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
This Office action is in response to the applicant’s communication filed 03/06/2026.
Status of the claims:
Claims 2 – 4, 6, and 8 – 10 are pending in the application.
Claim 2 is amended.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 – 4, 6, and 8 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al (US 2005/0137696 A1) in view of Zimmerman (US 2016/0151141 A1), Brandies er al (US 2020/0268500 A1), and Bardsley et al (US 2017/0079661 A1) (previously cited).
Regarding claim 2, Salahieh discloses an intravascular filter (embolic protection system 500) configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain (abstract, paragraphs [0008], [0055], [0073 – 0086], and Figs. 6A,B,C, 13A-G), comprising:
a self-expandable tubular wire frame (filter 520) having, a proximal face, a distal face, and a tubular sidewall extending axially from a proximal end to a distal end (paragraph [0055] and Figs. 6B,13B,13D) (Examiner’s note: as stated in paragraph [0055] the filter 520 self-expands and is formed of a Nitinol braid and is thus a self-expandable tubular wire frame); and
a porous membrane (permeable/porous membrane) carried by the tubular sidewall (Examiner’s note: as stated in paragraph [0055] the filter 520 may comprise a permeable/porous membrane for assisting in filtering. It would be obvious to one of ordinary skill in the art to modify the filter 520 frame to incorporate a porous membrane for the purpose of assisting in filtering. Thus, Salahieh encompasses or, in the alternative, at least makes obvious a porous membrane on the self-expandable tubular wire frame).
However, Salahieh is silent regarding (i) the percentage of open area of the tubular wire frame as claimed (i.e., at least 80% along the sidewall), (ii) the porous membrane comprising a plurality of layers, (iii) wherein the plurality of layers are made up of electro-spun fibers, the electro-spun fibers defining a plurality of pores having a random distribution of pore sizes extending along a length of the porous membrane and providing 360 degree coverage circumferentially about the tubular sidewall, (iv) wherein the pores are configured to block passage of all debris having a maximum dimension greater than 80 microns from entering three great vessels of the aortic arch while allowing for sufficient blood flow to the brain and imposing no measurable pressure drop along the length of the porous membrane, wherein the random distribution of pore sizes includes pores sized 8-10 microns (v) configured to avoid raising a pressure drop along the length of the porous membrane, and (vi) wherein a sum of an area of all pores of the plurality of pores is at least about 30% of a surface area of the porous membrane when the intravascular filter is in an unconstrained expanded configuration expansion.
As to (i), there is no evidence of record that establishes that changing the percent open area of the frame to be at least 80% would result in a difference in function of the Salahieh device as the device of Salahieh would still be able to filter out unwanted particulates from the flow of blood through the vessels. Further, a person having ordinary skill in the art, being faced with modifying the frame of Salahieh, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended, with the percent open area, to provide filtration to the vasculature being given the claimed percent open area of the frame as having an open area of at least 80% would still allow the frame to filter the blood flowing therethrough. Lastly, Applicant has not disclosed that the claimed range solves any stated problem and offers other acceptable ranges (e.g., at least 85% or at least 88%, specification at para. [0104]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, 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 percentage of open area of the frame to be within the claimed range (i.e., at least 80%) as an obvious matter of design choice within the skill of the art.
As to (ii), Zimmerman teaches, in the same field of endeavor, an intravascular filter (emboli capture triaxial protection device) configured for delivery to an aortic arch for blocking passage of debris comprising a porous membrane with a plurality of layers (3 layer braided tube construction) (abstract, paragraphs [0032 – 0033], and Fig. 17), wherein each layer has a different porosity for the purpose of providing the device with maximum filtration (paragraph [0062] and Fig. 17a) (Examiner’s note: as stated in paragraph [0062] and shown in Fig. 17A of Zimmerman the three layer braided tube is the filtering structure of the embolic protection device of Zimmerman; and as stated in paragraph [0055] of Salahieh the porous membrane is used to assist in filtering. Therefore, the three layer braided tube construction is functionally equivalent to the porous membrane of Salahieh).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the porous membrane of Salahieh to be comprised of a plurality of layers, based on the teachings of Zimmerman, for the purpose of maximizing filtration (paragraph [0062] – Zimmerman).
