DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive. Regarding the rejection of claims 1 and 11 under 35 U.S.C. 103(a) as being unpatentable over Gross in view of Kula, applicant argues Gross discloses an implant intended to forcefully reshape the thick, muscular walls of the aorta into an unnatural elliptical shape to stretch baroreceptors therefore Gross inherently requires a device with substantial rigidity and high radial force (hoop strength), while Kula is directed to the treatment of vulnerable plaque. The examiner does not find such a description in Gross. Gross does not disclose a requirement for high radial force (hoop strength) or what a “high” radial force would entail. In fact, Gross discloses embodiments where the rings are flexible (par.28). Applicant argues Kula explicitly warns that vulnerable plaques are subluminal pools of thrombotic material covered by a delicate thin fibrous cap, and that rupturing this cap causes the release of thrombotic contents leading to adverse cardiac events. Because Kula must gently treat delicate, rupture-prone plaques, Kula expressly engineers its device to lack the very mechanical forces that Gross requires. Kula explicitly teaches that its device "do not need to have the hoop strength and radial resiliency that is required by conventional stents" and that its prostheses "may have or lack such hoop strength and resiliency, and may be of a lighter construction". Applicant argues a person of ordinary skill in the art would not look to a low-force stent designed to gently contact highly delicate, rupture-prone plaques (Kula) to find structural features for a higher force, aorta-deforming implant (Gross) and that if a person of ordinary skill were to apply Kula's "lighter construction" to Gross, the resulting device would completely fail to operate as intended, therefore, Kula actively teaches away from the proposed combination, and modifying Gross with Kula would render the device inoperable for its intended purpose. These arguments are not persuasive because Kula was applied to show the conventional sinusoidal shape of stents that are useful for crimping a stent onto a catheter for delivery and for allowing the implant to self-expand to contact walls of the blood vessel (Kula par. 19 and 32). While Kula discloses the stent does not necessarily need a high hoop strength, Kula is not limited to such a design and also says “Accordingly, endoprostheses of the invention may have or lack such hoop strength and resiliency” (Kula par.19). Therefore, Kula does not teach away from Gross or the invention.
The arguments are further not persuasive because no actual hoop strength is disclosed by either of Gross or Kula, therefore, to argue that they teach away from each other based on hoop strength is an opinion not based on the facts of the prior art. The sinusoidal stent ends of Kula are expanded to contact the walls of the blood vessel (Kula par.19) and must be at least of sufficient strength to anchor against the wall so as not to dislodge. Since Gross requires sufficient strength to function as claimed, it would have been obvious to a person of ordinary skill in the art to maintain that strength upon modifying the ends in view of Kula to include the plurality of struts forming a sinusoidal shape which allow for crimping a stent onto a catheter for delivery and for allowing the implant to self-expand to contact walls of the blood vessel (Kula par. 19 and 32). As discussed in MPEP II C, “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton”. In other words, a person of ordinary skill in the art would not bodily incorporate an embodiment of Kula having “low” hoop strength and resiliency, and instead would understand that the stent ends of Gross are required to function to stretch the baroreceptors. A person of ordinary skill in the art would be capable of both looking to Kula for teaching sinusoidal rings that allow for crimping the stent onto a catheter for delivery and for allowing the stent to self-expand to contact walls of the blood vessel while also maintaining sufficient ring strength to function as desired in Gross. It is commonplace in the art of stents to have rings comprising struts forming a sinusoidal pattern and Kula specifically teaches these types of rings allowing for crimping a stent onto a catheter for delivery and for allowing the stent to self-expand to contact walls of the blood vessel. Therefore, the examiner maintains that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the rings of Gross to have struts as taught by Kula in order to allow for crimping a stent onto a catheter for delivery and for allowing the stent to self-expand to contact walls of the blood vessel.
