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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36, 53 and 54, and Claims 37-52 and 55 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 36, Claim 36 recites “a tunnel filler.” The Present Specification fails to convey to one of ordinary skill in the art what physical structure is contemplated by the term “tunnel filler.” The Present Specification waivers in its characterization of the term. At Pg. 3, Ln. , the Present Specification states “The device can include a folded length of a suture, string or a seton having a tunnel filler, which may be a fistula filler, comprising decellularized mammalian extracellular matrix (ECM) compressed thereon….” This is in contrast to Pg. 3, Ln. of the Present Specification, which states that “[i]n one embodiment, an implantable device for the treatment of a tunnel would is provided and comprises: a folded length of a suture, string, or seton having a proximal loop and two distal ends, a tunnel filler comprising decellularized mammalian ECM applied to the suture, string or seton….” The former suggests that a “tunnel filler” is contemplated as an object whose function is filling a tunnel wound, and in a particular embodiment “decellularized mammalian extracellular matrix (ECM)” is “compressed” onto that object. The latter suggests that a tunnel filler is “decellularized mammalian ECM applied to the suture” rather than such a discrete object of the preceding lines. Similar inconsistencies pervade the remainder of the Specification. The Present Specification thus fails to reasonably convey what a “tunnel filler” is contemplated to entail, and, accordingly, that the inventor had possession of the claimed invention at the time of filing.
For purposes of this Office Action, the term “tunnel filler” is being interpreted to mean an object whose function is filling a tunnel wound, and in a particular embodiment (i.e., that of Claim 37 et seq.) “decellularized mammalian extracellular matrix (ECM)” is “compressed” onto that object.
Were Claim 36 to be amended such that the alternatively noted interpretation was reflected, Claim 36 would be rejected in a similar manner to that by which Claim 37 is rejected herein.
Regarding Claim 53, Claim 53 also recites a “tunnel filler,” similarly to Claim 36. For the same reasons explained above with respect to Claim 36, the Present Specification thus fails to reasonably convey what a “tunnel filler” is contemplated to entail, and, accordingly, that the inventor had possession of the claimed invention at the time of filing.
Regarding Claim 54, Claim 54 recites “wherein introducing the device into the anal fistula includes removing a tunnel brush, which is engaged with the proximal end loop of the suture, from the tunnel filler.” The Present Specification does not provide support for this limitation (i.e., for “removing a tunnel brush … from the tunnel filler.”). Instead, the Present Specification describes the tunnel brush as being removable from a loop formed by the suture, which facilitates removal of the tunnel brush from the tunnel wound (see, e.g., Present Specification at Pg. 24, Ln. 16-20). The Present Specification fails to convey to a person of ordinary skill in the art in what sense the “tunnel brush” is removed “from the tunnel filler” because (a) it does not describe the tunnel filler and the tunnel brush being connected in a manner by which “removal” of the tunnel brush from the tunnel filler is possible and (b) instead describes removal of the tunnel brush from the tunnel wound.
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 53, 54, and Claim 55 by dependency, 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 53, Claim 53 recites “and securing a proximal end loop of the suture to an anal side opening of the anal fistula.” It is unclear what the recited “proximal end loop” is contemplated as being secured to. For example, it is unclear whether the term “anal side opening” is in reference to an opening on the “anal side” of the patient (i.e., the end of the fistula closest to the anus), to a “side opening” of the fistula, or something else. It is additionally unclear in what sense a loop can be secured to an opening, as the term “opening” suggests a lack of material to which an object may be secured.
Regarding Claim 54, Claim 54 recites “removing a tunnel brush, which is engaged with the proximal end loop of the suture, from the tunnel filler.” However, Claim 53 (from which Claim 54 depends) recites that the “tunnel filler” is “compressed onto the suture,” which suture forms the “proximal end loop” with which the tunnel brush of Claim 54 is engaged. It is unclear in what sense the “tunnel brush” is contemplated to be “remov[ed] … from the tunnel filler,” because the tunnel filler does not appear to interface with the tunnel brush in such a manner as would allow it to be removed.
