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 .
Claim Objections
Claims 1-16 are objected to because of the following informalities:
Claims 1 and 15 each recite “a band element” but the claims go on to recite “the band” interspersed with mentions of “the band element”. It is recommended that all instances be homogenized such that the claims only refer to either “the band element” or “the band”. Claim 16 only refers to “a band” and has no dependent claims, therefore it does not need to be homogenized. The instances which require attention are:
Claim 1, line 4: “a band element”
Claim 1, line 5: “a length of band”, which should additionally be amended to include an article and state “a length of the band” or “a length of the band element” as desired
Claim 1, line 7: “an end of the band”
Claim 1, line 8: “wherein the band is advanced”
Claim 1, line 11: “from the band element”
Claim 1, lines 11-12: “leaving the band”
Claim 2, lines 1-2: “segment of the band element”
Claim 2, line 2: “leave the band element”
Claim 3, line 1: “the band element is coated”
Claim 4, line 1: “the band element is radiopaque”
Claim 5, line 1: “the band has a circular cross section”
Claim 6, line 1: “the band is partially covered”
Claim 6, line 2: “between the band”
Claim 7, line 2: “connected to the end of the band”
Claim 7, line 3: “drawing the band”
Claim 8, lines 1-2: “over a section of band”, which should additionally be amended to include an article and state “over a section of the band” or “over a section of the band element” as desired
Claim 8, line 3: “the band element to open”
Claim 10, line 1: “the band element is molded”
Claim 11, line 3: “a band element”
Claim 11, line 4: “a length of band”, which should additionally be amended to include an article and state “a length of the band” or “a length of the band element” as desired
Claim 11, line 7: “an end of the band”
Claim 11, line 8: “the band is advanced”
Claim 11, line 12: “from the band element” and “leaving the band”
Claim 12, line 1: “the band is secured”
Claim 12, line 2: “along the band”
Claim 13, line 1: “the band is secured”
Claim 13, line 2: “between the band element”
Claim 14, line 2: “section of band”, which should additionally be amended to include an article and state “section of the band” or “section of the band element” as desired
Claim 14, line 3: “allows the band”
Claim 15, line 1: “disconnected from the band element”
Claim 15, line 2: “segment of the band element”
Claim 15, line 3: “leave the band element”
Claim 1, line 11: the limitation “the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 1, line 12: the limitation “to fix the band diameter” should be amended to recite “to fix the loop diameter” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 2, line 2: the limitation “the securing means lock” should be amended to only recite “the securing means” since the lock structure of the securing means is only introduced in claim 14, which is not part of the dependency chain of claim 2, or independent claim 1 which it depends from.
Claim 7, line 1: the limitation “the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 8, line 3: the limitation “the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 9, line 2: the limitation “the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 11, lines 5-6: the limitation “a mechanism for adjusting a diameter of the band” should be amended to recite “a mechanism for adjusting a diameter of a loop formed by the band” or an equivalent thereof, since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing. Please note that the recitation of “a loop” in subsequent line 7 should also be amended to reflect the proposed change.
Claim 11, line 10: the limitation “the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 14, lines 2-3: “maintains the diameter of the band” should be amended to recite “the diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 16, line 1: the preamble recites “the method comprising the Steps…” which contains an improper capitalization. It is recommended that the word “Steps” be amended such that it is not capitalized since it is not at the beginning of the claim.
Claim 16, line 9: “adjusting a diameter of the band using an adjusting mechanism” should be amended to recite “adjusting a diameter of the loop” instead since the diameter of the loop is the diameter that is adjustable. The diameter of the band filament itself is not changing.
Claim 16, line 11: “leave a secured band” should be amended to recite “leave the secured band” instead since the band is a structure that has already been introduced by the claim and since the securement of the band is introduced in the prior line.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examination will continue under the assumption that the claim requires a parylene coating. It is recommended that the claim be amended to recite “wherein the band element is coated with parylene to reduce its sliding friction or stiction” instead.
