellino ([0096]). This configuration may make marking simpler and reduce potential error as further recognized by Rebellino ([0089]). Shohat modified by the teachings of Rebellino to use an elongate stylet to break a frangible link to deploy a marker would predictably result wherein the modified invention would comprise the elongate stylet to break the frangible link, resulting in the separation of the proximal tube portion of the catheter shaft from the balloon assembly.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 1 above, and further in view of Hingston (US20190076274) and Tilson (US20090299401).
Regarding claim 8, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
Shohat teaches the bioabsorbable balloon (10) may be made of any biocompatible material including, but not limited to, copolyesters made from lactic and glycolic acid ([0228]). Shohat further teaches wherein the balloon (10) may be left in the body as an implant ([0018], [0079], [0132-0133], [0135]).
However, Shohat fails to teach wherein the bioabsorbable balloon is made of specifically a poly (glycolide-co-lactide) (PGLA material).
Hingston teaches examples for bioabsorbable polymers for implants includes poly(glycolide-co-lactide) (PGLA) ([0084]).
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 invention of Shohat to use poly(glycolide-co-lactide) (PGLA) as the bioabsorbable material for the balloon as taught by Hingston ([0084]). Shohat teaches wherein the balloon (10) comprises an implant ([0018], [0079], [0132-0133], [0135]) and wherein the balloon (10) may be made of any biocompatible material, particularly including copolyesters made from lactic and glycolic acid ([0228]). Therefore, it would be obvious to use PGLA as Hingston teaches it as a bioabsorbable/biocompatible material suitable for implants ([0084]).
However, the modified combination noted above fails to teach the invention further comprising at least one radiopaque and ultrasonically visible marker element imbedded in a wall of the balloon.
In an analogous breast implant and marker field of endeavor, Tilson teaches such a feature. Tilson teaches a device which may be used as a radiopaque and/or echogenic marker, and the device can be implanted and inflated to create an anatomical feature such as a breast implant ([0093]). Tilson teaches an inflatable balloon (20) including a balloon wall (22) (Fig. 1, [0232]). Tilson teaches the balloon may have vanes (186), marker spots (188), and marker wires (190) which may all be embedded within the balloon wall ([0344], [0349-0350], [0353]). Tilson teaches the vanes (186), the marker spots (188), and the marker wires (190) may be radiopaque and/or echogenic ([0346], [0349-0350]). Tilson therefore teaches imbedding at least one radiopaque and ultrasonically visible (echogenic) marker element in a wall (22) of a balloon (20).
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 invention of Shohat to embed radiopaque and echogenic material within the wall of the balloon as taught by Tilson ([0344], [0346], [0349-0350], [0353]). By embedding radiopaque and echogenic material or elements within the wall of the balloon, the balloon device may predictably be used as a radiopaque and echogenic marker as recognized by Tilson ([0093], “The device can be used as a radiopaque or echogenic marker”, [0349], “The marker spots 188 can be radiopaque and/or echogenic”, [0350], “The marker wire 190 can be radiopaque and/or echogenic”), improving ease of locating the balloon.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 1 above, and further in view of Small (US20200261067) and Beckman (US20050234336).
Regarding claim 9, Shohat in view of Squire, Burbank, and Sirimanne teaches the invention as claimed above in claim 1.
However, Shohat fails to teach wherein the proximal tube portion is made with a non-biodegradable material.
In an analogous breast biopsy marker field of endeavor, Small teaches such a feature. Small teaches using a cannula (162) for delivery of a biopsy marker (100) to a biopsy site (10) such as the breast (Figs. 1-3, Abstract, [0002-0003], [0025], [0029], [0033]). Small teaches the cannula (162) may be formed of a material such as polyether block amide (PEBA) or PEBAX ([0037]), wherein PEBAX comprises a non-biodegradable material. As shown in figure 2, the cannula (162) comprises a proximal tube portion. Small therefore teaches wherein a proximal tube portion is made with a non-biodegradable material and wherein the non-biodegradable material of the proximal tube portion is a PEBAX brand polymer.
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 invention of Shohat to have the proximal tube portion of the delivery device be made of PEBAX brand polymer as taught by Small (Fig. 2, [0037]). PEBAX is a suitable medical grade plastic or polymer for forming a cannula or delivery device as recognized by Small ([0037]). Shohat modified by the teachings of Shohat would predictably result wherein the catheter including a proximal tube portion is formed of PEBAX, a non-biodegradable material.
