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 Amendment
In response to the amendment filed on 03/26/2026, Claims 1-21 and 34-36 have been cancelled, and Claims 22-33 and 37-40 are pending.
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive.
Applicant argues, on Page 5, that the combination of references fails to disclose the that the plurality of elongate filaments comprise a shape memory metal and thus it would not have been obvious to modify the device of Sepetka to be a thermoplastic, however the Examiner respectfully disagrees.
The Examiner notes that Sepetka teaches that the elongate filaments comprise a shape memory metal. Paragraph 0010 of Sepetka discloses nitinol as a material for the expandable structure formed of filaments but also see Paragraphs 0139 and 0159 for more evidence. Sepetka also teaches delivering energy to the expandable device itself to generate heat (see Paragraph 0009). Paragraph 0012 clearly states “In a particularly advantageous embodiment of the invention, the expandable structure itself is used to transmit energy to heat the aneurysmal wall which causes the aneurysmal wall to fuse to the expandable structure, thereby reinforcing the aneurysmal wall and preventing migration of the expandable structure into the parental vessel.”
Roth is now being relied upon to teach that heating an expandable structure is known to make the structure softer after heating (in the claimed second energy state). While Applicant is correct in that Roth does focus on polymeric stents, Roth clearly states in Paragraph 0009 “As can also be appreciated, the present invention with make particular reference to polymeric stents and/or stents that include a polymeric coating; however, it will be appreciated that the present invention can be used with non-polymeric stents (e.g., metal stents, etc.) and/or stents that do not include a polymeric coating.” Since Sepetka teaches a metal stent (nitinol), it would have been obvious to one of ordinary skill in the art to look towards Roth for the teachings that heating up a expandable structure for the purpose of softening the material to better matching the contour of the anatomy in which the expandable structure is deployed (Paragraph 0010).
Alternatively, see Paragraph 0010 which also states that the device can be a polymeric coated stent in which the polymer coats a metallic stent. A polymeric coated nitinol stent would also read on the claims as currently recited.
For the reasons stated above, it is the Examiner’s position that the rejection of Sepetka and Roth be maintained, although, with a different motivational statement in view of the claim amendments.
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 22-24, 26-28, 30, 31, 37 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sepetka (US PGPub 2002/0169473) in view of Roth (US PGPub 2010/0036473).
Regarding Claim 22, Sepetka teaches a method of treating a cerebral aneurysm within a cerebral vasculature of a patient (Paragraph 0002, 0108) comprising the steps of:
advancing an implant (4) in a microcatheter to a region of interest in the cerebral vasculature (Paragraph 0108; Figure 1), wherein the implant (4) comprises:
a permeable shell (mesh; Figure 34 as described in Paragraph 0115) including a radially constrained elongated state (Figure 2; Paragraph 0115) configured for delivery within a catheter lumen (8; Paragraph 0108), an expanded state (Figure 5, Figures 30-31; Figure 34; Paragraph 0115) with a longitudinally shortened configuration relative to the radially constrained state (as best seen in Figures 30-31; Paragraph 0139), and a plurality of elongate filaments that are woven together to form a mesh (42; Figure 1; Paragraph 0115) (Figures 30-34; Paragraph 0139-0140), the expanded state having a proximal portion and a distal portion (Figure 6 in which the proximal portion is closest to tool 10) (Figures 30-31; where the proximal end is closest to tool 162)(as seen in Figure 34), wherein the plurality of elongate filaments comprise a shape memory metal (Paragraph 0010 discloses nitinol and also see Paragraphs 0139 and 0159), wherein each of the plurality of filaments has a proximal end and a distal end (Figure 6)(Figure 30)(Figure 34), and wherein the proximal ends of each of the plurality of filaments are gathered by a proximal hub (Paragraph 0140; Figure 34)(See also Figure 30-31) (see also Paragraph 0116; Figure 3);
deploying the implant (4) within the cerebral aneurysm, wherein the permeable shell expands to the expanded state in the interior cavity of the aneurysm (Paragraph 0109; as seen in Figures 5, 12, 14);
delivering energy (from energy source 12) to the deployed implant (4; Paragraph 0108, 0125, and 0131), wherein the implant has a first state (unheated) before the energy is delivered and a second state after the energy is delivered (heated) (Paragraph 0131-0133); and
withdrawing the microcatheter from the region of interest after deploying the implant (Paragraph 0119; see Figures 6-7).
Sepetka fails to explicitly teach:
wherein the implant has a first state before the energy is delivered and a second state after the energy is delivered, wherein the second state is softer than the first state.
