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 .
This Office Action is in response to the amendments dated October 27, 2025.
Claims 1-12 are pending.
Claim Objections
Claim 10 is objected to because of the following informalities: there appears to be a typographical error in line 6, in which “to” is missing before the phrase “increase pressure inside the target area”. Appropriate correction by Applicant is required.
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.
Claims 1 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”).
Regarding Claim 1, Siegel discloses:
A method for treating rhinosinusitis, the method comprising:
inserting a tubular spray device (Siegel FIG. 3, Fluid Introduction and Retention Unit 300) into a target area of nose and paranasal sinuses (Siegel col., 2 lines 43-47, “a primary use of the apparatus of the present invention is to provide prolonged and predictable contact with the nasal and sinus mucosa by a bathing fluid, and to deliver a saline bath or medication locally to the nose and sinuses to treat nasal/sinus conditions.”);
sending a gas into the target area through the spray device to expel deposits from the target area (Siegel FIG. 3, Fluid Agitation Unit 370 in Fluid Introduction and Retention Unit 300; Siegel col. 3 lines 58-60, “Fluid Agitation Unit can be used to introduce an agitation fluid, such as air, into the bathing liquid filling the nasal and sinus cavities. The agitation fluid creates turbulence in the liquid which assists in “scrubbing” the walls of the cavity structures to remove the thick sticky mucous and debris associated with inflammation and infection.”); and
spraying a drug into the target area through the spray device (Siegel FIG. 3, syringe 360, tip member 310, and through bore 335; Siegel col. 6 lines 38-42, “A channel or through bore 335 extends through the length of tip member 310 such that the bathing fluid from syringe 360 can be transmitted through the tip member and out through the distal end of nostril interface unit 320.”; Siegel col. 2, lines 44-47, ” a primary use of the apparatus of the present invention is to…medication locally to the nose and sinuses to treat nasal/sinus conditions”).
Siegel does not explicitly disclose sending a gas into the target area through the spray device to increase pressure inside the target area, to generate a flow of gas from the target area toward the opening which spurts the gas out from an opening of the target area and expels deposits from the target area.
Abate teaches sending a gas into the target area through the spray device to increase pressure inside the target area, to generate a flow of gas from the target area toward the opening which spurts the gas out from an opening of the target area and expels deposits from the target area (Abate FIG. 2, nasal mucus aspirator 1, air nozzle 12 and mucus inlet conduit 14; Abate Abstract, “a nasal mucus aspirator includes an accessory body suitable to be gripped and a terminal nozzle placed at a distal end of said accessory body and suitable to be at least partially inserted into a nostril of a user. In the accessory body, there are formed a compressed air inlet passage suitable to be fluidically connected to a compressed air source for receiving a flow of air at a positive pressure…and an aspiration duct…to aspirate the mucus”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Abate’s air nozzle and mucus inlet conduit with the method disclosed by Siegel. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that removes mucus from a nasal passage using air pressure that is gentle when dislodging mucus and yet generates a Venturi effect for removing the dislodged mucus (see Abate paragraph [0074]).
Regarding Claim 10, Siegel discloses:
A method for treating rhinosinusitis, the method comprising:
inserting a tubular spray device (Siegel FIG. 3, Fluid Introduction and Retention Unit 300) into a target area of nose and paranasal sinuses (Siegel col., 2 lines 43-47, “a primary use of the apparatus of the present invention is to provide prolonged and predictable contact with the nasal and sinus mucosa by a bathing fluid, and to deliver a saline bath or medication locally to the nose and sinuses to treat nasal/sinus conditions.”); and
sending a gas and a drug simultaneously into the target area through the spray device to spray the drug inside the target area while expelling deposits from the target area (Siegel FIG. 3, Fluid Agitation Unit 370 in Fluid Introduction and Retention Unit 300; Siegel col. 3 lines 58-60, “Fluid Agitation Unit can be used to introduce an agitation fluid, such as air, into the bathing liquid filling the nasal and sinus cavities. The agitation fluid creates turbulence in the liquid which assists in “scrubbing” the walls of the cavity structures to remove the thick sticky mucous and debris associated with inflammation and infection.”; Siegel col. 2, lines 43-47, “a primary use of the apparatus of the present invention is to provide…medication locally to the nose and sinuses to treat nasal/sinus conditions”).