However, the modified combination noted above fails to teach wherein the distal tube portion includes a non-biodegradable component configured to provide permanent ultrasound visibility, and wherein the non-biodegradable component of the distal tube portion is formed from polyvinyl alcohol.
In an analogous breast biopsy marker field of endeavor, Beckman teaches such a feature. Beckman teaches implantable markers for permanently marking the location of a biopsy and wherein the visualization of the markers is through MRI, X-ray, and ultrasound (Abstract, [0017-0020]). Beckman teaches wherein the permanent marker is echogenic and radiopaque ([0020]). Beckman teaches the permanent, non-erodible/non-degradable material for implantation of the marker may comprise polyvinyl alcohol (PVA) ([0055], [0126], wherein the “device” is the marker).
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 invention of Shohat to have the implant or marker comprise a permanent echogenic marker made of polyvinyl alcohol (PVA) as taught by Beckman (Abstract, [0017-0020], [0055], [0126]). Polyvinyl alcohols are non-biodegradable polymers as recognized by Beckman ([0021]), therefore allowing them to be used as permanent markers for reference during future examinations or procedures as further recognized by Beckman (Abstract). Because Shohat in view of Squire teaches wherein the distal tube portion is part of the implant/marker (is left behind with the balloon), Shohat modified by the teachings of Beckman to have the marker comprise a polyvinyl alcohol would predictably result wherein the distal tube portion may be comprised of the polyvinyl alcohol, a component configured to provide permanent ultrasound visibility.
Claims 11-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Hoffa (US20120078086), Burbank (US20090131825), and Sirimanne (US20130066195). Shohat is cited in the IDS filed 10/22/2024.
Regarding claim 11, Shohat teaches a biopsy marker system, comprising:
a catheter shaft having a lumen, a proximal tube portion, and a distal tube portion ([0082], [0088], [0240], [0246], wherein the guide being a catheter having a proximal end, a distal end, and possessing a lumen comprises a catheter shaft having a lumen, proximal tube portion, and a distal tube portion),
a bioabsorbable balloon (10) fixedly connected to the distal tube portion to define a balloon assembly (Figs. 1B-1D, [0081-0082], [0154], [0167], [0220-0221], [0237-0240], “To enable biodegradation, device 10 is constructed from polymers which are biocompatible and bioabsorbable…”, “In some embodiments of the invention the plug is detachably connected to a distal end of a catheter…”), the bioabsorbable balloon (10) configured for fluid communication with the lumen of the catheter shaft ([0239-0241], [0246]);
a syringe configured to carry a gel material, the syringe having an injection port connectable to the proximal tube portion of the catheter shaft, the syringe configured to deliver the gel material through the lumen of the catheter shaft to the bioabsorbable balloon (10) (Fig. 2, [0210], “In some embodiments of the invention, pressure is gradually increased, optionally using a syringe to inject fluid, such as, for example, saline, into the bladder”, [0239], “Port 14 can be a fluid filling port, in which case bladder 12 can be expanded by using gas, liquid or gel and collapsed via emptying”, [0246-0247], “The guide can be a thin catheter or a blunt tip needle (cannula)”, “The guide possess a lumen through which a bladder-expanding fluid (or rigid element) can be conducted from a device such as a syringe (in the case of fluid) to bladder 12”, [0259], “Once positioned, device 10 is optionally deployed by retracting both sheaths and expanding bladder 12 (by, for example, a syringe connected to port 34 of needle 22) at the proper location and orientation”, wherein the syringe connected to a port 34 to inject fluid such as gel comprises the syringe having an injection port connectable to the proximal tube portion of the catheter shaft, [0336-0337]).
However, Shohat fails to teach wherein the proximal tube portion is joined to the distal tube portion by a frangible link.
In an analogous balloon catheter field of endeavor, Squire teaches such a feature. Squire teaches a catheter (10) having an elongate shaft (12) and a balloon member (25) attached at a distal portion (20) of the elongate shaft (12) (Fig. 1, [0078]). Squire further teaches wherein the elongate shaft (12) includes a frangible link (24) (Fig. 1, [0080]). As shown in figure 1 of Squire, the elongate shaft (12) comprises a proximal tube portion and a distal tube portion separated by the frangible link (24) (Fig. 1). Squire teaches wherein the frangible link is configured to detach the balloon (24) from the catheter shaft (12) when breaking ([0080], [0085], [0095], [0097], [0099], [0101], [0103]). Squire therefore teaches joining of a proximal tube portion and distal tube portion with a frangible link (24) and wherein a balloon assembly (25) is configured to be separated from the proximal tube portion by breaking the frangible link (24).
