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 11/06/2025.
Status of the claims:
Claims 1 – 15 are pending in the application.
Claims 1 – 15 are amended.
Drawings
The objections to the drawings in the previous action dated 05/07/2025 have been withdrawn in light of the Applicant’s amendments filed 11/06/2025. Specifically, the objection to the drawings, regarding the reference number 28 in Fig. 2A not being mention in the description, has been withdrawn as reference number 28 has been taken out.
Claim Objections
The objections to claims 1 – 15 in the previous action dated 05/07/2025 have been withdrawn in light of the Applicant’s amendments filed 11/06/2025. Specifically, the objection to claims 2, 8, 9, and 10, regarding at least one of “the membrane”, “a porous membrane”, and/or “the tubular porous membrane”, the objection to claims 2 – 10 and 12 – 15 regarding one of “An intravascular filter” or “An embolic protection system”, and the objection claim 11 regarding the phrase “the welds” have all been withdrawn as the appropriate corrections have been made. However, the objection to claim 1 regarding “the porous membrane in line 13 has been maintained as the appropriate corrections were not made. The objection has been repeated below.
Claim 1 is objected to because of the following informalities:
Claims 1 recites “the porous membrane”, in line 13, although the line is understood by the Examiner to mean the tubular porous membrane as previously defined and repeated throughout the claim, the Examiner suggests the line be amended to read “the tubular porous membrane” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
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.
The rejection of claims 7 and 11 – 15 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 05/07/2025 have been withdrawn in light of the Applicant’s amendments filed 11/06/2025. Specifically, the rejection of claim 7, regarding the lack of clarity in the phrase "a pressure drop", the rejection of claim 11 regarding the phrase “tubular body”, and the rejection of claims 12 – 15 for being dependent on an indefinite claim have been withdrawn as the appropriate corrections have been made.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11 – 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, and 18 of U.S. Patent No. 11,382,734 (Jones et al) in view of Brandies (US 2020/0268500 A1) and, separately, over claims 10 – 13 and 19 of U.S. Patent No. 11,707,351 (Jones et al) in view of Brandies (US 2020/0268500 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would have been obvious over the claims of U.S. Patent No. 11,382,734 and U.S. Patent No. 11,707,351, separately. More specifically:
Regarding claim 11 of the Instant Application, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351, respectively, claim an embolic protection system (intravascular filter – claim 1 of U.S. Patent No. 11,382,734; embolic protection system – claim 10 of U.S. Patent No. 11,707,351), comprising:
a self-expandable frame having a proximal end and a distal end (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351);
a filter membrane supported by the tubular body (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351), surrounding the tubular body of the frame, the filter membrane covering the distal end (Examiner’s note: claim 1 of U.S. Patent No. 11,382,734 and claim 13 of U.S. Patent No. 11,707,351 claim that the filter membrane is supported by the tubular body, therefore the filter membrane(s) surround at least a portion of the tubular bodies. Furthermore, although claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351 are silent regarding wherein the filter membrane covers the distal end of the self-expandable frame, it would be obvious to one of ordinary skill in the art to have the filter membrane(s) of each patent extend to and, longitudinally, cover the distal end of the tubular body for the purpose of increasing the surface area of filter membrane, thereby increasing the filtration capabilities of the frame and reducing the amount of unwanted particulates that flow through the filter);
the filter membrane having distribution of pore sizes covering the proximal end or the distal end, the random distribution of pore sizes includes a first pore size and a second pore size larger than the first pore size (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351); and
a transition between the frame and a control wire extending proximally from the transition (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351);
wherein the transition comprises a first set of wires extending proximally from the frame to a first set of welds, and a second, smaller set of wires extending proximally from the welds, and the welds are axially displaced from each other (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351).
However, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351 do not claim (i) wherein the distribution of pores is random.
As the above, Brandeis teaches, in the same field of endeavor, an intravascular filter (aortic protection device 500) for blocking the passage of debris (paragraph [0005]), the device comprising a self-expandable frame (first / inner layer mesh 501; which is equated to the frame of Pal) (paragraphs [0304 — 0317] and Figs. 5A — 5C) with a tubular porous membrane (second / outer layer mesh 502; which equates to the membrane of Pal) wherein the filter membrane comprises a plurality of threads that are weaved in random directions (Examiner’s note: because the fibers are weaved in random directions the pore size will be random as the direction and angle of the braid are directly related to the pore size).