Applicant further argues Kula teaches away from Gross because Kula specifically designs its struts to contact the vessel wall to "promote endothelialization and remodeling" while Gross uses open rings specifically to "reduce the total surface contact" and "limit fibrosis". Applicant argues if Gross were modified as suggested in the Office Action, the resulting device would actively stimulate endothelialization and tissue encapsulation along the aortic wall. This tissue growth would stiffen the aorta, severely reducing the pulsatility required by the claims and preventing the long- term baroreceptor response Gross aims to achieve. A person of ordinary skill would not combine an implant meant to prevent fibrosis (Gross) with a structure explicitly designed to promote endothelialization (Kula). This is not persuasive because the rejection does not modify Gross to promote endothelialization and remodeling. The structure taught by Kula is not what promotes endothelization and remodeling per se. Rather, Kula discloses contacting the vulnerable plaque with the struts promotes endothelization and remodeling of the luminal surface of the vulnerable plaque region (Kula par.31). Since Gross does not disclose contacting vulnerable plaque, this aspect of Kula is irrelevant to the rejection. Further, Gross states in the same par. 27 relied upon by applicant to argue a reduced contact area to limit fibrosis, “Alternatively, as when the element comprises a stent, the contact surface area is not necessarily minimized, and the one or more rings are used as the non-circular element for a different purpose”. Therefore, it is clear that Gross is not limited to limiting fibrosis. Also, the shapes of the implants of both Gross and Kula having non-contacting regions formed by the connector struts and the end rings, similarly provide a minimal surface area which inherently limits fibrosis as compared to conventional stents having more struts located in the central section. In other words, both Gross and Kula have the same longitudinal struts in the central region. There is no reason that the struts of Kula would promote endothelization and remodeling while the struts of Gross would not when used in the method of Gross. They are the same and will function the same, depending on where they are placed within the body. In conclusion, the rejection does not rely on Kula for teaching promoting endothelization and instead relies on the Kula for teaching structure that allows for crimping a stent onto a catheter for delivery and for allowing the stent to self-expand to contact walls of the blood vessel. Sinusoidal stent rings are commonplace, very well-known in the art, and specifically taught by Kula, and the examiner maintains it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the rings of Gross to have the sinusoidal shape taught by Kula in order to allow for easier crimping of the stent onto a catheter for delivery and to allow the stent to self-expand to contact walls of the blood vessel.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4-7, 9-12, 14-17, 19-24, 26, 28, and 29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross US 2008/0033501 (hereafter referred to as Gross) in view of Kula US 2007/0239262 (hereafter referred to as Kula).
Regarding claim 1, Gross discloses an implant 20 for treating hypertension in a patient (fig. 3; abstract), the implant comprising: a first stent-like expandable structure 22 (fig.3; par.131 discloses an expandable ring) disposed at a first end, where the first structure 22 contacts arterial walls of an aorta of the patient when the stent-like expandable structure is deployed, wherein the first stent-like expandable structure has a changeable diameter so as to expand against the arterial walls of the aorta when deployed (par.127 discloses implantation in an aorta; par.131 discloses an expandable changeable diameter), a second stent-like expandable structure 24 disposed at a second end (fig.3), where the second structure contacts arterial walls of an artery when the second stent-like expandable structure is deployed, wherein the second stent-like expandable structure has a changeable diameter so as to expand against the arterial walls of the aorta when deployed (pars. 127 and 131), wherein each of the first and second stent-like expandable structures in the expanded configuration has an elliptical shape so as to reshape the aorta when the implant is deployed therein, at least during diastole (figs.1A, 1B, 3, and 4A-4B; pars. 25 and 127); a plurality of connector struts 26, 28 connecting the first and second stent-like expandable structures (fig.3), and the plurality of connector struts, the first stent-like expandable structures, and the second stent-like expandable structures defining a plurality of non-contact regions when the implant is deployed to enhance pulsatility of arterial walls of the aorta to maintain long-term baroreceptor response (fig.3 shows open regions that are considered “non-contact regions” that are capable of functioning as claimed), wherein the implant is sized and dimensioned for deployment proximate baroreceptors in the aorta (par.127); and wherein the implant can have a length of at least 50 mm (par.49). Par.49 of Gross states the two rings “are separated from each other by a distance that is between 20 mm and 50 mm”. Par.130 calls D2 a longitudinal separation and says this can be between about 20 mm and 50 mm. Par.130 defines D1 as the width of each ring and says D1 can be between 2 mm and 6 mm, e.g., 4mm. It seems that a maximum total length of the implant would then be 50 mm plus D1 x 2 which would be greater than 50 mm as claimed. Even if Gross does not specifically disclose the length is greater than 50 mm, it would have been obvious to a person of ordinary skill in the art at the time of the invention to select a length of greater than 50 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). Gross discloses the invention substantially as claimed, but Gross does not disclose that the first stent-like expandable structure is defined by first struts such that the first stent-like expandable structure is self-expandable from a crimped configuration to an expanded configuration, that the second stent-like expandable structure is defined by second struts such that the second stent-like expandable structure is self-expandable from a crimped configuration to an expanded configuration, or wherein each of the first and second struts are distributed and extend around an entire circumference of the implant at the first end and second end respectively such that the plurality of connector struts directly connect an inner end of the first struts to an inner end of the second struts at apexes of the first and second struts.