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 invention of Shohat to have the catheter shaft further include a frangible link at its distal end as taught by Squire (Fig. 1, [0078], [0080], [0085], [0095]). The frangible link provides for a method for detaching the balloon via breaking as recognized by Squire ([0004], [0080], [0085]). Having multiple methods to detach the balloon may improve robustness and reliability of the device.
However, the modified combination noted above fails to teach wherein the distal tube portion has a one-way valve located in the lumen and wherein the bioabsorbable balloon being configured for fluid communication with the lumen of the catheter shaft is at a location distal to the one-way valve of the distal tube portion of the catheter shaft.
While Shohat fails to teach such a feature, Shohat does teach a one-way valve located in a port (14) of the balloon (10) ([0154], [0220-0221], [0238-0240], [0247], [0259]). 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 invention of Shohat to place the one-way valve in the lumen of the distal tube portion. The position or particular placement of the one-way valve being in the distal tube portion rather than the port of the balloon would not have modified the operation of the device and is therefore an obvious matter of design choice. Moreover, the bioabsorbable balloon would predictably be configured for fluid communication with the lumen of the catheter shaft at a location distal to the one-way valve as a result of the modification. See MPEP § 2144.04 (VI) C., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
However, the modified combination noted above fails to teach an elongate stylet configured for insertion into the lumen of the catheter shaft to break the frangible link of the catheter shaft following inflation of the bioabsorbable balloon with the gel material delivered by the syringe, so as to separate the proximal tube portion of the catheter shaft from the balloon assembly.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Hoffa further teaches a tip deployment mechanism comprising a push-rod (32) configured to slide axially within the canula (12) and thus configured for insertion into the lumen of the cannula (12) (Figs. 3A-3B & 4A-4B, [0031], wherein push-rod 32 comprises a stylet). Hoffa teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036]). Moreover, Hoffa teaches wherein the frangible coupling or adhesive may be broken or overcome by a predetermined amount of force generated by the push-rod (32) for releasing/deploying the marker (20) ([0036]).
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 invention of Shohat to include a push-rod or stylet for insertion into the lumen of the catheter to break or overcome the frangible link as taught by Hoffa (Figs. 1-6, [0031], [0036]). The push-rod may comprise the deployment mechanism for delivering a marker to a biopsy site as recognized by Hoffa ([0001], [0031], [0036]). Shohat teaches filling the balloon with gel for delivery as an implant ([0018], [0239], [0247]). Therefore, Shohat modified by the teachings of Hoffa to use a push-rod configured for insertion and breaking the frangible link would predictably result wherein the push-rod is further configured to break the frangible link of the catheter shaft following inflation of the bioabsorbable balloon with the gel material delivered by the syringe, so as to separate the proximal tube portion of the catheter shaft from the balloon assembly.
However, the modified combination noted above fails to teach a breast biopsy marker system and wherein the bioabsorbable balloon and the distal tube portion define a breast biopsy marker shaped, in the inflated state to apply pressure to and fill a breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
In an analogous biopsy marker field of endeavor, Burbank teaches such a feature. Burbank teaches breast biopsy marker delivery devices (24; 54, 55) and corresponding markers (50) (Figs. 3-10, [0002], [0092], [0094], [0096], [0099]). Burbank teaches wherein the marker (50c) may comprise a bioabsorbable balloon (Fig. 10c, [0022], [0102], [0129-0131]). Moreover, Burbank teaches wherein the balloon (50c) may be released in a breast biopsy site (BC) (Fig. 10c, [0022], [0130]). Burbank teaches wherein the balloon is inflated within the breast biopsy cavity (BC) and teaches wherein the balloon may be detectably by either ultrasound or x-ray ([0129-0131]). As shown in figure 10c, the balloon 50c fills and thus applies pressure to the breast biopsy cavity (BC). Burbank therefore teaches a breast biopsy marker delivery device and wherein a biopsy marker is shaped, in the inflated state to apply pressure to and fill the breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
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 invention of Shohat to have the device be configured and shaped for breast biopsy as taught by Burbank (Figs. 3-10, [0002], [0022], [0092], [0094], [0096], [0099], [0102], [0129-131]). Configuring and shaping the device for breast biopsy may aid in the diagnosis and treatment of breast cancer, one of the most common cancer suffered by women in the US as recognized by Burbank ([0005-0006]). A breast biopsy marker may also aid a surgeon in finding the location in the breast from where tumor tissue has been taken during a biopsy procedure to further aid in removing an entire tumor as further recognized by Burbank ([0008]). Modifying Shohat in view of Squire with the teachings of Burbank to configure the device for breast biopsy would predictably result wherein the biopsy marker delivery device is a breast biopsy marker delivery device and wherein the marker comprising a balloon and a distal tube attached thereto define a breast biopsy marker shaped, in the inflated state to apply pressure to and fill the breast biopsy site after a breast biopsy procedure, wherein the breast biopsy marker is radiopaque, ultrasonically visible, or both.
