DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 06/30/26 have been fully considered but they are not persuasive.
On pages 6-10 regarding prior art rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first deployed state and second deployed state where the first graft material is spaced apart from the tubular body, the first peripheral side nested and collapsed within the first opening when the stent graft is in the first deployed state, the graft material regions (which cover the openings) being spaced from the tubular body and being aligned with the distal ends of the branches in the deployed state must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because item 200 is in the specification but not the figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2, 6-8, 10, 12-17, 20 are objected to because of the following informalities:
Claim 1 is objected to for claiming there are “openings covered with graft material regions” but this is unclear, since openings, by definition, are open. If the openings are covered with graft material, they are cannot be considered openings anymore. It is accordingly unclear how to interpret/reject this claim. If uncorrected/unaddressed, this could potentially become a 112b rejection.
Additionally, the claim is unclear for claiming the stent graft is “branchable” since it is unclear what it means for a stent graft to be “branchable”. It is understood that some stents might be branched (i.e. a branched stent graft), and that a stent might be able to accommodate a branch. However, the Examiner is unclear on, and the specification does not describe what a “branchable” stent graft might entail. It appears to impart the meaning that the stent is able to branch, but since the specification does not describe how the stent might be adjusted or manipulated in order to form a branch, this is unclear.
Additionally, the claim is unclear for claiming “the access regions arranged circumferentially spaced” since this is grammatically incorrect.
The claim is further unclear for claiming “in a deployed state” when it is unclear what has the deployed state (the branchable stent graft, the tubular body, the stents, the access regions, the peripheries, the openings, the graft material regions, something else, etc.).
Claim 2 is objected to for claiming “the distal ends forming the openings” when it is unclear whether or not this is referred to the “distal ends” of the tubular body, or the “distal ends” of the branches.
Claim 6 is objected to for claiming the access regions are fenestrations bounded by the peripheries, when claim 1, from which this claim depends, has defined the access regions as already including peripheries defining openings. It is unclear how the access regions include peripheries which define openings, and also fenestrations bounded by the peripheries. It appears the opening and fenestrations may be related, but the claims are identifying all these elements distinctly, making this unclear.
Claim 7 is objected to for referring to “the contour” with improper antecedent basis.
The claim is further objected to for claiming the access regions are fenestrations bounded by the peripheries, when claim 1, from which this claim depends, has defined the access regions as already including peripheries defining openings. It is unclear how the access regions include peripheries which define openings, and also fenestrations bounded by the peripheries. It appears the opening and fenestrations may be related, but the claims are identifying all these elements distinctly, making this unclear.
Claim 8 is objected to for appearing to positively claim “a first branch artery of a main artery” and “a second branch artery of the main artery”. The positive recitation of a part of the body would be improper under 35 U.S.C. 101 however, and without clarification in the claim, this might be rejected under 35 U.S.C. 101 in the future.
Claim 10 is objected to for the same reasons as claim 1 above with regards to the openings being covered, and with regards to being branchable.
Additionally, the claim is unclear for claiming “the interconnected stent arranged circumferentially spaced” since this is grammatically incorrect.
The claim is further unclear for claiming “in a deployed state” when it is unclear what has the deployed state (the branchable stent graft, the tubular body, the interconnected stent, the access regions, the peripheries, the openings, the graft material regions, something else, etc.).
Claim 12 is objected to for claiming the interconnected stent has a “honeycomb pattern” when it is unclear what exactly a honeycomb pattern is. The Examiner understands a honeycomb to be “a mass of hexagonal wax cells built by honeybees in their nest to contain their brood and stores of honey; something that resembles a honeycomb in structure of appearance, especially: a strong lightweight cellular structure; to cause to be full of cavities like a honeycomb; to make into a checkered pattern” (Merriam-Webster). However, it is unclear what a “honeycomb pattern” might be. For example, it is unclear if this requires a pattern filled with wax, a pattern made by honeybees, a pattern with hexagonal cells, a pattern that “resembles” the mass of hexagonal wax cells built by honeybees (and if so, exactly how similar the pattern must be to be considered to “resemble” that mass), to be full of cavities (nevermind the shape), or to be in a “checkered pattern” (“checkered being defined by Merriam-Webster as “marked by alternating squares of different colors, shades, or materials”), or more than one of those above requirements, or some other specific requirement. The Examiner is unclear exactly on what Applicant believes creates a “honeycomb pattern” and without being able to understand exactly the scope of the term, the Examiner also cannot determined the scope of the claim.
