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 .
Claim Objections
Claim 27 is objected to because of the following informalities: the clause “treatment of vessel” in the preamble is poor grammar and incorrect. Appropriate correction is required, possibly with the addition of “a” before the word vessel. Claim 43 is objected to because of the following informalities: the clause “one or more stent” in the preamble is poor grammar and incorrect. Appropriate correction is required, possibly with the addition of “a” added on the word stent.
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: the recitation of “the first stent delivery catheter is configured to be guided by a combination of the first guidewire and the second guidewire by inserting the proximal end of the first guidewire through the distal guidewire port and the proximal end of the second guidewire through the proximal guidewire port” was not found in the written disclosure. Additionally the recitation of “a third stent delivery catheter having a third balloon” was not found in the written disclosure.
Claim Rejections - 35 USC § 112
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 27-48 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.
The term “near” in claims 27, 30, 37, 43, 44 is a relative term which renders the claims indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not evident if the proximal guidewire port located “near” a proximal end of the balloon and the distal guidewire port located “near” a distal end of the balloon means that these recited ports are part of the balloon construction of part of the stent delivery catheter. Since “near” implies no specific distance, the claims are vague or unclear as to where exactly these guidewire ports are intended to be incorporated in or what element actually possesses a guidewire port specifically. In claim 27, it is not understood why or when the “proximal end of the first guidewire” is inserted “through the distal guidewire port” because this makes no sense if the “first guidewire is directed into a first side branch” with its distal end which leads one to understand this guidewire is being advanced distally from the system and this other step of inserting into the guidewire port is in the opposite direction which seems to contradict the ability of the guidewire’s use and arrangement.
In claim 37, it is not understood what is the location meant by the clause “directed into a non-target branch of the at least two side branches” for the inserted guidewire because this makes no sense or seems contradictory.
In claim 43, the step of “inserting the proximal end of the first guidewire through the distal guidewire port and the proximal end of the second guidewire through the proximal guidewire port” is ambiguous because it is not evident if the stent delivery catheter is separate and used distinctly from how the first and second guidewires were delivered into the side branches with separate apparatus.
Dependent claims carry the same issue as the independent.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 27, 30, 37,40 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018/208662) in view of Bourang (WO 2012/109382). Fig. 4A of Chen shows a system for treatment of vessel having a main branch 402 and at least two side branches 404,406, the system comprising: a first guidewire 300 and a second guidewire 302 configured to be guided into the vessel, each guidewire having a distal end and a proximal end, wherein the distal end of the first guidewire is directed into a first side branch and the distal end of the second guidewire is directed into a second side branch. Chen et al. also disclose (page 8, lines 21,22) a first stent delivery catheter having a balloon. It is noted that Chen discloses (page 5, lines 23-28) catheters with lumens for guidewires are used and known. i.e. rapid exchange catheters. Therefore, since Chen discloses a balloon catheter that a guidewire passes through the lumen it inherently has a first guidewire port and a second or distal guidewire port disposed near a distal end of the balloon, upon use of a rapid exchange catheter as Chen states balloon catheters can be used to deploy/expand a stent. However, Chen et al. was not explicitly disclosing a “proximal guidewire port disposed near a proximal end of the balloon” in the system. Bourang teaches (paragraph 16) that catheter systems include guidewire lumens and guidewire ports and the could be located anywhere on a catheter system (paragraph 49). Thus it would have been obvious to one of ordinary skill