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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/11/25 has been entered.
Response to Amendment
Claims 19-38 are pending in the application. Claims 1-18 have been canceled. Claims 19 and 29 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 19-22, 24-32, and 34-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drontle et al. (US 2010/0312101 A1) (“Drontle”) in view of Heimbecher (US 2012/0173217 A1).
Regarding claims 19 and 20, Drontle discloses (Figures 1-12) a sinus dilation instrument configured for accessing a region of a patient's nasal sinus system, the sinus dilation instrument comprising: a handle (12) including a tracking device (60); a probe (14) including a proximal end portion (21) coupled to the handle (Figure 7), a distal tip portion (44) opposite the proximal end portion (Figures 6A-6C), and a curved segment (16) disposed between the proximal end portion and the distal tip portion (Figures 6A, 6B); a balloon (36) coupled to the probe (Figure 7). Drontle discloses (Figures 6A-6C) that the degree of curvature of the curved segment is pre-shaped and the nature and degree of the curved segment is configured to reach specific anatomy (paragraphs 0025 and 0040-0041). For example, in Figure 6A, the “U” shape curved of the curved segment is useful to treat hard to reach ostia, such as the maxillary ostium. In Figure 6B, the radius of curvature is less pronounced, to treat a frontal recess anatomy (paragraph 0041).
However, Drontle fails to disclose a connector associated with the handle and configured to electronically couple to an image guidance system; and an electronic identifier device electronically coupled to the connector, the electronic identifier device storing information including of a location within a patient's nasal sinus system assigned to the sinus dilation instrument, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system.
Heimbecher teaches (Figures 1-5) an analogous catheter system. Heimbecher teaches a connector associated with the handle (38, Figure 1) and configured to electronically couple to an image guidance system (22); and an electronic identifier device (28) electronically coupled to the connector, the electronic identifier device storing information including of a location within a patient's anatomy assigned to a catheter, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system (paragraphs 0034-0035).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sinus dilation instrument disclosed by Drontle to include a connector associated with the handle and configured to electronically couple to an image guidance system; and an electronic identifier device electronically coupled to the connector, the electronic identifier device storing information including a location within a patient's nasal sinus system assigned to the sinus dilation instrument, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system, as taught by Heimbecher. This modification would identify the type of catheter for use in the diagnostic or therapeutic procedure and would identify the target location for diagnosis or treatment (Heimbecher, paragraphs 0034-0035).
Regarding claim 21, the balloon taught by Drontle in view of Heimbecher is capable of being disposed in fixed spatial relation (such as Figures 10 and 11 of Drontle) relative to the tracking device (60) of the handle.
Regarding claim 22, the probe taught by Drontle in view of Heimbecher defines a rigid configuration (Drontle, paragraph 0025) such that the balloon is capable of being disposed in fixed spatial relation (such as Figures 10 and 11 of Drontle) relative to the tracking device (60) of the handle.
Regarding claim 24, the tracking device (60) taught by Drontle in view of Heimbecher tracks movement of the balloon (Drontle, paragraph 0044).
Regarding claim 25, Drontle as modified by Heimbecher teaches (Drontle, Figure 6B) that the assigned location is a frontal sinus (Drontle, paragraph 0041).
Regarding claim 26, Drontle as modified by Heimbecher teaches (Drontle, Figure 6A) that the assigned location is a maxillary sinus (Drontle, paragraph 0041).
Regarding claim 27, Drontle as modified by Heimbecher teaches that the assigned location is a sphenoid sinus (Drontle, paragraph 0041).
Regarding claim 28, Drontle as modified by Heimbecher teaches (Drontle, Figure 5A) an inflation path (48) fluidly connected to an interior of the balloon (Drontle, paragraph 0027).
Regarding claims 29, 30, and 38, Drontle discloses (Figures 1-12) a sinus dilation instrument configured for accessing a region of a patient's nasal sinus system, the sinus dilation instrument comprising: a handle (12) including a tracking device (60); a probe (14) including a proximal end portion attached to the handle (Figure 7), a distal tip portion opposite the proximal end portion (Figure 6), and a curved segment disposed between the proximal end portion and the distal tip portion (Figure 2; paragraph 0045); a balloon (14) secured to the probe and capable of being disposed in fixed spatial relation (such as Figures 10 and 11 of Drontle) relative to the handle (12); and an inflation path (48) fluidly connected to an interior of the balloon (paragraph 0027). Drontle discloses (Figures 6A-6C) that the degree of curvature of the curved segment is pre-shaped and the nature and degree of the curved segment is configured to reach specific anatomy (paragraphs 0025 and 0040-0041). For example, in Figure 6A, the “U” shape curved of the curved segment is useful to treat hard to reach ostia, such as the maxillary ostium. In Figure 6B, the radius of curvature is less pronounced, to treat a frontal recess anatomy (paragraph 0041).
