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 Amendment
This Office action is in response to the applicant’s communication filed 02/11/2026.
Status of the claims:
Claims 1 – 6 and 10 – 25 are pending in the application.
Claims 12 – 20 are withdrawn.
Claims 1,10, 23, 24 and 25 are amended.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 1, 23, and 24 line 3: “an unsupported tubular graft”.
Claim Rejections - 35 USC § 112
Claims 2 – 5, 10, and 11 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 2, the phrase "a self-expanding anchor member with a distal end secured to the proximal end of the tubular main graft portion" renders the claim indefinite because claim 1 requires the tubular main graft portion to comprise an unsupported tubular graft and it is unclear how the tubular graft of the tubular main graft portion can be unsupported and attached to a self-expanding anchor member as the self-expanding anchor member provides support directly to the tubular graft of the tubular main graft portion. In light of Applicant’s specification and figures, the Examiner is interpreting claim 1 to mean that the tubular graft is “partially” unsupported, as Applicant’s specification and figures show the proximal end of the tubular graft being supported by a self-expandable anchor while the distal end is unsupported.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Examiner’s note: Applicant’s disclosure defines “proximal” as towards a patient’s heart and away from an operator, and defines “distal” as a location away from the patient’s heart and towards the operator (Specification paragraph [0048]). Therefore, the Examiner will read the claims such that the terms “proximal” and “distal” are read in the same manner as defined in Applicant’s disclosure.
Claim 1, 6, and 21 – 25 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S. 2015/0119972 A1) (previously cited), in view of Chobotov et al (U.S. 2006/0009833 A1) (previously cited), Farhat et al (US 2014/0277361 A1) (previously cited), Shull et al (US 6,143,022) (previously cited), and Bolduc (US 2003/0100943 A1).
Regarding claim 1, Davis discloses a delivery system (delivery system 5) for treatment of a vascular defect (abstract and paragraphs [0003] and [0070]), comprising:
an endoluminal prosthesis (prosthesis 10) (paragraph [0091] and Fig. 12A/B) for treatment of the vascular defect including:
a tubular main portion (support section 12) comprising a main inner lumen (lumen through support section 12), a proximal end (end closest to the tip of the balloon 32 – shown in Fig. 10A) and a distal end (end furthest from the tip of the balloon 32 – shown in Fig. 10A); and
a delivery catheter (catheter 30/150) (paragraph [0313] and Fig. 15) (Examiner’s note: as recited in paragraph [0312] catheter 150 are used with the prostheses described above, which includes prosthesis 10; therefore, it should be understood that the examiner is referencing the prosthesis 10 with the catheter of Fig. 15. For the sake of simplicity the examiner will designate the catheter as catheter 30/150), comprising:
an elongate shaft (catheter 30/150) including a distal section (section of catheter 152 prior to balloon 154 – shown in Fig. 15) and a proximal section (section of catheter 152 with balloon 154 – shown in Fig. 15), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (Examiner’s note: paragraphs [0300 – 0302] teaches wherein the prosthesis 10 is constrained to the catheter and balloon via constraining means 250c. It would be obvious for the catheter 150 / balloon 154 to also be disposed within and constrain the prosthesis with the constraining means 250c for the purpose of preventing unwanted deployment of the prosthesis), and
an inflatable balloon (balloon 154) secured to the elongate shaft (catheter 30/150) (paragraph [0314] and Fig. 15) and disposed within the main inner lumen of the tubular main portion (support section 12) of the endoluminal prosthesis (Examiner’s note: Figs. 9 – 11 shows wherein the balloon is disposed within the lumen of the support section 12),
wherein the elongate shaft (catheter 30/150) comprises an elongate multi-lumen member (catheter 30/150) extending from the distal section of the elongate shaft to the proximal section of the elongate shaft, the multi-lumen member (catheter 30/150) comprising an inflation lumen (inflation lumen – not shown) for inflation of the inflatable balloon (paragraph [0313]), and
wherein the inflatable balloon (balloon 154) is configured to be inflated and radially expanded so as to radially expand a portion of the main portion (support section 12) of the endoluminal prosthesis (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of performing as claimed; with that said, as stated in paragraphs [0318 – 0319] the balloon 154 (i.e., the inflatable balloon) is utilized for deploying / expanding the prosthesis which includes the main portion. Therefore, balloon 154 (i.e., the inflatable balloon) is configured to be inflated and to radially expand a portion of the prosthesis 10 / the support section 12 (i.e., the main portion)).
However, Davis is silent regarding (i) wherein the tubular main portion comprises a tubular graft.
As to (i), Shull, teaches, in the same field of endeavor, a treatment for vascular defect comprising an endoluminal prosthesis (stent-graft assembly) for treatment of a vascular defect comprising a support section (stent 9; which equates to the support section 12 of Davis) a tubular main graft portion (graft 20) comprising a main inner lumen, a proximal end, a distal end, and having a tubular structure therebetween (abstract, col. 6 lines 23 – 60, and Fig. 2) for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular main portion (i.e., the support section 12) to include a graft, thereby making the tubular main portion a tubular main graft portion, based on the teachings of Shull, for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20 – Shull). It should be understood that Shull makes it obvious to cover the entire support section 12 with the graft.
