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 .
Response to Amendment
The claims filed on July 16th, 2026, have been entered. Claims 21, 23, 25-30, 32, and 34-40 remain pending in the Application. Claim 33 has been canceled by the Applicant.
Response to Arguments
Applicant's arguments filed July 16th, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that Yang et al. (Pub. No. 2018/0193026) cannot be modified from an ordered woven structure to a nonwoven fleece (an electrospun covering with irregularly oriented filaments) because the architecture of the two materials is fundamentally different. Examiner respectfully disagrees. The claim language does not require a nonwoven fleece, only a covering made of an electrospun covering with a plurality of pores of irregular sizes, and Yang et al. discloses a covering in tubular sleeve 60 made of a plurality of pores ([0091]), where Yang et al. was then modified by Slager et al. (Pub. No. 2010/0292668) to have irregularly sized pores which allow for retention of more microparticles ([0015]).
Second, Applicant argues that Yang et al. does not disclose the limitation “the funnel-shaped section is free from the covering over an entire circumferential surface of the funnel-shaped section” because Yang et al. discloses that the sleeve extends the entire length of the device in [0188] and the disclosure that the sleeve need not extend the entire length of the device in [0187] does not explicitly mention the proximal section 28. Examiner respectfully disagrees. The quoted sentence by Applicant in [0091] (Applicant quotes paragraphs that do not exist in Yang et al.) is immediately proceeded by the sentence “In some embodiments, the sleeve 60 extends the length of the central section 20 of the device 10.” When the quoted sentence by Applicant is taken in full context of the paragraph [0091], along with FIG. 11A, Yang et al. explicitly discloses that the tapered proximal section 28 is not covered by the sleeve 60, which satisfies the claim limitation.
Third, Applicant argues that the prior art lacks guidance that would lead to the specific combination of features defined in Applicant’s claims because the prior art does not solve the specific issues that Applicant’s invention sets out to address. Examiner respectfully disagrees. As laid out in the Non-Final Rejection dated April 16th, 2026, Yang et al. was modified by references Kusleika et al. (Pub. No. 2008/0125848) and Slager et al. to have the claimed limitations of the present application for reasons which would be obvious to one of ordinary skill in the art. The modifications do not need to explicitly solve the same issues as Applicant unless those issues have been claimed.
Fourth, Applicant argues that Yang et al. does not disclose differential-perfusion notion because Yang et al. discloses occlusion/flow-diversion. Examiner would like to point out that differential-perfusion notion is not claimed, and that the claim limitation “the mesh structure is perfusible by blood in a longitudinal axial direction of the mesh structure” is satisfied by Yang et al. because the covering of Yang et al. minimizes disruption of blood flow by keeping the blood flow longitudinally along the blood vessel into the aneurysm.
Fifth, Applicant argues that Yang et al. does not disclose the claimed range of 0.1-3 microns because Yang et al. discloses less than 12.7 microns while a zero-diameter wire is impossible. Examiner respectfully disagrees. While a zero-diameter wire is impossible, Yang et al. anticipates all possible wires less than 12.7 microns by the explicit disclosure of “less than 0.0005 inches” (converted to 12.7 microns). This includes a value less than 0.1 microns, which means Yang et al. covers the entire range of 0.1-3.0 microns.
Sixth, Applicant argues that Yang et al. cannot be modified by Slager et al. because Yang et al. is a flow-diverter while Slager et al. is about microparticle delivery pore engineering. Examiner respectfully disagrees. As pointed out in the Non-Final Rejection, Slager et al. teaches retention of microparticles which are larger than blood particles so that blood is not prevented from flowing while the device is being utilized. One of ordinary skill in the art would understand that the direction of retention, whether out of a drug delivery stent or into an emboli capturing stent, is irrelevant to the advantages offered by the irregularly-sized pores.
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 21, 23, 25-30, 32, and 34-40 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.
Claims 21, 35, and 40 recites the limitation "the cells of the mesh structure" in line 21, line 21, and line 21, respectively. There is insufficient antecedent basis for this limitation in the claim. No cells have been previously introduced, though pores have been previously introduced, and the claims are unclear as to whether the pores and cells are different structures or the same structure. Claims 23, 25-30, 32, 34, and 36-39 are rejected for their dependency on claims 21 and 35, respectively.
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, 34-36, 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 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; [0056] the filaments of 10 help determine the location of the pores), wherein the covering has at least 10 pores ([0091] 60 can have a similar number of pores to the underlying device 10, and FIG. 11A shows 10 has far more than 10 pores) over an area of 100,000 microns squared ([0062] the central section 20 which 60 covers has a diameter of 4-5 mm and a length of at least 5 mm, which is an area of 20-25 mm squared, or 20 million microns squared),
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 forming 10),
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),
wherein the covering is disposed on an outside and an inside of the mesh structure ([0090] 60 can be carried by both the internal surface and outer surface of 10), wherein the covering extends on the inside of the mesh structure through the pores of the mesh structure ([0092] 60 provides coverage over all of the gaps in the mesh) and is bonded to the covering on the outside of the mesh structure ([0091] the inner and outer sleeves 60A and 60B are bonded to the device 10), so that mesh elements of the mesh structure are surrounded by the covering ([0090] 60A and 60B sandwich the struts of the sidewall between them).