However, Drontle fails to disclose a connector associated with the handle and configured to electronically couple to an image guidance system; and an electronic identifier device electronically coupled to the connector, the electronic identifier device storing information including a sinus procedure to be performed that is assigned to the sinus dilation instrument, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system.
Heimbecher teaches (Figures 1-5) an analogous catheter system. Heimbecher teaches a connector associated with the handle (38, Figure 1) and configured to electronically couple to an image guidance system (22); and an electronic identifier device (28) electronically coupled to the connector, the electronic identifier device storing information including a procedure to be performed that is assigned to the catheter, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system (paragraphs 0034-0035).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sinus dilation instrument disclosed by Drontle to include a connector associated with the handle and configured to electronically couple to an image guidance system; and an electronic identifier device electronically coupled to the connector, the electronic identifier device storing information including a sinus procedure to be performed that is assigned to the sinus dilation instrument, wherein the connector is configured to transmit the information from the electronic identifier device to the image guidance system when the connector is electronically coupled to the image guidance system, as taught by Heimbecher. This modification would identify the type of catheter for use in the diagnostic or therapeutic procedure and would identify the target location for diagnosis or treatment (Heimbecher, paragraphs 0034-0035).
Regarding claim 31, the balloon taught by Drontle in view of Heimbecher is capable of being disposed in fixed spatial relation (such as Figures 10 and 11 of Drontle) relative to the tracking device (60) of the handle.
Regarding claim 32, the probe taught by Drontle in view of Heimbecher defines a rigid configuration (Drontle, paragraph 0025) such that the balloon is capable of being disposed in fixed spatial relation (such as Figures 10 and 11 of Drontle) relative to the tracking device (60) of the handle.
Regarding claim 34, the tracking device (60) taught by Drontle in view of Heimbecher tracks movement of the balloon (Drontle, paragraph 0044).
Regarding claim 35, Drontle as modified by Heimbecher teaches (Drontle, Figure 6B) that the assigned location is a frontal sinus (Drontle, paragraph 0041).
Regarding claim 36, Drontle as modified by Heimbecher teaches (Drontle, Figure 6A) that the assigned location is a maxillary sinus (Drontle, paragraph 0041).
Regarding claim 37, Drontle as modified by Heimbecher teaches that the assigned location is a sphenoid sinus (Drontle, paragraph 0041).
Claims 23 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Drontle et al. (US 2010/0312101 A1) (“Drontle”) in view of Heimbecher (US 2012/0173217 A1) as applied to claims 20 and 30 respectively above, and further in view of Chang et al. (US 2006/0004286 A1).
Regarding claims 23 and 33, Drontle in view of Heimbecher teaches the tracking device (60) may include an antenna, transmitter, optical reflectors, or the like that communicates a wireless signal that is then received and processed to determine the orientation and/or positioning of the balloon dilation catheter. In certain embodiments, more than one tracking device (60) may be disposed on the balloon dilation catheter (Drontle, paragraphs 0042 and 0044).
However, Drontle in view of Heimbecher fails to teach an electromagnetically detectable receiver coil that generates tracking information for display by the image guidance system.
In the same field of endeavor, Chang teaches (Figures 4-4B) a sinus dilation instrument that comprises a tracking device that includes an electromagnetically detectable receiver coil (16), wherein the tracking device tracks movement and positioning of the balloon (paragraphs 0081).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sinus dilation instrument taught by Drontle in view of Heimbecher to further comprise an electromagnetically detectable receiver coil that generates tracking information for display by the image guidance system and tracking movement and positioning of the balloon during the step of pushing the distal tip end along the nasal sinus system of the patient to a target site, as taught by Chang. This modification would provide an accurate real time indication of the positioning and movement of the balloon during the treatment procedure (Chang, paragraph 0019).
Response to Arguments
Applicant’s arguments with respect to claims 19-38 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Goldfarb et al. (US 2008/0195041 A1) also teach (Figure 2) that different curvatures are useable to access the ostia of different sinuses. For example, a 70 degree guide is used to access the ostium of frontal sinus. A 90 degree or 110 degree guide is used to access the ostium of a maxillary sinus (paragraph 0045).
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/C.D.K/Examiner, Art Unit 3771 /DIANE D YABUT/Primary Examiner, Art Unit 3771