However, the combination of Davis and Shull is silent regarding (ii) wherein the tubular graft is at least partially unsupported (see 112(b) rejection of claim 2 for the Examiner’s interpretation of the “unsupported” language) and the inflatable configured to directly contact the tubular graft portion.
As to (ii), Bolduc teaches an expandable prosthesis comprising a vascular stent graft comprising a stent (which equates to the stented ‘support section 12’ of Davis) covered by a tubular graft (flexible semi-impermeable barrier; which equates to the graft material of Davis in view of Shull), wherein the stent can extend from the entire length of the graft or only small portions of the tubular graft (i.e., being present at one or two ends or other specific regions within the graft), wherein the individual stents are not directly connected to each other; therefore, Bolduc teaches wherein the tubular graft is partially unsupported (abstract and paragraph [0011]). Additionally, Bolduc teaches, in paragraph [0005], unsupported sections of the graft aid in accommodating changes in the morphology of the native vessel.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular graft supported by the stented support of Davis in view of Shull to have the tubular graft be only partially supported by the stent along the longitudinal length of the tubular graft, based on the teachings of Bolduc, for the purpose of allowing the stent graft / endoprosthesis to better accommodate the changes in morphology of the native vessels while implanted. Additionally, with the modification above, the combination would encompass wherein the inflatable balloon of Davis is configured to / capable of directly contacting the tubular graft portion in the locations where the stent(s) is(are) not located along the length of the tubular graft.
However, the combination of Davis, Shull, and Bolduc is silent regarding (iii) wherein a proximal portion of the tubular main graft portion of the endoluminal prosthesis comprises an inflatable cuff and (iv) the inflatable balloon is axially disposed such that a working length of the inflatable balloon is axially coextensive with the inflatable cuff.
As to (iii), Chobotov teaches, in the same field of endeavor, a delivery system for a prosthesis (abstract, paragraphs [0073 – 0075], and Fig. 1) comprising an endoluminal prosthesis (graft 11), a delivery catheter (inner tubular member 207) comprising an elongate multi-lumen member (inner tubular member 207) comprising an inflation lumen (inflation tube 211 lumen – shown in Fig. 2); and further comprising wherein a proximal portion (distal end 27) of the tubular main graft portion (graft 11) comprises an inflatable cuff (distal inflatable cuff 30), which serves to provide support for the graft, and help seal the graft to the inner wall of the vessel (paragraph [0165]) (Examiner’s note: as stated in paragraph [0162] the structure and materials discussed in paragraph [0165] are similar or the same as those referenced by the Examiner; therefore, the distal inflatable cuff 30 would also provide support for the graft and help seal the graft to the inner wall of the vessel).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the graft of Davis in view of Shull and Bolduc to incorporate the inflatable cuffs and the inflatable tube / inflation lumen of Chobotov, for the purpose of providing support for the graft, and help seal the graft to the inner wall of the vessel (paragraph [0165] - Chobotov). As to (iv), it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of positions for the inflatable cuff on the graft relative to the balloon, the inflatable cuff can either be: proximal, distal, or axially coextensive of the balloon. Therefore, it would have been obvious to one of ordinary skill in the art to modify inflatable cuff to be axially coextensive with the balloon since there are a limited number of possible positions for inflatable cuff on the graft relative to the position of the balloon, and the modified location would have yielded, with a reasonable expectation of success, the inflatable cuffs being able properly seal the graft to the vessel wall as intended.
However, the combination of Davis, Shull, Bolduc, and Chobotov is silent regarding (v) wherein a proximal end of the inflatable balloon is disposed adjacent but distal of the proximal end of the tubular main graft portion.
As to (v), Farhat teaches, in the same field of endeavor, a delivery system (stent delivery system 10) for treatment of a vascular defect (abstract, paragraphs [0003 – 0004], [0065], and Figs. 1 – 16), comprising an endoluminal prosthesis (stent 24) (paragraph [0065] and Figs. 1 – 16) including a tubular main graft portion (stent 24), an elongate shaft (core member 20) including a distal section (section closest the operator not shown) and a proximal section (section shown in Fig. 1), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (paragraphs [0068 – 0071] and Figs. 1), and an inflatable balloon (engagement members 176 and 178) (paragraphs [0052], [0078], and Fig. 3). Furthermore, Farhat teaches, in paragraph [0052], wherein the total axial length of the multiple engagement members can be greater than, less than, or the same as the length of the graft.
