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 § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1, lines 4-5 states “the first fixing stent being provided in the first lumen to support an inner wall of the first lumen” and line 6 states “the second fixing stent provided in the fistula and the second lumen”. In light of the specification, the “fistula” as well as the first and second lumens are human tissue (see paragraph 3). The limitations are positively reciting that the device is provided in the fistula/tissue and supports the lumen/tissue. Therefore the claims are positively reciting human tissue and the 101 is applicable. The examiner suggests the limitations should be amended to read “the first fixing stent configured to be provided in the first lumen to support an inner wall of the first lumen” and “the second fixing stent configured to be provided in the fistula” or similar amendments, respectively.
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 16-20 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.
The term “gradually” in claims 16, 17, and 19 is a relative term which renders the claim indefinite. The term “gradually” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the extent of the speed “gradually” with respect to how fast is the stent pulled/moved would read on gradually vs not. Therefore the limitations are considered to be indefinite.
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.
Claims 1, 6, 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,755,773 to Evans.
As to claim 1, Evans discloses a device capable of being a fistula blocking stent configured to block a fistula formed between a first lumen and a second lumen (col. 3 ll. 66-col. 4 ll. 20, the device is capable of being positioned in fistula between to lumens, where the device can block the fistula) the fistula blocking stent comprising: a first fixing stent (120, figure 9, col. 10 ll. 50-64) in a shape of a hollow tube, the first fixing stent having a proximal end (bottom of the device, figure 9), a distal end (top of the device), and a tube body (tube of 120) extending axially between the proximal end and the distal end, the first fixing stent being provided in the first lumen to support an inner wall of the first lumen (figure 9); a second fixing stent (126) provided in the fistula and the second lumen, the second fixing stent having a first end (the end connecting to 122) and a second end (opposite end) opposite to the first end, the first end being connected to the first fixing stent (figure 9); and a barrier film (124, col. 10 ll. 53-63) provided on at least one of the first fixing stent and the second fixing stent and configured to block the fistula. The membrane, while attached, can block a fistula that is located in the branch.
As to claim 6, Evans discloses the barrier film comprises a first covering film (the membrane 124 can be the first covering film) covering the first fixing stent (figure 9), the second fixing stent is connected to the first fixing stent to form a first connection track (figure 9), and the first covering film covers the first connection track (figure 9).
As to claim 7, Evans discloses the barrier film comprises a first barrier film (the membrane 124 can be the first covering film) connected to at least one of the first and second fixing stent (figure 9), the second fixing stent is connected to the first fixing stent to form a first connection track (figure 9), and the first barrier film covers the first connection track (figure 9).
Claims 1, 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2014/0277347 to Daugherty.
As to claim 1, Daugherty discloses a device capable of being a fistula blocking stent configured to block a fistula formed between a first lumen and a second lumen (paragraph 28, 29, 34, the device is capable of being positioned in fistula between to lumens, where the device can block the fistula), the fistula blocking stent comprising: a first fixing stent (100, figure 1-9) in a shape of a hollow tube, the first fixing stent having a proximal end (figure 1-9, the bottom of the device), a distal end (figure 1-9, top of the device), and a tube body (body of 100) extending axially between the proximal end and the distal end, the first fixing stent being provided in the first lumen to support an inner wall of the first lumen (paragraph 37); a second fixing stent (202, paragraph 44) provided in the fistula and the second lumen (the branch device 202 is configured to be placed within a fistula and the second lumen), the second fixing stent having a first end (figure 1-9, the end where the device 202 engages the main device 100) and a second end opposite to the first end (figure 1-9), the first end being connected to the first fixing stent (paragraph 44); and a barrier film (108, paragraph 4, 41, 43, 44, 45) provided on at least one of the first fixing stent and the second fixing stent and configured to block the fistula (paragraph 45, the patch can eliminate fluid flow where the fenestration is remained close and therefore configured to block the fistula).
As to claim 5, Daugherty discloses the first fixing stent and the second fixing stent are connected by a suture (paragraph 52). A thread can be used “reduce or eliminate” the gutter. Therefore the thread will cinch the fenestration to help connect the first fixing stent to the second fixing stent.
As to claim 6, Daugherty discloses the barrier film comprises a first covering film (the patch 108 can be the first covering film) covering the first fixing stent (figure 1, 6), the second fixing stent is connected to the first fixing stent to form a first connection track (figure 2, 3a, 4, 5), and the first covering film covers the first connection track (paragraph 44).