It should be understood that claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351 and Brandies are known references that teach a filtering device used within the vasculature comprising a tubular porous membrane (See claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351; See abstract and paragraphs [0005], [0014], [0059], [00158] of Brandies); and the Examiner contends 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 means of forming the woven fabric mesh for another (i.e. forming the porous membrane claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351 by random directional weaving), and the results of the substitution would have be predictable and resulted in the modified porous membrane of claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351 operating as intended filtering the blood therethrough. 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.
Regarding claim 12 of the Instant Application, as stated above, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351, respectively, in combination with Brandies claim the device of claim 11 above. Additionally, claim 18 of U.S. Patent No. 11,382,734 and claim 11 of U.S. Patent No. 11,707,351, respectively, further claim a tubular delivery catheter (sheath – claim 18 of U.S. Patent No. 11,707,351; tubular delivery catheter of U.S. Patent No. 11,707,351), and the frame is carried in a reduced cross-sectional configuration within the delivery catheter (claim 11 of U.S. Patent No. 11,707,351) (Examiner’s note: with respect to the above, claim 18 of U.S. Patent No. 11,382,734 claims that the filter is deployable from the sheath, and it would be obvious for the user to use a sheath that is smaller in diameter than the inner diameter of the vasculature (and thus smaller than the outer diameter of the filter) such that the filter (i.e., frame) would be in a reduced cross-section while within the sheath for the purpose of making the system easier to navigate through the vasculature to the desired location).
Regarding claim 13 of the Instant Application, as stated above, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351, respectively, in combination with Brandies claim the device of claim 12 above. Additionally, claim 18 of U.S. Patent No. 11,382,734 and claim 12 of U.S. Patent No. 11,707,351, respectively, further claim wherein the delivery catheter (sheath – claim 18 of U.S. Patent No. 11,707,351; tubular delivery catheter of U.S. Patent No. 11,707,351) has an outer diameter of less than 14 F (claim 18 of U.S. Patent No. 11,382,734 and claim 12 of U.S. Patent No. 11,707,351).
Regarding claim 14 of the Instant Application, as stated above, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351, respectively, in combination with Brandies claim the device of claim 11 above. Additionally, claim 16 of U.S. Patent No. 11,382,734 and claim 19 of U.S. Patent No. 11,707,351, respectively, further claim wherein the filter membrane comprises electrospun fibers (claim 16 of U.S. Patent No. 11,382,734 and claim 19 of U.S. Patent No. 11,707,351).
Regarding claim 15 of the Instant Application, as stated above, claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351, respectively, in combination with Brandies claim the device of claim 11 above. Additionally, claim 1 of U.S. Patent No. 11,382,734 and claim 13 of U.S. Patent No. 11,707,351, respectively, further claim wherein a first group of pores has pores with a maximum dimension of no more than about 25 microns and a second group of pores has pores with a maximum dimension of at least about 50 microns (claim 1 of U.S. Patent No. 11,382,734 and claim 13 of U.S. Patent No. 11,707,351), and the prevalence of pores in the first group is at least three times the prevalence of pores in the second group (claim 1 of U.S. Patent No. 11,382,734 and claim 10 of U.S. Patent No. 11,707,351).
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 1 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Pal (US 2012/0095543 A1) (previously cited) in view of Bardsley et al (US 2017/0079661 A1) (previously cited).