Siegel does not explicitly disclose sending a gas and a drug simultaneously into the target area through the spray device increase pressure inside the target area, to generate a flow of the gas from the target area toward the opening which spurts the gas out from an opening of the target area such that the drug is sprayed inside the target area while expelling deposits from the target area.
Abate teaches sending a gas and a drug simultaneously into the target area through the spray device increase pressure inside the target area, to generate a flow of the gas from the target area toward the opening which spurts the gas out from an opening of the target area such that the drug is sprayed inside the target area while expelling deposits from the target area (Abate FIG. 2, nasal mucus aspirator 1, air nozzle 12 and mucus inlet conduit 14; Abate Abstract, “a nasal mucus aspirator includes an accessory body suitable to be gripped and a terminal nozzle placed at a distal end of said accessory body and suitable to be at least partially inserted into a nostril of a user. In the accessory body, there are formed a compressed air inlet passage suitable to be fluidically connected to a compressed air source for receiving a flow of air at a positive pressure…and an aspiration duct…to aspirate the mucus”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Abate’s air nozzle and mucus inlet conduit with the method disclosed by Siegel. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that administers therapeutic drugs (Siegel) while removing mucus from a nasal passage using air pressure that is gentle when dislodging mucus and yet generates a Venturi effect for removing the dislodged mucus (see Abate paragraph [0074]).
Regarding Claim 11, Siegel in view of Abate teaches the features of Claim 1, as described above.
Abate further teaches wherein the sending of the gas into the target area through the spray device further comprises inserting a distal tip of the spray device into the opening; and the flow of the gas generated from the target area toward the opening which spurts the gas out from an opening of the target area and expels deposits from the target area is between an interior of the opening and an exterior of the spray device (Abate FIG. 2, nasal mucus aspirator 1, air nozzle 12 and mucus inlet conduit 14; Abate Abstract, “a nasal mucus aspirator includes an accessory body suitable to be gripped and a terminal nozzle placed at a distal end of said accessory body and suitable to be at least partially inserted into a nostril of a user. In the accessory body, there are formed a compressed air inlet passage suitable to be fluidically connected to a compressed air source for receiving a flow of air at a positive pressure…and an aspiration duct…to aspirate the mucus”).
Regarding Claim 12, Siegel in view of Abate teaches the features of Claim 10, as described above.
Abate further teaches wherein the sending of the gas into the target area through the spray device further comprises: inserting a distal tip of the spray device into the opening; and the flow of the gas generated from the target area toward the opening which spurts the gas out from an opening of the target area and expels deposits from the target area is between an interior of the opening and an exterior of the spray device (Abate FIG. 2, nasal mucus aspirator 1, air nozzle 12 and mucus inlet conduit 14; Abate Abstract, “a nasal mucus aspirator includes an accessory body suitable to be gripped and a terminal nozzle placed at a distal end of said accessory body and suitable to be at least partially inserted into a nostril of a user. In the accessory body, there are formed a compressed air inlet passage suitable to be fluidically connected to a compressed air source for receiving a flow of air at a positive pressure…and an aspiration duct…to aspirate the mucus”).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”) and Furlong et al. (US PGPUB 2017/0319188 – “Furlong”).
Regarding Claim 2, Siegel in view of Abate teaches the features of Claim 1, as described above.
Siegel further discloses before inserting the spray device into the target area, inserting the spray device up to an opening to the target area or the vicinity thereof (Siegel col. 6 lines 33-35, ”Tip member 310 has a nostril interface 320 that forms a fluid-tight seal with a nostril when pressed against a nostril opening”; Examiner interprets the contact between the tip member 310 and the nostril as occurring before the tip member approaches the vicinity of the sinuses.).
