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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 27th, 2026, has been entered.
Response to Amendment
The claims filed on February 27th, 2026, have been entered. Claims 21, 23, 25-30, and 32-40 remain pending in the Application. The claim amendments overcome the previous 112(b) rejection.
Response to Arguments
Applicant's arguments filed February 27th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that none of the references teach or disclose differing directional blood perfusion through the blood vessel versus the aneurysm. Examiner respectfully disagrees. In [0086] of Yang et al. (Pub. No. 2018/0193026), the covering 60 of the tubular sleeve 10 is described as minimizing the disruption to natural blood flow while occluding the aneurysm from the vascular blood flow, which is done by keeping blood flow from diverting from the natural course longitudinally along the blood vessel into the aneurysm. If the blood flow is not diverted, then the aneurysm could rupture or burst.
Second, Applicant argues that Yang et al. does not disclose the claimed range of wire diameter size because an implied range must be enabled, and an IDS prior art article provided by Applicant cites that the smallest nitinol DFT wire realistically available when Yang et al. was filed would be 0.0007 inches in diameter (17.78), which is larger than the claimed range of 0.1-3 microns. Examiner respectfully disagrees. First, the cited article does not state that the smallest nitinol DFT wire available is 0.0007 inches in diameter. The article answers the question of whether nitinol can be seen in x-rays, to which the author replies that the miniaturization of medical devices makes them increasingly harder to see, and that their DFT wire can improve visibility and is available down to 0.00075 inches in diameter. Second, Yang et al. directly discloses nitinol wires of less than 0.0005 inches in diameter. While Applicant is correct that a zero-diameter wire is impossible, the cited range is 0-0.0005 inches (0-12.7 microns), and thereby overlaps with the claimed range. As stated in the Final Rejection dated November 28th, 2025, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists.
Third, Applicant argues that the modification of Yang et al. in view of both Kusleika et al. (Pub. No. 2008/0125848) and Slager (Pub. No. 2010/0292668) is improper because Slager teaches in [0019-20] that microparticles can be embedded in the preformed polymeric network to create a primed network 25, which can then be released after being placed in the body, while Kusleika et al. teaches filtering of debris rather than retention and release. Examiner respectfully disagrees. Slager was brought in to teach that pores of irregular shapes and a variety of sizes result in a greater retention of microparticles, which is disclosed in [0015], and further discloses that up to 100 percent of the microparticles are retained by the electrospun network when the effective pore diameter is less than or equal to the average diameter of the microparticles being retained. While Slager does teach releasing microparticles, this is in a separate embodiment (also disclosed in [0015]) where the effective pore diameter is greater than the average diameter of the microparticles, resulting in most or all of the microparticles being released over time. Therefore, the teaching of Slager does not conflict with Kusleika et al. or change the operational teachings of Kusleika et al., as they both teach the retention of larger particles (such as debris in the blood) without retention of smaller particles (such as the blood), and the modification of Yang et al. in view of both references is proper.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21, 23, 25-27, 29-30, 32-36, 38, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Pub. No. 2018/0193026) in view of Kusleika et al. (Pub. No. 2008/0125848) and Slager (Pub. No. 2010/0292668).
