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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 04/24/2026. Claims 1-21 are currently pending and being examined.
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 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.
Election/Restrictions
Claims 6, 13, 14, and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. In response to applicant’s argument that “the characterization of, in particular, Species 1 and Species 2 as being comprised of "different material[s]" is not a distinction made in the claims nor are any specific materials required by the specification for these element” even though the species differences are not in the claims currently that does not negate the threat that later in prosecution the differences will not be manifested in the claims.
In response to applicant’s argument that “examination of all the pending claims presents no undue burden on the Examiner” examiner respectfully, but strongly, disagrees. The presence of the different iterations, including innumerable future combinations thereof represent a clear examination burden in both searching and writing of the office action.
Claim Objections
Claim 1 is objected to because of the following abnormalities: Claim 1 recites “a blood flow pathway” in line 9. However, “blood flow pathway” has already been instantiated in line 1. Examiner suggests reciting “the blood flow pathway”. Appropriate correction is required.
Claim 18 is objected to because of the following abnormalities: Claim 18 recites “a patient” in line 3. However, “patient” has already been instantiated in line 3. Examiner suggests reciting “the patient” in line 3. Appropriate correction is required.
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, 2, 4, 8, 9, 15, 17, and 19-21 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garcia (USPAP 2018/0104464).
In reference to independent claim 1, Garcia discloses a vascular access assembly (200, fig 9 & 10) for provide a blood flow pathway between two locations of a vasculature of a patient (shown explicitly in fig 9) comprising:
a bifurcated stent (230, fig 10) comprising a body (portion of 230 inside 80) and an arm (portion of 230 extending out of 80), the body of the bifurcated stent is disposed within a superior vena cava (claim 1 discloses “the expandable stent graft is configured to couple to an artery, vein or arteriovenous graft of a patient such that the artery, the vein, or the arteriovenous graft is in fluid communication with the second tubular conduit”, the superior vena cava is a vein in the human body) of the patient (a patient is shown in fig 9) and
the arm of the bifurcated stent extends out of the superior vena cava external to the vasculature of the patient (fig 10 shows the stent 230 extending out of 80 as claimed, claim 1 discloses that the stent can be placed in a vein, which the superior vena cava is); and a first tubular conduit (210) comprising a peripheral end (end placed into the heart in fig 9), a central end (at 222), and a lumen (pathway in the center), wherein the peripheral end of the first tubular conduit is configured to attached to a vessel of the patient (fig 9 shows the other end inserting thru the superior vena cava which is a vessel of the patient), and wherein the first tubular conduit (210) and the bifurcated stent (230) form a blood flow pathway between the vessel and the superior vena cava of the patient (Fig 9 shows the disclosed device forming a pathway between the superior vena cava and a vessel in the art. Although applicant’s claim 1 specifies the stent is in the vena cava, Garcia discloses that placement can be in any vein, which the superior vena cava is, and fig 9 shows the other end inserting thru the superior vena cava which is a vessel of the patient. Garcia’s device is claimed broadly enough to meet applicant’s broad claims. Furthermore, it has been held that the recitation with respect to the manner in which a claimed apparatus is intended to be employed (which parts of the vasculature the device is used on) does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex part Masham, 2 USPQ2d 1647 (1987). ).
In reference to dependent claim 18, Garcia discloses a method of assembling a vascular access assembly (200, fig 9 & 10) in a patient (shown explicitly in fig 9), comprising: disposing a bifurcated stent (230, fig 10) within a superior vena cava (claim 1 discloses “the expandable stent graft is configured to couple to an artery, vein or arteriovenous graft of a patient such that the artery, the vein, or the arteriovenous graft is in fluid communication with the second tubular conduit”, the superior vena cava is a vein in the human body) of a patient (a patient is shown in fig 9), the bifurcated stent (230) comprising a body (straight section in 80, fig 10) and an arm (branch of 230 that exits 80) that extends away from the body (fig 10 shows the branch extending out of the body); extending the arm of the bifurcated stent out of the superior vena cava so that the arm is external to the superior vena cava (seen in fig 10 the branch extends out of 80, which as stated before can be the superior vena cava); coupling a peripheral end (end of 210) of a first tubular conduit (210) to a vessel of the patient (fig 9 shows the other end inserting thru the superior vena cava which is a vessel of the patient); and creating a flow path from the peripheral end of the first tubular conduit (210) to the arm of the bifurcated stent (branch of 230 that exits 80 connects to 220 and then to 210, fig 10; Fig 9 shows the disclosed device forming a pathway between the superior vena cava and a vessel in the art. Although applicant’s claim 1 specifies the stent is in the vena cava, Garcia discloses that placement can be in any vein, which the superior vena cava is, and fig 9 shows the other end inserting thru the superior vena cava which is a vessel of the patient. Garcia’s device is claimed broadly enough to meet applicant’s broad claims.).