Kula teaches a stent, in the same field of endeavor, wherein a first stent-like expandable structure 110 (figs. 1 and 4) is defined by first struts such that the first stent-like expandable structure is self-expandable from a crimped configuration to an expanded configuration (par.32 discloses the stent may be crimped and self-expandable), a second stent-like expandable structure 111 (figs. 1 and 4) is defined by second struts such that the second stent-like expandable structure is self-expandable from a crimped configuration to an expanded configuration (par.32), and wherein each of the first and second struts are distributed and extend around an entire circumference of the stent at a first end and second end respectively such that a plurality of connector struts 140 directly connect an inner end of the first struts to an inner end of the second struts at apexes of the first and second struts (figs. 1 and 4; par.20) for the purpose of allowing the implant to be crimped onto a catheter for delivery and for allowing the implant to self-expand to contact walls of the blood vessel (par. 19 and 32).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify implant of Gross to have the self-expanding sinusoidal end structures comprising struts and connector struts connected to inner apexes of the end structures as taught by Kula, in order to allow for the implant to more easily be crimped and deployed at the desired location.
Regarding claim 2, as discussed above with respect to claim 1, it appears Gross discloses a maximum length of 62 mm (e.g., D1=6 mm and D2=50 mm) in par.130. Even if Gross did not specifically disclose a length between 50 mm and 80 mm, it would have been it would have been obvious to a person of ordinary skill in the art at the time of the invention to select a length in the claimed range since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 4, see figs. 1 and 4 of Kula and fig.3 of Gross which show the non-contact regions extending for less than an entire continuous length of the implant. The stent-like structures at the ends preclude any non-contact region from extending for the entire length.
Regarding claim 5, see Kula fig.4 for diamond shaped non-contact regions located between the struts of the end structures and the connector struts.
Regarding claims 6 and 7, see Kula par.37 which discloses Nitinol, which is a conventional shape-memory metal for use in stents.
Regarding claims 9 and 10, the claims are directed to an intended use of the implant. Due to the shape of the implant disclosed by Gross in view of Kula, which is the same elliptical shape of the implant of the application, the implant of Gross in view of Kula is capable of being used as claimed.
Regarding claim 11, see the rejection of claim 1 above for the implant as claimed in claim 11. Gross further discloses the method steps of delivering the stent to an aorta of the patient (par.127 discloses an aorta), deploying the stent proximate baroreceptors in the aorta (par.127), wherein deploying comprises an expanded configuration in which the stent contacts the walls of the aorta, and reshaping, at least during diastole, the aorta walls of the aorta proximate the baroreceptors by an elliptical shape of the deployed stent so as to increase strain in the walls of the aorta to enhance a response of the baroreceptors (pars.25 and 127; fig.1A). The implant of Gross in view of Kula implanted in the aorta as disclosed by Gross results in allowing pulsatility of the aorta walls due to the non-contact regions to maintain long-term responsiveness of the baroreceptors in the aorta.
Regarding claim 12, as discussed above with respect to claim 1, it appears Gross discloses a maximum length of 62 mm (e.g., D1=6 mm and D2=50 mm) in par.130. Even if Gross did not specifically disclose a length between 50 mm and 80 mm, it would have been it would have been obvious to a person of ordinary skill in the art at the time of the invention to select a length in the claimed range since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 14, see figs. 1 and 4 of Kula and fig.3 of Gross which show the non-contact regions extending for less than an entire continuous length of the implant. The stent-like structures at the ends preclude any non-contact region from extending for the entire length.