Regarding claim 21, Yang et al. discloses a medical set for treatment of aneurysm ([0067] device 10; see FIGs. 4A and 11A) comprising:
a main catheter ([0095] guide delivery catheter 104 deploys device 10; see FIG. 12F); and
a covering device ([0067] device 10; see FIGs. 4A and 11A) adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm (FIG. 12F illustrates 10 moved through 104 to the treatment site and temporarily covers the aneurysm), the covering device including a self-expanding mesh structure ([0093] device 10 may be self-expanding) having a cylindrical section that is open at a distal longitudinal end ([0067] central section 20 has a distal open face 31; see FIG. 4A) and at least partially provided with a covering ([0086] tubular sleeve 60; see FIG. 11A), wherein the covering is configured as having a plurality of pores respectively delimited by filaments ([0091] 60 may be made porous, which creates a plurality of pores delimited by the strands of material of 60), wherein the covering has a porosity of at least 40% ([0091] 60 can have a porosity of at least 40%),
wherein the covering includes intersection points where at most four filaments intersect each other ([0091] the strands of material defining the plurality of pores have intersections at two of the strands),
wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter ([0059] proximal section 28 is attached to push wire 24; see FIG. 4A), and
wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section ([0091] 60 covers 20 and does not cover 28; see FIG. 11A) such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure ([0086] 60 minimizes disruption to natural blood flow, so the structure must be perfusible by blood in a longitudinal axial direction), and wherein at least ingress of blood flow into the aneurysm is reduced ([0086] 60 occludes blood flow into the aneurysm to prevent the aneurysm from rupturing or bursting).
Yang et al. does not explicitly disclose that the covering has a porosity of at least 45%, though Yang et al. does disclose the porosity of the covering can be at least 40% ([0091] 60 can have a porosity of at least 40%). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of the covering of Yang et al. from at least 40% to at least 45% as applicant appears to have placed no criticality on the claimed range (Present Spec Page 10, Lines 11-14 indicating the porosity can be at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, and at least 45%, with no disclosure as to why any of the ranges would be better than the others) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. further does not explicitly disclose that the filaments have a thickness between 0.1 microns and 3 microns. However, [0061] does disclose that the covering device wires may have a wire diameter less than 0.0005 inches (12.7 microns) and [0091] discloses that the covering can have a similar or greater porosity than the covering device, which would mean the filaments comprising the covering would have a smaller diameter than the covering device wires. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the filament diameter of the covering of Yang et al. to be between 0.1 microns and 3 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. does not disclose the covering is configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared.
Kusleika et al. teaches in the same field of endeavor of devices for treating aneurysms ([0145]) and discloses a covering (212; FIGs. 18-19) made of an electrospun material ([0131]) and having at least 10 pores (FIG. 19 illustrates at least 16 pores) with a size of at least 15 microns squared ([0109] similar filter 50 of a different embodiment is 20-1500 microns; the filters are used for the same purpose and the different in embodiments is in the underlying structure) over an area of 100,000 microns squared (20 microns squared equals 400, which, multiplied by 16 pores, would be 6,400 microns squared) for the purpose of permitting blood flow while filtering out debris. It is noted that the size of the pores does not change; therefore, the pores would still be 20 microns squared over a larger area of 100,00 microns squared.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cover of Yang et al. to be configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared, as taught by Kusleika et al., for the purpose of permitting blood flow while filtering out debris.
Yang et al. as modified by Kusleika et al. does not disclose the plurality of pores of the electrospun covering are irregular sizes respectively delimited by filaments, and that are oriented in an irregular manner with respect to each other.
Slager et al. teaches in the same field of endeavor of devices for treating aneurysms ([0004]), and discloses making an electrospun covering out a plurality of pores of irregular sizes as respectively delimited by filaments ([0015] polymeric network 20 retains microparticles by the relative sizes of the pores and the microparticles, and 20 can have irregular shapes and vary in size), where the pores are oriented in an irregular manner with respect to each other ([0015] pores with irregular shapes and sizes will be oriented irregularly to each other) for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes ([0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the electrospun cover of modified Yang et al. to have the plurality of pores of the electrospun covering comprise irregular sizes respectively delimited by filaments and be oriented in an irregular manner with respect to each other, as taught by Slager et al., for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes.
Regarding claim 23, Yang et al. as modified by Kusleika et al. further discloses the covering is porous (Kusleika et al. includes porous covering 212; FIG. 19).
Regarding claim 25, Yang et al. further discloses the covering has a porosity of at most 70% ([0091] porosity of 60 can be 25-50 percent).
Regarding claim 26, Yang et al. further discloses the covering has a porosity of at least 50% ([0091] porosity of 60 can be 25-50 percent).