In reference to dependent claim 2, Garcia discloses the vascular access assembly of claim 1, wherein the first tubular conduit (210) is external to the vasculature of the patient (fig 9 shows 210 being external to the vasculature).
In reference to dependent claim 4, Garcia discloses the vascular access assembly of claim 1, wherein the bifurcated stent (230) is an expandable stent (para 0050 discloses “implanted vascular access assembly 200 with an expandable stent graft 230”).
In reference to dependent claim 8, Garcia discloses the vascular access assembly of claim 1, further comprising a second tubular conduit (220) comprising a peripheral end (shown in the superior vena cava in fig 9), a central end (at 222), and a lumen (lumen in the center), wherein the central end (at 222) of the first tubular conduit (210) couples to the peripheral end (at 222) of the second tubular conduit (220) and the central end (end of 220 shown in fig 10) of the second tubular conduit (220) is coupled to a peripheral end of the arm of the bifurcated stent (fig 10 shows the branch attached to the second tubular conduit 220).
In reference to dependent claim 9, Garcia discloses the vascular access assembly of claim 8, wherein the first tubular conduit (210) and the second tubular conduit (220) are external to the vasculature of the patient (fig 9 shows the connection 222 connecting external to the vasculature of the patient).
In reference to dependent claim 15, Garcia discloses the vascular access assembly of claim 8, wherein the first tubular conduit (210) and the second tubular conduit (220) are self-sealing (para 0030 discloses “In some embodiments, both the first tubular conduit and the second tubular conduit are self-sealing.” Examiner takes the position that the self-sealing is a feature which may cross embodiments).
In reference to dependent claim 17, Garcia discloses the vascular access assembly of claim 1, wherein the body comprises a wire frame with an opening in the wire frame at the junction between the body and the arm (stent 230, fig 10 shows a wire frame body with a branch coming off to provide flow to 220, necessitating an opening in the body).
In reference to dependent claim 19, Garcia discloses the method of claim 18, further comprising expanding the body and the arm of the bifurcated stent (claim 10 discloses “the expandable stent graft is a self-expanding stent graft”).
In reference to dependent claim 20, Garcia discloses the method of claim 18, further comprising coupling a peripheral end of the arm of the bifurcated stent (branch of 230, fig 10) to a central end of the first tubular conduit (the branch is coupled to the first tubular conduit 210 thru 220, figs 9 and 10).
In reference to dependent claim 21, Garcia discloses the method of claim 18, further comprising: coupling a central end (at 222) of the first tubular conduit (210) to a peripheral end (at 222) of a second tubular conduit (220); and coupling a central end (end of 220 shown in fig 10) of the second tubular conduit (220) to a peripheral end of the arm of the bifurcated stent (fig 10 shows the branch attached to the second tubular conduit 220).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia (USPAP 2018/0104464).
In reference to dependent claim 10, Garcia discloses the vascular access assembly of claim 8, however
Garcia is silent to the second tubular conduit is reinforced to be resistant to kinking and/or crush forces.
Garcia does disclose the first tubular conduit (210) is reinforced to be resistant to kinking and/or crush forces (para 0025 discloses “In some embodiments, the first tubular conduit 110 is resistant to kinking and/or crush forces. In some embodiments, the first tubular conduit 110 is reinforced with nitinol, such as braided nitinol, which provides resistance to kinking and/or crush forces.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material of the first conduit of Garcia in the second conduit of Garcia to “provide resistance to kinking and/or crush forces” para 0025; Garcia.
