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
Claims filed on September 18th, 2025 have been entered. Claims 14- 16 remain withdrawn for being drawn to a nonelected species. The amendment to claim 12 overcomes the previous claim objection.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-2 and 9 under 35 U.S.C. 102(a)(1) as being anticipated by Bates (US 2007/0142856) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Bates ‘571 (US 2013/0253571) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
The rejection of claim 4 under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Long (US 2018/0206862) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
The rejection of claims 5-7 and 11- 13 under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Eidenschink (US 2014/0257362) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
The rejection of claim 8 under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Eidenschink (US 2014/0257362) in further view of Brown et al. (US 2007/0265710) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
The rejection of claim 10 under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Panetta et al. (US 2005/0038468) has been withdrawn in light of applicant’s amendment; specifically Bates does not teach a mesh braid disposed on an internal catheter extending through the central lumen of the inner catheter.
Claim(s) 1-2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142856) in view of Tsugita (CA 2345655), as evidenced by the Merriam-Webster Dictionary.
Regarding claim 1, Bates teaches a catheter assembly (catheter 20)(Figs. 2- 5F) for providing embolic protection during an interventional procedure (abstract, Paragraphs 0031 and 0036), comprising:
An outer catheter (sheath 24) extending from a proximal end (26) to a distal end (25) and having an interior lumen (Paragraph 0037);
An inner catheter (catheter shaft 21) having an exterior surface and a central lumen (guidewire lumen mentioned in Paragraph 0038), the inner catheter extending from a proximal end to a distal end through the interior lumen of the outer catheter (see annotated Fig. 2 below)(Paragraph 0037);
An internal catheter (guide wire 35)(Merriam-Webster teaches that a catheter is defined as “a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection of withdrawal of fluids or to keep a passage open”, as the guidewire is a tubular medical device that is inserted into a vessel (Bates, Paragraphs 0031 and 0038), it is considered a catheter.) extending through the central lumen of the inner catheter (Paragraph 0038);
A compliant balloon (27)(Paragraph 0040) coupled to the exterior surface of the inner catheter at the distal end of the inner catheter (see annotated Fig. 3B below)(Paragraph 0037);
A mesh net (filter 32)(Paragraphs 0037 and 0044) coupled to the exterior surface of the inner catheter proximal to the compliant balloon (see annotated Fig. 3B below); and
Wherein the outer catheter (sheath 24) is movable between a first position and a second position with respect to the inner catheter (catheter shaft 21), such that in the first position the mesh net (filter 32, including struts 33) is in an expanded configuration and in the second position the mesh net is in a contracted configuration (see annotated Figs. 3A and 3B below)(Paragraph 0048).
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Bates does not teach a mesh braid disposed on the internal catheter, wherein the internal catheter is movable between a first position and second position with respect to the inner catheter, such that in the first position the mesh braid is distal to the compliant balloon and configured to be actuated into an expanded configuration and in the second position the mesh braid is arranged within the central lumen of the inner catheter.
Tsugita teaches a catheter assembly (abstract)(Figs. 3A- 3C) for providing embolic protection during an interventional procedure (abstract, Page 15, Lines 3- 11), comprising: an outer catheter (guiding catheter 30) having an interior lumen (lumen 33), an inner catheter (angioplasty catheter 50) having an exterior surface, the inner catheter extending through the interior lumen of the outer catheter (Page 15, Lines 14- 16); an internal catheter (guidewire 10)( Merriam-Webster teaches that a catheter is defined as “a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection of withdrawal of fluids or to keep a passage open”, as the guidewire is a tubular medical device that is inserted into a vessel (Tsugita, Page 15, Lines 3- 5 and 10- 11), it is considered a catheter.) extending through the central lumen of the inner catheter (Page 15, Lines 10- 11); a compliant balloon (balloon 52) coupled to the exterior surface of the inner catheter at the distal end of the inner catheter; a balloon (40); a mesh braid (20, 25, 27) disposed on the internal catheter (see annotated Fig. 3B below) and wherein the internal catheter is movable between a first position and second position with respect to the inner catheter, such that in the first position the mesh braid is distal to the compliant balloon and configured to be actuated into an expanded configuration and in the second position the mesh braid is arranged within the central lumen of the inner catheter (Page 15, Lines 4- 9 and Page 16, Lines 9- 16).
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It would have been obvious to one of ordinary skill in the art to modify the internal catheter as taught by Bates to have a mesh braid disposed on the internal catheter as taught by Tsugita, as Tsugita teaches that the mesh braid “is porous enough to allow adequate blood flow in a blood vessel while capturing mobile emboli” (Page 9, Lines 20- 21).
