DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Idemoto et al. (US Pat 5,058,570) in view of Lewis (US Pat 6,295,990), Lasheras et al. (PG PUB 2001/0039440) and Brisken (US Pat 6,228,046).
Re claim 19, Idemoto discloses an apparatus (Fig 1, with Fig 6A showing a cross sectional view of the tubular body; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 6A unless otherwise noted) for treating a blood clot (Col 5, Lines 22-28), the apparatus comprising: a tubular body 8 having a distal portion (the portion seen in Fig 5A); a central lumen 20 formed in the tubular body (as seen in Fig 6A); a fluid delivery lumen 18 (Col 5, Lines 30-32), separate from the central lumen (as seen in Fig 6A), formed in the tubular body (as seen in Fig 6A); an evacuation lumen 19 (Col 5, Lines 26-28), separate from the central lumen and separate from the fluid delivery lumen (as seen in Fig 6A), formed in the tubular body (as seen in Fig 6A); an inner core 17 disposed within the central lumen (as seen in Fig 6A), the inner core configured to transmit ultrasound energy to the blood clot (Col 5, Lines 22-28), wherein the tubular body includes a plurality of axially-spaced drug delivery openings (a first opening is located at the proximal-most end of fluid delivery lumen 18 to deliver fluid from the injector 14 to the lumen 18 and a second opening is located at the distal-most end of fluid delivery lumen 18 to deliver fluid from lumen 18 to the patient, as described in Col 5, Lines 30-32). Idemoto is silent as to the part of the body in which the apparatus is configured to be used and, therefore, does not disclose that the apparatus is structurally capable of treating the blood clot when it is located in the brain; Idemoto also does not disclose that the distal portion of the tubular body is configured to be advanced into the blood clot, that the ultrasound energy is transmitted from one or more ultrasound radiating elements coupled to the inner core, or that the apparatus comprises a pressure sensor coupled to the tubular body and disposed in the fluid delivery lumen.
Lewis, however, teaches an apparatus (Fig 14, with Fig 13 showing the distal portion of the tubular body 500; it is noted that all reference characters cited below refer to Fig 13 and/or Fig 14 unless otherwise noted) for treating a blood clot in a brain of a patient (Col 9, Lines 41-52) using ultrasound (Col 9, Lines 52-55; like Idemoto), the apparatus comprising a tubular body 500 having a distal portion (the portion seen in Fig 13) configured to be advanced into a blood clot (seen in Fig 13 but not labeled; labeled “TO” in Fig 8) in the brain (as seen in Fig 13; Col 3, Lines 41-45) for the purpose of treating intracerebral ischemia associated with stroke (Col 1, Lines 15-18). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Idemoto to include the tubular body such that it is sized to be advanced into a blood clot in the brain, as taught by Lewis, for the purpose of treating intracerebral ischemia associated with stroke (Col 1, Lines 15-18).
Additionally, Lewis teaches providing a pressure sensor 512 (Col 17, Lines 33-34) coupled to the tubular body (as seen in Fig 13) for the purpose of controlling the therapeutic agent being delivered into the patient’s brain in order to protect the vessel from reperfusion injury (Col 4, Lines 33-37 and 51-59; Col 17, Lines 48-50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include a pressure sensor coupled to the tubular body, as taught by Lewis, for the purpose of controlling the therapeutic agent being delivered into the patient’s brain in order to protect the vessel from reperfusion injury (Col 4, Lines 33-37 and 51-59; Col 17, Lines 48-50). Lewis does not teach that the pressure sensor is disposed in the fluid delivery lumen or that the ultrasound energy is transmitted from one or more ultrasound radiating elements coupled to the inner core.
Lasheras, however, teaches an apparatus (Fig 1) comprising a tubular body 100 (Fig 1) having a pressure sensor 77 (Fig 5) coupled thereto (as seen in Fig 5) wherein the pressure sensor is spaced proximally from a distal delivery port 110 (Fig 5) of a fluid delivery lumen 106 (Fig 5) (like in Lewis), and wherein the pressure sensor is disposed in the fluid delivery lumen (as seen in Fig 5 and described in Para 44); Lasheras teaches that the pressure sensor is employed to measure the pressure of the fluid surrounding the tubular body (Para 44) and use that pressure to control delivery of fluid (Para 65), like in Lewis. Since Lasheras discloses that a pressure sensor disposed in the fluid delivery lumen can be used to achieve the same result as a pressure sensor disposed outside the fluid delivery lumen (like in Lewis), such arrangements were art-recognized equivalents at the time the invention was made. Therefore, it would have been obvious to one of ordinary skill in the art to substitute a pressure sensor disposed in the fluid delivery lumen, as taught by Lasheras, in place of Lewis’s external pressure sensor in the apparatus of Idemoto since it has been held that substituting parts of an invention involves only routine skill in the art. Lasheras does not disclose that ultrasound energy is transmitted from one or more ultrasound radiating elements coupled to the inner core.
Brisken, however, teaches an apparatus 10 (Fig 2A) for treating a blood clot (Col 3, Lines 21-23) comprising a core 12 (Fig 2A,3E-3G) having ultrasound radiating elements 40,40 (Fig 3E-3G) coupled to the core (as seen in Fig 3E-3G) for the purpose of reducing the problem of recoil since the members can be designed to beat against themselves, offsetting some of the vibrations to the core (Col 3, Lines 45-48). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Idemoto/Lewis/Lasheras to include the core with ultrasound radiating elements coupled thereto, as taught by Brisken, for the purpose of reducing the problem of recoil since the members can be designed to beat against themselves, offsetting some of the vibrations to the core (Col 3, Lines 45-48).
Re claim 20, Idemoto discloses that the ultrasound radiating elements are configured to transmit ultrasound energy at a frequency between about 20 kHz and about 20 MHz (“20 – 30 kHz”, Col 3, Lines 39-42).
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered. The arguments directed to the rejections of claims 1, 3, 6-14 and 16-18 are moot in view of the amendments made to claims 1 and 12, resulting in their allowability (please see the reasons for allowability below). The argument that none of the previously-cited references teach the newly added subject matter of claim 19 is not persuasive since – as set forth above in the rejection of claim 19 – Idemoto discloses a first drug delivery opening located at the proximal-most end of fluid delivery lumen 18 to deliver fluid from the injector 14 to the lumen 18 and a second drug delivery opening located at the distal-most end of fluid delivery lumen 18 to deliver fluid from lumen 18 to the patient (Col 5, Lines 30-32).
Allowable Subject Matter
Claims 1, 3, 6-14 and 16-18 are allowed. The following is a statement of reasons for the indication of allowability:
Independent claim 1 has been amended to include the subject matter of now-cancelled dependent claim 5 which was indicated as allowable in the 12/23/2025 Detailed Action. Please see the 12/23/2025 Detailed Action for a detailed statement of reasons for allowance of the subject matter now required by claim 1.
Independent claim 12 has been amended to include the subject matter of now-cancelled dependent claim 15 which was indicated as allowable in the 12/23/2025 Detailed Action. Please see the 12/23/2025 Detailed Action for a detailed statement of reasons for allowance of the subject matter now required by claim 12.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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