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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/27/2026 (requesting entry of the reply filed 3/24/2026) has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8, 11-13 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulvihill (US Pat 9,308,348).
Re claim 1, Mulvihill discloses an instrument TC1 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) for removing a blockage from a catheter lumen (it is noted that the italicized text constitutes a functional limitation and, therefore, “a blockage” and “a catheter lumen” are not a part of the claimed invention; therefore, in order to read on this limitation, the instrument only has to be structurally capable of removing a blockage from a catheter lumen; this limitation is met in view of Col 9, Lines 20-26), comprising: an elongate member 26 configured for insertion in the catheter lumen (as set forth above, “the catheter lumen” is not part of the claimed invention; and, therefore, in order to read on this limitation, the elongate member only has to be capable of insertion into any sized catheter lumen; this limitation is met in view of Col 9, Lines 20-26), the elongate member including a plurality of protrusions 35,35,35 (Fig 6) extending away from the elongate member at the distal end of the elongate member (as seen in Fig 6); and an agitation actuator 1 coupled with the elongate member adjacent a proximal end of the elongate member (as seen in Fig 1), wherein operation of the agitation actuator is configured to cause agitation of a fluid adjacent a distal end of the elongate member (Col 18, Lines 36-40), the agitation comprises a lateral vibration of the distal end (Col 18, Lines 36-40 and Fig 12C), and the agitation actuator is configured for manual operation by a clinician (via enable switch 72 (Fig 3) – Col 20, Lines 31-49).
Re claim 2, Mulvihill discloses that the fluid includes a chemical agent configured to decompose the blockage and is disposed adjacent the blockage of the catheter lumen (as set forth in the rejection of claim 1 above, the “fluid” and the “catheter lumen”/”catheter” are only functionally recited and, therefore, not a part of the claimed invention; therefore, in order to read on the claim, Mulvihill only has to be structurally capable of agitating a fluid that includes a chemical agent configured to decompose a blockage and is disposed adjacent the blockage of the catheter lumen/catheter; this limitation is met since Mulvihill discloses that movement of the protrusions causes dislodging and moving of the blockage – as set forth in Col 14, Lines 42-47 – and one of ordinary skill in the art would recognize that the movement would result in movement/agitation of a fluid adjacent the distal tip).
Re claim 3, Mulvihill discloses that the chemical agent includes thrombolytic agent (as set forth in the rejection of claims 1 and 2 above, the “fluid” is only functionally recited and, therefore, not a part of the claimed invention; therefore, in order to read on the claim, Mulvihill only has to be structurally capable of agitating a fluid that includes a thrombolytic agent; this limitation is met since Mulvihill discloses that movement of the protrusions causes dislodging and moving of the blockage – as set forth in Col 14, Lines 42-47 – and one of ordinary skill in the art would recognize that this movement would result in movement/agitation of a fluid adjacent the distal tip).
Re claim 4, Mulvihill discloses that the blockage extends beyond a distal end of the catheter lumen (as set forth in the rejection of claim 1 above, the “blockage” is not a part of the claimed invention; therefore, in order to read on the claim, Mulvihill only has to be structurally capable of removing a blockage that extends beyond a distal end of the catheter lumen; this limitation is met since Mulvihill discloses that movement of the protrusions causes dislodging and moving of the blockage – as set forth in Col 14, Lines 42-47 – and one of ordinary skill in the art would recognize that this movement would result in movement/agitation acting on any matter located just beyond the distal tip).
Re claim 5, Mulvihill discloses that the blockage includes a portion of a fibrin sheath (as set forth in the rejection of claims 1 and 4 above, the “blockage” is not a part of the claimed invention; therefore, in order to read on the claim, Mulvihill only has to be structurally capable of removing a blockage that includes a portion of a fibrin sheath; this limitation is met since Mulvihill discloses that the blockage includes blood clots – as set forth in Col 27, Lines 38-39).
Re claim 8, Mulvihill discloses that the agitation actuator is an electro-mechanical device (Col 18, Lines 6).
Re claim 11, Mulvihill discloses that the vibration includes an ultrasound frequency (Col 18, Lines 36-40).
Re claim 12, Mulvihill discloses that the plurality of protrusions include posts, fins, or flaps (“brush 35” – Col 14, Lines 38-49).
Re claim 13, Mulvihill discloses that the catheter lumen is a lumen of an intravenous catheter (as set forth in the rejection of claim 1 above, the “catheter lumen”/”catheter” are not a part of the claimed invention; therefore, in order to read on the claim, Mulvihill’s elongate member only has to be capable of operating in an IV catheter; this limitation is met because Mulvihill discloses use in a catheter and to remove blood clots - as set forth in Col 27, Lines 22-27 and 38-39).
Re claim 41, Mulvihill discloses a catheter system (Col 9, Lines 20-26) comprising: an intravascular catheter 39 (Fig 4; Col 9, Line 23); and a medical instrument TC1 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) configured to remove a blockage obstructing a lumen of the catheter (Col 9, Lines 20-26), the instrument including: an elongate shaft 26 configured for insertion through the lumen (Col 9, Lines 20-26), the shaft including a plurality of protrusions 35,35,35 (Fig 6) extending away from the shaft adjacent a distal end of the shaft (as seen in Fig 6); and an agitation actuator 1 coupled with the shaft at a proximal end of the shaft (as seen in Fig 1), wherein the agitation actuator is configured to cause agitating movement of the distal end of the shaft (Col 18, Lines 36-40), the agitation comprises a lateral vibration of the distal end (Col 18, Lines 36-40 and Fig 12C), and the agitation actuator is configured for manual operation by a clinician (via enable switch 72 (Fig 3) – Col 20, Lines 31-49).
Response to Arguments
Applicant’s arguments filed 3/24/2026 have been fully considered. Applicant’s arguments directed to the Boyle reference utilized in the last Office Action are moot as this reference is not used in the present rejections. Applicant’s arguments directed to the Mulvihill reference utilized in the last Office Action and the present Office Action are not persuasive.
Applicant argues that Mulvihill does not teach that “the agitation actuator is configured for manual operation by a clinician” as recited in claims 1 and 41. The Examiner respectfully disagrees since Col 20, Lines 31-49 explicitly recite that “the enable switch 72 permits the operator to initiate the reciprocating motion”, “the enable switch 72 permits the control box 1 to maintain the reciprocating motion for a predetermined period of time”, “device TC1 remains in a disabled state until the enable switch 72 is activated by the operator”, “’enable button pressed’ stop 89 of the flow diagram represents activation of the enable switch 72 resulting in the enabled state 88 of the device where the clearing stem 26 is being reciprocated”. Since the pressing of switch 72 by a clinician activates the agitation actuator 1, the agitation actuator 1 is “configured for manual operation by a clinician” as claimed.
Conclusion
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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