As to claim 7, Daugherty discloses the barrier film comprises a first barrier film (a patch 108 of the plurality of patches in paragraph 44 can be the first barrier film) connected to at least one of the first and second fixing stent, the second fixing stent is connected to the first fixing stent to form a first connection track (figure 2, 3a, 4, 5, 7-9), and the first barrier film covers the first connection track (paragraph 44).
As to claim 8, Daugherty discloses the wherein the first barrier film is connected to the first fixing stent to form a second connection track (figure 2, 3a, 7-9), an area enclosed by the second connection track is greater than an area enclosed by the first connection track (figure 2, 3a, 7-9), and the first connection track is located within the second connection track (figure 2, 3a, 7-9). The second connection track is defined by the fenestration 114 which is wider than the outer diameter 202, which defined the first tract. Therefore the area of the second tract is greater than the first, where the first track is located within the second tract.
As to claim 9, Daugherty discloses the first barrier film is an acid resistant film (paragraph 40). The patch can comprise PTFE. The application states in paragraph 61 in the application as originally filed that the first film is made of PTFE which can be an acid resistant film. Therefore Daugherty can read on the acid-resistant film.
As to claim 10, Daugherty discloses the barrier film further comprises a second covering film (the adhesive, paragraph 40, and/or the gutter strips of materials gutters paragraph 51, 52) covering the second fixing stent and a second barrier film provided in the second fixing stent (paragraph 52, 63 the second stent can comprise a graft material and a coating, which can be interpreted to be in the second fixating stent), and the second barrier film is provided in a space surrounded by the second covering film to block the fistula. The adhesive/gutter strips will be outside the branch stent which will then surround the covering film.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over U U.S. Patent 5,755,773 to Evans in view of U.S. Patent Publication 2012/0253448 to Hartley and/or U.S. Patent 6,558,396 to Inoue.
As to claim 2, Evans discloses the device above but is silent about the traction wire provided at the second end, wherein the second is contracted by pulling the traction wire.
Hartley teaches a similar device (stent, abstract) having a traction wire (42, paragraph 67) provided at a second end of a second fixing stent, wherein the second end is contracted by pulling the traction wire (paragraph 67) for the purpose of constraining an end of a secondary stent for delivery. Using the traction wire of Hartley can help to constrict the second fixing stent of Daugherty during delivery so it will have a smaller profile. Then, releasing the sutures can help to deliver the stent as desired. Inoue also teaches a similar device (collapsible device placed in vessels, abstract) having a traction wire (53, 54, 9) provided at a second end of a second fixing stent (figure 2, 19, 20) wherein the second end is contracted by pulling the traction wire (col. 7, ll. 30-34, col. 8 ll. 43-67, figure 2, 17-20) for the purpose of preparing the stent for delivery. Inoue uses wires to constrict sew together a sleeve like element to constrict the branch portion for delivery. This allows the profile of the device to decrease to aid in delivery. Using a traction wire can help to constrict the second fixing stent of Daugherty in order to aid in delivery. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a traction wire provided at the second end of the second fixation stent of Evans, where the second end is contracted by pulling the traction in order for reducing the profile of the second fixating stent to aid in delivery.
Claim 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty in view of U.S. Patent Publication 2012/0253448 to Hartley and/or U.S. Patent 6,558,396 to Inoue.
As to claim 2, Daugherty discloses the device above but is silent about the traction wire provided at the second end, wherein the second is contracted by pulling the traction wire.
Hartley teaches a similar device (stent, abstract) having a traction wire (42, paragraph 67) provided at a second end of a second fixing stent, wherein the second end is contracted by pulling the traction wire (paragraph 67) for the purpose of constraining an end of a secondary stent for delivery. Using the traction wire of Hartley can help to constrict the second fixing stent of Daugherty during delivery so it will have a smaller profile. Then, releasing the sutures can help to delivery the stent as desired. Inoue also teaches a similar device (collapsible device placed in vessels, abstract) having a traction wire (53, 54, 9) provided at a second end of a second fixing stent (figure 2, 19, 20) wherein the second end is contracted by pulling the traction wire (col. 7, ll. 30-34, col. 8 ll. 43-67, figure 2, 17-20) for the purpose of preparing the stent for delivery. Inoue uses wires to constrict sew together a sleeve like element to constrict the branch portion for delivery. This allows the profile of the device to decrease to aid in delivery. Using a traction wire can help to constrict the second fixing stent of Daugherty in order to aid in delivery. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a traction wire provided at the second end of the second fixation stent of Daugherty, where the second end is contracted by pulling the traction in order for reducing the profile of the second fixating stent to aid in delivery.