Original Claim 29 contains a similar limitation, except that–consistent with the Present Specification–the tunnel brush is recited as being removed from the tunnel wound rather than from the tunnel filler. For purposes of this Office Action, Claim 54 is being interpreted to require that the tunnel brush be removed from the tunnel wound rather than from the tunnel filler.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 36, 39, 44, 45, 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0135991 A1 to Kawaura et al. (“Kawaura”)1.
Regarding Independent Claim 36, Kawaura teaches:
A device for treatment of a tunnel wound, comprising: (Title, “Tissue closure and tissue closing device;” Para. [0038), “The tissue closing device 1 shown in the drawing figures and described in more detail below is a device for closing (closing up) an undesirable opening such as a wound hole formed on a living body cavity wall as an in vivo tissue membrane, for example, a living organism lumen such as a blood vessel, an internal organ of a living organism, and an internal tissue of a living organism, and is percutaneously penetrating (a wound hole penetrating an in vivo tissue lumen).”);
a suture folded to form a proximal loop and two distal ends; (Para. [0011), “…a tissue closure for closing an opening on a wall of living body cavity comprises… and a thread member adapted to maintain the deformation portion in a desired form between the first form and the second form. The thread member is comprised of a double thread having one end portion thereof as a bent-back portion, and being disposed so that the deformation portion is located between the bent-back portion and the anchor portion. In addition, the bent-back portion forms a loop;” Fig. 2, see Annotated Fig 2, below);
and a tunnel filler positioned on the suture between the proximal loop and the two distal ends. (Para. [0039], “As shown in FIGS. 1 and 2, the tissue closing device 1 includes a clip 4, forming a tissue closure for closing an undesirable opening such as a wound hole penetrating an in vivo tissue membrane of a living body cavity wall…;” Fig. 2, “clip 4;” see Annotated Fig. 2, below).
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Regarding Claim 39, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura additionally discloses:
wherein the tunnel filler is compressed onto the suture between the proximal loop and the two distal ends, such that the proximal loop extends proximally of a proximal end of the tunnel filler (Para. [0011], “a tissue closure for closing an opening on a wall of living body cavity comprises an anchor portion positionable at and around the opening on one side of the wall of the living body cavity, a deformation portion deformable between a first form in which the deformation portion is elongated in a direction substantially perpendicular to the anchor portion and a second form in which the deformation portion is compressed from the first form toward the anchor portion, and a thread member adapted to maintain the deformation portion in a desired form between the first form and the second form;” Fig. 2, see Annotated Fig. 2, above, wherein the recited positioning of the “tunnel filler” relative to the “proximal loop” and “distal ends” is shown).
Regarding Claim 45, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura additionally discloses:
wherein the proximal end of the tunnel filler has a tapered shape or a conical shape (Para. [0080], “For example, the shape of the deformation portion of the clip (tissue closure) is not limited to the generally rectangular configuration shown, and may be other polygons for example, or may be cornerless frame-like shapes such as a circular annular shape and an elliptic annular shape.”).
Kawaura’s tunnel filler is oriented such that its rectangular configuration results in a taper at the proximal end.
Regarding Claim 45, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura additionally discloses:
further comprising a cap member positioned on the suture distal to the tunnel filler (Fig. 2, see Annotated Fig. 2, above).
Regarding Claim 52, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura additionally discloses:
wherein the suture comprises a material that is resorbable post-implantation (Para. [0072], “ In addition, the thread 46 also is preferably formed of a bioabsorbable material.”).
Claim 53 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0038128 A1 to Carrison (“Carrison”)2.