Regarding claim 2, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates further teaches wherein the mesh net has a diameter that increases from a proximal end to a distal end as the mesh net extends distally along a longitudinal axis of the catheter assembly (see annotated Fig. 2 below).
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Regarding claim 9, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates further teaches wherein the mesh net is contracted into a closed state when the outer catheter (sheath 24) is moved distally over the mesh net (filter 32, including struts 33) from the first position to the second position (Paragraphs 0048 and 0053).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142858) in view of Tsugita (CA 2345655), as applied to claim 1 above, in further view of Bates ‘571 (US 2013/0253571).
Regarding claim 3, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates and Tsugita do not teach wherein the mesh net includes an extended portion at its distal end over which the diameter of the mesh net is substantially constant.
Bates ‘571 teaches a similar catheter assembly (100)(abstract)(Figs. 1A- 1C) with an outer catheter (sheath 110) with a lumen (Paragraph 008), a mesh net (filter 120) coupled to the outer catheter (Paragraph 0029), wherein the mesh net has a diameter that increases from a proximal end to a distal end as the mesh net extends distally along a longitudinal axis of the catheter assembly (see annotated Fig. 1B below), and wherein the mesh net includes an extended portion (first ring 123) at its distal end over which the diameter of the mesh net is substantially constant (see annotated Fig. 1B below)(Paragraph 0032).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mesh net as taught by the combination to have an extended portion at its distal end as taught by Bates ‘571, since Bates ‘571 teaches that the extended portion allows for the filter to securely sit against the wall of a vessel and prevent “emboli from slipping past the filter” (Paragraph 0032).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142858) in view of Tsugita (CA 2345655), as applied to claim 1 above, in further view of Long (US 2018/0206862).
Regarding claim 4, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates and Tsugita do not teach wherein the mesh net comprises a single layer coupled to and extending distally from the inner catheter at a first attachment point, folded over at the distal end of the mesh net, and coupled to the inner catheter at a second attachment point that is distal to and adjacent the first attachment point. Long teaches a similar catheter assembly (peripheral embolectomy system 200)(Fig. 2A) for providing embolic protection during an interventional procedure (abstract)(Paragraph 0049) comprising an outer catheter (capture sleeve 210) having an interior lumen (see Fig. 2B, a shaft 211 extends through the catheter, therefore the catheter has a lumen), an inner catheter (shaft 211), a mesh net (funnel 216) coupled to the distal end of the outer catheter (Paragraph 0055) and a compliant balloon (compression device 220)(Paragraph 0050). Long further teaches wherein the mesh net comprises a single layer coupled to and extending distally from the inner catheter at a first attachment point, folded over at the distal end of the mesh net, and coupled to the inner catheter at a second attachment point that is distal to and adjacent the first attachment point (Paragraph 0057, as Long teaches that the mesh net (216) is inverted on itself and then heat set into the funnel shape, it would be obvious to one of ordinary skill in the art that the folded end can be attached to the inner catheter further down from the initial attachment point. Therefore, for purposes of examination, the first attachment point is the point from the part of the mesh net that was inverted, and the second attachment point is the initial attachment point of the mesh net.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the mesh net to be the mesh net as taught by Long for the purpose of capturing debris during a procedure (Bates, abstract and Paragraph 0044; Long, abstract and Paragraph 0065). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one mesh net for another because both mesh nets are disclosed as equivalent structures for capturing debris during a procedure (Bates, abstract and Paragraph 0044; Long, abstract and Paragraph 0065) and substitution of one for the other would have resulted in the predictable result of providing a mesh net that captures debris during a procedure. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 5- 7 and 11- 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142858 in view of Tsugita (CA 2345655), as applied to claim 1 above, in further view of Eidenschink (US 2014/0257362).
Regarding claims 5, 6, and 7, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates and Tsugita are silent to wherein the mesh net is composed of nitinol which is a shape- memory material and a shape- memory alloy.
Eidenschink teaches a similar catheter assembly (abstract and Paragraph 0019)(Figs. 1- 5C) comprising: an outer catheter (sheath 55) having an interior lumen (Paragraph 0023), an inner catheter (pull- wire support sleeve 50) extending through the lumen (Paragraph 0023), a mesh net (15), wherein the mesh net is composed of nitinol, which is a shape-memory material and a shape- memory alloy (Paragraph 0020).
