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 Objections
Claim(s) 1, 2, 3, 4, 5, 6, 9, 10, 11, 13, 14, 16 and 20 is/are objected to due to the following informalities:
In claim 1, line 4, “a cochlea” should be corrected to “the cochlea” since this term was previously introduced.
In claim 1, line 7, “cochlea delivery lumen” should be corrected to “the cochlea delivery lumen” since this phrase was previously introduced.
In claim 2, line 1, “flexible to assumes” should be corrected to “flexible to assume” for grammatical correctness.
In claim 2, line 3, “guide wire” should be corrected to “guidewire”.
In claim 4, line 3, “scala tympani” should be corrected to “the scala tympani” for claim language consistency.
In claim 5, line 2, “the scala tympani” should be corrected to “the scala tympani of the cochlea” for claim language consistency.
In claim 6, line 2, “micro-cannula” should be corrected to “the micro-cannula”.
In claim 6, line 3, “the scala tympani” should be corrected to “the scala tympani of the cochlea” for claim language consistency.
In claim 7, line 1, “wherein” should be inserted after the comma.
In claim 8, line 2, “a scala tympani” should be corrected to “the scala tympani” since this phrase was previously introduced.
In claim 9, line 2, “micro-cannula” should be corrected to “the micro-cannula”.
In claim 13, lines 1-2, “fluid from the cochlea” should be corrected to “the fluid from the cochlea”.
In claim 14, lines 1-2, “fluid from the cochlea” should be corrected to “the fluid from the cochlea”.
In claim 16, line 2, “a distal port” should be corrected to “the distal port” since this phrase was previously introduced.
In claim 16, line 2, “the scala tympani” should be corrected to “a scala tympani” since this phrase was not previously introduced.
In claim 20, line 7, “a scala tympani of the cochlea” should be corrected to “the scala tympani of the cochlea”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 10 recites “visualization from the endoscope”. Claim 1 previously introduced “visualization of a cochlea” in line 4, and it is unclear if the “visualization” from line 10 is intended to refer to the “visualization” of line 4 or introduce a different visualization. For the sake of examination, it is being interpreted that the “visualization” of line 10 is intended to refer to the “visualization” of line 4. Therefore, Applicant is suggested to amend claim 1 to recite in line 10, “visualization of the cochlea” to overcome rejection.
Claim 2-17 is/are rejected by virtue of their dependency on claim 1.
Claim 15, line 2 recites “visualization from the endoscope”. Claim 15 depends on claim 1 and therefore suffers the same issue as claim 1. For the sake of examination, it is being interpreted that the “visualization” of claim 15 is intended to refer to the “visualization” of claim 1, line 4. Therefore, Applicant is suggested to amend claim 15 to recite, “the visualization of the cochlea” to overcome rejection.
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the objections and rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) set forth in this Office Action.
The following is an examiner’s statement of reasons for allowance: Upon consideration of the prior art of record, the limitations recited in independent claim 1 are not taught or suggested by prior art and therefore define allowable subject matter.
Regarding claim(s) 1, Kim et al. (US 20200094030 A1, herein Kim) discloses a system (device in Fig. 1) for injecting a therapeutic agent (the application of a topical composition such as a topical anesthetic [0043]) into a cochlea (intracochlear administration is highly invasive but allows for direct access to the cochlea [0042]), the system comprising:
an endoscope (endoscope 100 in Fig. 1) having a shaft sized (elongated shaft 140 in Fig. 1) to advance through an outer ear canal (shaft 140 is inserted into ear in Fig. 2) and a tympanic membrane (intratympanic administration, in which drugs are administered to the middle ear [0042]; transcanal imaging for visualization of a portion of the ear, such as the tympanic membrane [0043]) such that a distal tip of the endoscope (see distal tip of endoscope in annotated Fig. 2 below) is positionable in a middle ear region (see distal tip positioned in middle ear region in annotated Fig. 2 below) for visualization of a cochlea (intracochlear administration is highly invasive but allows for direct access to the cochlea [0042]; see also visualization component 130 in Fig. 1; it can be interpreted that the visual component 130 is used for visualization of cochlea);
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Annotated Fig. 2 of Kim
a therapeutic agent for delivery into the cochlea (the three buttons 120 of FIG. 1 are configured to dispense the composition [0060]; the application of a topical composition such as a topical anesthetic [0043]);
a micro-cannula (the three buttons 120 of FIG. 1 are configured to dispense the composition, deploy the needle, and retract the needle [0060]; needle 180 in Fig. 12C can be interpreted as a micro-cannula; it is set forth in [0069] and Fig. 12C that the embodiment of Fig. 12C is an embodiment of endoscope 100 of Fig. 1 with similar configuration, except the inclusion of stopper 170 in Fig. 12C) including a cochlea delivery lumen (needle 180 can be interpreted to have a lumen since it is capable of delivering composition from reservoir 160), a proximal port in fluid communication with cochlea delivery lumen and configured to receive the therapeutic agent for delivery into the cochlea (see flexible tubing in annotated Fig. 12C below which can be interpreted as the proximal port establishing fluid communication between needle 180 and reservoir 160), and a distal port movable (end of needle 180 can be interpreted as the distal port) relative to the endoscope to advance adjacent to the shaft of the endoscope and through the tympanic membrane such that the distal port of the micro-cannula is insertable into the cochlea under visualization from the endoscope (it is set forth in para [0060] that the needle is retractable and deployable along the elongated shaft 140, and since shaft 140 is insertable in the cochlea, needle 180 can also be interpreted to be inserted into the cochlea under visualization component 130);
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Annotated Fig. 12C of Kim
However Kim failed to explicitly disclose wherein a first guidewire slidable within the micro-cannula and having a guidewire tip configured to pierce a round window membrane of the cochlea while at least a portion of the first guidewire is positioned within the micro-cannula, wherein the distal port of the micro-cannula is insertable through the round window membrane pierced by the guidewire tip to inject, via the cochlea delivery lumen of the micro-cannula, the therapeutic agent into the cochlea.