As to (iii), Brandies teaches in the same field of endeavor, an intravascular filter (device 10) configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain (abstract, paragraphs [0008], [0132], [0136], [0148 – 0151], [0158], and Figs. 1, 2A-I) comprising:
a self-expandable tubular wire frame (mesh layer of shape memory Nitinol wires – paragraphs [0148 – 0151]; which equates to the self-expandable Nitinol filter frame 520 of Salahieh), and
a porous membrane (second layer of a polymer mesh; which equates to each layer of the porous membrane of Salahieh in view of Zimmerman) carried by the tubular sidewall in a tubular configuration (paragraphs [0016 – 0017]), the porous membrane comprising electro-spun fibers with a random distribution of pores providing 360 degree coverage circumferentially about the tubular sidewall (Examiner’s note: as stated in paragraph [0158] the polymer mesh (i.e., the porous membrane) is made up by weaving a polymer threaded produced by electro-spinning the material. As stated in paragraph [0159] the weaving is random, which creates a random distribution of pores. Therefore, the porous membrane comprises electro-spun fibers with a random pore distribution along the length. Furthermore, as stated in paragraph [0016] the second mesh lumen (i.e., the porous membrane) surrounds the first mesh lumen (i.e., the frame), therefore, the distribution of pores provides 360 degree coverage circumferentially about the sidewall of the first layer mesh (i.e., the filter frame)).
It should be understood that Salahieh, in view of Zimmerman, and Brandies are known references in the art that teach an intravascular filter configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain comprising a self-expandable wire frame and a porous membrane (abstract, paragraphs [0008], [0055], [0073 – 0086], and Figs. 6A,B,C, 13A-G – Salahieh; abstract, paragraphs [0008], [0132], [0136], [0148 – 0151], [0158], and Figs. 1, 2A-I – Brandies); the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have the plurality of porous membrane layers of Salahieh in view of Zimmerman be formed from a randomly weaving electro-spun fibers, as the particular technique for forming porous membrane layers is known and recognized as part of the ordinary capabilities of one skilled in the art, and one of ordinary skill in the art would have been capable of applying this known technique to form the known device (i.e., each of the layers in the plurality of layers of the porous membrane of Salahieh in view of Zimmerman), and the results of the process would have been predictable, wherein the device would be able to function as intended to filter out particulates of the blood passing through the vessels. Therefore, the combination encompasses a porous membrane comprising a plurality of layers made up of electro-spun fibers with random distribution of pores in each layer.
As to (iv) – (vi), Bardsley, in a filed reasonably pertinent to the particular problem with which applicant was concerned with, namely an intravascular device for regulating flow comprising a mesh with pores, teaches an intravascular filter (implantable device 100) for blocking passage of debris (Examiner’s note: as stated in paragraph [0050] the implantable device is used to selectively restrict flow therethrough) comprising a porous membrane comprising multiple layers (first layer 102 and second layer 104) with a distribution of pores (paragraph [0083]). Additionally, Bardsley teaches wherein the distribution of pore sizes of the plurality of pores is configured to block passage of all debris having a maximum dimension greater than 80 microns and the distribution of pore sizes of the plurality of pores includes pores sized 8-10 microns (Examiner’s note: as stated in paragraph [0083] the porosity of the implantable device can comprise any combination of pore sizes of 1 μm or greater. Therefore, Bardsley makes obvious including pores 8 – 10 microns in size in combination with other pore sizes, which includes pores sized 20 μm to 50 μm).