There is no evidence of record that establishes that changing the length of the balloon 154 of Davis to be slightly less than the length of main graft portion would result in a difference in function of the balloon 154 of Davis. Further, a person having ordinary skill in the art, being faced with modifying the balloon of Davis, based on the teachings of Farhat, would have a reasonable expectation of success in making the length of the balloon be less than the length of the graft and it appears the balloon would function as intended being given the claimed relative length as the balloon would still be able to inflate the entire length of the graft. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Davis to have a length that is less than the length of the prosthesis as an obvious matter of design choice within the skill of the art.
Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of relative lengths for the balloon relative to the graft, the length of the balloon can be either: greater than, less than, or equal to the length of the graft. It would have been obvious to one of ordinary skill in the art to modify relative length of the balloon to be less than the length of the graft because there are a limited number of possible solutions, and the modified length would have yielded, with a reasonable expectation of success, the balloon being able to properly expand the graft against the vessel wall as intended.
Furthermore, it should be understood that with the balloon 154 being modified to be shorter in length than the stent graft, the proximal end (end closest to the tip of the catheter) will be distal to and adjacent to the proximal end of the stent graft (see annotated Fig. 10A of Davis which shows the modified dimensions of the balloon).
Annotated Figure 10A of Davis
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Regarding claim 6, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc. Additionally, Davis discloses wherein the endoluminal prosthesis (prosthesis 10) further comprises a plurality of radiopaque markers (markers 20 and 24) which are circumferentially disposed adjacent the proximal end of the tubular main graft portion and a proximal end of the inflatable section (see annotated Fig. 10A of Davis) of the inflatable balloon is disposed adjacent but distal of the radiopaque markers (Examiner’s note: as shown in Fig. 9A and annotated Fig. 10A the radiopaque markers are adjacent the proximal end of the main graft portion (i.e., support section 12 with the graft of Shull) and proximal to the inflation section of the balloon).
Regarding claim 21, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc. Additionally, the combination makes obvious wherein the inflatable balloon (balloon 154 - Davis) is disposed within the main inner lumen (lumen of support structure 12 of Davis with the graft of Shull) of the tubular main graft portion of the endoluminal prosthesis in an axial position (Examiner’s note: although the length of the balloon is modified to be shorter than the length of the prosthesis, it would be obvious for the balloon to remain in the tubular main graft portion, as shown in annotated Fig. 10A, for the purpose of being able to expand the tubular main graft portion).
Annotated Figure 10A of Davis
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Regarding claim 22, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc. Additionally, the combination makes obvious wherein a proximal end of an inflatable section (see annotated Fig. 10A) of the inflatable balloon (balloon 154 – Davis) is disposed adjacent the tubular main graft (support structure 12 of Davis with the graft of Shull) (Examiner’s note: as shown in the annotated Fig. 10A of Davis, the proximal end of the inflatable section is adjacent the tubular main graft).
Regarding claim 23, Davis discloses a delivery system (delivery system 5) for treatment of a vascular defect (abstract and paragraphs [0003] and [0070]), comprising:
an endoluminal prosthesis (prosthesis 10) (paragraph [0091] and Fig. 12A/B) for treatment of the vascular defect including:
a tubular main portion (support section 12) (paragraphs [0095 – 0096], [0298 – 0300]) comprising a main inner lumen (lumen through support section 12), a proximal end (end closest to catheter 30 – shown in Fig. 10A) and a distal end (end furthest from catheter 30 – shown in Fig. 10A), said tubular main portion having a tubular structure (support section 12) extending from the proximal end to the distal end in a deployed state (paragraph [0096] - a zig-zag series of struts, connected by a plurality of proximal apexes and a plurality of distal apexes and rolled into a cylindrical configuration, and Fig. 9A/9B,10A/10B), and
a delivery catheter (catheter 30/150) (paragraph [0313] and Fig. 15) (Examiner’s note: as recited in paragraph [0312] catheter 150 are used with the prostheses described above, which includes prosthesis 10; therefore, it should be understood that the examiner is referencing the prosthesis 10 with the catheter of Fig. 15. For the sake of simplicity the examiner will designate the catheter as 30 and 150), comprising:
an elongate shaft (catheter 30/150) including a distal section (section with radiopaque marker 176 – shown in Fig. 15) and a proximal section (section with radiopaque marker 174 – shown in Fig. 15), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (Examiner’s note: paragraphs [0300 – 0302] teaches wherein the prosthesis 10 is constrained to the catheter and balloon via constraining means 250c. It would be obvious for the catheter 150 / balloon 154 to also be disposed within and constrain the prosthesis with the constraining means 250c for the purpose of preventing unwanted deployment of the prosthesis), and
an inflatable balloon (balloon 154) secured to the elongate shaft (catheter 30/150) (paragraph [0314] and Fig. 15) and disposed within the main inner lumen of the tubular main portion (support section 12) of the endoluminal prosthesis (Examiner’s note: Figs. 9 – 11 shows wherein the balloon is disposed within the lumen of the support section 12),
wherein the elongate shaft (catheter 30/150) comprises an inflation lumen (inflation lumen of catheter 150 – not shown, described in paragraph [0313]) extending from a distal section of the elongate shaft to a proximal section of the elongate shaft for inflation of the inflatable balloon (Examiner’s note: as stated in paragraph [0313] the inflation lumen runs from the balloon, along the length of the delivery system, to an inflation source), and
wherein the inflatable balloon (balloon 154) is configured to be inflated and radially expanded so as to radially expand the tubular main portion (support section 12) of the endoluminal prosthesis (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of performing as claimed; with that said, as stated in paragraphs [0318 – 0319] the balloon 154 (i.e., the inflatable balloon) is utilized for deploying / expanding the prosthesis which includes the main portion. Therefore, balloon 154 (i.e., the inflatable balloon) is configured to be inflated and to radially expand at least a portion of the prosthesis 10 / the support section 12 (i.e., the main portion)).