It would have been obvious to one of ordinary skill in the art to modify the mesh net as taught by the combination to be composed of nitinol, since Eidenschink teaches that nitinol is “readily collapsible and that will automatically expand to an operative shape upon deployment” (Paragraph 0020).
Regarding claims 11, 12, and 13, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates does not teach the catheter assembly further comprising a closure mechanism arranged at the distal end of the mesh net and operable to reduce the diameter of the mesh net at the distal end of the mesh net, wherein the closure mechanism comprises one of a string or a wire extending around a circumference of the mesh net at the distal end of the mesh net, or wherein the closure mechanism is operated to close the mesh net by actuating one of a wire or a string coupled to the closure mechanism.
Eidenschink teaches a similar catheter assembly (abstract and Paragraph 0019)(Figs. 1- 5C) comprising: an outer catheter (sheath 55) having an interior lumen (Paragraph 0023), an inner catheter (pull- wire support sleeve 50) extending through the lumen (Paragraph 0023), a mesh net (15), a closure mechanism (snare 20 and pull wire 35) arranged at the distal end of the mesh net and operable to reduce the diameter of the mesh net at the distal end of the mesh net (Paragraphs 0025, 0026, and 0036), wherein the closure mechanism comprises a wire (snare 20) extending around a circumference of the mesh net at the distal end of the mesh net (Paragraph 0026), and wherein the closure mechanism is operated to close the mesh net by actuating a wire (pull wire 35) coupled to the closure mechanism (Paragraphs 0028 and 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter assembly as taught by Bates to have the closure mechanism, including the wire and the actuation wire, as taught by Eidenschink, since Eidenschink teaches that the closure mechanism captures and holds “any plaque and/or thrombus” during treatment (Paragraph 0030) thus preventing the thrombus from escaping the mesh net.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142858) in view of Tsugita (CA 2345655) and in view of Eidenschink (US 2014/0257362), as applied to claim 5 above, in further view of Brown et al. (US 2007/0265710).
Regarding claim 8, Bates, Tsugita, and Eidenschink make obvious the catheter assembly as discussed above.
Bates, Tsugita, and Eidenschink do not teach wherein the shape-memory material is a shape- memory polymer.
Brown (Brown et al.) teaches a device for use in the body (abstract)(Figs. 1- 2) comprising a biocompatible mesh net (10) made of a shape- memory material that is a shape-memory polymer (Paragraph 0007).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mesh net as taught by the combination to be made of a shape- memory polymer as taught by Brown, as the shape-memory polymer can be used in place of nitinol (Paragraph 0007 of Brown) and as Bates teaches part of the mesh net being made of a shape-memory material (Paragraph 0046 of Bates).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 2007/0142858) in view of Tsugita (CA 2345655), as applied to claim 1 above, in further view of Panetta et al. (US 2005/0038468).
Regarding claim 10, Bates and Tsugita make obvious the catheter assembly as discussed above.
Bates further teaches wherein the mesh net and the compliant balloon are separated by a distance (see annotated Fig. 2 below).
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Bates and Tsugita are silent to wherein the mesh net is spaced apart from the compliant balloon by a separation distance between 0 and 1 inch.
Panetta (Panetta et al.) teaches a similar catheter assembly (abstract)(Fig. 2) with a catheter (10), a compliant balloon (expandable balloon 14), and a mesh net (filter assembly 16) coupled to the catheter (Paragraph 0048). Panetta further teaches wherein the mesh net is spaced apart from the compliant balloon by a separation distance between 0 and 22 mm (Paragraph 0067)(The conversion of millimeters to inches shows that 22 mm is about 0.866 inches.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the mesh net and the compliant balloon be within the range as taught by Panetta, since Panetta teaches that this range allows for fluid to flow past the balloon and into the filter so that it maintains its shape and expansion (Paragraph 0067)
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be between 0 to 1 inch, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Response to Arguments
Regarding applicant’s arguments filed on September 18th, 2025, with respect to the 102 rejection of claims 1-2 and 9 over Bates and the 103 rejections have been fully considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments. However, it is noted that Bates is still relied upon.
Applicant’s arguments, see Pages 6- 8, regarding Bates not teaching an internal catheter has been fully considered but is not persuasive. As discussed above, Bates teaches an internal catheter (guide wire 35)(Merriam-Webster teaches that a catheter is defined as “a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection of withdrawal of fluids or to keep a passage open”, as the guidewire is a tubular medical device that is inserted into a vessel (Bates, Paragraphs 0031 and 0038), it is considered a catheter.) extending through the central lumen of the inner catheter (Paragraph 0038).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771