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 6/23/2025 have been fully considered but they are not persuasive. Applicant argues there is support for the implant sized and dimensioned for deployment in the aortic arch in pars. “[0005], [0007], and [0210]-0[020]”. This is not persuasive because par. 5 only recites “the aorta”, par.7 does not mention the aorta or the aortic arch, par.210 specifically says the “dog that had plates chronically implanted around only one carotid sinus” and does not mention the aorta or aortic arch, and it is unclear to the examiner what “-0[020]” specifically refers to. Applicant further states that it is widely recognized that the baroreceptors of the aorta are located in the aortic arch, thus placement of the implant proximate baroreceptors in the aorta necessarily places the implant within the aortic arch, which has a distinct highly curved morphology. This is not persuasive because the specification never refers to placing the implant within the aortic arch. It is not evident from the reference provided by applicant that baroreceptors are only located within the aortic arch of the aorta and in order for the specification to provide support specifically for the aortic arch, applicant would need to provide evidence that there are only baroreceptors in the aortic arch of the aorta and no other areas of the aorta such as the ascending, descending, and abdominal aorta. For example, US 2013/0178750 discloses there are baroreceptors in the abdominal aorta in par.60. Therefore, applicant has not provided sufficient evidence that the specification as originally filed provides support for the new limitations related to the implant being within the aortic arch.
Regarding the rejection of claim 1 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Case, applicant argues the implant of Case is not suitable for delivery in an aorta. Applicant argues the dimensions in figs.1A-1B of Case show the length is only marginally larger than the diameter and were such a design scaled up to dimensions closer to the relatively large aorta, the implant may flip as the aorta pulsates during the cardiac cycle. This is not persuasive because Case discloses dimensions of the implant that are suitable for implantation in the aorta including the length as claimed in claim 1 and a diameter of 25 mm as previously described in the non-final rejection. Applicant’s argument regarding the implant flipping as the aorta pulsates are not persuasive since Case teaches the same dimensions as the instant application and there is no mention of the implant of the application having issues with flipping.
Applicant further argues the straight orientation of Case would be unsuitable for deploying in the highly curved aortic arch where baroreceptors are located, thus the design in Case would need considerable modification for placement in the aorta. This is not persuasive because the claims do not require any particular curvature and the implant of the instant application also has a straight orientation (see figs.26A-26B which applicant stated provide support for the claim amendments). Therefore, there is no modification of Case needed to be used in the aorta, including the aortic arch, since the structure of Case is the same as the structure claimed.
Applicant further argues the embodiment of fig.2B of Case having an elliptical cross-section is suggested to correspond more closely with non-circular body lumens such that irritation of the vessel lining and strain on the implant is reduced, accordingly Case suggests the implant should be shaped to correspond to the natural shape of the body lumen, not to reshape the body lumen as claimed. This is not persuasive because the rejection is an anticipation rejection based on the structure specifically disclosed by Case. Applicant’s arguments are directed to the intended use of the implant in an aorta, but since the structure of Case is the same as the claimed structure, the examiner maintains the implant of Case is capable of being used as claimed.
Regarding the rejection of claim 11 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case in view of Gross, the amendments to claim 11 specifically referring to the aortic arch overcome the previous rejection since Gross discloses generally implanting the implant in the aorta and does not specifically disclose implanting the implant in the aortic arch. The examiner notes that applicant’s arguments regarding Gross contradict the arguments for support for the new limitations directed to the aortic arch in the instant application. Specifically, applicant argues although Gross makes a single mention of the aorta, the implant appears to be designed specifically for deployment in the carotid artery and despite the single mention of the aorta as a possible implantation site, Gross does not address the significant challenges of deploying an implant in the aorta nor teach a design that appears suitable for implantation within the aortic arch for treatment of hypertension. The examiner notes that the specification of the instant applicant only mentions “aorta” two times (pars.5 and 10) and like Gross also appears to be designed specifically for deployment in the carotid artery. For example, “carotid” is mentioned 158 times in the instant application as opposed to the two times “aorta” is mentioned. Like Gross, the instant application does not address the significant challenges of deploying an implant in the aorta nor teach a design for implantation within the aortic arch. The specification of the instant application never mentions the aortic arch let alone any particular specific design for the curved aortic arch. In other words, it can’t go both ways. Either both Gross and the application disclose an implant designed for implantation in the aortic arch based on the fact that Gross and the instant application disclose implantation near baroreceptors in the aorta, or neither disclose an implant designed for implantation in the aortic arch based on the fact that Gross and the instant application are mostly directed to implantation in the carotid artery, scarcely mention implantation in the aorta, and never mention an aortic arch. It is the examiner’s position that neither Gross nor the instant application specifically disclose a method comprising deploying the stent-like expandable structures in the aortic arch.