Claim 13 is objected to for claiming “the distal ends forming the openings” when as the Examiner best understands, there is only one distal end referred to in claim 10, and that is the distal end of the tubular body. It is unclear how the tubular body’s distal end forms the openings, when claim 10 has also defined the access regions being “arranged circumferentially spaced around the tubular body”, but also being defined by the distal end of the tubular body. It appears both limitations cannot be met at the same time.
Claim 14 is objected for claiming the access regions are “fenestrations…covered with the graft material regions”, for the same reasons as claim 1 above. It is unclear how something can be a fenestration but also covered at the same time.
Claim 15 is objected to for appearing to positively claim “a first branch artery of a main artery” and “a second branch artery of the main artery”. The positive recitation of a part of the body would be improper under 35 U.S.C. 101 however, and without clarification in the claim, this might be rejected under 35 U.S.C. 101 in the future.
The claim is further unclear for referring to ‘the deployed state” of the main artery multiple times, when claim 10 has defined the deployed state as being (a part of?) the branchable stent graft. While the Examiner is unclear on what the deployed state actually belongs to, it is not understood to be a part of the main artery, since this is not described in claim 10. Clarification is required.
Claim 16 is objected to for the same reasons as claim 1 above with regards to the openings and access regions being covered with graft material regions, and with regards to the stent graft being branchable.
The claim is also objected to for referring to “a branchable stent graft” with improper antecedent basis.
The claim is further objected to for referring to ‘a first graft material region” and “a second graft material region” when it is unclear how, if at all, this relates to the previously claimed “graft material regions”.
Claim 17 is objected to for referring to “the deploying step” with improper antecedent basis.
Claim 18 is unclear for referring to the stent graft being in “the first deployed state”, when claim 16 has identified the stent graft as having “an expanded state”, and claim 17 has defined the graft material region (presumably) as including the “first deployed state”. It is accordingly unclear whether or not the “first deployed state” is intended to actually be referencing the “expanded state” from claim 16, and rather than the first/second deployed states of the graft material region, claim 16 intends to reference two deployed states of the stent graft. If this is the case, it is unclear how the first/second deployed states relate to the previously referenced constrained and expanded states. If they are different, it is unclear how the stent graft is in the “first deployed state” when claim 17, from which this claim depends has defined the “first deployed state” as being a feature of the graft material region and not the stent graft. The Examiner is unclear on how to interpret this claim.
Claim 20 is objected to for referring to “the removing step” with improper antecedent basis.
The claim is further objected to for referring to an “in-situ” fenestration process, when it is believed “in-situ” should be italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 6-11, 13-14, 16-17, 19-20 is/are rejected under 35 U.S.C. 103a as being unpatentable over Hu (CN 112754738 A) in view of Marmur et al. (US 20170273809 A1) hereinafter known as Marmur.
Regarding claim 1 Hu discloses a branchable stent graft (Figure 7 item 10) comprising:
a tubular body (Figure 7 item 32) extending along a longitudinal axis and including proximal and distal ends ((see Figure 2), items 11, 12), and
stents attached to and supporting the tubular body and including first and second stents which circumferentially extend around the tubular body, the stents being spaced apart along the longitudinal axis (Figure 7 shows stents item 31),
wherein the first stent include alternating crests and troughs forming peaks and valleys therebetween (see the zig-zag shapes forming peaks/valleys in stents 31),
and wherein the tubular body includes an access region arranged around the tubular body (Figure 3 item 13), the access region being configured within the peaks/valleys of the first stent (see for example, figure 3 which shows how the region lies between peaks/valleys of at least one stent), and
wherein the access region includes a periphery (see Figures 3, 7 defined by the periphery of item 13) defining an opening covered with graft material regions in a deployed state (see page 1 of the translation, line 5 under the “summary of the invention” “the tube wall of the main tube body is provided with an opening region for providing a branch port, the opening region is made of an elastic soft coating material”, and page 2, line 10-11 “the open hole region is made of a soft cover film material, and the open hole region may not be provided with a hole in advance”),
but is silent with regards to there being more than one access region, the regions being circumferentially spaced around the tubular body.