However, Davis is silent regarding (i) wherein the tubular main portion is a tubular graft portion.
As to (i), Shull, teaches, in the same field of endeavor, a treatment for vascular defect comprising an endoluminal prosthesis (stent-graft assembly) for treatment of a vascular defect comprising a support section (stent 9; which equates to the support section 12 of Davis) a tubular main graft portion (graft 20) comprising a main inner lumen, a proximal end, a distal end, and having a tubular structure therebetween (abstract, col. 6 lines 23 – 60, and Fig. 2) for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular main portion (i.e., the support section 12) to include a graft, thereby making the tubular main portion a tubular main graft portion, based on the teachings of Shull, for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20 – Shull). It should be understood that Shull makes it obvious to cover the entire support section 12 with the graft.
However, the combination of Davis and Shull is silent regarding (ii) wherein the tubular graft is at least partially unsupported (see 112(b) rejection of claim 2 for the Examiner’s interpretation of the “unsupported” language) and the inflatable configured to directly contact the tubular graft portion.
As to (ii), Bolduc teaches an expandable prosthesis comprising a vascular stent graft comprising a stent (which equates to the stented ‘support section 12’ of Davis) covered by a tubular graft (flexible semi-impermeable barrier; which equates to the graft material of Davis in view of Shull), wherein the stent can extend from the entire length of the graft or only small portions of the tubular graft (i.e., being present at one or two ends or other specific regions within the graft), wherein the individual stents are not directly connected to each other; therefore, Bolduc teaches wherein the tubular graft is partially unsupported (abstract and paragraph [0011]). Additionally, Bolduc teaches, in paragraph [0005], unsupported sections of the graft aid in accommodating changes in the morphology of the native vessel.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular graft supported by the stented support of Davis in view of Shull to have the tubular graft be only partially supported by the stent along the longitudinal length of the tubular graft, based on the teachings of Bolduc, for the purpose of allowing the stent graft / endoprosthesis to better accommodate the changes in morphology of the native vessels while implanted. Additionally, with the modification above, the combination would encompass wherein the inflatable balloon of Davis is configured to / capable of directly contacting the tubular graft portion in the locations where the stent(s) is(are) not located along the length of the tubular graft.
However, the combination of Davis, Shull, and Bolduc is silent regarding (iii) wherein the delivery catheter further comprises an outer sheath disposed over the elongate shaft configured to removably cover the endoluminal prosthesis in the constrained state.
As to (iii), Chobotov teaches, in the same field of endeavor, a delivery system for a prosthesis (abstract, paragraph [0073], and Fig. 1) comprising an endoluminal prosthesis (graft 11), a delivery catheter (inner tubular member 207) comprising an elongate shaft (inner tubular member 207) and an outer sheath (outer tubular member 53) disposed over the elongate shaft (inner tubular member 207) (paragraph [0120] and Fig. 1) and configured to removably cover the endoluminal prosthesis (graft 11) (paragraphs [0120] and [0128 – 0129], and Figs. 1 and 10). Lastly, as stated in paragraph [0013] the outer sheath (outer tubular member 53) provides a protective layer for the prosthesis as the delivery system maneuvers through the vasculature.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the delivery system of Davis with an outer sheath, as taught by Chobotov, for providing a protective layer for the prosthesis as the delivery system maneuvers through the vasculature.
However, the combination of Davis, Shull, Bolduc, and Chobotov is silent regarding (iv) wherein a proximal end of the inflatable balloon is disposed adjacent but distal of the proximal end of the tubular main graft portion.
As to (iv), Farhat teaches, in the same field of endeavor, a delivery system (stent delivery system 10) for treatment of a vascular defect (abstract, paragraphs [0003 – 0004], [0065], and Figs. 1 – 16), comprising an endoluminal prosthesis (stent 24) (paragraph [0065] and Figs. 1 – 16) including a tubular main graft portion (stent 24), an elongate shaft (core member 20) including a distal section (section closest the operator not shown) and a proximal section (section shown in Fig. 1), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (paragraphs [0068 – 0071] and Figs. 1), and an inflatable balloon (engagement members 176 and 178) (paragraphs [0052], [0078], and Fig. 3). Furthermore, Farhat teaches, in paragraph [0052], wherein the total axial length of the multiple engagement members can be greater than, less than, or the same as the length of the graft.