Regarding Claim 53, Carrison teaches:
A method of treating an anal fistula in a mammal, comprising: (Abstract, “Disclosed herein are implantable fistula treatment devices and related methods;” Para. [0085], “The devices 5 may be utilized to treat a variety of clinically significant fistulas 10, as appropriate, including … anal fistulas…”);
introducing a device, including a suture and a tunnel filler compressed onto the suture, into the anal fistula; (Abstract, “In some embodiments, an implantable fistula treatment device may comprise a suture and a proximal anchor. The proximal anchor may comprise a tissue anchor and a suture tensioner. The suture tensioner may be configured to resiliently maintain the suture in tension over a range of distances between the proximal anchor and a distal anchor. In some variations, the suture tensioner may have a deformable elastic structure. The suture tensioner may have a tensioned configuration and a neutral configuration;” Para. [0092], “Any suitable methods may be used to deliver or deploy the fistula treatment devices described herein;” Para. [0083], “For example, and referring to FIGS. 1A-1D, in some embodiments, the device 5 may have a segmented expandable body 13 formed of a plurality of individual expandable bodies or members 15 that are coupled together. The members 15 may be coupled together in an immediately adjacent abutting fashion or in a spaced-apart fashion (as shown). Upon insertion of the device 5 into the fistula tract 10 with the expandable members 15 in a collapsed or compressed state, the expandable members 15 are allowed to expand to fill the portion of the fistula tract 10 in which each expandable member 15 is located.”);
Carrison’s “expandable members 15” are such a “tunnel filler” as claimed.
applying pressure to an end of the tunnel filler using a tamp member slidably positioned along the suture; (Para. [0149], “…the device 5 may be deployed from the lumen of a delivery sheath or catheter 900 via a long, flexible rod or a “pusher” 903. The pusher 903 may be inserted through the delivery device 900 and may enable the clinician to push or otherwise direct the segmented device body 13 into the tract 10, thereby minimizing the dead space or void that may be left between the individual segments of the device body 13 or between the body 13 and tract 10.”);
Carrison’s “pusher 903” is such a “tamp member” as claimed.
removing the tamp member from the suture; (Para. [0149]);
Carrison’s “pusher 903”
and securing a proximal end loop of the suture to an anal side opening of the anal fistula (Para. [0180], “When positioned on the proximal surface, the suture attachment structure may include a loop or other feature to fixedly couple the suture to the foldable member.”)
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.
Claims 37, 38 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”) as applied respectively to Claims 36 and 45 above, and further in view of US 2014/0023723 A1 to Leach et al. (“Leach”)3.
Regarding Claim 37, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura does not disclose:
wherein the tunnel filler comprises decellularized mammalian extracellular matrix (ECM)
Leach describes “[m]ethods for producing compositions of decellularized extracellular matrix (DM) tissue culture” (Abstract) for use “to treat diseases that can benefit from improved angiogenesis, cell proliferation and tissue regeneration” such as “wound” (Para. [0111]). Leach is analogous art.
Leach teaches:
wherein the tunnel filler comprises decellularized mammalian extracellular matrix (ECM) (Para. [0142], “The decellularized extracellular matrix can also be used alone or in combination with a polymer described above to form the medical device. The decellularized extracellular matrix can be dried to increase its mechanical strength. The dried decellularized extracellular matrix can then be used as the base material to form a whole or part of the medical device.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Leach (i.e., to manufacture Kawaura’s “tunnel filler” from such a decellularized extracellular matrix as taught by Leach) in order to “accelerate[] tissue formation in a natural manner and … enhance integration into the patient by presenting a cell-derived surface coating” (Leach at Para. [0002]).
Regarding Claim 38, the combination of Kawaura and Leach renders obvious the entirety of Claim 37 as explained above.
Leach additionally teaches:
wherein the decellularized mammalian ECM is decellularized porcine ECM or decellularized liver ECM (Para. [0072], “Any number of different cell types can be used in the methods described herein…. Human cells, as well as those from other mammalian species including, but not limited to, equine, canine, porcine, bovine, ovine, or rodent (e.g., mouse or rat) can be used.”).
Regarding Claim 47, Kawaura discloses the entirety of Claim 39 as explained above.
Kawaura does not disclose:
wherein the cap member comprises decellularized mammalian ECM, polycaprolactone, polylactic acid (PLA), polyglycolic acid (PGA), or co- polymers of PLA and PGA
Leach describes “[m]ethods for producing compositions of decellularized extracellular matrix (DM) tissue culture” (Abstract) for use “to treat diseases that can benefit from improved angiogenesis, cell proliferation and tissue regeneration” such as “wound” (Para. [0111]). Leach is analogous art.