However, regarding claim 1 Marmur teaches a stent graft (Figure 3a item 120) which extends along a longitudinal axis and includes proximal and distal ends (see at least Figure 6a), wherein the stent graft includes longitudinally spaced stents (Figures 1-6b shows struts 30 of the stents), with a first stent including peaks and troughs (Figure 3a shows the zig-zag formation of the struts 30),
and further teaches a plurality of access regions arranged around the tubular body and configured within the peaks/valleys of the first stent (Figure 3a items 50 and 150), and where the plurality of access regions each include peripheries defining openings (Figure 3a). Hu and Marmur are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent graft of Hu so that there are a plurality of circumferentially spaced access regions as is taught by Marmur in order to allow the stent graft of Hu to be adapted to various geometries of various patients, at various intended deployment locations for the device, thus allowing the flexible formation of the opening to occur at various locations circumferentially as would be required at different arterial locations (see Marmur [0003]).
Regarding claim 2 the Hu Marmur Combination teaches the stent graft of claim 1 substantially as is claimed,
wherein Hu further discloses the access regions include branches having peripheral sides extending from proximal ends of the branches, and the distal ends form openings (see at least Figure 7 which shows the graft material regions 13 after perforation/reaming, which are spaced from the tubular body as they extend upward around branches 21), and
wherein Marmur further teaches the access regions include branches having peripheral sides extending from proximal ends of the branches, and the distal ends form openings (see Figure 3a items 50, 150 which show there being graft material 34 and struts 84/70, 170 forming peripheral sides extending to openings at the distal ends of the branches).
Regarding claim 3 the Hu Marmur Combination teaches the stent graft of claim 2 substantially as is claimed,
wherein Hu further discloses the graft material regions are spaced from the tubular body and are aligned with the distal ends of the branches in the deployed state (see at least Figure 7 which shows the graft material regions after perforation/reaming, which are spaced from the tubular body as they extend upward around branches 21, and align with the branches that form them).
Regarding claim 6 the Hu Marmur Combination teaches the stent graft of claim 1 substantially as is claimed,
wherein the Combination further teaches the separated access regions are fenestrations bounded by the peripheries and covered with the graft material regions (see Marmur for the multiple access regions indicated at items 50, 150 spaced circumferentially from one another, and Hu Figures 3 and 7 which illustrates the form the access regions 13 take in the Combination, which turn into fenestrations for the side branches 20, 21, being covered with the soft cover film material (Hu’s translation, page 2 line 10).), and
at least a portion of the graft material regions are even with the tubular body (Hu Figures 2-3 and 7 show the graft material regions 13 being even with the tubular body).
Regarding claim 7 the Hu Marmur Combination teaches the stent graft of claim 1 substantially as is claimed,
wherein the Combination further teaches the separated access regions are fenestrations bounded by the peripheries and covered with the graft material regions (see Marmur for the multiple access regions indicated at items 50, 150 spaced circumferentially from one another, and Hu Figures 3 and 7 which illustrates the form the access regions 13 take in the Combination, which turn into fenestrations for the side branches 20, 21, being covered with the soft cover film material (Hu’s translation, page 2 line 10).), and
the graft material regions follow the contour of the tubular body (Hu Figures 2-3 and 7 show the graft material regions 13 following the same contour as the tubular body).
Regarding claim 8 the Hu Marmur Combination teaches the stent graft of claim 1 substantially as is claimed,
wherein Hu further teaches a first access region aligning with a first branch artery of a main artery in the deployed state in a first circumferential region of the tubular body (Figure 7 shows a left half of the access region 13 aligning with the leftmost branch of the aortic arch, and the leftmost circumferential region the stent 31 near the leftmost branch 21 occupies; see also Figure 6 showing the stent graft deployed within the main artery (aorta)), and a second access region aligning with a second branch artery of the main artery in the deployed state in a second circumferential region of the tubular body (Figure 7 shows a right half of the access region 13 aligning with the middle branch of the aortic arch, and the middle circumferential region the stent 31 near the middle branch 21 occupies; see also Figure 6 showing the stent graft deployed within the main artery (aorta)),
and wherein the Combination teaches there can be a plurality of access regions spaced circumferentially around the tubular body (Marmur Figure 3a shows two circumferentially spaced access sites 50, 150). The Combination is understood to render it obvious for both the first and second access regions to include two circumferentially spaced first/second regions.