In reference to dependent claim 11, Garcia discloses the vascular access assembly of claim 8, however
Garcia is silent to wherein the second tubular conduit is reinforced with a braided nitinol.
Garcia does disclose wherein the first tubular conduit (210) is reinforced with a braided nitinol (para 0025 discloses “In some embodiments, the first tubular conduit 110 is resistant to kinking and/or crush forces. In some embodiments, the first tubular conduit 110 is reinforced with nitinol, such as braided nitinol, which provides resistance to kinking and/or crush forces.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material of the first conduit of Garcia in the second conduit of Garcia to “provide resistance to kinking and/or crush forces” para 0025; Garcia.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia (USPAP 2018/0104464) in view of Gross (USPAP 2006/0217588).
In reference to dependent claim 3, Garcia discloses the vascular access assembly of claim 1, wherein the peripheral end of a tubular conduit (220) is coupled to an artery (80) in an arm of the patient (para 0050 discloses “the vascular access assembly 200 may be used to couple to an artery 80 of the patient 50”), however
Garcia is silent to the peripheral end of the first tubular conduit is coupled to an artery in an arm of the patient by an anastomosis.
Gross, a similar vascular system, teaches the peripheral end of a tubular conduit is coupled to an artery of the patient by an anastomosis (para 0154 discloses “a common conduit, coupled to the first conduit and the second conduit, and adapted to be coupled by anastomosis to a site of an artery of a subject”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the connection method and the connection locations disclosed in Gross with the assembly of Garcia to “allow[[s]] the blood to flow in the blood vessel substantially without harmful restriction” para 0133; Gross.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia (USPAP 2018/0104464) in view of Freitag (USPN 7785360).
In reference to dependent claim 5, Garcia discloses the vascular access assembly of claim 4, wherein at least a peripheral end of the arm of the bifurcated stent (branch coming off of 230 that exits 80, fig 10) connects to the central end of the first tubular conduit (20) and to create a seal between the first tubular conduit (210 connects to 220 and forms a seal therebetween) and the arm of the bifurcated stent (claim 20 discloses “the stent graft, when deployed, forms a fluid-tight seal that diverts essentially all of the blood from the arteriovenous graft to a flow path”), however
Garcia is silent to the stent extending into the end of the conduit.
Freitag, a similar vascular device, teaches a stent (130 / 2, fig 2) extending into the end of the conduit (3, fig 2) and expands to create a seal between the conduit and the stent (para 0041 discloses “the expandable stent graft 130 may be deployed, thereby forming a fluid-tight seal with the arteriovenous graft”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling of Freitag in the assembly of Garcia to “ensure a very good placement of a vascular prosthesis in the body lumen” col 2, lines 9-11; Freitag. To be clear, since both Garcia and Freitag disclose an expanding stent, a tight liquid seal can be formed with the conduit when the stent is inserted into it.
In reference to dependent claim 12, Garcia discloses the vascular access assembly of claim 8, wherein at least the peripheral end of the arm of the bifurcated stent (branch coming off of 230 that exits 80, fig 10) connects to the central end of the second tubular conduit (220) and to create a seal between the second tubular conduit (220) and the arm of the bifurcated stent (claim 20 discloses “the stent graft, when deployed, forms a fluid-tight seal that diverts essentially all of the blood from the arteriovenous graft to a flow path”).
Garcia is silent to the stent extending into the end of the conduit.
Freitag, a similar vascular device, teaches a stent (130 / 2, fig 2) extending into the end of the conduit (3, fig 2) and expands to create a seal between the conduit and the stent (para 0041 discloses “the expandable stent graft 130 may be deployed, thereby forming a fluid-tight seal with the arteriovenous graft”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling of Freitag in the assembly of Garcia to “ensure a very good placement of a vascular prosthesis in the body lumen” col 2, lines 9-11; Freitag. To be clear, since both Garcia and Freitag disclose an expanding stent, a tight liquid seal can be formed with the conduit when the stent is inserted into it.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolf (USPAP 2010/0057096) discloses a branch stent.
Hall (USPAP 2018/0250025) discloses a vascular access assembly.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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