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examination will continue under the assumption that the claim requires the band to be partially covered with a textile. It is recommended that the claim be amended to recite “wherein the band is partially covered with a textile to provide friction…” instead.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The claim limitations currently being interpreted under 35 U.S.C. 112(f) are:
The limitation “a securing means” in claims 1-2, and 11 is being interpreted to mean a structure which can be squeezed or pinched to lock the band in place (PP [057]: “The securing means 17 may be activated by pinching its sides to close over the tunnel section 89”)
The limitation “a mechanism for adjusting a diameter of the band” in claims 1 and 11 is being interpreted as a nut and threaded rod arrangement (PP [053]: “The adjusting nut 13 may include threads that may match with the screw 15 (also referred to as a threaded rod), such that turning the adjusting nut 13 may cause linear movement of the screw 15 and the receiver component 19, which may in turn changes the diameter of the band element 3”)
The limitation “a means to disconnect the controller” in claims 1 and 11 is being interpreted as a portion of the band configured to be cut (PP [061]: “The controller 5 may then be disconnected from the band element 3 by cutting across line of cut-off plane 41”)
The limitation “An indicator for displaying” in claim 9 is being interpreted as a scale (PP [050]: “The scale 9 is positioned to align with a specific marker, such as the front of the screw 15, providing an indication of the current diameter of the band 25”)
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function (as described above), and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7-9, and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lauren et al. (US PGPub 2019/0336675 A1).
With respect to claim 1, Lauren et al. discloses a device (10 in Fig. 3) for providing controlled restriction of a hollow conduit in a body (abstract: "A flow controller arranged to provide controlled constriction of a hollow body conduit"), the device comprising:
a band element (20 in Fig. 3) having a tunnel section (30 and 50) with a proximal opening (proximal opening of 50) and a distal opening (opening of 30),
a length of the band (20) extending from the proximal opening (50, see 20 extend through bore 58 of 50),
a controller (proximal end of 10 including 14) removably attached to the distal opening (30, PP [0054]: “After adjusting flow (i.e., setting the diameter of loop 26), tensioning means 14 may be removed”), comprising a mechanism (14) for adjusting a diameter of the band (20, PP [0046]: “as tensioning means 14 is tightened, thereby displacing threaded rod 90 with respect to housing 70, the diameter of loop 26 is reduced”),
wherein an end of the band (22) is insertable through the proximal opening (30, PP [0044]: “End 22 is operatively arranged to engage hole 38 to fixedly secure strap 20 to female connector 30”) to form a loop (26) around the hollow conduit (see Fig. 3 with loop 26 around vessel 2), and wherein the band (20) is advanced into the controller (proximal end of 10 including 14, see Fig. 3 where proximal end 24 of band 20 is advanced into through-bore 100) to permanently engage with the mechanism for adjusting the diameter of the band (14),
a securing means (60) to fix the band diameter after adjustment (PP [0046]: “Catheter 60 may further comprise tube 44 slidably arranged thereon. When loop 26 is set at a sufficient diameter, tube 44 may be crimped in order to fixedly secure strap 20 and catheter 60 together, thereby locking in the diameter of loop 26”), and
a means to disconnect (5 in Fig. 4) the controller (proximal end of 10 including 14) from the band element (20) after securing, leaving the band (20) and the securing means (60) around the hollow conduit (PP [0052]: “Once tube 44 is crimped thus locking catheter 60 and strap 20 together, securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12. Securing means 12, with the set desired diameter loop 26 (e.g., diameter D2) arranged around vein or vessel 2, may be left in place with minimal obstruction to the patient. Removing tensioning means 14 from securing means 12 also removes mass from flow controller 10 and may reduce pressure on vein or vessel”).
Regarding claim 2, Lauren et al. further discloses wherein the controller (proximal end of 10 including 14 in Fig. 3) is disconnected by cutting a short segment (5 in Fig. 4) of the band element (20) between the controller (proximal end of 10 including 14 in Fig. 3) and the securing means lock (60) so as to leave the band element (20) secured around the hollow conduit (PP [0052]: “Once tube 44 is crimped thus locking catheter 60 and strap 20 together, securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12. Securing means 12, with the set desired diameter loop 26 (e.g., diameter D2) arranged around vein or vessel 2, may be left in place with minimal obstruction to the patient. Removing tensioning means 14 from securing means 12 also removes mass from flow controller 10 and may reduce pressure on vein or vessel”).
Regarding claim 4, Lauren et al. further discloses wherein the band (20 in Fig. 3) is radiopaque (PP [0044]: “Bushing 40 may further act as a radiopaque marker”, bushing 40 is located on the band 20 and therefore a part of it, see Fig. 3, so it renders the band 20 radiopaque).
