DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 29-46 are pending in the application. Claims 1-28, 47, and 48 have been canceled. Claim 29 has been amended.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 29 has been amended to recite: “the locking assembly being configured to transition between a locked configuration and an unlocked configuration without rotation of the locking assembly with respect to the linear actuating body…” The Applicant has cited paragraphs 0093 and 0094 from the U.S. PG Publication (US 2023/0099181 A1) and Figures 25-28 as providing supporting disclosure for this limitation. The Examiner does not agree that the disclosure provides support for this limitation. Paragraph 0093 recites: “Collet axle 648 exerts a strong clamping force on the guide wire when the collet axle is tightened via longitudinal movement of barrel 646 (as is evident from a comparison of FIG. 25 where the collet axle is locked into the guide wire and FIG. 26 where the collet axle is unlocked from the guide wire).” Paragraph 0094 recites: Such grip features provide traction for the user to rotate or translate the barrel via operation with, for example, the user's thumb.” There is no explicit disclosure that precludes rotation of the locking assembly with respect to the linear actuating body as claimed. Appropriate correction is required.
Claims 30-46 are dependent on claim 29, thus also fail to comply with the written description requirement. Appropriate correction is required.
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 29-31, 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 Horzewski (US 5,392,778).
Regarding claims 29-31, 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 without rotation of the locking assembly with respect to the linear actuating body, 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; and the locking assembly comprising a barrel slidably attached to the collet.
In the same field of endeavor, Horzewski teaches (Figures 1-5) a linear actuating body (15) and a locking assembly (14, 21) coupled to the linear actuating body. Horzewski teaches that the locking assembly is configured to transition between a locked configuration (Figures 2 and 5) and an unlocked configuration (Figures 1 and 4) without rotation of the locking assembly (Column 3, lines 30-59), a portion of the guidewire (12) extending through the locking assembly (Figures 1, 2, 4, 5), the guidewire being configured to translate relative to the locking assembly while the locking assembly is in the unlocked configuration. Horzewski teaches (Figure 3) that the locking assembly (14, 21) comprises a collet (21) configured to compress against the guidewire (12) in the locked configuration to thereby affix the collet to the guidewire (Column 3, lines 30-59). Horzewski also teaches the locking assembly (14, 21) comprising a barrel (14) slidably attached to the collet.
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 without rotation of the locking assembly with respect to the linear actuating body, 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, and wherein the locking assembly comprises a barrel slidably attached to the collet, as taught by Horzewski. 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 regarding the specific mechanism that connects the linear actuating body to the guidewire. Modifying the linear actuating body to include the locking assembly taught by Horzewski would provide a mechanism that provides a strong grip on the guidewire (Column 3, line 54) and would allow manipulation with one hand to selectively transition the locking assembly between the locked and unlocked configurations (Column 3, lines 60-61).
Regarding claim 40, Ressemann as modified by Horzewski 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 Horzewski 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 Horzewski teaches (Horzewski, Figures 1-5) the linear actuating body comprising a nose piece, the nose piece being capable of receiving the guidewire (12) and directing the guidewire into the handle assembly (Horzewski, Column 2, lines 57-65).
Regarding claim 46, Ressemann as modified by Horzewski teaches (Horzewski, Figures 1-5) the linear actuating body comprising a hypo-tube (Horzewski, Column 2, lines 57-65).
Claim 36 is 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 Horzewski (US 5,392,778) as applied to claim 31 above, and further in view of Forber (US 5,851,189).
Regarding claim 36, Ressemann as modified by Horzewski teaches the invention substantially as claimed. Horzewski teaches the outer surface of the barrel may be knurled, specially contoured, or otherwise modified from a simple cylindrical surface (Column 3, line 60 – Column 4, line 3). 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 Horzewski to comprise a raised ring feature disposed on an outer surface of the barrel, as taught by Forber. This modification would facilitate manual gripping 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 Horzewski (US 5,392,778) 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 Horzewski teaches the invention substantially as claimed. Ressemann as modified by Horzewski 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 Horzewski 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 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 Horzewski (US 5,392,778) 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 Horzewski teaches the invention substantially as claimed. Ressemann as modified by Horzewski 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 Horzewski 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.
Allowable Subject Matter
Claims 32-35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include 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: Claim 32 recites that the collet is rotatably attached to the linear actuating body. This limitation, in combination with the limitations in claim 29 and intervening claims 30 and 31, is not disclosed or suggested in the prior art of record. The collet taught by Horzewski is not rotatably attached to the linear actuating body as claimed.
Claims 33-35 are dependent on claim 32, thus would also be allowable if rewritten in independent form and to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 29-31 and 36-45 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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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