There is no evidence of record that establishes that changing the length of the balloon 154 of Davis to be slightly less than the length of graft would result in a difference in function of the balloon 154 of Davis. Further, a person having ordinary skill in the art, being faced with modifying the balloon of Davis, based on the teachings of Farhat, would have a reasonable expectation of success in making the length of the balloon be less than the length of the graft and it appears the balloon would function as intended being given the claimed relative length as the balloon would still be able to inflate the entire length of the graft. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Davis to have a length that is less than the length of the prosthesis as an obvious matter of design choice within the skill of the art.
Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of relative lengths for the balloon relative to the graft, the length of the balloon can be either: greater than, less than, or equal to the length of the graft. It would have been obvious to one of ordinary skill in the art to modify relative length of the balloon to be less than the length of the graft since there are a limited number of possible solutions, and the modified length would have yielded, with a reasonable expectation of success, the balloon being able to properly expand the graft against the vessel wall as intended.
Furthermore, it should be understood that with the balloon 154 being modified to be shorter in length than the stent graft, the proximal end (end closest to the tip of the catheter) will be distal to and adjacent to the proximal end of the stent graft (see annotated Fig. 10A of Davis which shows the modified dimensions of the balloon).
Annotated Figure 10A of Davis
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Regarding claim 24, Davis discloses a delivery system (delivery system 5) for treatment of a vascular defect (abstract and paragraphs [0003] and [0070]), comprising:
an endoluminal prosthesis (prosthesis 10) (paragraph [0091] and Fig. 12A/B) for treatment of the vascular defect including:
a tubular main portion (support section 12) (paragraphs [0095 – 0096], [0298 – 0300]) comprising a main inner lumen (lumen through support section 12), a proximal end (end closest to catheter 30 – shown in Fig. 10A) and a distal end (end furthest from catheter 30 – shown in Fig. 10A), said tubular main portion having a tubular structure (support section 12) extending from the proximal end to the distal end in a deployed state (paragraph [0096] - a zig-zag series of struts, connected by a plurality of proximal apexes and a plurality of distal apexes and rolled into a cylindrical configuration, and Fig. 9A/9B,10A/10B), and
a delivery catheter (catheter 30/150) (paragraph [0313] and Fig. 15) (Examiner’s note: as recited in paragraph [0312] catheter 150 is used with the prostheses described above, which includes prosthesis 10; therefore, it should be understood that the Examiner is referencing the prosthesis 10 with the catheter of Fig. 15 shown. For the sake of simplicity the examiner will designate the catheter as 30 and 150), comprising:
an elongate shaft (catheter 30/150) including a distal section (section with radiopaque marker 176 – shown in Fig. 15) and a proximal section (section with radiopaque marker 174 – shown in Fig. 15), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (Examiner’s note: paragraphs [0300 – 0302] teaches wherein the prosthesis 10 is constrained to the catheter and balloon via constraining means 250c. It would be obvious for the catheter 150 / balloon 154 to also be disposed within and constrain the prosthesis with the constraining means 250c for the purpose of preventing unwanted deployment of the prosthesis), and
an inflatable balloon (balloon 154) secured to the elongate shaft (catheter 30/150) (paragraph [0314] and Fig. 15) and disposed within the main inner lumen of the tubular main portion (support section 12) of the endoluminal prosthesis (Examiner’s note: Figs. 9 – 11 shows wherein the balloon is disposed within the lumen of the support section 12; and additionally, paragraphs [0300 – 0302] teaches wherein the prosthesis 10 is constrained to the catheter and a balloon via constraining means 250c),
wherein the elongate shaft (catheter 30/150) comprises an inflation lumen (inflation lumen of catheter 150 – not shown, described in paragraph [0313]) extending from a distal section of the elongate shaft to a proximal section of the elongate shaft for inflation of the inflatable balloon (Examiner’s note: as stated in paragraph [0313] the inflation lumen runs from the balloon, along the length of the delivery system, to an inflation source), and,
wherein the inflatable balloon (balloon 154) is configured to be inflated and radially expanded so as to radially expand the main tubular portion (support section 12) of the endoluminal prosthesis (Examiner’s note: it should be understood that the preceding limitation is functional, which requires only that the structure of the prior art be capable of performing as claimed; with that said, as stated in paragraphs [0318 – 0319] the balloon 154 (i.e., the inflatable balloon) is utilized for deploying / expanding the prosthesis which includes the main tubular portion. Therefore, balloon 154 (i.e., the inflatable balloon) is configured to be inflated and to radially expand at least a portion of the prosthesis 10 / the support section 12 (i.e., the main portion)).
However, Davis is silent regarding (i) wherein the tubular main portion is a tubular main graft portion.