Siegel in view of Abate does not explicitly teach observing the nose and paranasal sinuses with an endoscope.
Furlong teaches observing the nose and paranasal sinuses with an endoscope (Furlong FIG. 1B, camera 112 and instrument channel 120; Furlong paragraph [0142], “instrument channel 120 through which an endoscopic instrument can be passed through to conduct a number of operations”; Examiner interprets Furlong’s camera 112 as observing the nose and paranasal sinuses when Siegel’s Fluid Introduction and Retention Unit 300 is inserted into Furlong’s instrument channel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Furlong’s endoscope having visualization capacity with Siegel’s Fluid Introduction and Retention Unit 300 in the method taught by Siegel in view of Abate. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method in which a person cleaning/treating a sinus target has an unobstructed view of the process.
Regarding Claim 3, Siegel in view of Abate and Furlong teaches the features of Claim 2, as described above.
Siegel in view of Abate and Furlong further teach wherein the inserting the spray device into the target area is performed while observing the target area with the endoscope (Examiner interprets Furlong’s camera 112 as observing the target area as Siegel’s Fluid Introduction and Retention Unit 300 is exiting Furlong’s instrument channel 120 and moving towards the target area).
Regarding Claim 4, Siegel in view of Abate and Furlong teaches the features of Claim 2, as described above.
Siegel in view of Abate and Furlong further teaches wherein the spray device is inserted up to the opening to the target area or the vicinity thereof through a channel in the endoscope (Furlong FIG. 1B, instrument channel 120; Examiner interprets Furlong’s camera 112 as observing the target area as Siegel’s Fluid Introduction and Retention Unit 300 is exiting Furlong’s instrument channel 120).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”) and Kojo (US PGPUB 2019/0336733 – “Kojo”).
Regarding Claim 5, Siegel discloses the features of Claim 1, as described above.
Siegel in view of Abate does not explicitly teach after spraying the drug, withdrawing the spray device from the target area; and withdrawing the spray device from the nose and paranasal sinuses.
Kojo teaches after spraying the drug, withdrawing the spray device from the target area; and withdrawing the spray device from the nose and paranasal sinuses (Kojo FIG. 2B, drug administration sheath 1 within maxillary sinus 100; Kojo paragraph [0062], “After the application of the drug 11 to the mucosa in the maxillary sinus 100 is completed…the drug administration sheath 1 is extracted from the maxillary sinus 100, and removed out of the body.”; Examiner interprets Kojo’s drug administration sheath 1 as a fluid delivery device, i.e., a spray device).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kojo’s step of removing the spray device from the patient with the method taught by Siegel in view of Abate. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a sinus cleaning/treating method in which the cleaning/treating instrument is withdrawn upon completion of the sinus cleaning/treating.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”), Furlong et al. (US PGPUB 2017/0319188 – “Furlong”), and Tanigami et al. (US PGPUB 2021/0386270 – “Tanigami”).
Regarding Claim 6, Siegel in view of Abate and Furlong teaches the features of Claim 2, as described above.
As described above, Siegel discloses a treatment device as the Fluid Introduction and Retention Unit 300 for spraying a drug. As described above, Furlong teaches a camera 112 for visualizing a target.
However, Siegel in view of Abate and Furlong does not explicitly teach before treating the target area (“before spraying the drug”), confirming a site of inflammation in the target area with an endoscopic image; and positioning the treatment device (”spray device”) with respect to the site of inflammation.