Regarding claims 1 – 5 and 8 – 9, Pal discloses an intravascular filter (retrieval device 210) for blocking passage of selected sizes of debris (abstract, paragraphs [0047], [0048], Figs. 6 and 7a/7b), comprising:
a self-expandable tubular wire frame (retrieval device 210), having a first end (proximal end – end without filter portion 213 shown in Fig. 7b), a second end (distal end – end with filter portion 213 shown in Fig. 7b) and a tubular sidewall (side of the retrieval device covered by the filter portion 213 shown in Fig. 7b) defining a central lumen (Examiner’s note: Pal recites in paragraph [0047] that the components that make up the retrieval device 210 are similar to those that make up the retrieval device 10, and Pal discloses paragraph [0034] that the device 10 is self-expanding device made up of shape-memory material. Therefore, Pal encompasses wherein the retrieval device 210 is also made up a shape-memory material and is a self-expandable);
a tubular porous membrane (filter portion 213) carried by the tubular sidewall (paragraphs [0047 – 0048] and Figs. 6 and 7a/b), the tubular porous membrane extending (filter portion 213) across the second end to form a closed end (Fig. 6); and
the porous membrane (filter portion 213) extending across the second end (distal portion) configured to capture debris entering the first end within the central lumen while permitting blood flow through the closed end of the tubular porous membrane (paragraphs [0031 – 0032], [0047 – 0048], and Figs. 6 and 7a/b).
However, Pal is silent (i) the membrane having a distribution of pore sizes throughout the sidewall and the closed end, wherein a first group of pores of the distribution of pores has pores with a maximum dimension of no more than about 25 microns and a second group of pores of the distribution of has pores with a maximum dimension of at least about 50 microns and [claims 2, 3, 4] block particles greater than about 120 microns / 100 microns / 80 microns, (ii) the prevalence of pores in the first group is at least three times / [claim 5] at least four times the prevalence of pores in the second group, and (iii) [claims 8 and 9] wherein the sum of the area of all of the pores is at least about 30% and/or 35% of the surface area of the membrane.
As to the above, 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 throughout the side wall and the closed end (paragraph [0083]) (Examiner’s note: as stated in paragraph [0083] the porosity in any (i.e., all) of the sections of the implantable device (i.e., the membrane); therefore, Bardsley encompasses or, in the alternative, makes obvious having the distribution of pores be along the side wall and the closed wall for the purpose of forming the device as desired). Additionally, Bardsley teaches wherein the porous membrane includes a first group of pores (pores of low porosity section 210) with a maximum dimension of no more than 25 microns and a second group of pores (pores of the high porosity section 212) with a maximum dimension of at least about 50 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 pores with a max diameter of 25 microns and high porosity section 212 of the porous membrane has pores with a maximum diameter of 50 microns). Bardsley further teaches wherein the first group of pores (pores of the low porosity section 210) has at least three times and/or four 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 and/or 4:1, meaning that the number of pores in the low porosity section is 3 and/or 4 times greater than the number of pores in the high porosity section. Therefore, Bardsley encompasses wherein the low porosity section has three and/or four times as many pores as the high porosity section).
Furthermore, Bardsley, in paragraphs [0081 — 0083], discloses the porosity to be a result effective variable in that the changing porosity changes the filters impact within the body and the degree of effectiveness therein; thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the porous membrane to have the claimed distribution of the claimed pore sizes in each of the claimed sections (i.e., the sidewall portion and the closed end) with the claimed ratio of pores as it involves only adjusting a parameter disclosed as required to be adjusted. Furthermore, Applicant has not provided evidence of the criticality for: (i) the range of pores sizes, (ii) the ratio of prevalence of said pore sizes, nor (iii) wherein the sum of the area of all of the pores is at least about 30% / 35% of the surface area of the membrane. On page 2 paragraphs [0007 – 0010], 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, the ratio can be 3 or 4 to 1, and wherein sum of the area of all of the pores may be about 30% / 35% of the surface area of the membrane. However, Applicant has not provided evidence as to how the claimed pore sizes, claimed pore distribution / combination of sizes, claimed ratio of prevalence and surface area 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 filter portion of Pal by to have the pores sized and distributed as claimed 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).
Regarding claims 6 and 7, as discussed above, it would have been obvious to modify the filter portion of Pal to have the claimed pore distribution of the claimed pore sizes in the claimed ratio in view of Bardsley. Additionally, the combination teaches wherein a pressure drop across the filter is less than about 10 mm Hg / less than about 5 mm Hg at physiologic flow rates (Examiner’s note: Applicant’s disclosure, in paragraph [0067], links the pressure drop across the device to the distribution of pore sizes across the device; therefore, because the filter portion of Pal in view of Bardsley has the claimed distribution of pore sizes, then the filter portion of Pal in view of Bardsley would also have the claimed pressure drop across the filter. Thus the combination encompasses the limitation above).