As to (i), Shull, teaches, in the same field of endeavor, a treatment for vascular defect comprising an endoluminal prosthesis (stent-graft assembly) for treatment of a vascular defect comprising a support section (stent 9; which equates to the support section 12 of Davis) a tubular main graft portion (graft 20) comprising a main inner lumen, a proximal end, a distal end, and having a tubular structure therebetween (abstract, col. 6 lines 23 – 60, and Fig. 2) for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular main portion (i.e., the support section 12) to include a graft, thereby making the tubular main portion a tubular main graft portion, based on the teachings of Shull, for the purpose of preventing excessive tissue prolapse or protrusion of tissue growth through the interstices of the stent (col. 2 lines 11 – 20 – Shull). It should be understood that Shull makes it obvious to cover the entire support section 12 with the graft.
However, the combination of Davis and Shull is silent regarding (ii) wherein the tubular graft is at least partially unsupported (see 112(b) rejection of claim 2 for the Examiner’s interpretation of the “unsupported” language) and the inflatable configured to directly contact the tubular graft portion.
As to (ii), Bolduc teaches an expandable prosthesis comprising a vascular stent graft comprising a stent (which equates to the stented ‘support section 12’ of Davis) covered by a tubular graft (flexible semi-impermeable barrier; which equates to the graft material of Davis in view of Shull), wherein the stent can extend from the entire length of the graft or only small portions of the tubular graft (i.e., being present at one or two ends or other specific regions within the graft), wherein the individual stents are not directly connected to each other; therefore, Bolduc teaches wherein the tubular graft is partially unsupported (abstract and paragraph [0011]). Additionally, Bolduc teaches, in paragraph [0005], unsupported sections of the graft aid in accommodating changes in the morphology of the native vessel.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular graft supported by the stented support of Davis in view of Shull to have the tubular graft be only partially supported by the stent along the longitudinal length of the tubular graft, based on the teachings of Bolduc, for the purpose of allowing the stent graft / endoprosthesis to better accommodate the changes in morphology of the native vessels while implanted. Additionally, with the modification above, the combination would encompass wherein the inflatable balloon of Davis is configured to / capable of directly contacting the tubular graft portion in the locations where the stent(s) is(are) not located along the length of the tubular graft.
However, the combination of Davis, Shull, and Bolduc is silent regarding (iii) wherein the endoluminal prosthesis comprises an inflatable portion and wherein the delivery catheter further comprises a fill tube including a fill tube lumen in fluid communication with the inflatable portion of the inflatable endoluminal prosthesis extending axially within the elongate shaft.
As to (iii), Chobotov teaches, in the same field of endeavor, a delivery system for a prosthesis (abstract, paragraphs [0073 – 0075], and Fig. 1) comprising an endoluminal prosthesis (graft 11), a delivery catheter (inner tubular member 207), further comprising wherein a proximal portion (distal end 27) of the tubular main graft portion (graft 11) comprises an inflatable portion (distal inflatable cuff 30), which serves to provide support for the graft, and help seal the graft to the inner wall of the vessel (paragraph [0165]) (Examiner’s note: as stated in paragraph [0162] the structure and materials discussed in paragraph [0165] are similar or the same as those referenced by the Examiner; therefore, the distal inflatable cuff 30 would also provide support for the graft and help seal the graft to the inner wall of the vessel); additionally, Chobotov further comprises a fill tube including a fill tube lumen (inflation tube 211 lumen – shown in Fig. 2) in fluid communication with the inflatable portion (inflatable cuff 30) and extending axially within the elongate shaft (paragraph [0120] and Fig. 1 and 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the graft of Davis to incorporate the inflatable cuffs and the fill tube, as taught by Chobotov, for the purpose of providing support for the graft, and to help seal the graft to the inner wall of the vessel (paragraph [0165] - Chobotov).
However, the combination of Davis, Shull, Bolduc, and Chobotov is silent regarding (iv) wherein a proximal end of the inflatable balloon is disposed adjacent but distal of the proximal end of the tubular main graft portion.
As to (iv), Farhat teaches, in the same field of endeavor, a delivery system (stent delivery system 10) for treatment of a vascular defect (abstract, paragraphs [0003 – 0004], [0065], and Figs. 1 – 16), comprising an endoluminal prosthesis (stent 24) (paragraph [0065] and Figs. 1 – 16) including a tubular main graft portion (stent 24), an elongate shaft (core member 20) including a distal section (section closest the operator not shown) and a proximal section (section shown in Fig. 1), the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state (paragraphs [0068 – 0071] and Figs. 1), and an inflatable balloon (engagement members 176 and 178) (paragraphs [0052], [0078], and Fig. 3). Furthermore, Farhat teaches, in paragraph [0052], wherein the total axial length of the multiple engagement members can be greater than, less than, or the same as the length of the graft.