Regarding Gross, applicant further argues Gross teaches an implant comprising two rings that appear to be of fixed diameter and which are connected by one or more straight rods which are suited for deployment in the relatively small diameter carotid which is substantially straight. These arguments are not persuasive because Gross shows a changing diameter in figs. 1C and 1D therefore Gross is not limited to a fixed diameter as applicant alleges. Gross is also not limited to the small diameter of the carotid artery since Gross also discloses implantation in the aorta. Applicant argues the embodiment of Gross having straight rods would not be able to accommodate the severe curve of the aortic arch nor accommodate the varying diameter along the aortic arch. This is not persuasive because while Gross shows straight rods, the instant application also only shows straight connector struts, so according to this argument the instant application would not be able to accommodate the severe curve of the aortic arch. Finally, Gross specifically refers to the implant as “a non-circular flexible implant element” in at least par.121. Therefore, the flexible implant of Gross is capable of accommodating the curve of the aortic arch since it is flexible. The examiner further notes that Gross teaches the non-circular elements may comprise a stent in at least pars. 27 and 127.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1, line 9 recites “the stent” which is believed to be in error for --the second stent-like expandable structure--.
Claim 11, line 3 recites “which comprising a first and second stent-like expandable structures” which is believed to be in error for perhaps --which comprises first and second stent-like expandable structures--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-12, and 14-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the application as originally filed does not disclose that the implant is sized and dimensioned for deployment within the aortic arch as recited in lines 20-21 and does not disclose that the implant is configured to accommodate the aortic arch as recited in lines 22-23. The application as originally filed only refers to the aorta in general and is primarily focused on implantation in the carotid artery. There is no discussion in the specification as originally filed of implantation in the aortic arch or any particular design for accommodating the aortic arch. In the arguments applicant explains that the substantially straight struts of the prior art would not be able to accommodate the severe curve of the aortic arch nor accommodate the varying diameter along the aortic arch. None of these design requirements are discussed in the specification which is primarily directed to implantation in a carotid artery and only twice mentions the aorta as a general location for implantation. Therefore, the implant being sized and dimensioned for deployment within the aortic arch as recited in lines 20-21 and the implant being configured to accommodate the aortic arch as recited in lines 22-23 is new matter.
Similarly, claim 11 requires the implant being sized and dimensioned for deployment within an aortic arch in line 9, deploying the stent-like expandable structures in the aortic arch in lines 10, enhancing a response of the baroreceptors within the aortic arch in lines 16-17 and the implant being deployed in the aortic arch in line 20, but these limitations are directed to new matter. As discussed above with respect to claim 1, the specification as originally filed is primarily focused on implantation in the carotid artery and only mentions the aorta twice. The specification does not discuss the implant being sized and dimensioned for deployment within an aortic arch or deploying the stent-like expandable structures in the aortic arch and these limitations are new matter. The only way that the mention of aorta twice within the specification could provide specific support for the aortic arch as claimed would be if applicant could show that baroreceptors are only located within the aorta in the aortic arch as this would mean that baroreceptors in the aorta are necessarily in the aortic arch.
Claim 18 requires a lateral span increases along the length of the implant “to accommodate the shape of the aorta in the aortic arch”. This feature is never discussed in the specification as originally filed. All discussion of the lateral span differences is directed to the carotid artery and the lateral span is not disclosed as being for accommodating the shape of the aorta in the aortic arch. See par.153 of the specification as filed which discloses the greater span being disposed in the common carotid artery and the smaller span being disposed in the internal carotid artery downstream of the bifurcation. The specification does not mention the lateral span as it relates to the shape of the aorta in the aortic arch.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 12, and 14-27 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.
Claim 11, line 4 recites “and connected by a plurality of connector struts”. It is unclear what is connected by a plurality of connector struts. For examination lines 3-4 are interpreted as requiring first and second stent-like expandable structures, the first and second stent-like expandable structures connected to each other by a plurality of connector struts.
Claims 15 and 19 depend from canceled claim 13 which is unclear. For examination each of claims 15 and 19 are assumed to depend from claim 11.
Claim 21, lines 1-2 recite “wherein the first is at a proximal end of the implant and a second stent-like expandable structure is at a distal end of the implant”. It is unclear what “the first” is referring to and it is unclear if “a second stent-like expandable structure” in line 2 is the same as the second stent-like expandable structure of claim 1. As best understood this limitation is interpreted to mean --the first expandable stent-like expandable structure is at a proximal end of the implant and the second stent-like expandable structure is at a distal end of the implant--.
Claim 25, line 2 recites “structures comprises crimping arch has a radius of curvature” which is unclear due to incorrect grammar. Please clarify.
