Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The amendments to the claims have overcome the previously presented claim objections and 35 USC 112b rejections. No specific arguments are presented with respect to the previously presented nonstatutory double patenting rejections, which are being maintained.
Applicant's arguments filed 4/2/2026 with respect to the 35 USC 103 rejections over Paul, JR. et al. in view of Saito (and in further view of Obana, Frimerman, or Anderson) have been fully considered but they are not persuasive. Applicant asserts that Paul fails to disclose a bag portion free of any frame or support structure because the bag portion (12) includes a second end engaged by a lumen formed in guiding member (16), considered the claimed “elongate member”. The examiner respectfully disagrees. Attachment of one end of the bag portion to the lumen of guiding member (16) does not appear to contradict the limitation of the bag portion being “free of any frame or support structure” as understood in view of the specification of the instant application since the bag portion of the instant application is disclosed as being attached to an area of the tip (108) of the elongate member (102) via weld or adhesive while still being considered free of any frame or support structure (see [0044], [0061]-[0062], [0077]-[0078] of the specification as filed 6/27/2024). According to the abstract of the instant application, the vascular filtering devices include an elongate member having an unsupported membrane bag portion attached thereto (emphasis added). Thus, a bag portion that is attached to the elongate member is still considered free of any frame or support structure if the bag portion itself does not include a frame or other support structure. The examiner considers only the membranous material (woven material formed by Dacron, Nylon or ePTFE filaments 19; [0025]) forming flexible filter portion (12) of Paul to be the claimed bag portion, and this portion (i.e., 12 only) is free of any frame or support structure as it is comprised entirely (and only) of the membranous material (woven filaments 19). Noting that the claim requires a bag portion, the bag portion may alternatively be considered only a portion of filter portion (12) of Paul that is not in contact with the lumen of the elongate member when the filter is expanded as shown in fig. 3 of Paul, and thus the bag portion is free of any frame or support in the expanded configuration even assuming arguendo the limitation “free of any frame or support structure” precludes direct contact of the bag portion to the elongate member (though this interpretation appears to contradict the instant application’s description of a bag portion that is attached directly to the elongate member via weld or adhesive and still considered free of any frame or support).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-10, 13-14, 16-18, 28-29 and 31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul, JR. et al. (US 2007/0112374) in view of Saito (US 2006/0173489)
Paul discloses a vascular filtration device comprising: an elongate member (16; fig. 1) including a wall and having a lumen, a first end, a second end, a first end portion adjacent the first end, a second end portion adjacent the second end, and one or more apertures (15; fig. 1-5) in the wall of the elongate member, each of the one or more apertures being in fluid communication with the lumen of the elongate member (16); a bag portion (12) positioned along the first end portion of the elongate member, the bag portion being free of any frame or support structure (noting only 12 is considered the bag portion) and comprised of a membranous material (woven material formed by Dacron, Nylon or ePTFE filaments 19; [0025]); and a plurality of elongate extensions (14) attached to the bag portion, the plurality of elongate extensions (14) extending to the second end of the elongate member ([0027]), each of the plurality of elongate extensions extending through an aperture of the one or more apertures (15; figs. 1-5) and through the lumen of the elongate member. Paul discloses that proximal movement of the extensions (14) cause the bag portion to evert and can be used to pull the bag portion tightly against the elongate member (16) ([0027]). Although Paul does not expressly disclose that each of the plurality of elongate extensions (14) exit the lumen at the second end portion (i.e., proximal end portion) of the elongate member, such a modification to the prior art of Paul would have been obvious in order to allow the user to grasp the proximal ends of the extensions to control the proximal movement of the extensions described by Paul. Although Paul discloses that the plurality of elongate extensions attach to the bag portion ([0027]), Paul does not expressly disclose that the plurality of extensions comprise the membranous material.
Saito discloses another vascular filtration device comprising an elongate member (1 or 10), a bag portion (4) free of any frame or support structure and comprised of a membranous material (filaments woven and twined together), and a plurality of elongate extensions (3) comprised of the membranous material. In particular, Saito discloses that the elongate extensions are integrally formed with the bag portion by twining the ends of the filaments of the membranous material to form each of the elongate extensions ([0019]). This simplifies manufacturing and advantageously allowing a smaller reduced profile by getting rid of any swollen nodal points that result from having to mechanically attach the elongate extensions to the bag portion ([0020]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Paul to integrally form the plurality of extensions from a portion of the membranous material forming the bag portion in view of Saito’s teaching in order to dispense processing to separately join the elongate extensions with the bag portion, thereby avoiding any swollen nodal parts.
Regarding claim 2, the membranous material is porous (woven ePTFE; [0025] of Paul).
Regarding claim 3, the membranous material is operable to permit blood to pass through the membranous material when the vascular filtration device is deployed in a blood vessel of a patient, and is operable to prevent embolic debris from passing through the porous membrane ([0026] of Paul).
Regarding claim 4, the plurality of elongate extensions and the bag portion are formed from a single sheet of material as taught by Saito (see fig. 2), noting that the sheet is then formed into a curved bag portion, similar to the instant application.