Regarding claim 27, Yang et al. further discloses the covering extends over an entire circumference of the cylindrical section ([0091] 60 can be wrapped around the entirety of the device, which would include the entire circumference of the central section 20; see FIG. 11A).
Regarding claim 29, Yang et al. further discloses the covering extends over at least 80% of a length of the cylindrical section ([0091] 60 can extend over the entire length of 20).
Regarding claim 30, Yang et al. further discloses the covering extends over at most 80% of a length of the cylindrical section ([0092] 60 can be applied over the middle 10% of the device) and wherein the covering is distanced from the distal longitudinal end of the cylindrical section ([0092] 60 can be applied over the middle 10% of the device, which leaves space from the distal longitudinal end).
Regarding claim 32, Yang et al. further discloses the covering is formed by a synthetic material ([0089] 60 can be made of polyurethane, which the Spec discloses as the preferred synthetic material).
Regarding claim 33, Yang et al. further discloses the covering is disposed on one of an outside or an inside of the mesh structure ([0090] 60 may be carried by the internal surface of 10 or the outer surface of 10).
Regarding claim 34, Yang et al. further discloses the mesh structure is formed from webs which are connected together in one piece and which delimit closed cells ([0056] 10 is made of wires joined together to form a single body and closed cells).
Regarding claim 35, Yang et al. discloses a medical set for treatment of aneurysm ([0067] device 10; see FIGs. 4A and 11A) comprising:
a main catheter ([0095] guide delivery catheter 104 deploys device 10; see FIG. 12F); and
a covering device ([0067] device 10; see FIGs. 4A and 11A) adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm (FIG. 12F illustrates 10 moved through 104 to the treatment site and temporarily covers the aneurysm), the covering device including a self-expanding mesh structure ([0093] device 10 may be self-expanding) having a cylindrical section that is open at a distal longitudinal end ([0067] central section 20 has a distal open face 31; see FIG. 4A) and at least partially provided with a covering ([0086] tubular sleeve 60; see FIG. 11A), wherein the covering is configured as having a plurality of pores respectively delimited by filaments ([0091] 60 may be made porous, which creates a plurality of pores delimited by the strands of material of 60), wherein the covering has a porosity of at least 40% ([0091] 60 can have a porosity of at least 40%),
wherein the covering includes intersection points where at most four filaments intersect each other ([0091] the strands of material defining the plurality of pores have intersections at two of the strands),
wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter ([0059] proximal section 28 is attached to push wire 24; see FIG. 4A), and
wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section ([0091] 60 covers 20 and does not cover 28; see FIG. 11A) such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure ([0086] 60 minimizes disruption to natural blood flow, so the structure must be perfusible by blood in a longitudinal axial direction), and wherein at least ingress of blood flow into the aneurysm is reduced ([0086] 60 occludes blood flow into the aneurysm to prevent the aneurysm from rupturing or bursting); and
at least one embolization means for placement in the aneurysm (under the 112(f) interpretation of means cited above, the present Spec on Page 23 indicates that the embolization means are labeled as 40 in FIGs. 4-5, and are made of a plastically deformable wire 42 or by a liquid; Yang et al. [0095] coils 120; see FIG. 12F correspond to the embolization means, as they are also plastically deformable wires that are placed within the aneurysm).
Yang et al. does not explicitly disclose that the covering has a porosity of at least 45%, though Yang et al. does disclose the porosity of the covering can be at least 40% ([0091] 60 can have a porosity of at least 40%). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of the covering of Yang et al. from at least 40% to at least 45% as applicant appears to have placed no criticality on the claimed range (Present Spec Page 10, Lines 11-14 indicating the porosity can be at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, and at least 45%, with no disclosure as to why any of the ranges would be better than the others) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. further does not explicitly disclose that the filaments have a thickness between 0.1 microns and 3 microns. However, [0061] does disclose that the covering device wires may have a wire diameter less than 0.0005 inches (12.7 microns) and [0091] discloses that the covering can have a similar or greater porosity than the covering device, which would mean the filaments comprising the covering would have a smaller diameter than the covering device wires. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the filament diameter of the covering of Yang et al. to be between 0.1 microns and 3 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. does not disclose the covering is configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared.