Tanigami teaches before treating the target area, confirming a site of inflammation in the target area with an endoscopic image; and positioning the treatment device with respect to the site of inflammation (Tanigami FIG. 1, endoscope apparatus 2 including camera unit 22, and treatment instrument 61; Tanigami paragraph [0071], “The user checks the display image displayed on the display apparatus 5, disposes the distal end portion of the insertion portion 6 at a position where an image of the treatment target site in the subject can be picked up, and also disposes the treatment unit 73 of the treatment instrument 61 near the living body tissue at this treatment target. In addition, for example, the user contacts the treatment unit 73 to the treatment target site and operates the switch unit 74, thereby performing instruction for starting energy supply from the treatment instrument control apparatus 62 to the treatment instrument 61.”; see also Tanigami paragraph [0153], which describes the target sight as being inflamed.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Tanigami’s method of identifying an inflammation site and positioning the treatment device thereupon with the method taught by Siegel in view of Abate and Furlong. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a therapeutic method that precisely treats a target site of inflammation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”), Furlong et al. (US PGPUB 2017/0319188 – “Furlong”), Tanigami et al. (US PGPUB 2021/0386270 – “Tanigami”), and Uemori et al. (US PGPUB 2021/0037173 – “Uemori”).
Regarding Claim 7, Siegel in view of Furlong and Tanigami teach the features of Claim 6, as described above.
Siegel in view of Abate, Furlong, and Tanigami does not explicitly teach wherein the confirming the site of inflammation includes observing at least one of a normal endoscopic image and an endoscopic image in which the site of inflammation is emphasized.
Uemori teaches the confirming the site of inflammation includes observing at least one of a normal endoscopic image and an endoscopic image in which the site of inflammation is emphasized (Uemori FIG. 6, block S22; Uemori paragraph [0096], “a pseudo color image is generated on the basis of a spectral image of a wavelength of light effective for a target, which is determined from a multispectral image captured using white light. This makes it possible to present a color image in which a feature of the target is emphasized to the user”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Uemori’s method of highlighting a target with the method taught by Siegel in view of Abate, Furlong, and Tanigami. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that displays a “feature of the target in an easy-to-understand manner” (see Uemori paragraph [0096]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”) and Maeda et al. (US PGPUB 2012/0176486 – “Maeda”).
Regarding Claim 8, Siegel in view of Abate teaches the features of Claim 1, as described above.
Siegel in view of Abate does not explicitly teach before sending the gas, aspirating the deposits inside the target area with an aspirating device.
Maeda teaches before sending the gas, aspirating the deposits inside the target area with an aspirating device (Maeda FIG. 12; Maeda paragraph [0108], “irrelevant objects are physically eliminated from the target site during the special inspection mode…Irrelevant objects may also be eliminated by suction into a catheter connected to an aspirator.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Maeda’s pre-op cleaning of the target using aspiration with the method taught by Siegel in view of Abate. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that cleans a target (sinus) area more thoroughly than a single-pass cleaning.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US Patent 10,279,155 – “Siegel”) in view of Abate et al. (US PGPUB 2018/0369459 – “Abate”), Furlong et al. (US PGPUB 2017/0319188 – “Furlong”) and Hunt (US PGPUB 2006/0135846 – “Hunt”).
Regarding Claim 9, Siegel in view of Abate and Furlong teaches the features of Claim 2, as described above.
Siegel in view of Abate and Furlong does not explicitly teach wherein a first operator operates the endoscope, and a second operator different from the first operator operates the treatment instrument (“the spray device”).
Hunt teaches wherein a first operator operates the endoscope, and a second operator different from the first operator operates the treatment instrument (Hunt paragraph [0002], “Endoscopes are known medical instruments having a handpiece…The handpiece typically includes knobs and buttons to allow a first operator of the endoscope to manipulate the distal end portion of the flexible tube in a body passageway…The handpiece also includes a working channel opening which allows a second operator to hold the handle of an endoscope adjunct device (such as a grasper, biopsy forceps, or a snare) while inserting a cable of the endoscope adjunct device into the working channel opening”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hunt’s method of utilizing a two-member endoscopic surgical team with the method taught by Siegel in view of Abate and Furlong. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows operation of different surgical components to be performed by different persons, thus preventing a single operator from becoming overburdened or having to release a first instrument in order to grasp a second instrument for control thereof.
Response to Arguments
Applicant’s arguments with respect to Claims 1-12 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
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/05/2026