Roth teaches an implant (see Paragraph 0009 which states “the present invention with make particular reference to polymeric stents and/or stents that include a polymeric coating; however, it will be appreciated that the present invention can be used with non-polymeric stents (e.g., metal stents, etc.) and/or stents that do not include a polymeric coating) , the implant is configured to be heated (abstract), and thus has a first state before the energy (heat) is delivered, and a second state after the energy (heat) is delivered, wherein the second state is softer for than the first state such that the polymeric implant can be expanded without fracturing and such that the polymeric implant can be softened and moldable to the patients anatomy (Paragraph 0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Sepetka, to include heating the implant to a second softer state, taught by Roth, for the advantage increasing “the ability to better match the contour and diameter of the body passageway when the stent is expanded in the body passageway.” (Paragraph 0010; Roth).
Regarding Claim 23, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is light energy (Paragraph 0111 states a laser which is light energy).
Regarding Claim 24, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is thermal energy (Paragraph 0111).
Regarding Claim 26, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is electromagnetic energy (Paragraph 0111 where RF and microwave are each a type of electromagnetic energy).
Regarding Claim 27, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is radio frequency energy (Paragraph 0111).
Regarding Claim 28, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is heat energy (Paragraph 0111).
Regarding Claim 30, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the implant (4) is advanced to the region of interest in the cerebral vasculature using a delivery system (2; Figure 1; Paragraph 0108), wherein the energy is delivered through the delivery system (2; Paragraph 0108-01113; the examiner notes that the guidewire in Figure 1).
Regarding Claim 31, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the energy is delivered via a separate elongate instrument (84; Figures 16-20; Paragraphs 0130-131) (see also Figures 39-40; Paragraph 0143-144).
Regarding Claim 37, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the implant (4) transfers heat to the region of interest when energy is delivered (Paragraph 0009, 0111).
Regarding Claim 40, the combination of references disclosed above teaches the method of claim 22, wherein Sepetka teaches the distal ends of each of the plurality of filaments are gathered by a distal hub (Paragraph 0140; Figure 34)(See also Figure 30-31) (see also Paragraph 0116; Figure 3).
Claim 25, 29, 32, 33, 38 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sepetka (US PGPub 2002/0169473) and Roth (US PGPub 2010/0036473) as applied to claim 22 above, and further in view of Shaolian (US PGPub 2006/0206140).
Regarding Claim 25 and 29, the combination of references disclosed above teaches the method of claim 22, but fails to disclose wherein the energy is vibrational energy (Claim 25) or ultrasonic energy (Claim 29).
Shaolian teaches an adjustable embolic aneurysm implant which can be adjusted by applying energy to the implant for the purpose of providing optimal filling of the aneurysm by the implant (abstract), wherein the energy delivered to the implant is vibrational energy or ultrasonic energy (Paragraph 0045 states that the energy delivered to the implant can be ultrasonic energy which is also a type of vibrational energy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Sepetka, such that the energy source was ultrasonic/vibrational and that the implant responds to this energy source, as taught by Shaolin, for the advantage that the size and shape of the embolic implant can be adjusted postoperatively to compensate for changes in the volume occupied by the coil within the aneurysm (paragraph 0044) and it is the Examiner' s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the type of energy taught by Sepetka with the types of energy as taught by Shaolin since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the energy sources taught by Shaolin would be sufficient to provide heat to the implant disclosed by Sepetka.
Regarding Claim 32-33, the combination of references disclosed above teaches the method of claim 22, but fails to disclose wherein a mechanical characteristic (Claim 32) or a structural characteristic (Claim 33) of the implant changes after the energy is delivered.
Shaolian teaches an adjustable embolic aneurysm implant which can be adjusted by applying energy to the implant for the purpose of providing optimal filling of the aneurysm by the implant (abstract), wherein a mechanical characteristic (Paragraph 0062-0063 states that when the implant reaches its activation temperature, it reaches the austenite phase which is more rigid than the martensite phase) or a structural characteristic (Paragraph 0063 discloses that the shape changes after energy is applied) of the implant changes after the energy is delivered.
It would have been obvious to one of ordinary skill in the art to modify the teachings of Sepetka such that the implant changes its mechanical/structural characteristics after heat is applied for the advantage of changing the size and shape of the embolic implant to compensate for changes in the volume occupied by the implant in the aneurysm to ensure confinement of the embolic coil to the aneurysmal cavity (Paragraph 0044).
Regarding Claim 38-39, the combination of references disclosed above teaches the method of claim 22, but fails to disclose wherein the implant further comprises a drug (Claim 38)/bioactive agent (Claim 39), and wherein the drug (Claim 38)/bioactive agent (Claim 39) is released after energy is delivered.
Shaolian teaches an adjustable embolic aneurysm implant which can be adjusted by applying energy to the implant for the purpose of providing optimal filling of the aneurysm by the implant (abstract), wherein the implant further comprises a drug/bioactive agent, and wherein the drug/bioactive agent is released after energy is delivered (Paragraph 0049 and 0096).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant of Sepetka to include a drug/bioactive agent which is released after energy is delivered for the advantage of providing a therapeutic agent which can further promote coagulation, fibrosis, or the like within the aneurysm (Paragraph 0096).
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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