Regarding claim 9 the Hu Marmur Combination teaches the stent graft of claim 8 substantially as is claimed,
wherein the Combination further teaches the first and second circumferential regions are spaced apart (see Hu Figure 7 which shows the leftmost and middle circumferential regions being spaced apart).
Regarding claim 10 Hu discloses a branchable stent graft comprising:
a tubular body (Figure 7 item 32) extending along a longitudinal axis and including proximal and distal ends ((see Figure 2), items 11, 12), and
an interconnected stent (Figure 7 shows how each stent 31 is interconnected to itself around the circumference to form the whole stent) attached to an supporting the tubular body (Figure 7), and forming an access region within the stent arranged around the tubular body (Figures 3, 7 item 13),
wherein the access region includes a periphery (see Figures 3, 7 defined by the periphery of item 13) defining an opening covered with graft material regions in a deployed state (see page 1 of the translation, line 5 under the “summary of the invention” “the tube wall of the main tube body is provided with an opening region for providing a branch port, the opening region is made of an elastic soft coating material”, and page 2, line 10-11 “the open hole region is made of a soft cover film material, and the open hole region may not be provided with a hole in advance”),
but is silent with regard to there being a plurality of separated access regions arranged circumferentially around the tubular body.
However, regarding claim 10 Marmur teaches a stent graft (Figure 3a item 120) which extends along a longitudinal axis and includes proximal and distal ends (see at least Figure 6a),
and further teaches a plurality of access regions arranged around the tubular body and configured within the peaks/valleys of a stent (Figure 3a items 50 and 150 show the access regions within the stent formed from struts 30), and where the plurality of access regions each include peripheries defining openings (Figure 3a). Hu and Marmur are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent graft of Hu so that there are a plurality of circumferentially spaced access regions as is taught by Marmur in order to allow the stent graft of Hu to be adapted to various geometries of various patients, at various intended deployment locations for the device, thus allowing the flexible formation of the opening to occur at various locations circumferentially as would be required at different arterial locations (see Marmur [0003]).
Regarding claim 11 the Hu Marmur Combination teaches the stent graft of claim 10 substantially as is claimed,
wherein Marmur further teaches the access regions include first and second access regions separated by a portion of the stent (Figure 3a shows a portion of the struts 30 of the stent separating the access regions 50, 150).
Regarding claim 13 the Hu Marmur Combination teaches the stent graft of claim 10 substantially as is claimed,
wherein Marmur further teaches the access regions include branches having peripheral sides extending from proximal ends of the branches, and the distal ends form openings (see Figure 3a items 50, 150 which show there being graft material 34 and struts 84/70, 170 forming peripheral sides extending to openings at the distal ends of the branches).
Regarding claim 14 the Hu Marmur Combination teaches the stent graft of claim 10 substantially as is claimed,
wherein the Combination further teaches the separated access regions are fenestrations bounded by the peripheries and covered with the graft material regions (see Marmur for the multiple access regions indicated at items 50, 150 spaced circumferentially from one another, and Hu Figures 3 and 7 which illustrates the form the access regions 13 take in the Combination, which turn into fenestrations for the side branches 20, 21, being covered with the soft cover film material (Hu’s translation, page 2 line 10).).