Regarding claim 5, Lauren et al. further discloses wherein the band (20 in Fig. 3) has a circular cross section, a rectangular cross section, or is shaped to provide a specifically-shaped restriction (PP [0043]: “In some embodiments, strap 20 comprises a cylindrical cross-section having a diameter of approximately 1-5 mm. It should be appreciated that strap 20 may comprise any geometry cross-section (e.g., ovular, rectangular, etc.) suitable for forming a loop and tightening around a vessel (e.g., vein, gastrointestinal (GI) tract, urethra, genitourinary, vascular graft, blood vessel, artery, lungs, etc.)”).
Regarding claim 7, Lauren et al. further discloses wherein the mechanism for adjusting the diameter of the band (14 in Fig. 3, PP [0046]: “as tensioning means 14 is tightened, thereby displacing threaded rod 90 with respect to housing 70, the diameter of loop 26 is reduced”) comprises a captured nut (110) that linearly moves a threaded rod (90) connected to the end of the band (PP [0048]: “As shown in the drawings, end 24 of strap 20 is fed through through-bore 100 and is fixedly secured at end 94 of threaded rod 90 via a crimp”) thereby drawing the band (20) into the controller (proximal end of 10 including 14, see Figs. 4-5).
Regarding claim 8, Lauren et al. further discloses wherein the securing means (60 in Fig. 3) is a lock that compresses the tunnel over a section of band (20, PP [0046]: “tube 44 may be crimped in order to fixedly secure strap 20 and catheter 60 together, thereby locking in the diameter of loop 26”) to produce a controlled resistance to band movement which maintains the diameter of the band under normal clinical conditions (PP [0047]: “The locking function of tube 44 allows tensioning means 14 to be removed from securing means 12 while loop 26 remains secured at the set diameter around vein or vessel 2”), and allows the band element (20) to open from its secured state in response to a pressurized balloon placed inside the hollow conduit (PP [0046]: “tube 44 comprises stainless steel”, stainless steel can be plastically deformed from the force of a pressurized balloon, the present application states in PP [088] that “the band element 3 may incorporate a strategically designed weak point that allows the band to break or stretch open in response to an angioplasty balloon”, so the crimpable deformable tube 44 is configured to allow the band element 20 to open in response to the inflation force of a pressurized balloon placed inside the hollow conduit, see MPEP 2112.01).
Regarding claim 9, Lauren et al. further discloses an indicator (70 in Fig. 1B) for displaying the diameter of the band (PP [0047]: “Measuring surface 76 may include calibrated measurements that indicate the diameter of loop 26, for example, in millimeters or inches… measuring surface 76 comprises a scale, which is arranged to indicate the diameter of loop 26 based on the position of end 92 of threaded rod 90, or some other marking on threaded rod 90”).
With respect to claim 11, Lauren et al. discloses a device (10 in Fig. 3) for providing controlled restriction of a hollow conduit in a body (abstract: "A flow controller arranged to provide controlled constriction of a hollow body conduit"), the device comprising:
a band element (20 in Fig. 3) having a tunnel section (30 and 50) with a proximal opening (proximal opening of 50) and a distal opening (opening of 30),
a length of the band (20) extending from the proximal opening (50, see 20 extend through bore 58 of 50),
a controller (proximal end of 10 including 14) removably attached to the distal opening (30, PP [0054]: “After adjusting flow (i.e., setting the diameter of loop 26), tensioning means 14 may be removed”), comprising a mechanism (14) for adjusting a diameter of the band (20, PP [0046]: “as tensioning means 14 is tightened, thereby displacing threaded rod 90 with respect to housing 70, the diameter of loop 26 is reduced”),
wherein an end of the band (22) is insertable through the proximal opening (30, PP [0044]: “End 22 is operatively arranged to engage hole 38 to fixedly secure strap 20 to female connector 30”) to form a loop (26) around the hollow conduit (see Fig. 3 with loop 26 around vessel 2), and wherein the band (20) is advanced into the controller (proximal end of 10 including 14, see Fig. 3 where proximal end 24 of band 20 is advanced into through-bore 100) to permanently engage with the mechanism for adjusting the diameter of the band (14),
a securing means (60) located inside the tunnel section (30 and 50, PP [0046]: “end 62 is fixedly secured to surface 59 and concentrically aligned with through-bore 58”) to secure the diameter of the band (20, PP [0046]: “Catheter 60 may further comprise tube 44 slidably arranged thereon. When loop 26 is set at a sufficient diameter, tube 44 may be crimped in order to fixedly secure strap 20 and catheter 60 together, thereby locking in the diameter of loop 26”), and
a means to disconnect (5 in Fig. 4) the controller (proximal end of 10 including 14) from the band element (20), leaving the band (20) and the securing means (60) around the hollow conduit (PP [0052]: “Once tube 44 is crimped thus locking catheter 60 and strap 20 together, securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12. Securing means 12, with the set desired diameter loop 26 (e.g., diameter D2) arranged around vein or vessel 2, may be left in place with minimal obstruction to the patient. Removing tensioning means 14 from securing means 12 also removes mass from flow controller 10 and may reduce pressure on vein or vessel”).