Claim 10 rejected under 35 U.S.C. 103 as being unpatentable over Pal (US 2012/0095543 A1) (previously cited) in view of Bardsley et al (US 2017/0079661 A1) (previously cited), as applied to claim 1 above, and further in view of Brandies (US 2020/0268500 A1).
Regarding claim 10, as discussed above, the combination of Pal and Bardsley teaches the device of claim 1.
However, the combination of Pal and Bardsley is silent regarding (i) wherein the porous membrane is made up of electrospun fibers.
As to the above, Brandeis teaches, in the same field of endeavor, an intravascular filter (aortic protection device 500) for blocking the passage of debris (paragraph [0005]), the device comprising a self-expandable frame (first / inner layer mesh 501; which is equated to the frame of Pal) (paragraphs [0304 — 0317] and Figs. 5A — 5C) with a tubular porous membrane (second / outer layer mesh 502; which equates to the membrane of Pal) wherein the filter membrane comprises a plurality of electrospun fibers (Examiner’s note: as recited in paragraph [0014] the second mesh is made out a flexible material and as stated in paragraphs [0059] and [0158] the flexible material is an electro spun polymer thread; therefore, Brandies teaches wherein the second mesh (i.e., the porous membrane) is made out of electro spun fibers).
It should be understood that Pal (in view of Bardsley) and Brandies are known references that teach a filtering device used within the vasculature comprising a woven tubular porous membrane (See paragraphs [0047 – 0048] and Figs. 6 - 7a/b of Pal ; See abstract and paragraphs [0005], [0014], [0059], [00158] of Brandies); and the Examiner contends 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 means of forming the woven fabric mesh for another (i.e. forming the porous membrane Pal in view of Bardsley by electrospinning fibers), and the results of the substitution would have be predictable and resulted in the modified porous membrane of Pal operating as intended filtering the blood therethrough. 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. Furthermore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in forming the filter membrane of Pal by electrospinning the fibers, as it only involves making a known device by known methods of making said device, and the results would be predictable such that the filter membrane would operate as intended to filter blow flowing therethrough.
Claims 11 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pal (US 2012/0095543 A1) (previously cited) in view of Bardsley et al (US 2017/0079661 A1) (previously cited), Brandies (US 2020/0268500 A1), and Teitelbaum (US 2016/0158038 A1) (previously cited).
Regarding claims 11 – 15, Pal an embolic protection system (retrieval device 210) (abstract, paragraphs [0047], [0048], Figs. 6 and 7a/7b), comprising:
a self-expandable frame (retrieval device 210) having a proximal end and a distal end (see annotated Fig. 7b) (Examiner’s note: Pal recites in paragraph [0047] that the components that make up the retrieval device 210 are similar to those that make up the retrieval device 10, and Pal discloses paragraph [0034] that the device 10 is self-expanding device made up of shape-memory material. Therefore, Pal encompasses wherein the retrieval device 210 is also made up a shape-memory material and is a self-expandable);
a filter membrane (filter portion 213) supported by the tubular body of the self-expandable frame (retrieval device 210) and surrounding the tubular body and covering the proximal end or the distal end (paragraphs [0047 – 0048] and Figs. 6 and 7a/b); and
a transition (see annotated Fig. 7b) between the frame and a control wire extending proximally from the transition (see annotated Fig. 7b);
wherein the transition comprises a first set of wires extending proximally from the frame to a first set of connections (see annotated Fig. 7b), and a second, smaller set of wires extending proximally from the connections, and the connections are axially displaced from each other (Examiner’s note: as shown in annotated Fig. 7b, the second wires are smaller (i.e., shorter) than the first wires, and the first connections are axially displaced).
However, Pal is silent regarding [claims 11 and 15] (i) the filter membrane has a distribution of pore sizes covering the proximal end or the distal end, wherein the distribution of pores includes a first pore size with a maximum dimension of no more than about 25 microns and a second pore size greater than the first pore size with a maximum dimension of at least about 50 microns, and the first pore size is at three times as prevalent as the second pore size, (ii) wherein the distribution of pores is random, (iii) wherein the first connections are welds, [claims 12 and 13] (iv) comprising a tubular delivery catheter with an outer diameter less than 14F, the frame is carried in a reduced cross-sectional configuration within the delivery catheter, and [claim 14] (v) wherein the filter membrane comprises electrospun fibers.