However, the modified combination noted above fails to teach wherein the bioabsorbable balloon has a circular cross section in the axial plane when in its inflated state.
In an analogous breast biopsy marking device field of endeavor, Sirimanne teaches such a feature. Sirimanne teaches an implantable device configured for marking breast tissue during a biopsy procedure (Abstract). Sirimanne teaches the device (100) has a generally spherical body (102) (Figs. 1A & 2A-2B, [0029], [0089], [0104], [0106]). Sirimanne teaches the marker (110) may be a sphere (150) or hollow sphere (152) (Figs. 2A-2B, [0104], [0106]).
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 invention of Shohat to have the marker be spherical as taught by Sirimanne (Figs. 1A & 2A-2B, [0029], [0089], [0104], [0106]). A biopsy marker may be any shape including spherical as recognized by Sirimanne ([0089]). Sirimanne teaches wherein the particular shape of the marker may be chosen to match the biopsy cavity in which the marker is placed ([0089]); by making the marker be spherical, it may help match the shape of the biopsy cavity, i.e. a breast biopsy cavity. Shohat similarly teaches wherein the shape of the balloon may be defined according to anatomic considerations ([0151]). Shohat further teaches wherein the balloon having a substantially planar shape while inflated is optional ([0163]). Shohat in view of Burbank teaches wherein the balloon comprises a breast biopsy marker. Therefore Shohat in view of Burbank modified by the teachings of Sirimanne to have the marker have spherical body would predictably result in the balloon comprising the marker to have a circular cross section in an axial plane when inflated.
Regarding claim 12, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
Shohat further teaches wherein the bioabsorbable balloon (10) has a deflated state and an inflated state (Abstract, [0019-0025], [0044], [0063], [0078], [0147-0148]), and wherein the gel material is configured to be inserted into the bioabsorbable balloon (10) through the one-way valve of the distal tube portion of the catheter shaft to effect the inflated state of the bioabsorbable balloon (10), the one-way valve configured to prevent a return from the inflated state to the deflated state ([0239-0240], [0246], “The guide can be a thin catheter or a blunt tip needle (cannula), of about 1-10 mm in diameter, optionally 2-3 mm in diameter, optionally a 16 French catheter. The guide possess a lumen through which a bladder-expanding fluid (or rigid element) can be conducted from a device such as a syringe (in the case of fluid) to bladder 12”, [0247], “Such self-sealing can be effected by a one-way valve incorporated into port 14, by viscosity of a bladder expanding liquid (e.g. one that forms a gel)”, [0259], “Device 10 is then sealed to prevent deflation by using a one way valve or a self-sealing mechanism as described above”).
Regarding claim 17, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
However, Shohat fails to teach wherein the elongate stylet is configured as an elongate tube or rod for insertion into the lumen of the catheter shaft to break the frangible link to separate the proximal tube portion of the catheter shaft from the balloon assembly.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Hoffa further teaches a tip deployment mechanism comprising a push-rod (32) configured to slide axially within the canula (12) and thus configured for insertion into the lumen of the cannula (12) (Figs. 3A-3B & 4A-4B, [0031], wherein push-rod 32 comprises a stylet). As shown in figures 1, 3A-3B, & 4A-4B of Hoffa, the push-rod 32 is configured as an elongate tube or rod for insertion into the lumen (18) of the cannula shaft (12) (Figs. 1, 3A-3B, & 4A-4B, [0030-0031]). Hoffa teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036]). Moreover, Hoffa teaches wherein the frangible coupling or adhesive may be broken or overcome by a predetermined amount of force generated by the push-rod (32) for releasing/deploying the marker (20), thereby separating the marker (20) from the cannula (12) ([0036]).