Furthermore, Bardsley states in paragraphs [0081 – 0083] the porosity is disclosed to be a result effective variable in that the changing porosity changes the filters impact within the body and the degree of effectiveness therein, Salahieh also states in paragraph [0067] the size and density of the pores of the device can vary as desired to enhance blood flow or to more finely filter particles; therefore, Salahieh also teaches it is well within the purview of one of ordinary skill in the art to modify the number of pores and the sizing of the pores as desired in order to change the filters impact of the filter within the body. Thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the porous membrane’s (iv) pore sizes (i.e., having a pore sized to block passage of debris greater than 80 microns), (v) combination of pore sizes (i.e., the pore distribution including pores 8-10 microns), and (vi) porosity (i.e. the percent sum of the area of all the pores relative to the sum of the area of the porous membrane = 30%), as it involves only adjusting the dimension disclosed as required to be adjusted; and Applicant has not provided evidence of the criticality for the range of pores sizes and the sum of an area of all of the pores relative to the total surface area of the porous membrane ratio. On page 3 paragraphs [0011 – 0013], Applicant states a first group of pores can be no greater than 25 microns and a second group of pores no greater than 50, 120, 100, or 80 microns and the ratio (i.e., the percent sum of the area of all the pores relative to the sum of the area of the porous membrane) can be at least 30%, 35%, or 40%. Furthermore, Applicant has not provided evidence as to how the claimed pore sizes, claimed pore distribution / combination of sizes, and claimed ratio would yield unexpected results. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the porous membrane, comprising multiple layers, of Salahieh in view of Zimmerman and Brandies to have the pores sized to block debris no greater than 80 microns, have the random pore distribution (as taught by Brandies) include pores 8 – 10 microns small, and have the sum of an area of all of the pores of the porous membrane be at least 30% of a surface area of the porous membrane when the filter is in the unconstrained state as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, with respect to (iv) and (v), it should be understood that the limitations are intended use and require only that the structure of the prior art combination be capable of functioning as claimed; with that said, the modified filtering device of Salahieh, Zimmerman, Brandies, and Bardsley is structured in the same manner as the claimed filtering device and is, thus, capable of functioning in the manner claimed to block passage of all debris having a maximum dimension greater than 80 microns from entering three great vessels of the aortic arch while allowing for sufficient blood flow to the brain and imposing no measurable pressure drop along the length of the porous membrane.
Regarding claim 3, as discussed above, it would be obvious to modify the porous membrane of Salahieh to include multiple layers of the electro-spun fibers as taught by Zimmerman and Brandies, respectively, and in view of Bardsley. Additionally, the combination further makes obvious wherein the plurality of layers of electro-spun fibers extend circumferentially around the self-expandable tubular wire frame (filter frame 520 – Salahieh) (Examiner’s note: Brandies teaches in paragraph [0163] wherein the polymer mesh (i.e., the porous membrane) protects the aortic arch by preventing the stiffer material (i.e., the equivalent of the frame of Salahieh) from touching the aortic wall; and It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have the multilayered porous membrane of Salahieh in view of Zimmerman, Brandies, and Bardsley extend circumferentially around the frame for the purpose of protecting the aortic wall).
Regarding claim 4, as discussed above, it would be obvious to modify the porous membrane of Salahieh to include multiple layers of the electro-spun fibers as taught by Zimmerman and Brandies, respectively, and in view of Bardsley. Additionally, the combination teaches wherein the plurality of layers of electrospun fibers are formed from a dispersion, a solution, a suspension, a liquid, a molten material, a semi-molten material, or a semi-fluid material (Examiner’s note: molten material is defined as any material that can be liquefied by heat; with that said, Brandies discloses in paragraphs [0058] and [0154] wherein the flexible material (i.e., the material of the second mesh which comprises the electrospun fibers) is made up of polyurethane. And the process of electrospinning polyurethane involves having the polymer be a polymer solution as evidenced by Electrospinning of polyurethane fibers - ScienceDirect).
Regarding claim 6, as discussed above, it would be obvious to modify the porous membrane of Salahieh to include multiple layers of the electro-spun fibers as taught by Zimmerman and Brandies, respectively, and in view of Bardsley. Additionally, the Zimmerman teaches wherein a layer of the plurality of layers of electrospun fibers has a different average pore size than at least one of the plurality of layers of electrospun fibers (paragraph [0062] – Zimmerman). Therefore, the combination encompasses the device as claimed.
Regarding claims 8, 9, and 10, as discussed above, it would be obvious to modify the porous membrane of Salahieh to include multiple layers of the electro-spun fibers as taught by Zimmerman and Brandies, respectively, and in view of Bardsley.
However, the combination of Salahieh, Zimmerman, Brandeis, and Bardsley is silent regarding [claim 8] wherein the random distribution of pore sizes includes a first group of pores with a maximum dimension of no more than 25 microns, [claim 9] wherein the random distribution of pore sizes further includes a second group of pores with a maximum dimension of at least 50 microns, and [claim 10] wherein the first group of pores has at least three times as many pores as the second group of pores.