As to (i), 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 porous membrane includes a first group of pores (pores of low porosity section 210) with a maximum dimension of no more than 25 microns and a second group of pores (pores of the high porosity section 212) with a maximum dimension of at least about 50 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 pores with a max diameter of 25 microns and high porosity section 212 of the porous membrane has pores with a maximum diameter of 50 microns). Bardsley further teaches 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 three times as many pores as the high porosity section).
Furthermore, Bardsley, in paragraphs [0081 — 0083], discloses the porosity is a result effective variable in that the changing porosity changes the filters impact within the body and the degree of effectiveness therein; thus one of ordinary skill in the art would have had a reasonable expectation of success in modifying the porous membrane to have the claimed distribution of the claimed pore sizes in each section (i.e., all of the sections of the tubular membrane; which includes the proximal end and distal end) with the claimed ratio of pores as it involves only adjusting a parameter disclosed as required to be adjusted. Furthermore, Applicant has not provided evidence of the criticality for the range of pores sizes and the ratio of prevalence of said pore sizes. On page 2 paragraphs [0007 – 0008], 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 can be 3 or 4 to 1. However, 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 filter portion of Pal by to have the pores sized and distributed as claimed 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).
As to (ii) and (v), Brandeis teaches, in the same field of endeavor, an intravascular filter (aortic protection device 500) for blocking the passage of debris (paragraph [0005]), the device comprising a self-expandable frame (first / inner layer mesh 501; which is equated to the frame of Pal) (paragraphs [0304 — 0317] and Figs. 5A — 5C) with a tubular porous membrane (second / outer layer mesh 502; which equates to the membrane of Pal) wherein the filter membrane comprises a plurality of electrospun fibers (Examiner’s note: as recited in paragraph [0014] the second mesh is made out a flexible material and as stated in paragraphs [0059] and [0158] the flexible material is an electro spun polymer thread; therefore, Brandies teaches wherein the second mesh (i.e., the porous membrane) is made out of electro spun fibers). Additionally, Brandies teaches in paragraph [0159] wherein the threads are weaved in random directions (Examiner’s note: as stated in paragraph [0521] each of the features of a single embodiment can be combined; therefore, the Brandies encompasses, or in the alternative, makes obvious having the electro spun fibers be woven in random directions).
It should be understood that Pal (in view of Bardsley) and Brandies are known references that teach a filtering device used within the vasculature comprising a woven tubular porous membrane (See paragraphs [0047 – 0048] and Figs. 6 - 7a/b of Pal ; See abstract and paragraphs [0005], [0014], [0059], [00158] of Brandies); and the Examiner contends 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 means of forming the woven fabric mesh for another (i.e. forming the porous membrane Pal in view of Bardsley by electrospinning fibers), and the results of the substitution would have be predictable and resulted in the modified porous membrane of Pal operating as intended filtering the blood therethrough. 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. Furthermore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in forming the filter membrane of Pal by electrospinning the fibers, as it only involves making a known device by known methods of making said device, and the results would be predictable such that the filter membrane would operate as intended to filter blow flowing therethrough. Lastly, it should be understood that the prior art makes obvious having the modified tubular membrane be comprised of electro spun fibers with the random distribution of pores. Therefore, the prior art encompasses the limitations as claimed.
As to (iii), Pal teaches in another embodiment a retrieval device 10 (which equates to the retrieval device 210) with a tubular delivery catheter (outer catheter 60) configured for housing the device 10, in a reduced cross-sectional configuration, therein during delivery and retrieval (paragraph [0042]). Furthermore, in paragraph [0042] Pal states that the outer catheter 60 is within the introducer sheath 58 and recites in paragraph [0041] wherein the introducer sheath 58 is a 4Fr to 8Fr sized catheter, therefore, because the outer catheter 60 is within the introducer sheath 58 then the outer catheter 60 must have an outer diameter of less than 4Fr to 8Fr (i.e., less than 14F) and is within the claimed range. Additionally, the Examiner notes that Pal teaches in paragraph [0049] wherein the expandable body of the retrieval device 210 expands and collapses.
