DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed April 6, 2026 has been entered. Claims 21-26, 28-47, and 49-66 are currently pending.
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 21-26, 28-47, and 49-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-59 of U.S. Patent No. 11,065,017. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a catheter, an elongate body insertable through the catheter, the elongate body (or guidewire) comprising one or more perforations and an inflatable membrane seal. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 21-26, 28-47, and 49-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 14-24, and 38-40 of U.S. Patent No. 11,793,532. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a catheter, an elongate body insertable through the catheter, the elongate body comprising one or more perforations and an inflatable membrane seal. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 21-26, 28-47, and 49-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,950,795. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a catheter, an elongate body insertable through the catheter, the elongate body (or guidewire) comprising one or more perforations and an inflatable membrane seal. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 21-26, 28-47, and 49-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,336,727. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a catheter, an elongate body insertable through the catheter, the elongate body (or guidewire) comprising one or more perforations and an inflatable membrane seal. The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
Claim(s) 21-26 and 49-53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kokish et al. (US 6,485,500, hereinafter “Kokish”).
Regarding claim 21, Kokish discloses an intravascular system for removing a blood clot from a blood vessel, comprising:
a catheter (50) configured to be inserted into the blood vessel, the catheter defining a lumen therethrough (Figs 3, 4); and
an elongate body (352) configured to be inserted through the lumen of the catheter (Fig 14), the elongate body defining a lumen (366) therethrough;
and an inflatable membrane seal (inflatable balloon 362) having a distal end coupled to the elongate body (col 20, ln 50-66) and an opening between a proximal-most end of the inflatable membrane seal and the elongate body (at least one of the openings 364 at the proximal end) (col 20, ln 66 - col 21, ln 9),
the inflatable membrane seal being configured to transition between a delivery configuration (uninflated configuration) in which the inflatable membrane seal has a first cross-sectional area and a deployed configuration (inflated configuration; Fig 14) in which the inflatable membrane seal is radially expanded to a second cross-sectional area greater than the first cross-sectional area,
the inflatable membrane seal configured to be delivered via the elongate body in its delivery configuration through the lumen of the catheter, beyond the blood clot, and disposed distal to the blood clot, with the catheter remaining proximal to the blood clot (Figs 3, 4 – fully capable of positioning inflatable membrane seal distal and beyond blood clot and positioning catheter proximal to the blood clot),
the inflatable membrane seal configured to transition from the delivery configuration to the deployed configuration in response to fluid conveyed via the lumen of the elongate body (inflation fluid) and into a volume defined by and within the inflatable membrane seal (within balloon), and such that the inflatable membrane seal forms and maintains a pressure seal against an interior wall surface of the blood vessel distal to the blood clot, thereby limiting any blood flow across the inflatable membrane seal (col 20, ln 62-col 21, ln 10).
[AltContent: textbox (At least one perforation in elongate body)][AltContent: textbox (Proximal-most end extending proximally to attach to elongate body)]
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[AltContent: textbox (Clot position – such that seal positioned distal to clot and catheter remaining proximal to clot)][AltContent: textbox (Catheter)]
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[AltContent: connector][AltContent: textbox (Continuous elongate body section spanning area between blood clot and interior vessel wall)][AltContent: ][AltContent: textbox (PROXIMAL)][AltContent: textbox (DISTAL)]
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Regarding claim 22, wherein the proximal-most end of the inflatable membrane seal extends proximally and is at least partially attached to the elongate body (Figs 4, 14).
Regarding claim 23, wherein the elongate body has a section proximal to the inflatable membrane that is configured to span an area between the blood clot and an interior wall surface of the blood vessel against which the blood clot abuts, the section being continuous such that the fluid conveyed via the lumen does not contact the blood clot before exiting the opening between elongate body and the proximal-most end of the inflatable membrane seal (see annotated Fig 4 above).
Regarding claims 24-26, wherein the inflatable membrane seal (362) is devoid of a stent structure, frame structure, or shape memory material (Figs 4, 14; balloon material).
Regarding claim 49, wherein at least a portion of the proximal-most end of the inflatable membrane seal is coupled to the elongate body (see annotated Fig 14 above).
Regarding claim 50, wherein only a portion of the proximal-most end of the inflatable membrane seal is coupled to the elongate body to form an incomplete seal between the inflatable membrane seal and the elongate body (see annotated Fig 14 above; forms incomplete seal due to the presence of openings 364).