As to the above, Bardsley further teaches, in a separate embodiment, a porous membrane (tubular member 200 – comprising low porosity section 210 and high porosity section 212) (paragraph [0058] and Fig. 3) and [claim 8 and claim 9] wherein the porous membrane includes a first group of pores (pores of low porosity section 210) with a maximum dimension greater than 25 microns and a second group of pores (pores of the high porosity section 212) with a maximum dimension of no more than 25 microns (Examiner’s note: Bardsley states in paragraph [0083] wherein each porosity section can have an average pore size within any range listed therein; and further paragraph [0083] states a range for the pore size of each section can range from 15 microns to 80 microns. Therefore, Bardsley encompasses or, in the alternative, makes obvious wherein low porosity section 210 of the porous membrane has an average pore size of 15 microns and high porosity section 212 of the porous membrane has an average pore size of 50 microns). Bardsley further teaches [claim 10] wherein the first group of pores (pores of the low porosity section 210) has at least three times as many pores as the second group of pores (pores of the high porosity section 212) (Examiner’s note: as stated in paragraph [0053] “pic count” is defined as the number of filament crossing per unit length, which directly relates to the number of pores along a length, and since a pore is formed by crossing filaments then a section with a higher ‘pic count’ will also have a higher pore count; and as stated in paragraph [0060] the low porosity section and the high porosity section can have a pic count ratio of 3:1, meaning that the number of pores in the low porosity section is 3 times greater than the number of pores in the high porosity section. Therefore, Bardsley encompasses wherein the low porosity section has 3 times as many pores as the high porosity section).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the multi layered porous membrane of Salahieh in view of Zimmerman, Brandeis and Bardsley to further incorporate a low porosity section and a high porosity section within pores within the claimed ranges and ratios, based on the teachings of Bardsley, for the purpose being able to maximize filtration (paragraph [0062] – Zimmerman).
Claims 2 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al (US 2005/0137696 A1) in view of Brandies er al (US 2020/0268500 A1) and Bardsley et al (US 2017/0079661 A1) (previously cited). (Alternate Interpretation).
Regarding claim 2, Salahieh discloses an intravascular filter (embolic protection system 500) configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain (abstract, paragraphs [0008], [0055], [0073 – 0086], and Figs. 6A,B,C, 13A-G), comprising:
a self-expandable tubular wire frame (filter 520) having, a proximal face, a distal face, and a tubular sidewall extending axially from a proximal end to a distal end (paragraph [0055] and Figs. 6B,13B,13D) (Examiner’s note: as stated in paragraph [0055] the filter 520 self-expands and is formed of a Nitinol braid and is thus a self-expandable tubular wire frame); and
a porous membrane (permeable/porous membrane) carried by the tubular sidewall (Examiner’s note: as stated in paragraph [0055] the filter 520 may comprise a permeable/porous membrane for assisting in filtering. It would be obvious to one of ordinary skill in the art to modify the filter 520 frame to incorporate a porous membrane for the purpose of assisting in filtering. Thus, Salahieh encompasses or, in the alternative, at least makes obvious a porous membrane on the self-expandable tubular wire frame).
However, Salahieh is silent regarding (i) the percentage of open area of the tubular wire frame as claimed (i.e., at least 80% along the sidewall), (ii) the porous membrane comprising a plurality of layers of electro-spun fibers defining a plurality of pores having a random distribution of pore sizes extending along a length of the porous membrane and providing 360 degree coverage circumferentially about the tubular sidewall, (iii) wherein the random distribution of pore is configured to block passage of all debris having a maximum dimension greater than 80 microns from entering three great vessels of the aortic arch while allowing for sufficient blood flow to the brain and imposing no measurable pressure drop along the length of the porous membrane, wherein the random distribution of pore sizes of the plurality of pores includes pores sized 8-10 microns (iv) configured to avoid raising a pressure drop along the length of the porous membrane, and (v) wherein a sum of an area of all pores of the plurality of pores is at least about 30% of a surface area of the porous membrane when the intravascular filter is in an unconstrained expanded configuration expansion.
As to (i), there is no evidence of record that establishes that changing the percent open area of the frame to be at least 80% would result in a difference in function of the Salahieh device as the device of Salahieh would still be able to filter out unwanted particulates from the flow of blood through the vessels. Further, a person having ordinary skill in the art, being faced with modifying the frame of Salahieh, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended, with the percent open area, to provide filtration to the vasculature being given the claimed percent open area of the frame as having an open area of at least 80% would still allow the frame to filter the blood flowing therethrough. Lastly, Applicant has not disclosed that the claimed range solves any stated problem and offers other acceptable ranges (e.g., at least 85% or at least 88%, specification at para. [0104]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, 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 percentage of open area of the frame to be within the claimed range (i.e., at least 80%) as an obvious matter of design choice within the skill of the art.