in the art to provide the proximal guidewire port “near” a proximal end of the balloon per the teaching of Bourang in the system of Chen et al. since finding the optimal dimensions of the system to meet the needs of the patient site and thus selecting the location of a guidewire port only involves routine skill in the art and finding a correct length catheter to treat a site as to where the guidewire enters and exits a guidewire lumen. Please note the recitation of “inserting the proximal end of the first guidewire through the distal guidewire port and the proximal end of the second guidewire through the proximal guidewire port” is an intended use recitation and as best understood the first stent delivery catheter is configured to be guided by a combination of the first guidewire and the second guidewire as seen (Fig. 4A) shows two guidewires used; thus it can be interpreted and as seen in Fig. 5D the proximal end of the first guidewire could be inserted through the distal guidewire port as it would be at the distal end of the stent on the catheter. Fig. 5B shows a first stent 102 having a distal end 106 and a proximal end 104, the first stent configured to be delivered by the first stent delivery catheter; Fig. 4A shows the first guidewire 300 is configured to guide the first stent delivery catheter to the first side branch and the proximal guidewire port is configured to cooperate with the second guidewire 302 to halt advancement of the proximal end of the first stent past an ostium 400 of the first side branch due to the second branch guidewire having equal pull or force to limit the catheter to go further, please note as mentioned above in the 112 rejection and the limitation above in claim 1, that “near” was recited in the claim and the exact proximity to an end is not evident, thus Chen meets the scope of the claim for the proximal guidewire port, in addition with the teaching of Bourang. As mentioned above Chen also discloses (page 8, lines 21,22) the system can be provided such that activation of the balloon deploys the first stent at the ostium of the first side branch. With respect to claim 30, Chen et al. also disclose (page 8, lines 21,22) a second stent delivery catheter having a second balloon. It is noted that Chen discloses (page 5, lines 23-28) catheters with lumens for guidewires are used and known. i.e. rapid exchange catheters. Therefore, since Chen discloses a balloon catheter that a guidewire passes through the lumen it can be said there is a proximal guidewire port disposed near a proximal end of the second balloon, and a distal guidewire port disposed near a distal end of the second balloon. Fig. 4B shows the second stent delivery catheter is configured to be guided by a combination of the first guidewire and the second guidewire 302 by inserting the proximal end of the second guidewire through the distal guidewire port and the proximal end of the first guidewire through the proximal guidewire port; Fig. 5E show a second stent 112 having a distal end 116 and a proximal end 114, the second stent configured to be delivered by the second stent delivery catheter; Fig. 4B show the second guidewire 302 is configured to guide the second stent delivery catheter (discloses rapid exchange catheters for the stent and guidewire) to the second side branch and the proximal guidewire port (note the scope of the limitation of “near” as mentioned above in the 112 rejection the port is not necessarily limited to being at the end but at a distance from the end. It also is noted that since the two guidewires extend in different directions or in some way pull in opposing direction, it can be construed the port is configured to halt advancement of the proximal end of the second stent past an ostium of the second branch. As mentioned above Chen also discloses (page 8, lines 21,22) the system can be provided such that activation of the second balloon deploys the second stent at the ostium of the second branch. Regarding claim 37, as best understood, Chen et al. show (Fig. 5E) a system for delivery of a stent to a vessel having a main branch and at least two side branches, the system comprising: a first guidewire and a second guidewire configured to be guided into the vessel, each guidewire having a distal end and a proximal end, wherein the distal end of the first guidewire is directed into a target branch 406 of the at least two side branches and the distal end of the second guidewire is directed into a non-target branch 404 of the at least two side branches. Note as detailed above, Chen discloses stents can be