Regarding claim 16 Hu discloses a method of deploying a branchable stent graft (Figure 7 item 10) in a main artery (Figure 6 shows the stent graft 10 within a main artery (aorta: see the translation, page 1, line 1 under “background of the invention” which describes placement within the “aortic arch”) branching into a branch artery (Figure 6 shows the stent graft branch portions 20, 21 located within the branch arteries; see also page 3, the last paragraph, lines3-4 which describe the branch vessels off the aortic arch), the method comprising:
delivering the branchable stent graft (page 2, lines 4-5), the stent graft including a tubular body extending along a longitudinal axis (Figures 3, 7), and including one or more stents attached to and supported the tubular body (Figure 7 items 31),
wherein the tubular body includes a first access region (Figures 3, 7 item 1) defining a first periphery (see Figures 3, 7 defined by the periphery of item 13) defining a first opening, covered with graft material regions (see page 1 of the translation, line 5 under the “summary of the invention” “the tube wall of the main tube body is provided with an opening region for providing a branch port, the opening region is made of an elastic soft coating material”, and page 2, line 10-11 “the open hole region is made of a soft cover film material, and the open hole region may not be provided with a hole in advance”),
deploying the stent graft at a deployment site within the main artery in an expanded state (see Figures 6-7 which show the stent deployed within the aortic arch in an expanded state),
wherein the first opening of the first periphery of the first access region is covered with a first graft material region in the expanded state of the stent graft (see page 1 of the translation, line 5 under the “summary of the invention” “the tube wall of the main tube body is provided with an opening region for providing a branch port, the opening region is made of an elastic soft coating material”, and page 2, line 10-11 “the open hole region is made of a soft cover film material, and the open hole region may not be provided with a hole in advance”),
at least partially removing the first graft material region from the first access region and the deployment site (page 2 lines 10-12: when the soft cover film material is reamed, it is considered to be removed from the access region and deployment site since it no longer extends to cover the opening), and
extending a branch stent graft through the first opening and into the branch artery (Figure 7; see also page 2 lines 4-6),
but is silent with regards to the branchable stent graft being delivered in a constrained state so the deployment includes transitioning the stent graft from the constrained state to the expanded state,
there being a plurality of separated access regions arranged circumferentially around the tubular body,
the second access region defining a second opening, which is also covered with a second graft material region in the expanded state of the stent graft, and the first access region being closer than the second access region to the branch artery.
However, regarding claim 16 Marmur teaches a stent graft (Figure 3a item 120) which can be delivered in a constrained state so the deployment transitions the stent graft from the constrained state to an expanded state ([0010]), extends along a longitudinal axis and includes proximal and distal ends (see at least Figure 6a),
and further teaches a plurality of access regions arranged around the tubular body and configured within the peaks/valleys of a stent, including a second access region (Figure 3a items 50 and 150 show the first and second access regions within the stent formed from struts 30), and where the plurality of access regions each include first/second peripheries defining first/second openings (Figure 3a).
Hu and Marmur are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Hu so that there are a plurality of circumferentially spaced access regions as is taught by Marmur in order to allow the stent graft of Hu to be adapted to various geometries of various patients, at various intended deployment locations for the device, thus allowing the flexible formation of the opening to occur at various locations circumferentially as would be required at different arterial locations (see Marmur [0003]). Further, it would have been obvious to one of ordinary skill to modify the method of Hu so that the stent graft is deliverable from a compressed state as is taught by Marmur in order to allow both the main stent and side branches to be deliverable via catheter in a trans-femoral access procedure, thus ensuring easy delivery and minimal risk to the patient.
Further, regarding claim 16 the Hu Marmur Combination is understood to teach the second opening of the second periphery of the second access region the be covered with a second graft material region in the expanded state of the stent graft as the claim requires, since Hu is simply modified to include additional access sites (Hu Figures 3, 7 item 13), and the Combination would result in an additional circumferentially spaced access site with the same characteristics of Hu’s first access site 13. The Combination would also result in the first access region being closer than the second access region to the branch artery, since the branch artery is the artery the first access region allows the branch (Hu items 20, 21) access to.
Regarding claim 17 the Hu Marmur Combination teaches the method of claim 16 substantially as is claimed,
wherein Hu further discloses deploying the stent graft includes maintaining the first graft material region even with the tubular body in a first deployed state (see Figures 2-3 and 7 which shows the first graft material of the first access site 13 being even with the tubular body), and moving the first graft material region into a second deployed state where the first graft material region is spaced apart from the tubular body (page 2 lines 10-12 the soft cover film material in its pushed aside/fenestrated configuration, after reaming, is understood to be the second deployed state. See also Figure 7 which shows the overlap of the side branches 21 with the access site material 13 near the connection to the main body 10).
Regarding claim 19 the Hu Marmur Combination teaches the method of claim 17 substantially as is claimed,
wherein the Combination further teaches maintaining the second graft material region within the second access region in the second deployed state (Hu perforates or opens one branch stent at a time, meaning the Combination does not teach touching any second access region when moving the graft material of the first access region).
Regarding claim 20 the Hu Marmur Combination teaches the method of claim 17 substantially as is claimed,
wherein Hu further discloses the partial removal of the first graft material region is performed using an in-situ fenestration process (page 2 lines 11-12).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu and Marmur as is applied above, further in view of Plante (US 6520987 B1).
Regarding claim 12 the Hu Marmur Combination teaches the stent graft of claim 10 substantially as is claimed,
but is silent with regards to the interconnected state having a honeycomb pattern.