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 invention of Shohat to have the push-rod or stylet be configured as an elongate tube or rod as taught by Hoffa (Figs. 1-6, [0031], [0036]). The push-rod being an elongate tube or rod may suitably be insertable into a cannula or catheter and thus comprise the deployment mechanism for delivering a marker to a biopsy site as recognized by Hoffa (Figs. 1, 3A-3B, & 4A-4B, [0001], [0031], [0036]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Hoffa (US20120078086), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 11 above, and further in view of Kontos (US5861005).
Regarding claim 13, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
However, Shohat fails to teach the proximal tube portion having a first end portion; the distal tube portion having a second end portion having a proximal end surface, and wherein the second end portion of the distal tube portion is positioned inside the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region, and such that the proximal end surface of the distal tube portion is proximally exposed in the lumen of the catheter shaft.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). As shown in figures 4A and 4B, the cannula (12) comprises a proximal tube portion having a first end portion and the tip member (20) comprises a distal tube portion having a second end portion having a proximal end surface, and wherein the second end portion of the distal tube portion is positioned inside the first end portion of the proximal tube portion such that the first end portion of the proximal tube portion radially overlaps the second end portion of the distal tube portion to define an overlap region (Fig. 4A). Moreover, figure 4A shows wherein the proximal end surface of the tip member (20) is exposed to the lumen (18) of the shaft (12). Moreover, Hoffa teaches wherein the tip member (20) may be attached to the cannula (12) via a frangible coupling or by an adhesive ([0036]).
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 invention of Shohat to arrange for the distal tube portion of the marker to be inserted within the proximal tube portion of the shaft as taught by Hoffa (Figs. 1-6, [0029-0030], [0036]). In this arrangement, the marker may be releasably attached to the distal end of the marking device, be guided to the biopsy site, and be deployed as recognized by Hoffa ([0029-0030]).
However, the modified combination noted above fails to teach wherein the one-way valve is positioned inside the second end portion within a reduced diameter region of the second end portion.
In an analogous balloon catheter field of endeavor, Kontos teaches such a feature. Kontos teaches a balloon catheter (520) (Fig. 14, Column 6 lines 21-47). Kontos teaches wherein the balloon catheter includes an inflation port (151) which includes a check valve (152) (Fig. 14, Column 6 lines 42-47). As shown in figure 14, the check valve (152) is positioned within a reduced diameter region of an end portion (151) (Fig. 14).
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 invention of Shohat to include a check valve inside the balloon inflation port as taught by Kontos (Fig. 14, Column 6 lines 21-47). Shohat teaches wherein the balloon includes an inflation port (14) positioned adjacent the balloon (12) (Fig. 1B, [0238-0240]). Shohat teaches wherein the port (14) includes a one-way valve incorporated into it ([0247]). Modifying Shohat with the teachings of Kontos to include a check valve inside the port would predictably result wherein the check valve (152) is positioned in a reduced diameter region of the second end portion as shown in Kontos’s figure 14. The check valve as taught by Kontos may predictably and similarly allow for fluid to be added to the balloon for its inflation as recognized by Kontos (Fig. 14, Column 6 lines 42-47).
Regarding claim 14, Shohat in view of Squire, Hoffa, Burbank, Sirimanne, and Kontos teaches the invention as claimed above in claim 13.
However, Shohat fails to teach wherein the frangible link that joins the proximal tube portion to the distal tube portion is located at the overlap region between the proximal tube portion and the distal tube portion.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Figure 4A shows wherein the cannula (12) comprising the proximal tube portion forms an overlap region with the marker (20) comprising the distal tube portion. Hoffa further teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036], wherein an adhesive would also comprise a frangible link). In the case that the attachment/frangible link is an adhesive, the adhesive/frangible link would predictably be located within the overlap region as the marker (20) is attached to the cannula (12) in the overlap region.
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 invention of Shohat to attach the marker to the shaft of the catheter via an adhesive as taught by Hoffa ([0036]). By using an adhesive, the marker may be released when pushed by a stylet or push-rod as recognized by Hoffa ([0036]). Since the frangible link is an adhesive, the adhesive/frangible link would necessarily be located in the overlap region as that is where the proximal and distal tubes are in contact/attached.