There is no evidence of record that establishes that changing the length of the balloon 154 of Davis to be slightly less than the length of graft would result in a difference in function of the balloon 154 of Davis. Further, a person having ordinary skill in the art, being faced with modifying the balloon of Davis, based on the teachings of Farhat, would have a reasonable expectation of success in making the length of the balloon be less than the length of the graft and it appears the balloon would function as intended being given the claimed relative length as the balloon would still be able to inflate the entire length of the graft. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Davis to have a length that is less than the length of the prosthesis as an obvious matter of design choice within the skill of the art.
Additionally, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of relative lengths for the balloon relative to the graft, the length of the balloon can be either: greater than, less than, or equal to the length of the graft. Therefore, it would have been obvious to one of ordinary skill in the art to modify relative length of the balloon to be less than the length of the graft since there are a limited number of possible solutions, and the modified length would have yielded, with a reasonable expectation of success, the balloon being able properly expand the graft against the vessel wall as intended.
Furthermore, it should be understood that with the balloon 154 being modified to be shorter in length than the stent graft, the proximal end (end closest to the tip of the catheter) will be distal to and adjacent to the proximal end of the stent graft (see annotated Fig. 10A of Davis which shows the modified dimensions of the balloon).
Annotated Figure 10A of Davis
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Regarding claim 25, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc. Additionally, Davis encompasses wherein the inflatable balloon (balloon 154) is disposed within a non-deployed and constrained state of the endoluminal prosthesis (Examiner’s note: the balloon 154 is used to expand the prosthesis, as discussed in paragraph [0319], and because the prosthesis is inflated by the balloon 154, the balloon 154 must be disposed within endoluminal prosthesis when un-deployed; furthermore, as stated in the rejection of claim 1 above, Davis makes obvious having the prosthesis 10 constrained, via constraining means 250c, to the balloon 154 / catheter 150).
Claims 2 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S. 2015/0119972 A1) (previously cited) in view of Chobotov et al (U.S. 2006/0009833 A1) (previously cited), Farhat et al (US 2014/0277361 A1) (previously cited), Shull et al (US 6,143,022) (previously cited), and Bolduc (US 2003/0100943 A1) as applied to claim 1 above, and further in view of Leonhardt et al (US 2002/0065545 A1).
Regarding claim 2, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc.
However, the combination of Davis, Chobotov, Farhat, Shull, and Bolduc is silent regarding (i) wherein the endoluminal prosthesis comprises a self-expanding anchor member wherein the self-expanding anchor member have a distal end thereof being secured to the proximal end of the tubular main graft and extending proximally from the proximal end of the tubular main graft portion.
As to the above, Leonhardt et al teaches, in the same field of endeavor, a delivery system for treatment of a vascular defect comprising an endoluminal prosthesis (prosthetic device graft 20 with distal spring 48) including a main tubular main graft portion with an inner support structure (graft 20 with distal spring portion 52; which equates to the support structure 12 of Davis with the graft of Shull) and a self-expanding anchor member (proximal spring portion 50 of distal spring 48) having a distal end thereof being secured to the proximal end of the tubular main graft (Examiner’s note: as discussed in paragraph [0059] the anchor spring 48 is made out of Nitinol and is described as a spring, and because Nitinol is a self-expandable material, then the proximal spring portion 50 of anchor spring 48 is a self-expandable anchor; additionally, proximal spring portion 50 of the distal spring anchor 48 is connected to the proximal end of the graft via connecting bar 54) and extending proximally from the proximal end of the tubular main graft portion for the purpose of providing increased posited integrity (paragraphs [0025 – 0026], [0056 – 0059], and Fig. 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the endoluminal prosthesis of Davis in view of Chobotov, Farhat, Shull, and Bolduc to incorporate a distal self-expandable anchor (distal is equal to the claimed proximal), based on the teachings Leonhardt, for the purpose of providing increased posited integrity (paragraph [0059] – Leonhardt).
Regarding claim 3, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc to incorporate the self-expandable anchor member of Leonhardt. Additionally, the combination makes obvious wherein a proximal end of an inflatable section (length of the balloon) of the inflatable balloon (balloon 154 – Davis) is disposed adjacent but distal of the self-expanding anchor member (proximal spring portion 50 of distal spring 48 – Leonhardt) (Examiner’s note: as shown in annotated Fig. 10A of the modified Davis device, the balloon is disposed adjacent / distal to the proximal end of the tubular main graft portion, and because the modified device comprises the self-expandable anchor extending from proximal end, then the modified device would also comprise the self-expandable anchor being disposed adjacent but proximal to the inflatable balloon as claimed). Therefore, the combination encompasses the limitations above.
Annotated Figure 10A of Davis
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Regarding claim 4, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, Bolduc, and Leonhardt. Additionally, Davis discloses wherein the multi-lumen member (catheter 30/150) comprises a guidewire lumen (guidewire lumen – not shown, described in paragraph [0313]).