Regarding claim 12, Lauren et al. further discloses wherein the band (20 in Fig. 3) is secured using a detent-type mechanism (see bore 38 in Fig. 3, PP [0044]: “Female connector 30 may further comprise bushing 40 to aid in fixedly securing end 22 in hole 38. For example, bushing 40 may be bonded to etched end 22 using a heat-cured epoxy, and bushing 40 is then bonded within hole 38”) within the tunnel section (30 and 50), wherein periodically spaced elements along the band (20, PP [0044]: “end 22 of strap 20 is etched to provide a surface for bonding or fixing to female component 30”) engage with a fixed complimentary geometry inside the tunnel section (30 and 50).
Regarding claim 13, Lauren et al. further discloses wherein the band element (20 in Fig. 3) is secured by creating a friction-fit between the band element (20) and the tunnel section (30 and 50, PP [0043]: “end 22 of strap 20 is etched to provide a surface for bonding or fixing to female component 30”, the etching provides texture which creates friction), and wherein the controller (proximal end of 10 including 14) is a disposable or a reusable controller (PP [0052]: “Removing tensioning means 14 from securing means 12”, PP [0049]: “end 24 of strap 20 is fed through through-bore 100 and is fixedly secured at end 94 of threaded rod 90 via a crimp (i.e., crimp portion 102 is crimped or squeezed together around strap 20 and thus fixedly secures end 94 and end 24)”, the end 24 of band 20 is crimped and attached to 14, either the controller can be disposed of or the crimp broken and the band 20 removed for the controller to be reused, see MPEP 2112.01).
Regarding claim 14, Lauren et al. further discloses wherein the securing means (60 in Fig. 3) is a lock that compresses the tunnel over a section of band (20, PP [0046]: “tube 44 may be crimped in order to fixedly secure strap 20 and catheter 60 together, thereby locking in the diameter of loop 26”) to produce a controlled resistance to band movement which maintains the diameter of the band under normal clinical conditions (PP [0047]: “The locking function of tube 44 allows tensioning means 14 to be removed from securing means 12 while loop 26 remains secured at the set diameter around vein or vessel 2”), and allows the band element (20) to open from its secured state in response to a pressurized balloon placed inside the hollow conduit (PP [0046]: “tube 44 comprises stainless steel”, stainless steel can be plastically deformed from the force of a pressurized balloon, the present application states in PP [088] that “the band element 3 may incorporate a strategically designed weak point that allows the band to break or stretch open in response to an angioplasty balloon”, so the crimpable deformable tube 44 is configured to allow the band element 20 to open in response to the inflation force of a pressurized balloon placed inside the hollow conduit, see MPEP 2112.01).
Regarding claim 15, Lauren et al. further discloses wherein the controller (proximal end of 10 including 14 in Fig. 3) is disconnected by cutting a short segment (5 in Fig. 4) of the band element (20) between the controller (proximal end of 10 including 14 in Fig. 3) and the securing means lock (60) so as to leave the band element (20) secured around the hollow conduit (PP [0052]: “Once tube 44 is crimped thus locking catheter 60 and strap 20 together, securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12. Securing means 12, with the set desired diameter loop 26 (e.g., diameter D2) arranged around vein or vessel 2, may be left in place with minimal obstruction to the patient. Removing tensioning means 14 from securing means 12 also removes mass from flow controller 10 and may reduce pressure on vein or vessel”).