Regarding claim 51, wherein the opening (364) between the elongate body and the proximal-most end of the inflatable membrane seal is configured to allow the fluid to be in fluid communication with an area distal to the clot and proximal to the inflatable membrane seal when the inflatable membrane seal is in the deployed configuration, disposed distal to the clot, and maintains the pressure seal against the interior wall surface of the blood vessel distal to the blood clot (see annotated Fig 14 above; fluid configured to flow proximally from opening 364 to the area as claimed).
Regarding claim 52, wherein the elongate body (352) is a guidewire (col 20, ln 58-66).
Regarding claim 53, wherein a distal tip (354) of the elongate body (352) is a guidewire (col 20, ln 58-66).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 29 and 55-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokish (US 6,485,500) in view of Walzman (US 10,342,573, hereinafter “Walzman”).
Regarding claim 29, Kokish discloses the invention substantially as claimed, as shown above. However, Kokish fails to disclose the fluid for inflating and expanding the membrane seal (362) comprises a dye. Walzman discloses a method of treating a vessel including introducing a fluid through at least one perforation in an elongate body for irrigating the vessel and teaches the procedure “can be further monitored actively by using a combination of contrast in the irrigant, and irrigating under fluoroscopic guidance, so irrigation can be stopped if it is seen to be overcoming the aspiration” (col 3, In 4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kokish such that the fluid delivery apparatus delivered an imaging agent for the purpose of allowing the procedure to be actively monitored under fluoroscopy, as taught by Walzman.
Regarding claim 55, Kokish discloses the invention substantially as claimed including an intravascular system for imaging and removing a blood clot intact from a blood vessel (fully capable of being used to image and remove a blood clot intact from a blood vessel), comprising:
a catheter (50) configured to be inserted into the blood vessel, the catheter defining a lumen therethrough (Figs 3, 4), the catheter configured to apply a suction fluid pressure proximal to the blood clot to urge the blood clot proximally towards the catheter within the blood vessel (through evacuation port 60; fully capable of having a vacuum source connected to catheter 50); and
an elongate body (352) configured to be inserted through the lumen of the catheter (Fig 14), the elongate body defining a lumen (366) therethrough;
an inflatable membrane seal (inflatable balloon 362) coupled to the elongate body (col 20, ln 50-66), a proximal portion of the inflatable membrane seal defining a hole (at least one of the openings 364 at the proximal end) (col 20, ln 66 - col 21, ln 9),
the inflatable membrane seal being configured to transition between a delivery configuration (uninflated configuration) in which the inflatable membrane seal has a first cross-sectional area and a deployed configuration (inflated configuration; Fig 14) in which the inflatable membrane seal is radially expanded to a second cross-sectional area greater than the first cross-sectional area,
the inflatable membrane seal configured to be delivered via the elongate body in its delivery configuration through the lumen of the catheter, beyond the blood clot, and disposed distal to the blood clot, with the catheter remaining proximal to the blood clot (Figs 3, 4 – fully capable of positioning inflatable membrane seal distal and beyond blood clot and positioning catheter proximal to the blood clot),
the inflatable membrane seal configured to transition from the delivery configuration to the deployed configuration in response to fluid conveyed via the lumen of the elongate body (inflation fluid) and into a volume defined by and within the inflatable membrane seal (within balloon), and such that the inflatable membrane seal forms and maintains a pressure seal against an interior wall surface of the blood vessel distal to the blood clot, thereby limiting any blood flow across the inflatable membrane seal (col 20, ln 62-col 21, ln 10),
the hole in the inflatable seal configured to allow the fluid to exit the volume of the inflatable seal to increase a pressure within an area between the blood clot and the inflatable seal to dislodge the blood clot from the vessel while the blood clot is intact (see annotated Fig 14 above; fluid configured to flow proximally from opening 364 to the area as claimed and fully capable of dislodging the blood clot while the blood clot is intact depending on the size and composition of the blood clot),
However, Kokish fails to disclose the fluid for inflating and expanding the membrane seal (362) comprises a dye. Walzman discloses a method of treating a vessel including introducing a fluid through at least one perforation in an elongate body for irrigating the vessel and teaches the procedure “can be further monitored actively by using a combination of contrast in the irrigant, and irrigating under fluoroscopic guidance, so irrigation can be stopped if it is seen to be overcoming the aspiration” (col 3, In 4-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kokish such that the fluid delivered through the elongate body comprised an imaging agent viewable via an imaging modality when the imaging agent is disposed within the area (see annotated Fig 14 above) such that at least a portion of the blood clot within the blood vessel can be identified for the purpose of allowing the procedure to be actively monitored under fluoroscopy, as taught by Walzman.
Regarding claim 56, wherein the elongate body (352) defines one or more perforations at a distal portion thereof (see annotated Fig 14 above), the inflatable seal being disposed about the perforations (Fig 14), the fluid (inflation fluid) configured to be conveyed via the lumen of the elongate body, through the perforations, and into the volume defined by and within the inflatable seal (col 20, ln 66 – col 21, ln 4).