Regarding claim 15, see Kula fig.4 for diamond shaped non-contact regions located between the struts of the end structures and the connector struts.
Regarding claims 16 and 17, see Kula par.37 which discloses Nitinol, which is a conventional shape-memory metal for use in stents.
Regarding claim 19, see fig.1A and par.26 of Gross which discloses a more elliptical shape during diastole which functions as claimed.
Regarding claim 20, the stent of Gross in figs. 1A and 1B is rigid, therefore the stent maintains its shape during both diastole and systole. Gross specifically teaches an elliptical shape of the stent and artery in diastole, and this elliptical shape inherently increases strain in the reduced curvature/flattened regions. Gross does not specifically disclose that the stent is configured such that the regions have increased strain during diastole and systole. However, since the stent of Gross in view of Kula must be expanded against the artery wall so as to not move within the artery and to keep the artery open, the stent of Gross in view of Kula engages the wall such that the set of regions has a least some increased strain during diastole and systole. If the stent of Gross in view of Kula did not press against the artery wall during both diastole and systole, the stent could be dislodged from its intended location. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Gross in view of Kula, if necessary, to apply increased strain during diastole and systole with the stent in order to ensure the stent maintains its placement within the aorta.
Regarding claims 21 and 22, see Kula figs.1 and 4. The distance between connector struts is more than 1.5 times an inter-strut distance between adjacent struts of each of the first and second stent-like expandable structures at least for the inter-strut distance close to the terminal ends of the implant.
Regarding claim 23, Kula shows five connector struts in figs. 1 and 4, which includes at least between 2-4 connector struts. Claim 23 says “comprises between 2-4” which means there can be additional struts. Further, Kula discloses there can be less struts in par.23. Additionally, Gross discloses two or more rods/connectors or three or more rods/connectors (par.130).
Regarding claims 24 and 26, see the meandering or zig-zag design of the first and second stent-like expandable structures 110, 111 of Kula figs. 1 and 4.
Regarding claims 28 and 29, see Kula figs. 1-4 which show ends of adjacent connector struts aligned along a corresponding circumference of the implant for each end.
Claims 8 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross in view of Kula as applied to claims 1 and 11 above, and further in view of Laborde et al. US 2008/0046072 (hereafter referred to as Laborde). Gross in view of Kula discloses the implant of claim 1 and the method of claim 11 as discussed above, but Gross in view of Kula does not disclose a tapered shape of the implant wherein a lateral span increases along the length of the implant such that the lateral span at a first end is greater than the lateral span at the second end.
Laborde teaches a stent, in the same field of endeavor, wherein the stent may be tapered such that the stent has a lateral span that increases along the length of the stent such that the lateral span at a first end is greater than the lateral span at the second end (figs.23C and 24A) for the purpose of accommodating a particular bifurcation into which the stent is to be deployed par.176.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the stent of Gross in view of Kula to be tapered as taught by Laborde in order to be able to use the stent in a location near a bifurcation.
Claims 25 and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gross in view of Kula as applied to claims 11 and 24 above, and further in view of Lauterjung US 5,630,829 (hereafter referred to as Lauterjung). Gross in view of Kula discloses the implant of claim 24 and the method of claim 11 as discussed above but does not disclose that each of the first and second stent-like expandable structures comprises a crimping arch that has a radius of curvature that is less than 6 mm.
Lauterjung teaches a stent, in the same field of endeavor wherein the stent comprises crimping arches 16 or 18 having a radius of curvature of 0.4 mm (col.7, Il.1- 5 discloses the pin diameter is 0.8 mm therefore the radius of curvature of the bend is 0.4 mm) for the purpose of providing sufficient strength to the device for providing long term radial support (col.2, II.12- 35) as well as allowing for the device to be fully collapsed without plastic deformation such that the device returns substantially to its original shape upon deployment (col.6, II.18-29).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first and second stent-like expandable structures of Gross in view of Kula to include crimping arches having a radius of curvature of 0.4 mm as taught by Lauterjung in order to provide improved long term strength as well as allow for improved delivery in a collapsed position that returns the device to its original configuration upon deployment. The crimping arches taught by Lauterjung facilitate crimping of the first and second stent-like expandable structures about the crimping arch.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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