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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 7-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Poe (US 20150080764 A1) in view of Flanagan (US 20220095901 A1).
Regarding claim 1, Poe discloses a trans-eustachian multi-function system, comprising:
a body configured for disposition within an eustachian tube (body 12 in Fig. 1), the body comprising:
a proximal end (proximal end 16 in Fig. 1),
a distal end (distal end 14 in Fig. 1),
a transverse cross-sectional shape shaped to correspond with a cross-section of the eustachian tube (shown in Fig. 4),
a longitudinally-extending length (longitudinally extending axis 22 in Fig. 2),
an outer wall configured for disposition proximate a wall of the eustachian tube (see below), and
an inner portion defining a passageway (entrapment portion 20 and passageway 24 in Fig. 1 are both passageways).
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Poe is silent to a distal anchor disposed proximate the distal end, the distal anchor configured to releasably anchor the body against the wall of the eustachian tube.
However, Flanagan discloses a distal anchor (paragraph [0055] discloses an external expandable member 340) disposed proximate the distal end (distal end 314 in Fig. 3A) the distal anchor configured to releasably anchor the body against the wall of the eustachian tube (paragraph [0055] discloses that the expandable member 340 anchors the device by pressing up against the walls of the body lumen). Flanagan teaches that having an expandable guide device as disclosed is advantageous because it anchors the instrument with respect to the device and allows the user to translate the instrument and device simultaneously (paragraph [0055]). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to modify the system as taught by Poe to include the teaching of Flanagan to allow simultaneous translation of the instrument and the device within the body.
Regarding claim 2, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, and Poe further discloses an imaging device (endoscope 44 in Fig. 5) having a proximal end portion configured for attachment to a manipulation device (paragraph [0048], lines 1-4) and a distal end comprising a lens (paragraph [0044], lines 4-19), the imaging device movably disposed within the passageway configured for longitudinal, radial, and/or lateral movement of the lens from a first position proximate the distal end of the body outwardly to a second position within a middle ear space (paragraph [0042], lines 1-6).
Regarding claim 7, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, and Poe further discloses an audio-transmitting device (paragraph [0053] discloses that the embedded instrument can be a variety of sensors including speakers) having a proximal end portion configured for attachment to a manipulation device (paragraph [0048]) and an audio-emitting portion (speaker 54 in paragraph [0053]), the audio-transmitting device movably disposed within the passageway configured for longitudinal, radial, and/or lateral movement of the audio-emitting portion from a first portion proximate the distal end of the body outwardly to a second portion within a middle ear space (paragraph [0043]).
While Poe does not explicitly disclose that the distal end portion comprises the audio-emitting portion, Poe teaches that the distal end of the device comprises the functional end (paragraph [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effecting filing date of the claimed invention to modify the distal end of the audio-transmitting device as taught by Poe to comprise the audio-emitting portion, as Poe appears to already contemplate such modification and such modification would enable the speaker to be located so as to stimulate the treatment area (paragraph [0053]).
Regarding claim 8, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, and Poe further discloses a suction tube or infusion tube (paragraph [0053] discloses that the embedded instrument 18 can be a retractable injection needle 56 or an aspiration needle 56’) having a proximal end portion configured for attachment to a manipulation device (paragraph [0048]), the suction tube or infusion tube movably disposed within the passageway configured for longitudinal, radial, and/or lateral movement of distal opening from a first portion proximate the distal end of the body outwardly to a second portion within a middle ear space (paragraph [0043]).
While Poe does not explicitly disclose that the distal end portion comprises the distal opening, Poe teaches that the distal end of the device comprises the functional end (paragraph [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effecting filing date of the claimed invention to modify the distal end of the suction tube or infusion tube as taught by Poe to comprise the distal opening, as Poe appears to already contemplate such modification and such modification would enable the opening to be located so as to stimulate the treatment area (paragraph [0053]).
Regarding claim 9, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 8, and Poe further discloses that the suction tube or infusion tube comprises the suction tube (aspiration needle 56’ in Fig. 10), and the suction tube is configured for attachment of the proximal end portion to an evacuation device, and the distal end is configured for removal of a fluid or tissue, or a combination thereof, from the middle ear space (the proximal end 16 is capable of being fluidically attached to an evacuation unit and the distal end is capable of removing fluid, as discussed above with regards to claim 8).