delivered with a balloon (also note Bourang illustrates such a technique) and a stent delivery catheter having a balloon configured to deploy the stent, which thus the catheters inherently include ports for the guidewires illustrated by Chen and it can understood there is a distal guidewire port having an opening near a distal tip of the balloon, but it was not explicitly evident that Chen suggested a proximal guidewire port disposed near a proximal end of the balloon. Bourang teaches (paragraph 16) that catheter systems include guidewire lumens and guidewire ports and the could be located anywhere on a catheter system (paragraph 49). Thus it would have been obvious to one of ordinary skill in the art to provide the proximal guidewire port “near” a proximal end of the balloon per the teaching of Bourang in the system of Chen et al. since finding the optimal dimensions of the system to meet the needs of the patient site and thus selecting the location of a guidewire port only involves routine skill in the art and finding a correct length catheter to treat a site as to where the guidewire enters and exits a guidewire lumen. Fig. 5E of Chen show the stent delivery catheter configured to be guided by a combination of the first and second guidewires. Please note this is an intended use recitation the proximal end of the first guidewire is inserted through the distal guidewire port and the proximal end of the second guidewire is inserted through the proximal guidewire port and these guidewires are capable of positioning prior to delivery. Further it is also noted the intended use recitation of “as the stent delivery catheter is advanced toward the target branch, a combination of the second guidewire and the guidewire port is configured to halt advancement of a proximal end of the stent past an ostium of the target branch” and it must be noted that (fig. 5E) that the guidewire extending off into a branch provides forces or pull since it is out from a guidewire port along the side to thus halt further advancement in the other direction. As mentioned above Chen also discloses (page 8, lines 21,22) the system can be provided such that activation of the balloon deploys the stent at an ostium of the target branch. With respect to claim 40, Fig. 5F of Chen show a second stent delivery catheter element 304 configured to deliver an additional stent to the non-target branch without re-positioning the first and second guidewires by inserting the proximal end of the second guidewire through the distal guidewire port 306 and inserting the proximal end of the first guidewire through the proximal guidewire port 308 (please note per the modification with Bourang one can place a guidewire port in any location and is an obvious expedient based on where one wants to direct the guidewire).
Claim(s) 28,29,38,39 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018/208662) in view of Bourang (WO 2012/109382) as applied to claims 27,37 above, and further in view of Ischinger (2017/0056626). Chen et al. in view of Bourang is explained supra. However, Chen et al. as modified by Bourang did not disclose the proximal end of the first stent has a slanted edge configured to cover a carina between the at least two side branches and extend into the main branch. It is noted Bourang did suggest (Fig. 7) to alter the proximal end and provide a notch 154a of a first stent or branch stent. Ischinger teaches (Fig. 5) the proximal end 41 of a stent 40 has a slanted edge configured to cover a carina between the at least two side branches and extend into the main branch, see Fig. 13C. It would have been obvious to one of ordinary skill in the art to alternatively provide a stent with its proximal end having a slanted edge configured to cover a carina between the at least two side branches and extend into the main branch as taught by Ischinger in the stent delivery system of Chen et al. as modified with Bourang for bridging accordingly with a second stent into the other branch vessel, see paragraph 57 of Ischinger. Regarding claim 29, Ischinger teaches the recited proximal end of the stent to be provided with a slanted edge as described above for claim 28. It is also noted that the further recitation of a “location of the proximal guidewire port is configured to facilitate orientation of the first stent within the first side branch” is non-narrowing because the independent claim (27) recited “near” the proximal end and the use of the term “location for the guidewire port”, possibly broadens with providing no clarity as to how it performs the function.