With respect to claim 16, Lauren et al. discloses a method to controllably reduce a flow in a blood conduit (abstract: “A flow controller arranged to provide controlled constriction of a hollow body conduit”), the method comprising the Steps of:
leading an end (22) of a band (20) around a blood conduit (see Figs. 1A-B where 20 is looped around vessel 2);
inserting the end (22) of the band (20) into a hollow section (50, 22 and 30 are inserted into attachment with hollow section 50 via protrusions 54 and notches 34, PP [0045]: “The diameter of radially inward facing surface 32 may be of a certain dimension such that it “snaps” together with radially outward facing surface 52, such that female connector 30 is removably secured to male connector 50”) connected to an opposite end of the band (opposite end of band 20 near 24 which is connected to 50) so as to form a loop (26) around the blood conduit (2);
advancing the band (20) through the hollow section (50) to connect to a mechanism (14, 20 extends proximally to connect to 14) detachably connected to the opposite side of the hollow section (50, see Fig. 5, PP [0052]: “securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12”), said mechanism (14) being capable of controllably drawing the band (20) in and out of the hollow section (50) so as to vary a size of the loop (PP [0047]: “tensioning means 14 can be connected to securing means 12 in order to provide the necessary tightening of loop 26 around vein or vessel 2”);
adjusting a diameter of the band (20) using an adjusting mechanism (110 and 90, PP [0047]: “according to FIG. 1B, rotating nut 110 toward the small circle (i.e., in circumferential direction CD1) decreases the diameter of loop 26, whereas rotating nut 110 toward the large circle (i.e., in circumferential direction CD2) increases the diameter of loop 26”);
securing the band (20, PP [0051]: “Once the desired diameter of loop 26 is set, tube 44 can be crimped to fixedly secure strap 20 to catheter 60 and prevent any further adjustment of loop 26”); and
detaching the mechanism (14) from the hollow section (50, PP [0052]: “securing means 12 may be cut, along cut line 5 for example, thus separating tensioning means 14 from securing means 12”) so as to leave a secured band (20) in place around the blood conduit (PP [0052]: “Securing means 12, with the set desired diameter loop 26 (e.g., diameter D2) arranged around vein or vessel 2, may be left in place with minimal obstruction to the patient”).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lauren et al. (US PGPub 2019/0336675 A1), as applied to claim 1 above, and further in view of Pai et al. (US PGPub 2019/0321607 A1).
Regarding claim 3, Lauren et al. fails to disclose wherein the band element is coated with a material, such as parylene to reduce its sliding friction or stiction.
In the field of dilation (abstract), which is relevant because dilation systems can comprise components which are slidable relative to one another (PP [0031]: “A low-friction outer surface reduces the force needed to achieve translational motion between the dilation member and the next outermost component of the dilation device”) for use within the vasculature (PP [0099]: “the apparatus and methods described herein may also be used for dilating other body passages within a patient's body, e.g., a blood vessel within a patient's vasculature”) as is the aim of the Lauren et al. device which concerns itself with the band (20 in Fig. 3) sliding relative to the tunnel section (30 and 50, more specifically band 20 slides relative to 50, PP [0045]: “Through-bore 58 extends through male connector 50 and is arranged to be slidably engaged with strap 20”), Pai et al. teaches that a low coefficient of friction can be achieved through the use of a parylene coating (PP [0030]: “The low coefficient of friction may be obtained as an inherent characteristic of the component material of the dilation member (e.g., acetal/Delrin, fluoropolymers/Teflon, and the like), due to the application of a surface coating (e.g., PTFE, parylene, hydrophilic polymer coatings, and the like) to the internal or external surfaces of the dilation member”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Lauren et al. device according to the teachings of Pai et al. to include a parylene coating on the band to reduce sliding friction or stiction because doing so would have constituted the application of a known technique (the use of a parylene coating to reduce friction between components which experience relative translation in vascular procedures as taught by Pai et al.) to a known device (the device of Lauren et al.) ready for improvement to yield predictable results. The modification as proposed, the application of a parylene coating to the band (20 in Fig. 3), would not alter the operating principle of the Lauren et al. device but would instead reduce sliding friction between the band (20) and the tunnel section (30 and 50, more specifically band 20 slides relative to 50, PP [0045]: “Through-bore 58 extends through male connector 50 and is arranged to be slidably engaged with strap 20”) in order to “reduce the force needed to achieve translational motion” (Pai et al. PP [0031]), which would improve the smoothness of operation of the tensioning process (Lauren et al. PP [0046]: “It should be appreciated that strap 20 is slidable with respect to male connector 50, catheter 60, and housing 70. As such, as tensioning means 14 is tightened, thereby displacing threaded rod 90 with respect to housing 70, the diameter of loop 26 is reduced”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lauren et al. (US PGPub 2019/0336675 A1), as applied to claim 1 above, and further in view of Kuzmak (US Patent No. 5,910,149).