Regarding claim 10, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 8, and Poe further discloses that the suction tube or infusion tube comprises the infusion tube (retractable injection needle 56 in Fig. 10), and the infusion tube is configured for attachment of the proximal end portion to a fluid infusion device, and the distal end is configured for infusion of a fluid into the middle ear space ((the proximal end 16 is capable of being fluidically attached to an infusion unit and the distal end is capable of infusing fluid, as discussed above with regards to claim 8).
Regarding claim 12, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, and Flanagan further discloses that the distal anchor comprises a selectively expandable seal member or a compressible seal member (paragraph [0055], lines 1-7 and lines 39-41).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Poe in view of Flanagan as applied to claims 1 and 2 above, and further in view of de Juan (US Patent 11,467,386).
Regarding claim 3, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 2 but fails to disclose that the imaging device comprises an endoscopic camera.
However, de Juan discloses a device for treating the ear, including an imaging device (endoscope 300 in Fig. 5), wherein the imaging device comprises an endoscopic camera (Col. 14, lines 29-30). Furthermore, de Juan teaches that having an endoscopic camera is advantageous to provide visualization of the ear canal during treatment (Col. 38, lines 54-56). Therefore, one of ordinary skill in the art would find it obvious before the effective filing date of the claimed invention to modify the system as disclosed by Poe in view of Flanagan to include the endoscopic camera as taught by de Juan to provide visualization of the ear canal.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Poe in view of Flanagan as applied to claim 1 above, and further in view of Charles (US Patent 11,033,427).
Regarding claim 4, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, and Poe discloses an illuminator (paragraph [0053], lines 25-27), the illuminator movably disposed within the passageway configured for longitudinal, radial, and/or lateral movement of the light emitting portion from a first position proximate the distal end of the body outwardly to a second position within a middle ear space (paragraph [0043], lines 18-23), but is silent as to the specifics of the proximal end portion configured for attachment to a manipulation device and the distal end portion comprising a light emitting portion.
However, Charles discloses an illuminator having a proximal end portion configured for attachment to a manipulation device and a distal end portion comprising a light emitting portion (Col. 8, lines 20-27). Merriam-Webster defines “emit” as “to give off or let out”. As disclosed in Col. 9, lines 38-41, the light transmitting window 86 permits transmission of light emitted from the optical fiber to provide illumination. Charles further teaches that it is advantageous to provide an illuminator with such a configuration to avoid the necessity to carry a separate illuminator and allow the user to hold another instrument if desired (Col. 8, lines 27-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as disclosed by Poe in view of Flanagan to have the proximal end configured for attachment to a light source and the light emitting portion on the distal end, as taught by Charles to yield a system configured to prevent the necessity to carry a separate illuminator and allow the user to hold another instrument.
Regarding claim 5, in the modified device of Poe, Charles further discloses that the illuminator comprises an optical light fiber (Col. 8, lines 17-18).
Regarding claim 6, in the modified device of Poe, Charles discloses the multi-function system of claim 4, and Charles further discloses that the illuminator comprises a light emitting device disposed at the light emitting portion (light transmitting window 86 in Fig. 3A).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Poe in view of Flanagan as applied to claim 1 above, and further in view of Larkin (US 20080065101).
Regarding claim 11, Poe in view of Flanagan discloses the trans-eustachian multi-function system of claim 1, but is silent to a tubular member attached to the proximal end of the body, the tubular member extending to and attached to an instrument housing configured to house a plurality of medical instruments, the plurality of medical instruments configured for selective insertion through an inner diameter of the tubular member and the passageway into a eustachian tube and/or middle ear space.
However, Larkin teaches a tubular member (see below) attached to the proximal end of the body, the tubular member extending to and attached to an instrument housing (instrument magazine 3002 in Fig. 30) configured to house a plurality of medical instruments (instruments 3004a, 3004b, 3004c), the plurality of medical instruments configured for selective insertion through an inner diameter of the tubular member and the passageway (paragraph [0283]) into a eustachian tube and/or middle ear space. Larkin teaches that having such a mechanism is advantageous to allow for components to be automatically replaced during surgery instead of by hand (paragraph [0283]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the system as disclosed by Poe in view of Flanagan to have a tubular member attached to an instrument housing configured to house a plurality of medical instruments which are configured for selective insertion through the tubular member and into the passageway, as disclosed by Larkin, in order to better facilitate replacements of components during operation.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AIDAN L NATHAN whose telephone number is (571)270-0798. The examiner can normally be reached Monday-Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AIDAN L NATHAN/ Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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