Claim(s) 31,33,34,41 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018/208662) in view of Bourang (WO 2012/109382) as applied to claims 30,40 above, and further in view of Wilson et al. (6165195). Chen et al. in view of Bourang is explained supra. It is noted Bourang discloses (Figs. 6G,H) a third stent 152 and balloon 108 can be used in the system to place in main vessel. However, Chen et al. as modified by Bourang did not disclose the third stent having a distal end and a proximal end, such that the third stent is configured to be delivered by a third stent delivery catheter having a third balloon by inserting the proximal ends of each of the first and second guidewires into a distal guidewire port of the third stent delivery catheter and advancing the third stent to abut the proximal ends of each of the first stent and the second stent, wherein activation of the third balloon deploys the third stent in the main branch. Wilson et al. teach (Fig. 26B) treatment of a vessel having a main branch 6 and at least two side branches 5 can be performed using a third stent 78A to abut the proximal ends of each of the first and second stents 78B with the third stent deployed in the main branch 6. Wilson et al. further teach (Fig. 16A) a main vessel or third stent 60 is delivered on a third stent delivery catheter 50 having a balloon 54. Wilson et al. disclose (col. 19, lines 3-5) that activation of the third balloon 54 deploys the third stent in the main branch 6. It would have been obvious to one of ordinary skill in the art to use a third stent for the main branch vessel as taught by Wilson et al. with the system of Chen et al. as modified with Bourang such that it provides the user/surgeon the ability to individually control the expansion of each stent at its location via the use of a balloon for each stent, such as the third balloon taught by Wilson et al. for deploying in the main branch vessel. Regarding claim 33, Chen et al. did not explicitly disclose the distal end of the third stent and the proximal ends of each of the first and second stents overlap. It is noted that Chen et al. disclose (page 7, lines 20-22) that when placing stents together at a bifurcation, one can overlap the ends. Thus, per the modification with Wilson that use two branch stents and a main vessel stent, one can overlap the branch proximal ends with the distal end of the third stent in combining the teachings. Regarding claim 34, Chen et al. did not explicitly disclose the proximal ends of each of the first and second stents are slanted to ensure coverage of the ostium of each of the first and second side branches and overlap with the distal end of the third stent. Wilson et al. teach (Fig. 26B) that in a system to treat a main vessel along with two branch vessels, the system is provided with the proximal ends of each of the first and second stents 78B being slanted to ensure coverage of the ostium of each of the first and second side branches. It is also noted that Chen et al. disclose (page 7, lines 20-22) that when placing stents together at a bifurcation, one can overlap the ends. Thus per the modification of Wilson teaching slanted branch proximal end stents and three stents, one can overlap the branch proximal ends with the distal end of the third stent and additionally noting Bourang teaches the bringing together of stent ends to provide sufficient coverage at the ostium.
Claim(s) 32,42 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018/208662) in view of Bourang (WO 2012/109382) and also in view of Wilson et al. (6165195) as applied to claims 31,41 above, and further in view of MacGregor (4994071). Chen et al. in view of Bourang and Wilson et al. is explained supra. However, Chen et al. as modified by Bourang and Wilson et al. did not explicitly disclose the third balloon has a main body with split distal extensions configured to enter the proximal ends of each of the first and second stents. Macgregor teaches (Fig. 3C) a balloon 70 for bifurcation treatment with a stent 10” which the balloon is constructed with a main body with split distal extensions configured for use with branch stent structure. It would have been obvious to one of ordinary skill in the art to use a balloon with split distal extensions as taught by MacGregor with the system of Chen et al. as modified with Wilson et al. such that the balloon can be placed in the proximal ends of each of the first and second (additional) stents and an equal pressure for expansion of branches would be able to be applied via the balloon.
Claim(s) 35,36 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2018/208662) in view of Bourang (WO 2012/109382) as applied to claim 27 above, and further in view of Levine et al. (2004/0127975). Chen et al. in view of Bourang is explained supra. However, Chen et al. as modified by Bourang did not disclose the first and second guidewires each have a diameter between about 0.007 and 0.038 inch or between about 0.013 and 0.035 inch. Levine et al. teach (paragraph 27) that a guidewire be provided with a diameter between 0.007 and 0.038 inches. It would have been obvious to one of ordinary skill in the art to use a diameter between 0.007 and 0.038 inches as taught by Levine et al. for the guidewires in the system of Chen et al. as modified by Bourang such that the appropriate properties to allow delivery in a flexible system. Further regarding the other range between about 0.013 and 0.035 inch it would have been obvious to one of ordinary skill in the art to optimize and find the suitable diameter since it only involves routine skill in the art and the range falls within the broader range disclosed by Levine.
Allowable Subject Matter
Claim 43 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Dependent claims carry the same issue and need to be clarified.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Amundson et al. (5484449) show (Fig. 17) that a rapid exchange catheter having the balloon 34 includes a lumen 36 for a guidewire 42 which establishes a proximal and distal port for the guidewire..
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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