Regarding claim 5, the membranous material is comprised of ePTFE ([0025] of Paul).
Regarding claim 6, the elongate member includes a total number of apertures in the wall of the elongate member equal to a total number of elongate extensions of the plurality of elongate extensions, and where each elongate extension passes through a separate aperture in the wall of the elongate member (see figs. 1-5 of Paul).
Regarding claim 7, Paul discloses that the elongate member has two apertures in the wall of the elongate member each receiving a respective one of the elongate extensions. However, it would have been obvious to add another elongate extension and corresponding aperture to the prior art of Paul in view of Saito’s teaching that it is known to have more than three elongate extensions connected to a bag portion as alternative to two elongate extensions (see [0046]) and such a modification can be considered a mere duplication of the essential working parts of a device, which has been held to involve only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 8, the plurality of elongate extensions extend from the bag portion toward the second end portion of the elongate member (see figs. 1-5 of Paul).
Regarding claim 9, the plurality of elongate extensions are spaced approximately equidistantly about a perimeter of the bag portion (see figs. 1-6 of Paul).
Regarding claim 10, an application of a force to the plurality of elongate extensions imparts a distributed force about the perimeter of the bag portion (as understood in view of figs. 1-5).
Regarding claim 13, the elongate member (16) is a tubular member, and wherein the lumen is a central lumen of the tubular member.
Regarding claim 14, the elongate member is a tubular member, and the lumen is defined within the wall of the tubular member (noting the central lumen is surrounded by wall of the tubular member as understood in view of figs. 1-5 of Paul).
Regarding claim 16, the elongate member of Paul comprises a guidewire. It is noted that claim 1, from which claim 16 depends, requires a lumen, which is best understood as being present in the elongate member (see 35 USC 112b rejection above). Because the elongate member of Paul can be used to guide another catheter having a larger diameter than that of the elongate member to a site within the body, it is considered a guidewire, noting guidewires can be hollow and the term “guide” is drawn to an intended use.
Regarding claim 17, the elongate member comprises a hypotube (fig. 1-5 of Paul).
Regarding claim 18, an application of a proximally directed force to the plurality of elongate extensions causes the bag portion to collapse against an external surface of the elongate member (see fig. 4 to fig. 5).
Regarding claim 28, Paul discloses a vascular filtration device comprising: an elongate member (16) having a lumen extending from a proximal region of the elongate member; a bag portion (12) positioned along a distal portion of the elongate member, the bag portion not including a frame or support structure (noting bag portion comprises only woven ePTFE filaments 19; [0025]) and comprised of a membrane (woven ePTFE); and a plurality of elongate extensions (14) attached to the bag portion, and wherein each elongate extension extends through the lumen of the elongate member (via apertures 15; figs. 1-5). Paul discloses that proximal movement of the extensions (14) causes the bag portion to evert and can be used to pull the bag portion tightly against the elongate member (18). Although Paul does not expressly disclose that each of the plurality of elongate extensions exit the lumen at the second end portion (i.e., proximal end portion) of the elongate member, such a modification to the prior art of Paul would have been obvious in order to allow the user to grasp the proximal ends of the extensions to control movement of the extensions proximally relative to the elongate tube. Paul fails to disclose that the elongate extensions are integral with the bag portion such that the bag portion and the elongate extensions form a unibody.
Saito discloses another vascular filtration device comprising an elongate member (1 or 10), a bag portion (4) free of any frame or support structure and comprised of a membranous material (filaments woven and twined together), and a plurality of elongate extensions (3) integral with the bag portion such that the bag portion and the elongate extensions form a unibody. In particular, Saito discloses that the elongate extensions are integrally formed with the bag portion by twining the ends of the filaments of the membranous material of the bag portion to form each of the elongate extensions ([0019]). This simplifies manufacturing and advantageously allowing a smaller reduced profile by getting rid of any swollen nodal points that result from having to mechanically attach the elongate extensions to the bag portion ([0020]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Paul to integrally form the plurality of elongate extensions (14) with the bag portion (12) such that the bag portion and the elongate extensions form a unibody in view of Saito’s teaching in order to dispense processing to separately join the elongate extensions with the bag portion, thereby avoiding any swollen nodal parts.
Regarding claim 29, the bag portion comprises a porous membrane (woven ePTFE; [0025], [0026] of Paul) and the plurality of elongate extensions do not comprise the porous membrane (the elongate extensions comprise extension of strands forming porous portion of membrane that have been twined together as taught by Saito; strands, although part of the membrane, are not porous as they are not woven in the same manner as the bag portion of the membrane).
Regarding claim 31, a rim of the bag portion of Paul comprises only the membrane (woven ePTFE) as disclosed by Paul.
Claims 11 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul in view of Saito as applied to claim 11 above, and further in view of Obana et al. (US 2006/0100658). Paul in view of Saito discloses the invention substantially as stated above including an elongate member (16) that is able to traverse vasculature (see figs. 1-6), but does not expressly disclose that the elongate member comprises a shapeable tip portion comprising a coil.