However, regarding claim 12 Plante teaches an interconnected stent (Abstract, Figures 1a-c) with a honeycomb pattern (Figures 1a-c). Hu and Plante are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Hu Marmur Combination so the interconnected stent had a honeycomb pattern as is taught by Plante as one known method to limit foreshortening (Plante Column 11 line 54-65).
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu and Marmur as is applied above, further in view of Kaufmann et al. (US 20060195177 A1) hereinafter known as Kaufmann.
Regarding claim 15 the Hu Marmur Combination teaches the stent graft of claim 10 substantially as is claimed,
wherein Hu further teaches a first access region aligning with a first branch artery of a main artery in the deployed state in a first circumferential region of the tubular body (Figure 7 shows a left half of the access region 13 aligning with the leftmost branch of the aortic arch, and the leftmost circumferential region the stent 31 near the leftmost branch 21 occupies; see also Figure 6 showing the stent graft deployed within the main artery (aorta)), and a second access region aligning with a second branch artery of the main artery in the deployed state in a second circumferential region of the tubular body (Figure 7 shows a right half of the access region 13 aligning with the middle branch of the aortic arch, and the middle circumferential region the stent 31 near the middle branch 21 occupies; see also Figure 6 showing the stent graft deployed within the main artery (aorta)),
and wherein the Combination teaches there can be a plurality of access regions spaced circumferentially around the tubular body (Marmur Figure 3a shows two circumferentially spaced access sites 50, 150). The Combination is understood to render it obvious for both the first and second access regions to include two circumferentially spaced first/second regions.
However, the Combination is silent with regard to the interconnected stent spanning both the first and second circumferential regions.
However, regarding claim 15 Kaufmann teaches that stents which span multiple branches (Figure 1 item 18, 19) can comprise an interconnected stent that spans the circumferential regions of both branches (Figures 1-2 item 31). Hu and Kaufmann are involved in the same field of endeavor, namely aortic arch stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent graft of the Hu Marmur Combination so that the stent is interconnected to span the two circumferential regions as is taught by Kaufmann in order to make it possible to omit part of the circumferential surface of the stent in order to ensure blood supply to the branch arteries, while ensuring the stent stays securely fixed within the aortic arch (Kaufmann [0013]).
Claims 4-5, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu and Marmur as is applied above, further in view of Arbefeuille (US 20190269497 A1).
Regarding claim 4 the Hu Marmur Combination teaches the stent graft of claim 1 substantially as is claimed,
wherein Marmur further teaches the access regions include branches having peripheral sides which extend away from the openings when the stent graft is in the deployed state (see Figure 3a items 50, 150 which show there being graft material 34 and struts 84/70, 170 forming peripheral sides extending to openings at the distal ends of the branches),
but is silent with regards to the branches’ peripheral sides being nested and collapsed within the openings with the stent graft is in a delivery state.
However, regarding claim 4 Arbefeuille teaches a stent graft which includes an access region (Figure 2 item 42) with a first periphery side (Figure 2 item 47) nested and collapsed within the first opening (Figure 2). Hu and Arbefeuille are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Hu Marmur Combination so that first access region has a periphery side that nests and collapses within the first opening in the first deployed state as is taught by Arbefueille since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have found it obvious to have the access region’s periphery take on any configuration known in the art.
Regarding claim 5 the Hu Marmur Arbefeuille Combination teaches the stent graft of claim 4 substantially as is claimed,
wherein Arbefeuille further teaches the peripheral sides nested and collapsed within the openings includes a first fold within a second fold (Figure 2 shows at least two folds).
Regarding claim 18 the Hu Marmur Combination teaches the method of claim 17 substantially as is claimed,
but is silent with regards to the first access region having a first periphery side nested and collapsed within the first opening when the stent graft is in the first deployed state.
However, regarding claim 18 Arbefeuille teaches a stent graft which includes an access region (Figure 2 item 42) with a first periphery side (Figure 2 item 47) nested and collapsed within the first opening (Figure 2). Hu and Arbefeuille are involved in the same field of endeavor, namely stent grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Hu Marmur Combination so that first access region has a periphery side that nests and collapses within the first opening in the first deployed state as is taught by Arbefueille since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have found it obvious to have the access region’s periphery take on any configuration known in the art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
Prosecution Insights