Kusleika et al. teaches in the same field of endeavor of devices for treating aneurysms ([0145]) and discloses a covering (212; FIGs. 18-19) made of an electrospun material ([0131]) and having at least 10 pores (FIG. 19 illustrates at least 16 pores) with a size of at least 15 microns squared ([0109] similar filter 50 of a different embodiment is 20-1500 microns; the filters are used for the same purpose and the different in embodiments is in the underlying structure) over an area of 100,000 microns squared (20 microns squared equals 400, which, multiplied by 16 pores, would be 6,400 microns squared) for the purpose of permitting blood flow while filtering out debris. It is noted that the size of the pores does not change; therefore, the pores would still be 20 microns squared over a larger area of 100,00 microns squared.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cover of Yang et al. to be configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared, as taught by Kusleika et al., for the purpose of permitting blood flow while filtering out debris.
Yang et al. as modified by Kusleika et al. does not disclose the plurality of pores of the electrospun covering are irregular sizes respectively delimited by filaments, and that are oriented in an irregular manner with respect to each other.
Slager et al. teaches in the same field of endeavor of devices for treating aneurysms ([0004]), and discloses making an electrospun covering out a plurality of pores of irregular sizes as respectively delimited by filaments ([0015] polymeric network 20 retains microparticles by the relative sizes of the pores and the microparticles, and 20 can have irregular shapes and vary in size), where the pores are oriented in an irregular manner with respect to each other ([0015] pores with irregular shapes and sizes will be oriented irregularly to each other) for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes ([0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the electrospun cover of modified Yang et al. to have the plurality of pores of the electrospun covering comprise irregular sizes respectively delimited by filaments and be oriented in an irregular manner with respect to each other, as taught by Slager et al., for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes.
Regarding claim 36, Yang et al. further discloses an additional catheter having a proximal region, a central region, and a distal region ([0095] guide delivery catheter 102; see FIG. 12F), the additional catheter configured to deliver the embolization means into the aneurysm ([0095] 102 delivers 120; see FIG. 12F), wherein the additional catheter is one of independent of the main catheter or relatively movable with respect to the main catheter ([0095] 102 and 104 are independent of each other; see FIG. 12F).
Regarding claim 38, Yang et al. further discloses the proximal region of the additional catheter is disposed parallel to the main catheter ([0095] 102 and 104 are parallel to each other; see FIG. 12I) and wherein the central and distal regions of the additional catheter are disposed outside of the covering device (FIG. 12I illustrates the distal and central regions of 102 are outside of 60).
Regarding claim 40, Yang et al. discloses a medical set for treatment of aneurysm ([0067] device 10; see FIGs. 4A and 11A) comprising:
a main catheter ([0095] guide delivery catheter 104 deploys device 10; see FIG. 12F); and
a covering device ([0067] device 10; see FIGs. 4A and 11A) adapted to move through the main catheter to a treatment site to temporarily cover the aneurysm (FIG. 12F illustrates 10 moved through 104 to the treatment site and temporarily covers the aneurysm), the covering device including a self-expanding mesh structure ([0093] device 10 may be self-expanding) having a cylindrical section that is open at a distal longitudinal end ([0067] central section 20 has a distal open face 31; see FIG. 4A) and at least partially provided with a covering ([0086] tubular sleeve 60; see FIG. 11A), wherein the covering is configured as having a plurality of pores respectively delimited by filaments ([0091] 60 may be made porous, which creates a plurality of pores delimited by the strands of material of 60), wherein the covering has a porosity of at least 40% ([0091] 60 can have a porosity of at least 40%),
wherein the covering includes intersection points where at most four filaments intersect each other ([0091] the strands of material defining the plurality of pores have intersections at two of the strands),
wherein the mesh structure further has a funnel-shaped section permanently connected to a transport wire displaceable inside the main catheter ([0059] proximal section 28 is attached to push wire 24; see FIG. 4A), and
wherein the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section ([0091] 60 covers 20 and does not cover 28; see FIG. 11A) such that, in an expanded state, the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure ([0086] 60 minimizes disruption to blood flow, so the structure must be perfusible by blood in a longitudinal axial direction), and wherein at least ingress of blood flow into the aneurysm is reduced ([0086] 60 occludes blood flow into the aneurysm to prevent the aneurysm from rupturing or bursting); and
at least one embolization means for placement in the aneurysm, the embolization means formed by one of a plastically deformable wire or a liquid ([0095] coils 120; see FIG. 12F correspond to the embolization means, as they are also plastically deformable wires that are placed within the aneurysm).