Leach teaches:
wherein the cap member comprises decellularized mammalian ECM, polycaprolactone, polylactic acid (PLA), polyglycolic acid (PGA), or co- polymers of PLA and PGA (Para. [0142], “The decellularized extracellular matrix can also be used alone or in combination with a polymer described above to form the medical device. The decellularized extracellular matrix can be dried to increase its mechanical strength. The dried decellularized extracellular matrix can then be used as the base material to form a whole or part of the medical device.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Leach (i.e., to manufacture Kawaura’s “tunnel filler” from such a decellularized extracellular matrix as taught by Leach) in order to “accelerate[] tissue formation in a natural manner and … enhance integration into the patient by presenting a cell-derived surface coating” (Leach at Para. [0002])
Claims 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”) as applied to Claim 39 above, and further in view of AU 2013257459 B2 to Fette et al. (“Fette”)4.
Regarding Claim 40, Kawaura discloses the entirety of Claim 39 as explained above.
Kawaura does not disclose:
wherein the tunnel filler is radially compressed or torsionally compressed onto the suture
Fette describes “Volumetric grafts for treatment of fistulae and related methods and systems” (Title). Fette is analogous art.
Fette teaches:
wherein the tunnel filler is radially compressed or torsionally compressed onto the suture (Pg. 3, Ln. 32-34, “Aspects of the present invention provide for the treatment of a fistula of the alimentary canal, such as an anorectal fistula, by filling its primary opening with a layered volumetric graft construct;” Pg. 4, Ln. 30-31; Pg. 22, Ln. 18-20, Additionally, bonding can occur or be assisted by placing a suitable bonding material or agent between the layers of the rolled construct, such as before the sheet material is rolled…”).
Fette’s “rolling” is such radially compressing as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Fette (i.e., to form Kawaura’s tunnel filler via such rolling as taught by Fette) in order to increase adhesion and control stiffness (Fette at Pg. 3, Ln. 32-34; Pg. 4, Ln. 30-31; Pg. 22, Ln. 18-20).
Regarding Claim 41, the combination of Kawaura and Fette renders obvious the entirety of Claim 40 as explained above.
Fette additionally teaches:
wherein a compressed diameter of the tunnel filler is about 1 millimeter to about 6 millimeters, inclusive (Claim 4, “…wherein each bead portion has a diameter of from 1 mm to 20 mm”)
Fette’s range of 1 mm to 20 mm overlaps the claimed range of 1 mm to 6 mm. In 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). Although Fette does not disclose the precise range of 1 mm to 6 mm as claimed, it would have been obvious to select any diameter from Fette’s range of 1 mm to 20 mm including such a range as 1 mm to 6 mm because doing so would be likely to result in success.
Regarding Claim 42, the combination of Kawaura and Fette renders obvious the entirety of Claim 40 as explained above.
The combination of Kawaura and Fette does not disclose:
wherein a pre-compressed size of the tunnel filler is about 3 centimeters to about 8 centimeters, inclusive, in both width and height
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura and Fette such that the pre-compressed size of the tunnel filler is about 3 centimeters to about 8 centimeters, inclusive, in both width and height because such a modification entails only a change in size, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient MPEP 2144.04(IV).
Regarding Claim 43, the combination of Kawaura and Fette renders obvious the entirety of Claim 40 as explained above.
The combination of Kawaura and Fette does not disclose:
wherein a compressed length of the tunnel filler is about 2 centimeters to about 12 centimeters, inclusive.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura and Fette such that a compressed length of the tunnel filler is about 2 centimeters to about 12 centimeters, inclusive because such a modification entails only a change in size, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient MPEP 2144.04(IV).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”).
Regarding Claim 46, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura additionally discloses:
and wherein the cap member is sized and shaped to hold the tunnel filler in place within the tunnel wound (Fig. 2, see Annotated Fig. 2, above).