Claim 25 recites the limitation "the respective stent" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 27, line 2 recites “structures comprises crimping arch has a radius of curvature” which is unclear due to incorrect grammar. Please clarify.
Claim 27 recites the limitation "the respective stent" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2, 4-7, 9, 10, and 21-24 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Case et al. US 2007/0038291 (hereafter referred to as Case).
Regarding claim 1, Case discloses an implant for treating hypertension in a patient, the implant comprising: a first stent-like expandable structure 100 (top row of struts in fig.1B) defined by struts such that the first stent-like expandable structure is self-expandable (par.63) from a crimped configuration (fig.1C) to an expanded configuration (fig.1B) where the struts are capable of contacting arterial walls of an aorta of the patient when the first stent-like expandable structure is deployed (the stent of Case is capable of being deployed in the aorta proximate baroreceptors in the aorta at least based on the diameters disclosed by Case in par.60; for example see 25 mm expanded external diameter), wherein the first stent-like expandable structure has a changeable diameter so as to expand against the arterial walls of the aorta when deployed (figs. 1B and 1C show the implant changing from a crimped configuration to an expanded configuration therefore the first stent is capable of changing diameter), a second stent-like expandable structure 200 (bottom row of struts in fig.1B) defined by struts such that the second stent-like expandable structure is self-expandable (par.63) from a crimped configuration to an expanded configuration where the struts are capable of contacting arterial walls of an artery when the second stent-like expandable structure is deployed (the stent of Case is capable of being deployed in the aorta proximate baroreceptors in the aorta at least based on the diameters disclosed by Case in par.60; for example see 25 mm expanded external diameter), wherein the second stent-like expandable structure has a changeable diameter so as to expand against the arterial walls of the aorta when deployed (figs. 1B and 1C show the implant changing from a crimped configuration to an expanded configuration therefore the second stent is capable of changing diameter), wherein each of the first and second stent-like expandable structures in the expanded configuration has an elliptical shape (fig.2B; par.51) so as to reshape the aorta when the implant is deployed therein, at least during diastole (this is directed to an intended use; since Case discloses the structure claimed, it would follow that the stent of Case is capable of being used as claimed), and a plurality of connector struts 300 connecting the first and second stent-like expandable structures and 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 (see the annotated fig.1B below; the implant of Case has the same structure claimed and is therefore capable of being used as claimed), wherein the implant is sized and dimensioned for deployment within the aortic arch proximate baroreceptors in the aorta (the size of the implant, for example 25 mm diameter, means the implant is capable of being deployed within the aortic arch proximate baroreceptors in the aorta), and wherein the implant has a length greater than 50 mm (par.59 discloses “50 mm or higher” and a length of 50.25 mm) and is capable of accommodating the aortic arch. According to MPEP 2114, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). In the instant case, since Case teaches all the structural limitations as claimed by applicant it would follow that the elliptical implant of Case would be capable of performing the recited functions, i.e., contact arterial walls, reshape the artery, and deployment within the aortic arch proximate baroreceptors. Furthermore, one of ordinary skill in the art at the time of the invention could have used the structure of Case in order to achieve this function should they have desired.
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Regarding claim 2, par.59 discloses a length of 50.25 mm which is greater than 50 mm and less than 80 mm.
Regarding claim 4, see figs. 1B and 2A which show all of the non-contact regions extending for less than an entire length of the stent.
Regarding claim 5, see fig.1A for large diamond shaped cells formed by the parallel struts and upper and lower struts as well as small diamond shaped cells formed by struts 110 and adjacent struts.
Regarding claims 6 and 7, see par.63 for Nitinol.
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 Case, which is the same elliptical shape of the implant of the application, the implant of Case is capable of being used as claimed.
Regarding claim 21, see the annotated fig.1B above which shows the first stent-like expandable structure is at a proximal end, the second stent-like expandable structure is at a distal end, the connector structs space apart the first and second stent-like expandable structures.
Regarding claim 22, see the annotated fig.1A below which shows an inter-strut distance between adjacent connector struts being more than 1.5 times an inter-strut distance between adjacent struts of each of the first and second stent-like expandable structures.
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Regarding claim 23, there are at least 2-4 connector struts in the implant of Case. The claim does not limit the implant to having only 2-4 connector struts since the claim says “comprises between 2-4”. The large non-contact regions of Case are capable of allowing portions of the vessel wall in between the connector struts to pulsate freely.
Regarding claim 24, see the first and second stent-like expandable structures 100, 200 of Case which each comprise struts in a meandering design (figs. 1A-1C; par.42 refers to the structures as “undulating” which is considered meandering).
Claim Rejections - 35 USC § 103
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.