Obana discloses another filtration device comprising an elongate member (40; figs. 6a-c) and a bag portion (filter 50). The elongate member comprises a shapeable tip portion (noting tip portion has curved to follow the path of vasculature; fig. 1), the shapeable tip portion comprising a coil (41; noting coil extends all the way to radiopaque marker 42; fig. 2 and [0034])). As is known in the art, such reinforcement coils enhance pushabiity of a medical tube and maintain dimensional stability of the tube. It would have been obvious to one of ordinary skill in the art to have modified the tip portion of the elongate member of Paul to be shapeable and comprise a coil in view of Obana in order to allow the tip portion to bend/curve during advancement through tortuous vasculature, to enhance pushability of the elongate member through vasculature, and to maintain dimensional stability along its length.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul in view of Saito as applied to claim 14 above, and further in view of Frimerman (US 2010/0262219). Paul discloses an elongate member comprises a tubular member that includes a central lumen, but fails to disclose a lumen defined within a wall of the tubular member in addition to the central lumen.
Frimerman discloses another filtration device comprising an elongate member (32), a bag portion (42) and an elongate extension (44), wherein the elongate member comprises a central lumen (39) housing a wire (38), and a lumen (57) defined within the wall of the elongate member (see fig. 2c) housing the elongate extension. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Paul to include, in addition to the central lumen, a lumen defined within a wall of the tubular member for each of the elongate extensions in view of the teachings of Frimerman in order to prevent interference between the elongate extensions and the advancement member (17) by providing each with its own isolated lumen as understood by one of ordinary skill in the art.
Claim 19-21 and 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul in view of Saito as applied to claim 1 above, and further in view of Anderson et al. (US 2003/0171771). Regarding claim 19, Paul in view of Saito disclose the invention substantially as stated above except for a first stop member operable to limit an amount of distal translation of an elongate extension of the plurality of elongate extensions of the bag portion.
Anderson discloses another filtration device comprising an elongate member (142; fig. 14D), a bag portion (141d) and an elongate extension (147d). Anderson teaches providing a first stop member (149b) operable to limit an amount of distal translation of the elongate extension. Regarding claims 20 and 21, the first stop member (149b; fig. 14D) is disposed proximal of the second end portion (149a) of the elongate member, and proximal of the one or more apertures (aperture at end of elongate member) in the wall of the elongate member. The first stop member ensures that the elongate extension (147d) and the elongate member (142) do not become disassociated during use ([0082]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Paul in view of the teachings of Anderson to include a stop member on an elongate extension of each of the plurality of elongate extensions proximal of the second end portion of the elongate member and proximal of the apertures in the wall of the elongate member in order to ensure that the elongate extensions do not become disassociated with the apertures of the elongate member during use. Regarding claim 23, a stop member on one of the elongate extensions of Paul as modified in view of Saito and Anderson can be considered the claimed first stop member while the stop member on the other of the elongate extensions of Paul can be considered the claimed second stop member.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paul in view of Saito and Anderson as applied to claim 19 above, and further in view of Drake et al. (US 2009/0326631). Paul in view of Saito and Anderson discloses the invention substantially as stated above (see claim 19, noting 35 USC 112b rejection above) including a first stop member, but fails to disclose that the first stop member comprises a knot in at least one of the elongate extensions of the plurality of elongate extensions of the bag portion.
In the same field of endeavor, namely medical treatment devices, Rafiee teaches a first stop member (109), wherein the first stop member comprises a knot (paragraph 0041) in at least one of the elongate extensions of the plurality of elongate extensions (see figure 3). It would have been obvious to one of ordinary skill in the art at the time of applicant's invention to have provided the stop member of Paul in view of Saito and Anderson in the form of a knot in view of Rafiee’s teaching that it is known to provide an enlargement along the length of an elongate extension that serves as a stop member in the form of a knot, and such a modification can be considered a substitution of one form of stop member for another, wherein the results are predictable (knot forms a stop to ensure free end of the elongated extension does not pull through the aperture in the elongate member) and one skilled in the art would have had a reasonable expectation of success.
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 1-12 and 16-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-21, respectively, of U.S. Patent No. 12,042,370. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are merely broader than the above listed claims of ‘370 and are therefore “anticipated” by claims 1-12 and 14-21, respectively, of ‘370.
Claims (28,31) and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1) and 6, respectively, of U.S. Patent No. 10,143,545 in view of Paul. Claims (1) and 6 claim the invention of claims (28,31) and 29 substantially except for specifically claiming that the bag portion does not include a frame or support structure. However, such unsupported bag portions of filtration devices are known in the art according to Paul. Paul discloses a filtration device having a bag portion (12) free of any frame or support structure (noting extensions 14 do not pass inside of bag) as a known alternative to a bag portion with a frame structure (figs. 6-8; control wires 42 pass within bag portion to form frame; [0036]). It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1 and 6 of ‘545 to have a bag portion that does not include a frame or support structure in view of Paul’s teaching that a mesh bag portion free of any support or frame is able to effectively expand within a blood vessel to filter out debris, and is a known alternative to a bag portion that comprises a support structure. Regarding claim 31, the rim of the bag portion comprises only the membrane (woven fibers 19) as further taught by Paul.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KSH 5/22/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Prosecution Insights