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 embodiment of Figs. 6 and 7a/7b of Pal with the outer catheter of the embodiment of Figs. 1 – 5 of Pal for the purpose of housing the device in the reduced cross-section during the delivery of the device, which prevents unnecessary damage to the vessel wall that would be caused by the retrieval device in the expanded state as it is delivered through the vasculature.
As to (iv), Teitelbaum teaches a self-expandable wire frame (flow diversion device 100) comprising a plurality of wire elements 105a/b (which are equated to the first and second wires of Pal) that are longitudinally coupled to each other via staggering welds (paragraphs [0019 – 0020] and Fig. 1). It should be understood that Pal (in view of Bardsley) and Teitelbaum are known references that teach an expandable wire frame used within the body (See abstract, paragraphs [0047], [0048], Figs. 6 and 7a/7b of Pal ; See paragraphs [0019 – 0020] and Fig. 1 of Teitelbaum); and the Examiner contends it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to apply / use welding to connect two members of an expandable device, as welding is known technique for connecting two members of an expandable device and one of ordinary skill in the art would have been capable of coupling the two wires of Pal by welding and the modification would have been predictable and resulted in the modified transition zone operating as intended to expand and collapse. 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 C, outlined in MPEP 2143. Furthermore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in connecting the two wires of Pal by welding, as it only involves connecting known elements by known methods of connecting said elements.
Annotated Figure 7b of Pal
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Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “Applicant submits that Bardsley is silent regarding “the tubular porous membrane having a distribution of pore sizes throughout the sidewall and the closed end” as recited in Claim 1.”, as stated in the rejection of claims 1 and 11 above, Bardsley, in paragraph [0083], teaches wherein the porosity may vary along any portion / section of the porous membrane, thereby making it well within the purview of one of ordinary skill in the art to have the pore distribution of the modified device be along the sidewall and closed end sections of the porous membrane of Pal. Thus, the argument is not persuasive.
In response to applicant's argument that “Bardsley” is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Bardsley relates to a porous membrane for filtering fluid flow therethrough, which is reasonably pertinent to the particular problem with which the inventor, namely a filter membrane for blocking the passage of debris (Applicant’s Disclosure Paragraph [0007]). Therefore, Bardsley is considered to be analogous art.
With respect to the argument that “Additionally, the Examiner states that “Applicant has not provided evidence of the criticality for: (1) the range of pores sizes, (11) the ratio of prevalence of said pore sizes, and (111) wherein the sum of the area of all of the pores is at least about 30% / 35% of the surface area of the membrane.”” However, evidence of the importance of these features can be found throughout the Specification as Filed. MPEP 716.02(f) states that “the totality of the record must be considered when determining whether a claimed invention would have been obvious to one of ordinary skill in the art at the time the invention was made.”” and “The Specification as filed states, for example, that “the filter pore size preferably substantially maintains filter efficiency”, “this pore size distribution creates multiple levels of filtering, created by the multiple average pore size groups in the filter,” and “additional filtering is achieved with no clinically significant reduction on blood flow to the brain, and in some implementations no measurable drop in pressure across the membrane.” Paragraphs [0060], [0064], and [0065]. Additional support for the criticality of these features may be found in paragraphs [0067]-[0070]. Therefore, Applicant further submits that one of skill in the art would not modify the device of Pal in light of Bardsley.”, the Examiner acknowledges the importance of the pore size and the other claimed ranges of the Instant device. However, Applicant’s disclosure does not provide criticality for the claimed ranges such that the device of Pal in view of Bardsley would operate differently than the device of the Instant Application with the claimed ranges. Criticality must be tied to unexpected results, such that the device of the Instant Application with the claimed ranges produces an unexpected result that would not be produced by the device of the prior art having the claimed ranges. Therefore, because Applicant has not provided evidence to prove that the device of Pal in view of Bardsley would not operate as intended with the pore distribution within the claimed ranges, the argument is found to be not persuasive.
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.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771