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case as applied to claim 1 above, and further in view of Laborde et al. 2008/0046072 (hereafter referred to as Laborde). Case discloses the implant of claim 1 as discussed above, but Case does not disclose a tapered shape of the stent wherein a lateral span 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.
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 Case to be tapered as taught by Laborde in order to be able to use the stent in a location near a bifurcation.
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case as applied to claim 24 above, and further in view of Lauterjung US 5,630,829 (hereafter referred to as Lauterjung; cited in IDS). Case discloses the implant of claim 24 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 arches of the first and second stent-like expandable structures of Case 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.
Claims 11, 12, 14-17, 19, 20, and 26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case in view of Gross US 2008/0033501 (hereafter referred to as Gross; note that Gross was published more than one year prior to the effective filing date of the application) in further view of Kieval et al. US 2005/0251212 (hereafter referred to as Kieval; cited in IDS).
Regarding claim 11, Case discloses the stent of claim 1 which comprises a self-expandable implant comprising first and second stent-like expandable structures which are connected by a plurality of connector struts, the implant having a length greater than 50 mm and an expanded elliptical shape, as discussed above. The implant of Case defines a plurality of non-contact regions defined by the connector struts and the first and second stent-like expandable structures, which are considered empty regions between struts (see Case figs. 1B and 2A). The non-contact regions allow for pulsatility on the walls of the artery since they are free of material. Case further discloses delivering the implant in a crimped configuration through vasculature of the patient and deploying the implant by self-expanding the implant from the crimped configuration to an expanded configuration (par.9). However, Case does not disclose a method comprising delivering the implant to an aorta of the patient, deploying the implant proximate baroreceptors in the aorta, wherein deploying comprises an expanded configuration in which the struts contact 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 implant so as to increase strain in the walls of the aorta to enhance a response of the baroreceptors, and allowing pulsatility of the aorta walls with the plurality of non-contact regions defined by the connector struts and first and second stent-like expandable structures.
Gross teaches a method of treating hypertension in a patient, in the same field of endeavor, the method comprising 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).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the stent of Case in the method taught by Gross including deploying the stent proximate baroreceptors in the aorta and reshaping the aorta walls with the elliptical shape of the stent in order to reduce hypertension of a patient (par.32). While Case in view of Gross discloses the invention substantially as claimed Gross does not specifically state that deploying the implant in the aorta includes deploying the implant in the aortic arch proximate baroreceptors.
Kieval teaches a method of treating hypertension, in the same field of endeavor, wherein the implant is deployed within an aortic arch near a baroreceptor for the purpose of activating baroreceptors to address hypertension (par.14).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to place the implant of Case in view of Gross in the aortic arch as taught by Kieval since Kieval teaches this location is ideal for activating baroreceptors to treat hypertension.
Regarding claim 12, par.59 of Case discloses a length of 50.25 mm which is greater than 50 mm and less than 80 mm.
Regarding claim 14, see Case figs. 1B and 2A which show all of the non-contact regions extending for less than an entire length of the stent.
Regarding claim 15, see Case fig.1A for large diamond shaped cells formed by the parallel struts and upper and lower struts as well as small diamond shaped cells formed by struts 110 and adjacent struts.
Regarding claims 16 and 17, see par.63 of Case for Nitinol.
Regarding claim 19, see fig.1A of Gross and par.26 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 Case in view of Gross in view of Kieval must be expanded against the artery wall so as to not move within the artery and to keep the artery open, the stent of Case in view of Gross in view of Kieval engages the wall such that the set of regions has a least some increased strain during diastole and systole. If the stent of Case in view Gross in view of Kieval 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 Case in view of Gross in view of Kieval, if necessary, to apply increased strain during diastole and systole with the stent in order to ensure the stent maintains its placement within the artery.
Regarding claim 26, see the first and second stent-like expandable structures 100, 200 of Case which each comprise struts in a meandering design (Case figs. 1A-1C; par.42 refers to the structures as “undulating” which is considered meandering).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case in view of Gross in view of Kieval as applied to claim 11 above, and further in view of Laborde. Case in view of Gross in view of Kieval discloses the method of claim 11 as discussed above, but Case in view of Gross in view of Kieval does not disclose a tapered shape of the stent wherein a lateral span 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.
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 Case in view of Gross in view of Kieval to be tapered as taught by Laborde in order to be able to use the stent in a location near a bifurcation.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Case in view of Gross in view of Kieval as applied to claim 11 above, and further in view of Lauterjung US 5,630,829 (hereafter referred to as Lauterjung). Case in view of Gross in view of Kieval discloses 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 arches of the first and second stent-like expandable structures of Case in view of Gross in view of Kieval 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
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.
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 6am-3pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774