Regarding claims 57 and 58, wherein the inflatable seal (362) is a balloon or membrane (col 20, ln 62-66).
Regarding claim 59, wherein the inflatable seal (362) is configured to form and maintain the pressure seal against the interior wall surface of the blood vessel while simultaneously expelling a portion of the fluid through the hole (when inflation pressure greater than a threshold to have fluid flow through the hole – col 3, ln 33-44; col 11, ln 14-26).
Regarding claim 60, the combination teaches a fluid delivery apparatus configured to deliver the fluid imaging agent through the lumen of the elongate body (to provide inflation fluid – col 3, ln 33-44; col 11, ln 14-26).
Regarding claim 61, wherein the inflatable seal (362) has a distal end coupled to the elongate body and a proximal end coupled to the elongate body (Figs 4 and 14 above).
Regarding claim 62, wherein (1) when the inflatable seal is in the deployed configuration and the blood clot is lodged within the vessel, the hole is not in fluid communication with the lumen of the catheter (fully capable of having hole not be in fluid communication with the lumen of the catheter if clot blocks hole), and (2) when the inflatable seal is in the deployed configuration and the blood clot is dislodged within the vessel, the hole is in fluid communication with the lumen of the catheter (hole in fluid communication with catheter if nothing is blocking the hole and if inflation pressure is greater than a threshold to have fluid flow through the hole – col 3, ln 33-44; col 11, ln 14-26).
Regarding claim 63, Kokish fails to disclose the fluid imaging agent is non-thrombolytic to encourage intact blood clot dislodgement. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention modify Kokish such that the fluid imaging agent was non-thrombolytic as claimed, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 64, wherein the elongate body (352) is a guidewire (col 20, ln 58-66).
Regarding claim 65, wherein a distal tip (354) of the elongate body (352) is a guidewire (col 20, ln 58-66).
Allowable Subject Matter
Claims 28, 30-47, 54, and 66 would be allowable if rewritten or amended to overcome the rejection(s) under on the ground of nonstatutory double patenting or if a terminal disclaimer is filed. Furthermore, claim 28 would need to be rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 28 and 66, the prior art fails to teach and/or disclose the membrane seal is more compliant at a distal portion thereof than at a proximal portion thereof, to expand from the delivery configurations towards the deployed configuration first at the distal portion in response to the fluid conveyed into the volume.
Regarding claim 30, the prior art fails to teach and/or disclose a method of using an intravascular device for removing a blood clot from a blood vessel comprising introducing a catheter and elongate body having a radially expandable seal, as claimed, particularly wherein fluid is introduced via the elongate body into an area between the blood clot and distal seal to “(1) radially pressurize the distal seal against an interior wall surface of the blood vessel distal to the blood clot, and (2) increase a pressure within the area thereby urging the blood clot in a proximal direction”. Of the closest prior art, Kokish teaches delivering fluid via the elongate body into an area within the distal seal to radially pressurize the distal seal. Kokish fails to disclose “fluid is introduced via the elongate body into an area between the blood clot and distal seal” as claimed.
Regarding claim 41, the prior art fails to teach and/or disclose a method of using an intravascular device for removing a blood clot from a blood vessel comprising introducing a catheter and elongate body having a radially expandable seal, as claimed, particularly wherein “with the distal seal disposed distal to the blood clot, introducing via the elongate body fluid into an area defined between a distal end of the blood clot and a distal end of the distal seal to provide a uniform pressurized region within the area thereby urging the blood clot in a proximal direction and radially pressurizing the distal seal against an interior wall surface of the blood vessel distal to the blood clot”.
Response to Arguments
Applicant's arguments filed April 6, 2026 have been fully considered but they are not persuasive. Applicant argues Kokish fails to disclose “an inflatable membrane seal…having a distal end coupled to the elongate body and an opening between a proximal-most end of the inflatable membrane seal and the elongate body”. The Examiner respectfully disagrees. As Applicant acknowledges, Kokish teaches holes or perforations 364 in the proximal face of the balloon 362 (col 20, ln 50 – col 21, ln 61 and Fig 14). Thus, as discussed above, the holes or perforations may be interpreted as the claimed “opening”. It is further noted, Applicant claims “the proximal-most end of the inflatable membrane seal extends proximally and is at least partially attached to the elongate body” (claim 22) supporting the interpretation that the proximal-most end comprises both the opening (364) and the extension that is at least partially attached to the elongate body (see annotated 4 and 14 above).
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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