Yang et al. does not explicitly disclose that the covering has a porosity of at least 45%, though Yang et al. does disclose the porosity of the covering can be at least 40% ([0091] 60 can have a porosity of at least 40%). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of the covering of Yang et al. from at least 40% to at least 45% as applicant appears to have placed no criticality on the claimed range (Present Spec Page 10, Lines 11-14 indicating the porosity can be at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, and at least 45%, with no disclosure as to why any of the ranges would be better than the others) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. further does not explicitly disclose that the filaments have a thickness between 0.1 microns and 3 microns. However, [0061] does disclose that the covering device wires may have a wire diameter less than 0.0005 inches (12.7 microns) and [0091] discloses that the covering can have a similar or greater porosity than the covering device, which would mean the filaments comprising the covering would have a smaller diameter than the covering device wires. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the filament diameter of the covering of Yang et al. to be between 0.1 microns and 3 microns since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Yang et al. does not disclose the covering is configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared.
Kusleika et al. teaches in the same field of endeavor of devices for treating aneurysms ([0145]) and discloses a covering (212; FIGs. 18-19) made of an electrospun material ([0131]) and having at least 10 pores (FIG. 19 illustrates at least 16 pores) with a size of at least 15 microns squared ([0109] similar filter 50 of a different embodiment is 20-1500 microns; the filters are used for the same purpose and the different in embodiments is in the underlying structure) over an area of 100,000 microns squared (20 microns squared equals 400, which, multiplied by 16 pores, would be 6,400 microns squared) for the purpose of permitting blood flow while filtering out debris. It is noted that the size of the pores does not change; therefore, the pores would still be 20 microns squared over a larger area of 100,00 microns squared.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the cover of Yang et al. to be configured as an electrospun covering having at least 10 pores with a size of at least 15 microns squared over an area of 100,000 microns squared, as taught by Kusleika et al., for the purpose of permitting blood flow while filtering out debris.
Yang et al. as modified by Kusleika et al. does not disclose the plurality of pores of the electrospun covering are irregular sizes respectively delimited by filaments, and that are oriented in an irregular manner with respect to each other.
Slager et al. teaches in the same field of endeavor of devices for treating aneurysms ([0004]), and discloses making an electrospun covering out a plurality of pores of irregular sizes as respectively delimited by filaments ([0015] polymeric network 20 retains microparticles by the relative sizes of the pores and the microparticles, and 20 can have irregular shapes and vary in size), where the pores are oriented in an irregular manner with respect to each other ([0015] pores with irregular shapes and sizes will be oriented irregularly to each other) for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes ([0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the electrospun cover of modified Yang et al. to have the plurality of pores of the electrospun covering comprise irregular sizes respectively delimited by filaments and be oriented in an irregular manner with respect to each other, as taught by Slager et al., for the purpose of being able to retain most or all microparticles due to the different shaped and sized pores catching a wider variety of microparticle shapes and sizes.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of Kusleika et al. and Slager et al., and in further view of Wulfman et al. (Pub. No. 2003/0139802).
