DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/25 has been entered.
Response to Amendment
Claims 29-46 are pending in the application. Claims 1-28, 47, and 48 have been canceled. Claims 29, 32, 45, and 46 have been amended.
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 29-35, 40, 41, 45, and 46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ressemann et al. (US 2007/0250105 A1) (“Ressemann”) in view of Kring (US 5,217,435).
Regarding claims 29-35, Ressemann discloses (Figures 11A-11D) an apparatus, comprising: a handle assembly comprising a handle body (130) extending from a proximal portion to a distal portion; a shaft (18) extending from the distal portion of the handle body, the shaft defining a lumen; a guidewire (24) slidably disposed within the lumen of the shaft, the guidewire defining a longitudinal axis, the guidewire comprising a distal tip that is configured to actuate distally past the shaft (Figures 11C and 11D; paragraph 0096); and a linear actuating body (26) slidably coupled (via recess 134) to the handle body of the handle assembly (paragraph 0117). Ressemann discloses that the linear actuating body connects to a proximal end of the guide wire (paragraph 0096) and linear actuating body is axial and rotationally moved within the recess (134; paragraph 0117). Ressemann discloses that when the linear actuating body is connected to the guidewire, it is configured to translate along the handle body to move the guidewire relative to the handle body within the lumen without rotating the guidewire relative to the handle body about the longitudinal axis (paragraph 0119).
However, Ressemann fails to disclose a locking assembly coupled to the linear actuating body, the locking assembly being configured to transition between a locked configuration and an unlocked configuration, a portion of the guidewire extending through the locking assembly, the guidewire being configured to translate relative to the locking assembly while the locking assembly is in the unlocked configuration, the linear actuating body, while the locking assembly is in the locked configuration being configured to translate along the handle body to move the guidewire relative to the handle body within the lumen without rotating the guidewire relative to the handle body about the longitudinal axis. Ressemann further fails to disclose:
the locking assembly comprising a collet configured to compress against the guidewire in the locked configuration to thereby affix the collet to the guidewire;
the locking assembly comprising a barrel slidably attached to the collet;
the collet being rotatably attached to the linear actuating body;
the barrel defining an opening, the collet extending through the opening;
wherein a surface of the barrel being configured to compress the collet in the locked configuration; and
the barrel being configured to rotate both the collet and the guidewire in the locked configuration.
In the same field of endeavor, Kring teaches (Figures 1-4) an apparatus, comprising: a handle assembly comprising a handle body (16) extending from a proximal portion to a distal portion; a shaft (12) extending from the distal portion of the handle body, the shaft defining a lumen; a guidewire (11) slidably disposed within the lumen of the shaft, the guidewire defining a longitudinal axis, the guidewire comprising a distal tip that is configured to actuate distally past the shaft (Figure 1); a linear actuating body (20) coupled to the handle body of the handle assembly; and a locking assembly (22, 30, 36) coupled to the linear actuating body, the locking assembly being configured to transition between a locked configuration and an unlocked configuration, a portion of the guidewire extending through the locking assembly (Figure 2), the guidewire being configured to translate relative to the locking assembly while the locking assembly is in the unlocked configuration (Column 3, lines 1-24 and Column 4, lines 1-53).
Kring teaches (Figure 2) the locking assembly comprising a collet (30) configured to compress against the guidewire (11) in the locked configuration to thereby affix the collet to the guidewire.
Kring teaches (Figures 1-4) the locking assembly comprising a barrel (36) slidably attached to the collet (30).
Kring teaches (Figures 1-4) the collet being rotatably attached to the linear actuating body (via swivel 25).
Kring teaches (Figure 2) the barrel (36) defining an opening, the collet (80) extending through the opening.
Kring teaches (Figure 2) a surface (39) of the barrel (36) being configured to compress the collet (30) in the locked configuration (Figure 2).