Regarding claim 5, as discussed above, it would have been obvious to modify the device of Davis in view of Farhat, Shull, Bolduc, and Leonhardt to incorporate the inflatable cuffs and the inflatable tube / inflation lumen of Chobotov. The combination further teaches wherein the multi-lumen member (catheter 30/150 – Davis) comprises a release member lumen (inflation lumen for the inflation tube 211, used to inflate the inflatable cuffs – Chobotov). Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S. 2015/0119972 A1) (previously cited) in view of Chobotov et al (U.S. 2006/0009833 A1) (previously cited), Farhat et al (US 2014/0277361 A1) (previously cited), Shull et al (US 6,143,022) (previously cited), Bolduc (US 2003/0100943 A1), and Leonhardt et al (US 2002/0065545 A1) (previously cited), as applied to claim 2 above, and further in view of Chuter (US 5,562,726) (previously cited).
Regarding claim 10, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc to incorporate the self-expandable anchor member of Leonhardt. Additionally, Leonhardt teaches wherein the self-expanding anchor member (proximal spring portion 50 of distal spring 48 – Leonhardt) comprises a piece of continuous metallic material (paragraph [0059] and Fig. 2 – Leonhardt).
However, the combination of Davis in view of Chobotov, Farhat, Shull, Bolduc, and Leonhardt is silent regarding (i) wherein the self-expandable anchor comprises a monolithic structure formed from a single piece with no joints formed therein.
As to the above, Chuter teaches, in the same field of endeavor, a delivery system for treatment of a vascular defect (abstract) comprising an endoluminal prosthesis (graft 1 with spring assembly 6) including a tubular main graft portion (graft 1; which equates to the tubular support 12 of Davis with the graft of Shull) and a self-expandable anchor (spring assembly 6; which equates to the spring portion 50 of Leonhardt on the device of Davis) (abstract, col. 7 line 61 – col. 8 line 10), wherein the self-expandable anchor (spring assembly 6) comprises a monolithic structure formed from a single piece with no joints formed therein (col. 8 lines 4 – 6).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use a known technique of making a device known to be made in such a way; and forming the self-expandable anchor of Leonhardt (on the device of Davis) via a single monolithic and continuous piece of material (i.e., Nitinol – disclosed by Leonhardt) is well within the ordinary capabilities of one skill in the art. Additionally, the results of the modification would been predictable and resulted in the modified self-expandable anchor being able to operate as intended.
Regarding claim 11, as discussed above, it would be obvious modify the medical device of Davis in view of Chobotov, Farhat, Shull, and Bolduc to incorporate the self-expandable anchor member of Leonhardt.
However, the combination is silent regarding (i) the self-expandable anchor comprising barbs with tissue penetrating tips.
As to the above, Chuter teaches, in the same field of endeavor, a delivery system for treatment of a vascular defect (abstract) comprising an endoluminal prosthesis (graft 1 with spring assembly 6) including a tubular main graft portion (graft 1; which equates to the tubular support 12 of Davis with the graft of Shull) and a self-expandable anchor (spring assembly 6; which equates to the spring portion 50 of Leonhardt on the device of Davis), wherein the self-expandable anchor (spring assembly 6) comprises barbs (barbs 10) with tissue penetrating tips (tips 13) for the purpose of providing a more secure anchor (abstract, col. 7 line 61 – col. 8 line 10, col. 8 lines 37 – 63, and Fig. 2).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Davis in view of Chobotov, Farhat, Shull, Bolduc, and Leonhardt to incorporate barbs, based on the teachings of Chuter, for the purpose of providing a more secure anchor (col. 8 lines 37 – 63 – Chuter).
Response to Arguments
Applicant’s arguments, filed 07/24/2026, with respect to the rejection of claims 1, 23, and 24 under Davis in view of Chobotov, Farhat, and Shull have been considered and are moot as the arguments are based on Applicant’s amendments and the previous rejection has been withdrawn in light of said amendments. Specially, the rejections were withdrawn as Davis in view of Chobotov, Farhat, and Shull does not teach the tubular graft being partially unsupported. However, a new rejection has been set forth above under Davis, Chobotov, Farhat, Shull, and Bolduc; wherein Bolduc is relied upon for teaching limitation above.
Applicant's arguments filed 07/24/2026 with respect to the rejection of claim 2 under Davis in view of Chobotov, Farhat, Shull, Leonhardt have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “As evident, the fronds section extends distally from the distal end. Thus, Davis must also fail to teach "wherein the endoluminal prosthesis comprises a self-expanding anchor member with a distal end thereof being secured to the proximal end of the tubular main graft portion, said self- expanding anchor member, extending proximally from the proximal end of the tubular main graft portion." For at least these reasons, Applicant, respectfully requests withdrawal of the §103 rejections as well.”, the Examiner does not rely on Davis to teach the self-expanding anchor member. As recited in the previous rejection and the rejection herein, the Examiner relies upon Leonhardt for incorporating the self-expanding anchor member into the device of Davis. Therefore, Applicant’s arguments are not persuasive as the combination encompasses the limitations as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/Andrew Restaino/Examiner, Art Unit 3771
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