Yang et al. does not explicitly disclose that the covering has a porosity of at least 45%. However, 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. to be at least 45% because 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 therefore, this is a mere obvious design choice that fails to patentably distinguish the invention from the prior art.
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 device wires may have a wire diameter less than 0.0005 inches (12.7 microns). 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 pores with a size of at least 15 microns squared and 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 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 ([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 effective pore diameter of the pores is at least 10 microns ([0039], where a diameter of 10 microns for a circular pore leads to an area of 78.54 microns squared, which is far greater than the claimed 15 microns squared), and 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, where the microparticles can have a variety of different impacts such as being therapeutic agents ([0015] and [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering of Yang et al. to be an electrospun covering comprising a plurality of pores of irregular sizes, an effective pore size of at least 78.54 microns squared, and to be oriented in an irregular manner with respect to each other, as taught by Slager, 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 Slager further discloses the covering is porous (Slager FIGs. 1A-1B: 20 is porous).
Regarding claim 25, Yang et al. does not explicitly disclose that the covering has a porosity of at least 70%. However, as discussed above, 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. to be at least 45% because applicant appears to have placed no criticality on the claimed range, and therefore, this is a mere obvious design choice that fails to patentably distinguish the invention from the prior art.
Regarding claim 26, Yang et al. does not explicitly disclose that the covering has a porosity of at least 50%. However, as discussed above, 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. to be at least 45% because applicant appears to have placed no criticality on the claimed range, and therefore, this is a mere obvious design choice that fails to patentably distinguish the invention from the prior art.
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; [0056] the filaments of 10 help determine the location of the pores), wherein the covering has at least 10 pores ([0091] 60 can have a similar porosity to the underlying device 10, and FIG. 11A shows 10 has far more than 10 pores) over an area of 100,000 microns squared ([0062] the central section 20 which 60 covers has a diameter of 4-5 mm and a length of at least 5 mm, which is an area of 20-25 mm squared, or 20 million microns squared),
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 forming 10),
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),
wherein the covering is disposed on an outside and an inside of the mesh structure ([0090] 60 can be carried by both the internal surface and outer surface of 10), wherein the covering extends on the inside of the mesh structure through the pores of the mesh structure ([0092] 60 provides coverage over all of the gaps in the mesh) and is bonded to the covering on the outside of the mesh structure ([0091] the inner and outer sleeves 60A and 60B are bonded to 10), so that mesh elements of the mesh structure are surrounded by the covering ([0090] 60A and 60B sandwich the struts of the sidewall between them); 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%. However, 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. to be at least 45% because 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 therefore, this is a mere obvious design choice that fails to patentably distinguish the invention from the prior art. Furthermore, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Garner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984). In the present case, the device of Yang et al. would not operate differently with the claimed porosity, and as discussed above, applicant appears to place no criticality on the claimed porosity.
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). 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 pores with a size of at least 15 microns squared and 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 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 ([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 effective pore diameter of the pores is at least 10 microns ([0039], where a diameter of 10 microns for a circular pore leads to an area of 78.54 microns squared, which is far greater than the claimed 15 microns squared), and 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, where the microparticles can have a variety of different impacts such as being therapeutic agents ([0015] and [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering of Yang et al. to be an electrospun covering comprising a plurality of pores of irregular sizes, an effective pore size of at least 78.54 microns squared, and to be oriented in an irregular manner with respect to each other, as taught by Slager, 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; [0056] the filaments of 10 help determine the location of the pores), wherein the covering has at least 10 pores ([0091] 60 can have a similar porosity to the underlying device 10, and FIG. 11A shows 10 has far more than 10 pores) over an area of 100,000 microns squared ([0062] the central section 20 which 60 covers has a diameter of 4-5 mm and a length of at least 5 mm, which is an area of 20-25 mm squared, or 20 million microns squared),
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 of 10),
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),
wherein the covering is disposed on an outside and an inside of the mesh structure ([0090] 60 can be carried by both the internal surface and outer surface of 10), wherein the covering extends on the inside of the mesh structure through the pores of the mesh structure ([0092] 60 provides coverage over all of the gaps in the mesh) and is bonded to the covering on the outside of the mesh structure ([0091] the inner and outer sleeves 60A and 60B are bonded to 10), so that mesh elements of the mesh structure are surrounded by the covering ([0090] 60A and 60B sandwich the struts of the sidewall between them); 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%. However, 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. to be at least 45% because 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 therefore, this is a mere obvious design choice that fails to patentably distinguish the invention from the prior art.
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). 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 pores with a size of at least 15 microns squared and 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 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 ([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 effective pore diameter of the pores is at least 10 microns ([0039], where a diameter of 10 microns for a circular pore leads to an area of 78.54 microns squared, which is far greater than the claimed 15 microns squared), and 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, where the microparticles can have a variety of different impacts such as being therapeutic agents ([0015] and [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the covering of Yang et al. to be an electrospun covering comprising a plurality of pores of irregular sizes, an effective pore size of at least 78.54 microns squared, and to be oriented in an irregular manner with respect to each other, as taught by Slager, 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 Slager, and in further view of Wulfman et al. (Pub. No. 2003/0139802).
Regarding claim 28, Yang et al. as modified by Slager 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 Slager, and in further view of Gianotti et al. (U.S. Patent No. 10,632,005).
Regarding claim 37, Yang et al. as modified by Slager 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 Slager 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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