As to claim 3, with the device of Daugherty and Hartley/Inoue above, Hartley further teaches when the traction wire is pulled, the second end is contracted to enable the second fixing stent to enter the second lumen through the fistula, when the traction wire is released, the second end is expanded to position the second fixing stent (figure 4-7). The second lumen of Daugherty is configured to be enter the second lumen through the fistula. Hartley teaches to constrict the second end of the second stent so that it can make it easier entering the second lumen.
As to claim 4, with the device of Daugherty and Hartley/Inoue above, Hartley further teaches the traction wire is circumferentially provided at the second end (as seen as the wire 42 looped in figure 8), when the second end is in a contracted state, a free section of the traction wire extends out of the second end and is placed toward the distal end of the first fixing stent (figure 5). The claim is a device claim and would not be able to positively recite a method step. However, Hartley does disclose a free end section of the wire is placed towards the distal end of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty in view of U.S. Patent 5,674,241 to Bley.
As to claim 11, Daugherty discloses the first end is provided with a fistula blocking section (figure 2, 3a) and the second covering film covers the fistula blocking section ( paragraph 51, 52, 63) but is silent about the second end is provided with a flange, a diameter of the flange is greater than a diameter of the fistula blocking section.
Bley teaches a similar device (stent, abstract) having a flange (16, col. 5 ll. 37-43) which is a greater diameter for the purpose of assisting in maintaining the positioning of the structure. The flange of Bley can be used on the second end of Daugherty since it is the free end of the second fixation stent. Further, the flange will have a greater diameter than a section closer to the first end which is designated to be the fistula blocking section. The greater diameter at the second end will help secure the second fixating stent in place. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the second end of Daugherty have a flange which has a greater diameter than the diameter of the fistula blocking section in order for assisting in maintaining the positioning of the structure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty in view of U.S. Patent Publication 2011/0046720 to Shalev.
As to claim 12, Daugherty discloses the first end is provided with a fistula blocking section (figure 2, 3a), but is silent about the second end is provided with a flange, the flange is in the shape of a hollow tube, and a central axis of the flange is parallel to a central axis of the first fixating stent.
Shalev teaches a similar device (lumen body connector) having a second fixating stent (20: figure 3a,b; 106, figure 7a-d) having a second end provided with a flange (104; 164,166), the flange is in the shape of a hollow tube, and a central axis of the flange is parallel to a central axis of a first fixating stent (figure 3a,b, 7b, d,) for the purpose of connecting parallel lumens. Daugherty does disclose that the device can be used in different lumens (paragraph 28, 29). Using a flange on the second fixating with a parallel central axis with the first fixating stent will allow the device to connect parallel lumens. It would have been obvious to one ordinary skill in the art before the effective filing date for the second fixating stent of Daugherty have a flange in the shape of a hollow tube, and a central axis of the flange is parallel to a central axis of the first fixating stent in order for connecting parallel lumens.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty.
As to claim 13, Daugherty discloses the first fixing stent is woven by metal wires, and the second fixing stent is woven by degradable wires or metal wires (paragraph 63, 67). Daugherty discloses the device can be biodegradable, metal, and made of a wire wound stent. If it would not be known that Daugherty can be able to read on the first fixing stent is woven by metal wires, and the second fixing stent is woven by degradable wires or metal wires it would have been obvious to make the device out of any known biocompatible materials (disclosed paragraph 63,67) in order for using a known material and method to manufacture the device as desired.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty in view of U.S. Patent Publication 2018/0116840 to McHugo.
As to claim 14, Daugherty is silent about the delivering device comprising the first handle, boosting tube, middle tube, inner tube, pushing head, second handle, outer tube, and a safety lock.