Kobayashi et al. (US 20160338771 A1, herein Kobayashi) teaches knife wire 30 in Fig. 6 which includes a cutting portion 34 which incises a target portion to be treated. The cutting portion 34 protrudes from the first distal communication hole 23 and the second distal communication hole 24, extends between the first distal communication hole 23 and the second distal communication hole 24, and is provided so as to incise tissues [0070].
Claim 1 requires a guidewire tip on the first guidewire that is configured to pierce a round window membrane. Kim discloses a retractable needle 180 [0060] which may be structurally different from a guidewire and therefore fails to disclose a first guidewire with a guidewire tip configured to pierce membranes.
The knife wire 30 of Kobayashi would also be incapable of performing the function of piercing a round window membrane in the cochlea since the cutting portion 34 can be seen located along the wire 30 in Fig. 6 and is intended to make incisions on tissues as taught in Para [0070] as opposed to piercing. Therefore, modifying the endoscope device of Kim with the knife wire of Kobayashi would render the device of Kim inoperable to perform the functions as required of claim 1.
Dueck et al. (US 20240277528 A1, herein Dueck) discloses an ear system endoscope in Fig. 30 with cannula 2420 that is capable of puncturing the round window due to a beveled tip and deliver therapeutic substance as taught in Para [0191] but suffers from the same issue as Kim due to lacking a first guidewire.
Claims 18 and 19 are allowed. Claim 20 depends from claim 18 and would be allowable if rewritten to overcome the objection set forth above.
The following is an examiner’s statement of reasons for allowance: Upon consideration of the prior of record, the limitations recited in independent claim 18 are not taught or suggested by prior art and therefore define allowable subject matter.
Regarding claim 18, Kim discloses a method (multimodal endoscope and methods of use [0043]) for injecting a therapeutic agent (the application of a topical composition such as a topical anesthetic [0043]) into a cochlea (intracochlear administration is highly invasive but allows for direct access to the cochlea [0042]) of a patient (the use of a single device may improve handling for the operator and minimize risk for the patient [0043]), the method comprising:
advancing, via an outer ear canal of the patient (shaft 140 is inserted into ear in Fig. 2), a shaft (elongated shaft 140 in Fig. 1) of a handheld otic visualization instrument (endoscope 100 in Fig. 1) such that a distal tip (see distal tip of endoscope in annotated Fig. 2 above) of the handheld otic visualization instrument is positioned in a middle ear region of the patient (see distal tip positioned in middle ear region in annotated Fig. 2 below);
advancing, through a working channel (shaft 140 can be interpreted to have a channel through which needle 180 is retracted or deployed) of the handheld otic visualization instrument, a micro-cannula (the three buttons 120 of FIG. 1 are configured to dispense the composition, deploy the needle, and retract the needle [0060]; needle 180 in Fig. 12C can be interpreted as a micro-cannula; it is set forth in [0069] and Fig. 12C that the embodiment of Fig. 12C is an embodiment of endoscope 100 of Fig. 1 with similar configuration, except the inclusion of stopper 170 in Fig. 12C) defining a lumen (needle 180 can be interpreted to have a lumen since it is capable of delivering composition from reservoir 160);
However Kim failed to explicitly disclose advancing, through the lumen of the micro-cannula, a first guidewire;
piercing a round window membrane of the patient using a tip of the first guidewire; and injecting, via the lumen of the micro-cannula, the therapeutic agent into the cochlea.
Kobayashi et al. (US 20160338771 A1, herein Kobayashi) teaches knife wire 30 in Fig. 6 which includes a cutting portion 34 which incises a target portion to be treated. The cutting portion 34 protrudes from the first distal communication hole 23 and the second distal communication hole 24, extends between the first distal communication hole 23 and the second distal communication hole 24, and is provided so as to incise tissues [0070].
Claim 18 requires a tip on a first guidewire that is configured to pierce a round window membrane. Kim discloses a retractable needle 180 [0060] which may be structurally different from a guidewire and therefore fails to disclose a first guidewire with a guidewire tip configured to pierce membranes.
The knife wire 30 of Kobayashi would also be incapable of performing the function of piercing a round window membrane in the cochlea since the cutting portion 34 can be seen located along the wire 30 in Fig. 6 and is intended to make incisions on tissues as taught in Para [0070] as opposed to piercing. Therefore, modifying the endoscope device of Kim with the knife wire of Kobayashi would render the device of Kim inoperable to perform the functions as required of claim 18.
Dueck et al. (US 20240277528 A1, herein Dueck) discloses an ear system endoscope in Fig. 30 with cannula 2420 that is capable of puncturing the round window due to a beveled tip and deliver therapeutic substance as taught in Para [0191] but suffers from the same issue as Kim due to lacking a first guidewire.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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