The embodiment of Kawaura’s Fig. 2 does not disclose:
wherein the suture passes through a center of the cap member,
However, in the embodiment of Kawaura’s Figs. 18(a) and 18(b), Kawaura’s “cap” (i.e., “stopper 47”) is shown with a different suture passing through its center.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura’s embodiment of Fig. 2 with the teachings of Kawaura’s embodiment of Figs. 18(a) and 18(b) (i.e., to replace the “cap” of the embodiment of Fig. 2 with the “cap” of the embodiment of Figs. 18(a) and 18(b)) because such a modification entails a simple substitution of one known element for another to obtain predictable results.
The prior art contained a device (i.e., that of Kawaura’s embodiment of Fig. 2) which differed from the claimed device by the substitution of some components (i.e., a “cap” that is attached at a portion other than its center) with other components (i.e., a “cap” that is attached through its center).
The substituted components and their functions were known in the art. For example, Kawaura teaches such a cap in the embodiment of Figs. 18(a) and 18(b).
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”) as applied to Claim 45 above, and further in view of US 2007/0198059 A1 to Patel et al. (“Patel”).
Regarding Claim 48, Kawaura discloses the entirety of Claim 45 as explained above.
Kawaura does not disclose
wherein the cap member is in the form of a compressed sheet
Patel describes “medical graft products, systems, and methods for treating fistulae” (Abstract). Patel is analogous art.
Patel teaches:
wherein the cap member is in the form of a compressed sheet (Para. [0139], “This in turn will cause disc-shaped member 206 to exert a substantially even force across the end of graft body distal portion 202, causing cap-forming portion 205 to longitudinally compress while contacting patient tissue at and around fistula opening 222 to provide a capping member for blocking the opening.”).
Patel’s “disc shape member 206” is “in the form of a compressed sheet” in the manner claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Patel (i.e., to shape Kawaura’s cap member in the form of such a compressed sheet as taught by Patel) because such a modification entails only a change in shape, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient MPEP 2144.04(IV).
Claims 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”) as applied to Claim 45 above, and further in view of US 2016/0038128 A1 to Carrison (“Carrison”).
Regarding Claim 49, Kawaura discloses the entirety of Claim 45 as explained above.
Kawaura does not disclose:
further comprising a tamp member positioned over the suture distal to the cap member
Kawaura discloses a tamp member (“pusher tube 7;” see Para. [0069]), but Kawauar’s tamp member is not positioned distal to Kawaura’s cap as claimed.
Carrison describes “Fistula treatment devices and related methods” (Title). Carrison is analogous art.
Carrison teaches:
further comprising a tamp member positioned over the suture distal to the cap member (Para. [0149], “As can be understood from FIG. 98, in one embodiment, the device
5 may be deployed from the lumen of a delivery sheath or catheter 900 via a long, flexible rod or a ‘pusher’ 903;” Fig. 9B, “pusher 903;” see Annotated Fig. 9B, below);
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It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Carrison (i.e., to add such a cap and tamp member as taught by Carrison to the device of Kawaura) in order to “produce an occluding and anchoring effect” upon expansion of the “porous body” “cap” (Carrison at Para. [0099]).
To be clear, the contemplated modification entails adding at least one of Carrison’s “porous bodies” to the end of Kawaura’s suture (the new “cap” of the modified device), and using Carrison’s “pusher” as a tamp to expand the porous body cap in the manner of Carrison. The benefit of so-doing is to “produce an occluding and anchoring effect” upon expansion of the “porous body,” as Carrison explains to be the benefit of Carrison’s configuration. The device-as-modified thus makes use of two separate mechanisms for fistula treatment: Kawaura’s methodology and Carrison’s.
Regarding Claim 50, the combination of Kawaura and Carrison renders obvious the entirety of Claim 49 as explained above.
Carrison additionally teaches:
further comprising a handle member attached to the suture and positioned distal to the tamp member (Para. [0250], “Push device 3500 may comprise a handle 3502 and a distal head 3504.”).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0135991 A1 to Kawaura et al. (“Kawaura”) as applied to Claim 45 above, and further in view of US 2005/0049626 A1 to Burgard (“Burgard”).