As to (ii), (alternate interpretation – changes italicized below) Brandies teaches in the same field of endeavor, an intravascular filter (device 10) configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain (abstract, paragraphs [0008], [0132], [0136], [0148 – 0151], [0158], and Figs. 1, 2A-I) comprising:
a self-expandable tubular wire frame (mesh layer of shape memory Nitinol wires – paragraphs [0148 – 0151]; which equates to the self-expandable Nitinol filter frame 520 of Salahieh), and
a porous membrane (second layer of a polymer mesh; which equates to the porous membrane of Salahieh) carried by the tubular sidewall in a tubular configuration (paragraphs [0016 – 0017]), the porous membrane comprising a plurality of layers of electro-spun fibers with a random distribution of pores providing 360 degree coverage circumferentially about the tubular sidewall (Examiner’s note: as stated in paragraph [0158] the polymer mesh (i.e., the porous membrane) is made up by weaving a polymer threaded produced by electro-spinning the material. A weaved structure inherently comprises at least two layers as the strands are interlaced / crossing over and under each other; additionally, as stated in paragraph [0159] the weaving is random, which creates a random distribution of pores. Therefore, the porous membrane comprises a plurality of layers of electro-spun fibers with a random pore distribution along the length. Furthermore, as stated in paragraph [0016] the second mesh lumen (i.e., the porous membrane) surrounds the first mesh lumen (i.e., the frame), therefore, the distribution of pores provides 360 degree coverage circumferentially about the sidewall of the first layer mesh (i.e., the filter frame)).
It should be understood that Salahieh and Brandies are known references in the art that teach an intravascular filter configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain comprising a self-expandable wire frame and a porous membrane (abstract, paragraphs [0008], [0055], [0073 – 0086], and Figs. 6A,B,C, 13A-G – Salahieh; abstract, paragraphs [0008], [0132], [0136], [0148 – 0151], [0158], and Figs. 1, 2A-I – Brandies); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one porous membrane / second layer on a metal wire frame for another, and the results of the substitution would have been predictable and resulted in the modified filter device of Salahieh being able to function as intended to properly keep particulates from traveling through branched vessels. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Alternatively, because Salahieh and Brandies are known references in the art that teach an intravascular filter configured for delivery to an aortic arch for blocking passage of debris while allowing sufficient blood flow to a brain comprising a self-expandable wire frame and a porous membrane (abstract, paragraphs [0008], [0055], [0073 – 0086], and Figs. 6A,B,C, 13A-G – Salahieh; abstract, paragraphs [0008], [0132], [0136], [0148 – 0151], [0158], and Figs. 1, 2A-I – Brandies); the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have the porous membrane of Salahieh be formed from a random pattern weaved mesh made up of electro-spun fibers, as the particular technique is known and recognized as part of the ordinary capabilities of one skilled in the art, and one of ordinary skill in the art would have been capable of applying this known technique to form the known device (i.e., the porous membrane of Salahieh), and the results of the process would have been predictable, wherein the device would be able to function as intended to filter out particulates of the blood passing through the vessels.
As to (iii) – (v), Bardsley, in a filed reasonably pertinent to the particular problem with which applicant was concerned with, namely an intravascular device for regulating flow comprising a mesh with pores, teaches an intravascular filter (implantable device 100) for blocking passage of debris (Examiner’s note: as stated in paragraph [0050] the implantable device is used to selectively restrict flow therethrough) comprising a porous membrane comprising multiple layers (first layer 102 and second layer 104) with a distribution of pores (paragraph [0083]). Additionally, Bardsley teaches wherein the distribution of pore sizes of the plurality of pores is configured to block passage of all debris having a maximum dimension greater than 80 microns and the distribution of pore sizes of the plurality of pores includes pores sized 8-10 microns (Examiner’s note: as stated in paragraph [0083] the porosity of the implantable device can comprise any combination of pore sizes of 1 μm or greater. Therefore, Bardsley makes obvious including pores 8 – 10 microns in size in combination with other pore sizes, which includes pores sized 20 μm to 50 μm).