Regarding claim 28, Yang et al. as modified by Kusleika et al. and Slager et al. discloses the invention substantially as claimed in claim 21. Yang et al. is silent regarding the covering extends over a portion of at most 50% of a circumference of the cylindrical section.
Wulfman et al. teaches in the same field of endeavor of devices for treating aneurysms (Abstract), and discloses a cylindrical section ([0033] occlusion device 20 has a cylindrical section; see FIG. 3) and a covering ([0033] substantially impermeable layer 28; see FIG. 3) which extends over a portion of at most 50% of a circumference of the cylindrical section ([0030] and [0033] substantially impermeable layer 28 is added to occlusion device 20 and covers less than 50% of the circumference; see FIG. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering of modified Yang et al. to extend over a portion of at most 50% of a circumference of the cylindrical section, as taught in Wulfman et al., for the purpose of reducing blood flow in and out of the aneurysm without affecting the flow in the rest of the area (Wulfman et al. Abstract and [0033]).
Claim(s) 37 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of Kusleika et al. and Slager et al., and in further view of Gianotti et al. (U.S. Patent No. 10,632,005).
Regarding claim 37, Yang et al. as modified by Kusleika et al. and Slager et al. discloses the invention substantially as claimed in claim 36, as discussed above, and further discloses the proximal region of the additional catheter is disposed parallel to the main catheter ([0095] 102 and 104 are parallel to each other; see FIG. 12I). Yang et al. does not disclose the central region of the additional catheter is disposed inside the covering device and the distal region of the additional catheter is disposed outside the covering device.
Gianotti et al. teaches in the same field of endeavor of devices for treatment of aneurysms (C25:L45-53: catheter system for treating aneurysm 1510; see FIG. 15), and discloses the central region of the additional catheter is disposed inside the covering device (C25:L45-53: microcatheter 1540 can be advanced through the braided member 1520, putting the central region of 1540 within 1520; see FIG. 15) and the distal region of the additional catheter is disposed outside the covering device (C25:L45-53: the distal region of 1540 is outside of 1520 and is within the aneurysm; see FIG. 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the additional catheter of modified Yang et al. so that the central region of the additional catheter is disposed inside the covering device and the distal region of the additional catheter is disposed outside the covering device, as taught by Gianotti et al., for the purpose of adequately positioning the covering device adjacent to an aneurysm while consecutively advancing embolization means into the aneurysm sac (Gianotti et al. C25:L45-53).
Regarding claim 39, Yang et al. as modified by Kusleika et al. and Slager et al. discloses the invention substantially as claimed in claim 36, as discussed above. The modified invention does not disclose in the expanded state, cells of the mesh structure one of (i) have an inscribed circle diameter or (ii) are expanded to the inscribed circle diameter, wherein the inscribed circle diameter at least corresponds to an external diameter of the additional catheter.
Gianotti et al. teaches in the same field of endeavor of devices for treatment of aneurysms (C25:L45-53: catheter system for treating aneurysm 1510; see FIG. 15), and discloses in the expanded state, cells of the mesh structure one of (i) have an inscribed circle diameter or (ii) are expanded to the inscribed circle diameter (C25:L45-53: the cells of 1520 can be expanded to be big enough for 1540 to pass through them), wherein the inscribed circle diameter at least corresponds to an external diameter of the additional catheter (C25:L45-53: the cells of 1520 can be made big enough for 1540 to pass through them, which would make their diameter greater than the external diameter of 1540) for the purpose of allowing the additional catheter to pass through the mesh structure to get to the aneurysm sac (C25:L49-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mesh structure of Yang et al. so that the cells of the mesh structure are expanded to the inscribed circle diameter to at least correspond to an external diameter of the additional catheter, as taught by Gianotti et al., for the purpose of allowing the additional catheter to pass through the mesh structure to get to the aneurysm sac.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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