Regarding claim 15, Shohat in view of Squire, Hoffa, Burbank, Sirimanne, and Kontos teaches the invention as claimed above in claim 13.
However, Shohat fails to teach wherein the frangible link that joins the proximal tube portion to the distal tube portion is connected to each of the proximal end surface of the second end portion of the distal tube portion and the proximal tube portion.
In an analogous breast biopsy marker field of endeavor, Hoffa teaches such a feature. Hoffa teaches marking a breast biopsy site with a marker (20) (Figs. 1-6, [0001], [0029], [0036]). Hoffa teaches a device (10) comprising an elongated body or cannula (12) configured to deploy the marker (20) (Figs. 1-2 & 4A-4B, [0029-0030]). Figure 4A shows wherein the cannula (12) comprising the proximal tube portion forms an overlap region with the marker (20) comprising the distal tube portion. Hoffa further teaches wherein the tip member (20) is attached to the cannula (12) via a frangible coupling or adhesive ([0036], wherein an adhesive would also comprise a frangible link). In the case that the attachment/frangible link is an adhesive, the proximal end of the distal tube portion of the marker (20) including the proximal end surface would predictably be coated with said adhesive, resulting in the adhesive (frangible link) being connected to both the proximal end surface of the distal tube portion (20) and the proximal tube portion (12).
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 invention of Shohat to use a frangible link comprising an adhesive to couple the distal and proximal tubes as taught by Hoffa (Figs. 1-6, [0029-0030], [0036]). The adhesive may be adapted to release the marker when overcome by a predetermined force generated from a push-rod or stylet as recognized by Hoffa ([0036]). Those having ordinary skill in the art would recognize the marker may be secured to the distal end of the shaft in a number of ways, allowing for the marker to remain attached until the marker reaches the biopsy site and is acted upon by a push-rod as further recognized by Hoffa ([0036]). Shohat modified by the teachings of Hoffa would predictably result in coating a proximal end of the marker including the proximal end surface with an adhesive such that the marker including the proximal end surface and the proximal tube portion are connected via the adhesive.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Hoffa (US20120078086), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 11 above, and further in view of Wales (US20210128140).
Regarding claim 16, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
However, Shohat fails to teach wherein the frangible link is a spot weld.
In an analogous elongate medical tool field of endeavor, Wales teaches such a feature. Wales teaches a medical device (700) including an elongate shaft (714), a sleeve (730), and a cutter (740) (Figs. 18-20, [0105-0106]). As shown in figures 18-20, the sleeve (730) comprises a proximal tube portion and the cutter (740) comprises a distal tube portion. Wales teaches the cutter (740) is releasably coupled to the sleeve (730) by a frangible link (744), the frangible link (744) being a spot weld ([0108]). Wales therefore teaches wherein a frangible link that joins a proximal tube portion with a distal tube portion may be a spot weld.
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 invention of Shohat to have the frangible link be a spot weld as taught by Wales (Figs. 18-20, [0105-0108]). The spot welded frangible link may hold two tube portions during delivery of the device to a location within the body and may be broken when desired as recognized by Wales ([0108]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Hoffa (US20120078086), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 11 above, and further in view of Hingston (US20190076274) and Tilson (US20090299401).
Regarding claim 18, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
Shohat teaches the bioabsorbable balloon (10) may be made of any biocompatible material including, but not limited to, copolyesters made from lactic and glycolic acid ([0228]). Shohat further teaches wherein the balloon (10) may be left in the body as an implant ([0018], [0079], [0132-0133], [0135]).
However, Shohat fails to teach wherein the bioabsorbable balloon is made of specifically a poly(glycolide-co-lactide) (PGLA) material.
Hingston teaches examples for bioabsorbable polymers for implants includes poly(glycolide-co-lactide) (PGLA) ([0084]).
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 invention of Shohat to use poly(glycolide-co-lactide) (PGLA) as the bioabsorbable material for the balloon as taught by Hingston ([0084]). Shohat teaches wherein the balloon (10) comprises an implant ([0018], [0079], [0132-0133], [0135]) and wherein the balloon (10) may be made of any biocompatible material, particularly including copolyesters made from lactic and glycolic acid ([0228]). Therefore, it would be obvious to use PGLA as Hingston teaches it as a bioabsorbable/biocompatible material suitable for implants ([0084]).
However, the modified combination noted above fails to teach the invention further comprising at least one radiopaque and ultrasonically visible marker element imbedded in a wall of the balloon.