Furthermore, Bardsley states in paragraphs [0081 – 0083] the porosity is disclosed to be a result effective variable in that the changing porosity changes the filters impact within the body and the degree of effectiveness therein, Salahieh also states in paragraph [0067] the size and density of the pores of the device can vary as desired to enhance blood flow or to more finely filter particles; therefore, Salahieh also teaches it is well within the purview of one of ordinary skill in the art to modify the number of pores and the sizing of the pores as desired in order to change the filters impact of the filter within the body. Thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the porous membrane’s (iii) pore sizes (i.e., having a pore sized to block passage of debris greater than 80 microns), (iv) combination of pore sizes (i.e., the pore distribution including pores 8-10 microns), and (vi) porosity (i.e. the percent sum of the area of all the pores relative to the sum of the area of the porous membrane = 30%), as it involves only adjusting the dimension disclosed as required to be adjusted; and Applicant has not provided evidence of the criticality for the range of pores sizes and the sum of an area of all of the pores relative to the total surface area of the porous membrane ratio. On page 3 paragraphs [0011 – 0013], Applicant states a first group of pores can be no greater than 25 microns and a second group of pores no greater than 50, 120, 100, or 80 microns and the ratio (i.e., the percent sum of the area of all the pores relative to the sum of the area of the porous membrane) can be at least 30%, 35%, or 40%. Furthermore, Applicant has not provided evidence as to how the claimed pore sizes, claimed pore distribution / combination of sizes, and claimed ratio would yield unexpected results. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the porous membrane of Salahieh in view of Brandies to have the pores sized to block debris no greater than 80 microns, have the random (taught by Brandies) pore distribution include pores 8 – 10 microns small, and have the sum of an area of all of the pores of the porous membrane be at least 30% of a surface area of the porous membrane when the filter is in the unconstrained state as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, with respect to (iii) and (vi), it should be understood that the limitations are intended use and require only that the structure of the prior art combination be capable of functioning as claimed; with that said, the modified filtering device of Salahieh, Brandies, and Bardsley is structured in the same manner as the claimed filtering device and is, thus, capable of functioning in the manner claimed to block passage of all debris having a maximum dimension greater than 80 microns from entering three great vessels of the aortic arch while allowing for sufficient blood flow to the brain and imposing no measurable pressure drop along the length of the porous membrane.
Regarding claim 3, as discussed above, it would be obvious to modify the device of Salahieh to include the electrospun fiber porous membrane as taught by Brandies in view of Bardsley. Additionally, the combination further teaches wherein the plurality of layers of electro-spun fibers extend circumferentially around the self-expandable tubular wire frame (filter frame 520 – Salahieh) (Examiner’s note: as discussed in paragraph [0016] of Brandies, the second mesh layer (i.e., the electrospun layer) surrounds the first layer (i.e., the filter frame layer); therefore, the Brandies makes obvious wherein the combination would encompass the second mesh layer (i.e., the electrospun fibers) extend circumferentially around the frame 520 (i.e., the tubular wire frame) of Salahieh).
Regarding claim 4, as discussed above, it would be obvious to modify the device of Salahieh to include the electrospun fiber porous membrane as taught by Brandies in view of Bardsley. Additionally, the combination teaches wherein the plurality of layers of electrospun fibers are formed from a dispersion, a solution, a suspension, a liquid, a molten material, a semi-molten material, or a semi-fluid material (Examiner’s note: molten material is defined as any material that can be liquefied by heat; with that said, Brandies discloses in paragraphs [0058] and [0154] wherein the flexible material (i.e., the material of the second mesh which comprises the electrospun fibers) is made up of polyurethane. And the process of electrospinning polyurethane involves having the polymer be a polymer solution as evidenced by Electrospinning of polyurethane fibers - ScienceDirect).
Response to Arguments
The Affidavit responded to in the response to the Pre-Appeal mailed on 04/10/2026 and repeated below for convenience.
The Affidavit under 37 CFR 1.132 filed 09/24/2026 is sufficient to overcome the rejection of claim 2 based upon Clubb.
Applicant’s arguments in the Pre-Appeal filed 03/06/2026, with respect to the rejection(s) of claim 2 under Pigott in view of Wulfman, Frid, Bardsley, and Brandies have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Salahieh in view of Zimmerman, Brandies, and Bardsley. More specifically, the arguments directed to Wulfman and Frid not teaching a plurality of layers was found persuasive. Therefore, the previous rejection has been withdrawn.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yodfat (US 2003/0100940 A1) teaches an aortic arch filter with a plurality of layers.
Cox et al (US 2014/0303667 A1) teaches an aortic arch filter with a plurality of support braids surrounded by multiple filtering braids.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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