Regarding claim 6, Lauren et al. fails to disclose wherein the band is partially covered with a material, such as a textile to provide friction between the band and an outside surface of the hollow conduit to prevent band migration.
In the related field of gastric banding devices (abstract), which is relevant because the gastric band art is concerned with the wrapping of a band of material around a hollow conduit within the body to affect the flow rate of material through said conduit (col. 1, lines 6-7: “to form a stoma opening of reduced diameter so as to restrict food intake”) similarly to the fistula control device of the Lauren et al. disclosure, Kuzmak teaches a device (10 in Fig. 1) comprising a band (12) and further discloses wherein the band (12) is partially covered with a material (30, col. 3, lines 41-43: “The holding element 30 is secured to band 12… by being affixed to a surface thereof”), such as a textile (col. 1, lines 60-65: “An important feature of the holding means is that at least part of the securing portions of the holding means are formed of a mesh material or other perforate material so that tissue can grow therethrough and assist in holding the gastric band in place”, mesh is a type of textile due to its interwoven filaments) to provide friction between the band and an outside surface of the hollow conduit to prevent band migration (col. 3, lines 33 -36: “one or more holding elements, generally denoted 30 in FIG. 1, for holding the band 12 in place and thereby preventing the band 12 from slipping or migrating”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Lauren et al. device according to the teachings of Kuzmak to incorporate a textile covering on the band for the prevention of band migration. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted the use of a known technique (employing the mesh textile covering as taught by Kuzmak on a band to prevent migration from a target conduit within the body) to a known device (the device of Lauren et al.) ready for improvement to yield predictable results. Incorporating the textile coverings as taught by Kuzmak would not change the operating principle of the Lauren et al. device, since Kuzmak is concerned with preventing the migration of a band similar to the vascular band of the Lauren et al. disclosure, and would simply prevent migration of the band away from the target area, which Kuzmak teaches could lead to “medical complications” (col. 1, lines 40-41).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lauren et al. (US PGPub 2019/0336675 A1), as applied to claim 1 above, and further in view of Hall et al. (US PGPub 2021/0283302 A1).
Regarding claim 10, Lauren et al. further discloses wherein the band element (20 in Fig. 3) is molded using a biomedical polymer (PP [0043]: “In some embodiments, strap 20 comprises TEFLON® PTFE, or another biocompatible polymer”).
However, Lauren et al. fails to explicitly disclose wherein the biomedical polymer has a durometer from about 60A to 90A.
In the related field of vascular graft conduits (abstract), which is related since it is also concerned with integrating a prosthesis with a patient’s vasculature, Hall et al. teaches a graft (100 in Fig. 1) comprising an inner sleeve (111 in Fig. 2) including PTFE, a biomedical polymer (PP [0024]: “the inner sleeve 111 may comprise a fibrous polytetrafluoroethylene (PTFE) film. Fibrous PTFE film layers within the scope of this disclosure include expanded PTFE (ePTFE) layers and layers formed by rotational spinning or electrospinning a PTFE dispersion through an orifice to form fibers and collecting spun fibers on a mandrel to create an electrospun or rotational spun fibrous layer”). Hall et al. further teaches wherein “A hardness of the first polymer may range from about 5A to about 80A, from about 40A to about 60A, and may be about 50A on a Shore A hardness scale” (PP [0024]).
It would have been prima facie obvious for one of ordinary skill in the art to have modified the Lauren et al. according to the teachings of Hall et al. to include wherein the biomedical polymer, PTFE as disclosed by Lauren et al., has a durometer from about 60A to 90A since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been a simple substitution of PTFE types that would have yielded predictable results, as Lauren et al. is silent on any required hardness and Hall et al. teaches that PTFE comprising a hardness within the claimed range is suitable for use in vascular conduits similar to the band of the Lauren et al. disclosure. Furthermore, modifying the Lauren et al. device to include a band with the claimed Shore scale hardness would not change the operating principle of the disclosure, since Lauren et al. emphasizes that “Strap 20 generally comprises a flexible material” (PP [0043]). Modifying the strap to specifically have a durometer from about 60A to 90A would only improve the flexibility of the component in accordance with the operational goals of the Lauren et al. disclosure. Lastly, the present disclosure does not offer any statements of criticality regarding the claimed durometer, stating only that the durometer “generally” falls between 60A and 90A (PP [042]).
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771