Kring teaches the barrel being capable of rotating both the collet and the guidewire in the locked configuration (Column 3, lines 1-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the linear actuating body disclosed by Ressemann to comprise a locking assembly coupled to the linear actuating body, the locking assembly being configured to transition between a locked configuration and an unlocked configuration, a portion of the guidewire extending through the locking assembly, the guidewire being configured to translate relative to the locking assembly while the locking assembly is in the unlocked configuration, the linear actuating body, while the locking assembly is in the locked configuration being configured to translate along the handle body to move the guidewire relative to the handle body within the lumen without rotating the guidewire relative to the handle body about the longitudinal axis, wherein the locking assembly comprises a collet configured to compress against the guidewire in the locked configuration to thereby affix the collet to the guidewire; the locking assembly comprises a barrel slidably attached to the collet; the collet being rotatably attached to the linear actuating body; the barrel defining an opening, the collet extending through the opening; wherein a surface of the barrel is configured to compress the collet in the locked configuration; and the barrel is configured to rotate both the collet and the guidewire in the locked configuration, as taught by Kring. Ressemann discloses that the linear actuating body “connects” to the guidewire to allow axial and rotational movement of the linear actuating body (and thus the guidewire) within the recess in the handle body, but is silent as how the linear actuating body connects to the guidewire. Modifying the linear actuating body to include the locking assembly taught by Kring would allow an operator to selectively “connect” and lock the linear actuating body to the guidewire, which will enable the operator to freely advance, torque, and retract the attached guidewire (King, Column 3, lines 1-6).
Regarding claim 40, Ressemann as modified by Kring teaches (Ressemann, Figures 11A-11D) the shaft (18) being rotatable relative to the handle assembly (130; Ressemann, paragraph 0117).
Regarding claim 41, Ressemann as modified by Kring teaches (Ressemann, Figures 11A-11D) the shaft (18) being capable of selectively locking into a plurality of rotational positions relative to the handle assembly (130; Ressemann, paragraph 0117).
Regarding claim 45, Ressemann as modified by Kring teaches (Kring, Figure 2) that the linear actuating body comprises a nose piece (45), the nose piece configured to receive the guidewire (within bore 29) and direct the guidewire into the handle assembly (as disclosed by Ressemann).
Regarding claim 46, Ressemann as modified by Kring teaches (Kring, Figure 2) that the linear actuating body comprises a hypo-tube (45).
Claim 36 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ressemann et al. (US 2007/0250105 A1) (“Ressemann”) in view of Kring (US 5,217,435) as applied to claim 31 above, and further in view of Forber (US 5,851,189).
Regarding claim 36, Ressemann as modified by Kring teaches the invention substantially as claimed. However, the combined teaching fails to teach the barrel comprising a raised ring feature disposed on an outer surface of the barrel.
Forber teaches (Figures 1-8) a locking assembly comprising a barrel (80) slidably attached to a collet (20), the barrel comprising a raised ring feature (84) disposed on an outer surface of the barrel (Column 5, lines 41-52). NOTE: Forber teaches that features (84) are a series of bumps spaced uniformly axially and circumferentially around external surface (82) of cap (80). Since the features extend circumferentially around the external surface of the barrel, the Examiner Is interpreting this as a "raised ring feature.' Additionally, Forber teaches other structures, including ridges. A ridge that extends circumferentially around the external surface would also read on a "raised ring feature" required by the claim.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the barrel taught by Ressemann in view of Kring to comprise a raised ring feature disposed on an outer surface of the barrel, as taught by Forber. This modification would facilitate manual gripping and rotation of the barrel (Forber, Column 5, lines 41-52).
Claims 37-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ressemann et al. (US 2007/0250105 A1) (“Ressemann”) in view of Kring (US 5,217,435) as applied to claim 29 above, and further in view of Drontle et al. (US 2010/0312101 A1) (“Drontle”).