In an analogous breast implant and marker field of endeavor, Tilson teaches such a feature. Tilson teaches a device which may be used as a radiopaque and/or echogenic marker, and the device can be implanted and inflated to create an anatomical feature such as a breast implant ([0093]). Tilson teaches an inflatable balloon (20) including a balloon wall (22) (Fig. 1, [0232]). Tilson teaches the balloon may have vanes (186), marker spots (188), and marker wires (190) which may all be embedded within the balloon wall ([0344], [0349-0350], [0353]). Tilson teaches the vanes (186), the marker spots (188), and the marker wires (190) may be radiopaque and/or echogenic ([0346], [0349-0350]). Tilson therefore teaches imbedding at least one radiopaque and ultrasonically visible (echogenic) marker element in a wall (22) of a balloon (20).
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 invention of Shohat to embed radiopaque and echogenic material within the wall of the balloon as taught by Tilson ([0344], [0346], [0349-0350], [0353]). By embedding radiopaque and echogenic material or elements within the wall of the balloon, the balloon device may predictably be used as a radiopaque and echogenic marker as recognized by Tilson ([0093], “The device can be used as a radiopaque or echogenic marker”, [0349], “The marker spots 188 can be radiopaque and/or echogenic”, [0350], “The marker wire 190 can be radiopaque and/or echogenic”), improving ease of locating the balloon.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shohat (US20120330340) in view of Squire (US20160228126), Hoffa (US20120078086), Burbank (US20090131825), and Sirimanne (US20130066195) as applied to claim 11 above, and further in view of Small (US20200261067) and Beckman (US20050234336).
Regarding claim 19, Shohat in view of Squire, Hoffa, Burbank, and Sirimanne teaches the invention as claimed above in claim 11.
However, Shohat fails to teach wherein the proximal tube portion is made with a non-biodegradable material.
In an analogous breast biopsy marker field of endeavor, Small teaches such a feature. Small teaches using a cannula (162) for delivery of a biopsy marker (100) to a biopsy site (10) such as the breast (Figs. 1-3, Abstract, [0002-0003], [0025], [0029], [0033]). Small teaches the cannula (162) may be formed of a material such as polyether block amide (PEBA) or PEBAX ([0037]), wherein PEBAX comprises a non-biodegradable material. As shown in figure 2, the cannula (162) comprises a proximal tube portion. Small therefore teaches wherein a proximal tube portion is made with a non-biodegradable material and wherein the non-biodegradable material of the proximal tube portion is a PEBAX brand polymer.
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 invention of Shohat to have the proximal tube portion of the delivery device be made of PEBAX brand polymer as taught by Small (Fig. 2, [0037]). PEBAX is a suitable medical grade plastic or polymer for forming a cannula or delivery device as recognized by Small ([0037]). Shohat modified by the teachings of Shohat would predictably result wherein the catheter including a proximal tube portion is formed of PEBAX, a non-biodegradable material.
However, the modified combination noted above fails to teach wherein the distal tube portion includes a non-biodegradable component configured to provide permanent ultrasound visibility, and wherein the non-biodegradable component of the distal tube portion is formed from polyvinyl alcohol.
In an analogous breast biopsy marker field of endeavor, Beckman teaches such a feature. Beckman teaches implantable markers for permanently marking the location of a biopsy and wherein the visualization of the markers is through MRI, X-ray, and ultrasound (Abstract, [0017-0020]). Beckman teaches wherein the permanent marker is echogenic and radiopaque ([0020]). Beckman teaches the permanent, non-erodible/non-degradable material for implantation of the marker may comprise polyvinyl alcohol (PVA) ([0055], [0126], wherein the “device” is the marker).
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 invention of Shohat to have the implant or marker comprise a permanent echogenic marker made of polyvinyl alcohol (PVA) as taught by Beckman (Abstract, [0017-0020], [0055], [0126]). Polyvinyl alcohols are non-biodegradable polymers as recognized by Beckman ([0021]), therefore allowing them to be used as permanent markers for reference during future examinations or procedures as further recognized by Beckman (Abstract). Because Shohat in view of Squire teaches wherein the distal tube portion is part of the implant/marker (is left behind with the balloon), Shohat modified by the teachings of Beckman to have the marker comprise a polyvinyl alcohol would predictably result wherein the distal tube portion may be comprised of the polyvinyl alcohol, a component configured to provide permanent ultrasound visibility.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797