Regarding Claim 51, Kawaura discloses the entirety of Claim 36 as explained above.
Kawaura does not disclose:
wherein a folded length of the suture is about 20 centimeters to about 40 centimeters, inclusive.
Burgard describes “…a fistula blocker for clearing up a fistula passage with a plug-like closure device…” (Abstract). Burgard is analogous art.
Burgard teaches:
wherein a folded length of the suture is about 20 centimeters to about 40 centimeters, inclusive (Para. [0047], “The application string can have a length of about 20 cm.”)
Burgard’s application string is analogous to the folded suture of Claim 51.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawaura with the teachings of Burgard (i.e., to modify the suture of Kawaura such that its folded length is 20 cm in the manner of Burgard) because such a because such a modification entails only a change in size, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient MPEP 2144.04(IV).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0038128 A1 to Carrison (“Carrison”) as applied to Claim 53 above, and further in view of US 2009/0112238 A1 to Pitts et al. (“Pitts”).
Regarding Claim 54, Carrison discloses the entirety of Claim 53 as explained above.
Carrison does not disclose:
wherein introducing the device into the anal fistula includes removing a tunnel brush, which is engaged with the proximal end loop of the suture, from the tunnel filler
Pitts describes a “Fistula brush device” (Title). Pitts is analogous art.
Pitts teaches:
wherein introducing the device into the anal fistula includes removing a tunnel brush, which is engaged with the proximal end loop of the suture, from the tunnel filler (Para. [0004], “A brush is disposed upon the elongate member between the first end portion and the second end portion. A first aperture is defined in the first end portion and a second aperture is defined in the second end portion. A first suture is disposed through the first aperture and tied to itself to define a first loop and a second suture disposed through the second aperture and tied to itself to define a second loop, wherein each of the first and second loops are configured to receive an implantable material;” Para. [0035], “As the device 10 is fully withdrawn, the second suture 180 still extends through the fistula (and the vagina and rectum).”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Carrison with the teachings of Pitts (i.e., to modify the method of Carrison such that a brush engaged with the proximal end loop of the suture is removed ahead of introducing the tunnel filler) in order to “aid[] in the removal of any dead or unhealthy tissue bordering the fistula tract,” thereby allowing contact with healthier tissue after insertion (Carrison at Para. [0032]).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0038128 A1 to Carrison (“Carrison”) as applied to Claim 53 above, and further in view of US 9,238,090 B1 to Fette (“Fette ‘090”).
Regarding Claim 55, Carrison discloses the entirety of Claim 53 as explained above.
Carrison does not disclose:
further comprising hydrating the tunnel filler, thereby expanding the tunnel filler within the anal fistula about two-fold from its compressed, non- hydrated size
Fette ‘090 describes “Compositions comprising extracellular matrix (ECM) materials and methods of use thereof” (Abstract), including use in treating fistulae (Col. 9, Ln. 19-34). Fette ‘090 is analogous art.
Fette ‘090 teaches:
further comprising hydrating the tunnel filler, thereby expanding the tunnel filler within the anal fistula about two-fold from its compressed, non- hydrated size (Col. 6, Ln. 61-64, “…an ECM material in sheet form may be about 200 μm thick when dry, and may increase to a thickness from about 300 μm to about 500 μm when rehydrated.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Carrison with the teachings of Fette ‘090 (i.e., to use such ECM material as taught by Fette ‘090 to form the tunnel filler of Carrison, and to expand Carrison’s tunnel filler via rehydrating it in the manner of Fette ‘090) in order to assist with healing and tissue repair while providing sufficient structural integrity (Fette ‘090 at Col. 1, Ln. 11-25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 US 2006/0135991 A1 was disclosed by Applicant in the IDS dated 6/17/2024.
2 US 2016/0038128 A1 was disclosed by Applicant in the IDS dated 6/17/2024.
3 US 2014/0023723 A1 was disclosed by Applicant in the IDS dated 6/17/2024.
4 AU 2013257459 B2 was disclosed by Applicant in the IDS dated 6/17/2024.