Regarding claims 37-39, Ressemann as modified by Kring teaches the invention substantially as claimed. Ressemann as modified by Kring teaches that once the position of the guidewire (24) has been confirmed to be in the desired position, a balloon catheter (12) can then be confidently placed into the sinus ostium (e.g., MO) and dilated (Ressemann, paragraph 0122). However, the combined teaching fails to teach the apparatus comprising a rail extending distally from the shaft, the balloon catheter slidably disposed on the rail, and the rail and the shaft defining an annular space housing a portion of the balloon catheter.
In the same field of endeavor, Drontle teaches (Figures 1-12) an apparatus, comprising: a handle assembly comprising a body (12) extending from a proximal portion to a distal portion; a shaft (40) extending from the distal portion of the body, the shaft defining a lumen; a guidewire (64) slidably disposed within the lumen of the shaft, the guidewire defining a longitudinal axis, the guidewire comprising a distal tip that is configured to actuate distally past the shaft (Figure 9). Drontle teaches (Figure 1) a rail (14) extending distally from the shaft, a balloon catheter (30) slidably disposed on the rail (paragraph 0027), and the rail (14) and the shaft (40) defining an annular space housing a portion of the balloon catheter (Figure 5A).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus taught by Ressemann in view of Kring to comprise a rail extending distally from the shaft, the balloon catheter slidably disposed on the rail, and the rail and the shaft defining an annular space housing a portion of the balloon catheter, as taught by Drontle. This modification would provide a rigid inner guide shaped to place the balloon at the target location in the patient's anatomy (Drontle, paragraph 0006).
Claims 42-44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ressemann et al. (US 2007/0250105 A1) (“Ressemann”) in view of Kring (US 5,217,435) as applied to claim 29 above, and further in view of Makower et al. (US 2008/0275483 A1) (“Makower”).
Regarding claims 42-44, Ressemann as modified by Kring teaches the invention substantially as claimed. Ressemann as modified by Kring teaches that once the position of the guidewire (24) has been confirmed to be in the desired position, a balloon catheter (12) can then be confidently placed into the sinus ostium (e.g., MO) and dilated (Ressemann, paragraph 0122). However, the combined teaching fails to teach the apparatus comprising a second actuating body, the second actuating body being slidably coupled to the handle assembly, and the second actuating body being fixed to a balloon catheter.
In the same field of endeavor, Makower teaches (Figures 27A-27H) an apparatus (2700), comprising: a handle assembly (2724) comprising a handle body (2702) extending from a proximal portion to a distal portion; a shaft (2718) extending from the distal portion of the handle body, the shaft defining a lumen; a guidewire (2710) slidably disposed within the lumen of the shaft, the guidewire defining a longitudinal axis, the guidewire comprising a distal tip that is configured to actuate distally past the shaft (Figures 27D); a linear actuating body (2712) slidably coupled to the handle body of the handle assembly. Makower teaches that the apparatus comprises a second actuating body (2706), the second actuating body being slidably coupled to the handle assembly (paragraphs 0213-0214), and the second actuating body being fixed to a balloon catheter (Figure 27D; paragraph 0213-0214).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus taught by Ressemann in view of Kring to comprise a second actuating body, the second actuating body being slidably coupled to the handle assembly, and the second actuating body being fixed to a balloon catheter, as taught by Makower. This modification would provide an apparatus with a first actuator to navigate the guidewire through the anatomy to a desired location within the body and a second actuator to advance a balloon catheter over the guidewire to perform a diagnostic or therapeutic procedure (Makower, paragraph 0214). This modification would provide an apparatus that combines the navigation and diagnostic/therapeutic procedure into a single device to treat a sinus ostium.
Response to Arguments
Applicant’s arguments with respect to claims 29-46 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. The Ressemann et al. reference in newly cited. Ressemann discloses a linear actuating body that is configured to translate along a handle body to move a guidewire relative to the handle body within a lumen without rotating the guidewire relative to the handle body about the longitudinal axis, as amended.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771