McHugo teaches a similar device (stent delivery, abstract) having a stent delivering system, comprising: a delivering device comprising: a first handle (proximal end of 126, figure 12, 13a,b), a boosting tube (see annotated figure below) connected to the first handle, a middle tube (see annotated figure below) connected to the boosting tube, an inner tube (122, paragraph 64, the shaft has a lumen, see annotated figure below) connected to the middle tube, a pushing head (141, see annotated figure below) connected to the inner tube; a second handle (167), an outer tube (112, see annotated figure below) connected to the second handle, and a safety lock (the locking mechanism that locks/unlocking the constraining shuttle, paragraph 65) configured to lock or unlock a relative position between the second handle and the boosting tube, wherein the first handle is closer to an operator than the second handle (figure 12a, 13a,b), the booster tube extending through the second handle and being connected to the middle tube (figure 12a, 13a,b), a diameter of the inner tube being less than a diameter of a distal end of the middle tube and a diameter of a proximal end of the pushing head (figure 12a, 13a,b), and the inner tube, the distal end of the middle tube, the proximal end of the pushing head, and the outer tube cooperatively form an accommodation space (130, figure 12a, 13a,b, where the stent will be placed, paragraph 65); and the fistula blocking stent according to claim 1 (of Daugherty, as referenced by stent 128, paragraph 63) provided in the accommodation space, wherein when the safety lock is released and the second handle is operated to retract the outer tube, the fistula blocking stent is released from the accommodation space (paragraph 65) for the purpose of controlling the delivery of the stent to place the stent in the desired position. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a delivery device of McHugo to delivery the stent of Daugherty in order for controlling the delivery of the stent to place the stent in the desired position.
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Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2014/0277347 to Daugherty in view of U.S. Patent Publication 2018/0116840 to McHugo as applied to claim 14 above, and further in view of U.S. Patent Publication 2007/0078506 to McCormick.
As to claim 15, Daugherty as modified by McHugo discloses the system above but is silent about the fistula blocking stent comprises a traction wire circumferentially provided at the second end, when the second end is in a contracted state, a free section of the traction wire extends out of the second end and is placed toward the distal end of the first fixing stent, an outer surface of the outer tube is provided with a positioning mark corresponding to the free section. McHugo does teach wire like elements (244/246) that can be used to deploy the stent.
Hartley teaches a similar device (stent, abstract) having a traction wire (42, paragraph 67, figure 8) circumferentially provided at a second end of a second fixing stent, is circumferentially provided at the second end (as seen as the wire 42 looped in figure 8), when the second end is in a contracted state, a free section of the traction wire extends out of the second end and is placed toward the distal end of the first fixing stent (figure 5, paragraph 67) for the purpose of constraining an end of a secondary stent for delivery. McHugo also teaches that wires can be used with the delivery system and can extend distally with respect to the stent (figure 10a-d, 12). Using the traction wire at the second end can help to deploy the second fixation stent. Hartley/McHugo teaches similar wires that can be circumferentially placed at the second end and have a free end section that extends distally. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a traction wire circumferentially provided at the second end of the second fixation stent of Daugherty, when the second end is in a contracted state, a free section of the traction wire extends out of the second end and is placed toward the distal end of the first fixing stent in order for reducing the profile of the second fixating stent to aid in delivery.
McCormick teaches a similar device (stent delivery, abstract) having an outer surface of the outer tube is provided with a positioning mark (333) corresponding to the free section (paragraph 140) for the purpose of helping to position the device. The radiopaque marker helps to position the device at the desired position in the body since it is located at the distal end of the delivery system. The free section can be a part of the general device or where the stent is located, so the radiopaque marker can correspond to the free section. It would have been obvious to one of ordinary skill in the art before the effective filing date have a outer surface of the outer tube be provided with a positioning mark corresponding to the free section in order for helping to position the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,713,948 to Uflacker, U.S. Patent 5,941,908 to Goldsteen, U.S. Patent 5,980,554 to Lenker, U.S. Patent Publication 2004/0044391 to Porter, U.S. Patent Publication 2007/0078504 to Mialhe, U.S. Patent Publication 2007/0225750 to Ren, U.S. Patent Publication 2007/0282453 to Weitzner, U.S. Patent Publication 2009/0125100 to Mead, U.S. Patent Publication 2010/0049294 to Zukowski, U.S. Patent Publication 2011/0172697 to Jonsson, U.S. Patent Publication 2011/0257723 to McNamara, U.S. Patent Publication 2014/0148888 to Barrand, U.S. Patent Publication 2015/0133925 to Sun, and U.S. Patent Publication 2020/0093622 to Nolan all disclose similar subject matter capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771