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 .
Specification
The amendments to the Specification and the Abstract filed 10/28/2025 are acceptable and have 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, 10-13 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).
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 oft eh 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 10, Mulvihill discloses that the agitation comprises a lateral vibration of the distal end (Col 18, Lines 36-40 and Fig 12C).
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), the agitation actuator configured to cause agitating movement of the distal end of the shaft (Col 18, Lines 36-40).
Claims 1-5, 13 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyle Jr (US Pat 7,854,728).
Re claim 1, Boyle discloses an instrument (Fig 15B; it is noted that all reference characters cited below refer to Fig 15B 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 since Boyle discloses this in Col 14, Lines 39-41), comprising: an elongate member 24c 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 since Boyle discloses that the elongate instrument is inserted in a catheter in Col 3, Lines 57-60), the elongate member including a plurality of protrusions 44,44 extending away from the elongate member at the distal end of the elongate member (as seen in Fig 15A,B); and an agitation actuator 45a (Fig 12A) coupled with the elongate member adjacent a proximal end of the elongate member (as seen in Fig 12A), wherein operation of the agitation actuator is configured to cause agitation of a fluid adjacent a distal end of the elongate member (it is noted that the italicized text constitutes a functional limitation and, therefore, “a fluid” is not a part of the claimed invention; therefore, in order to read on this limitation, the agitation actuator only needs to be capable of causing agitation of a fluid that would be adjacent a distal end of the elongate member; this limitation is met since Boyle discloses that operation of the actuator causes inflation of the protrusions 44,44 and that inflation of the protrusions causes dislodging and moving of foreign material – as set forth in Col 13, Lines 18-29 and Col 14, Lines 39-41).
Re claim 2, Boyle 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, Boyle 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 Boyle discloses that inflation of the protrusions causes dislodging and moving of foreign material – as set forth in Col 14, Lines 39-41 – and one of ordinary skill in the art would recognize that this inflation would result in movement/agitation of a fluid adjacent the distal tip).
Re claim 3, Boyle 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, Boyle only has to be structurally capable of agitating a fluid that includes a thrombolytic agent; this limitation is met since Boyle discloses that inflation of the protrusions causes dislodging and moving of foreign material – as set forth in Col 14, Lines 39-41 – and one of ordinary skill in the art would recognize that this inflation would result in movement/agitation of a fluid adjacent the distal tip).
Re claim 4, Boyle 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, Boyle 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 Boyle discloses that inflation of the protrusions causes dislodging and moving of foreign material – as set forth in Col 14, Lines 39-41 – and one of ordinary skill in the art would recognize that this inflation would result in movement/agitation acting on any matter located just beyond the distal tip).
Re claim 5, Boyle 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, Boyle only has to be structurally capable of removing a blockage that includes a portion of a fibrin sheath; this limitation is met since Boyle discloses that the blockage includes fibrinous material – as set forth in Col 2, Lines 8-9).
Re claim 13, Boyle 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, Boyle’s elongate member only has to be capable of operating in an IV catheter; this limitation is met because Boyle discloses use in a catheter and use to remove the accumulation of blood – as set forth in Col 3, Lines 53-60).
Re claim 40, Boyle discloses that the agitation actuator is configured for manual operation by a clinician, the manual operation defining agitating movement of the elongate member (Col 13, Lines 18-29).
Response to Arguments
Applicant’s arguments filed 10/28/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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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