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 August 10, 2026.
Claims 1, 3, 5-19, and 21 are pending.
Claim Rejections - 35 USC § 112(b)
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, 10, and 21 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. More specifically, it is unclear what is meant by “determining, by observation with the endoscope, whether sufficient deposits are expelled from the target area; if it is observed that the deposits are not sufficiently expelled from the target area, repeating the sending of the gas into the target area to continue to expel the deposits from the target area (Claim 21), or “confirming by observation with the endoscope whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area, repeating the spraying of the drug to the target area” (Claims 1, 10, and 21). It is unclear, and the specification does not provided guidance to, what is meant by “sufficiently” when describing expulsion of deposits (Claim 21) or spraying a target area (Claims 1, 10, and 21).
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets “sufficient deposits are expelled from the target area” as “
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 3, 10-12, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holman et al. (US PGPUB 2020/0406012 – “Holman”).
Regarding Claim 1, Holman discloses:
A method for treating rhinosinusitis (Holman paragraph [0065], “Chronic rhinosinusitis (CRS) can be inflammation of paranasal sinuses”), the method comprising:
inserting a tubular spray device (Holman FIG. 3B, medical device 200) up to an opening (Holman FIG. 3B, sinus ostium 236) to a target area of nose and paranasal sinuses or the vicinity thereof (Holman FIG. 3B, sinus cavity 234; Holman FIG. 4, block 256, “positioning the distal end of the delivery device near a sinus ostium”) through a channel in an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”; Holman paragraph [0084], “the cleansing can be performed by delivering the cleansing agent via a working channel of an endoscope”);
inserting the tubular spray device (Holman FIG. 3B, medical device 200) into the opening (Holman FIG. 3B, sinus ostium 236) leading to a target area (Holman FIG. 3B, sinus cavity 234);
sending a gas into the target area through the spray device to increase a positive pressure inside the target area, to generate a flow of gas from the target area toward the opening which spurts the gas out from the opening of the target area and expels deposits from the target area (Holman paragraph [0072], “One or more fluids can be delivered to the medical device 200. The fluid(s) can include a liquid or a gas. The fluid can include any suitable fluid. For example, the fluid can include saline or air, such as for flushing mucus out of the sinus cavity, for aerating the sinus cavity, for cleansing the sinus cavity, for treating inflammation, and/or for lubricating dry sinus passages, or other cavity in which the medical device 200 can be inserted”; see also Holman FIG. 3B dispenser and Holman paragraph [0077], “dispenser 240 can be shown as being a syringe in FIG. 3B, but can be a gas cylinder, squeeze pump, hand-held dispenser with or without triggers, buttons or other actuators, or any other suitable dispenser in alternate embodiments”. Examiner interprets dispenser 240 as generating positive pressure that exits from medical device 200 into sinus cavity 234 in Holman Fig. 3B; see also Holman paragraph [0084], “The cleansing agent can include a saline liquid or a gas that flows across the walls of the sinus cavity 234 to cleanse the sinus cavity 234. The cleansing agent can flow out of the sinus cavity 234, through the nasal cavity 232, and into a throat or out of a nose.”); and
spraying a drug into the target area through the spray device (Holman paragraph [0072], “The fluid can also be…nitrous oxide for mild sedation during treatment”).
As described above, Holman discloses observing the target area with an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”).
Holman further discloses confirming whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area repeating the spraying of the drug to the target area. That is, Holman further discloses repeating application of the drug to the target area until the target area is sufficiently cured (Holman FIG. 4, operation 268; Holman paragraph [0095], “Operation 268 can include delivering a fluid to the medical device 200 using the dispenser 240…The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug”; Holman paragraph [0093], “Operations 266-272 can be repeated any number of times, (as needed) such as to deliver a fluid to sinus cavity 234.”).
Regarding Claim 3, Holman teaches the features of Claim 1, as described above.
Holman further discloses wherein the inserting the spray device into the target area is performed while observing the target area with the endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”).
Regarding Claim 10 Holman discloses a method for treating rhinosinusitis (Holman paragraph [0065], “Chronic rhinosinusitis (CRS) can be inflammation of paranasal sinuses”), the method comprising:
inserting a tubular spray device (Holman FIG. 3B, medical device 200) up to an opening (Holman FIG. 3B, sinus ostium 236) to a target area of nose and paranasal sinuses or the vicinity thereof (Holman FIG. 3B, sinus cavity 234; Holman FIG. 4, block 256, “positioning the distal end of the delivery device near a sinus ostium”) through a channel in an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”; Holman paragraph [0084], “the cleansing can be performed by delivering the cleansing agent via a working channel of an endoscope”);
inserting the tubular spray device (Holman FIG. 3B, medical device 200) into the opening (Holman FIG. 3B, sinus ostium 236) leading to a target area (Holman FIG. 3B, sinus cavity 234);
sending a gas and a drug simultaneously (Holman paragraph [0095], “The fluid can be a cleansing agent used to cleanse the sinus cavity 234, including a saline or gas. The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug.”) into an opening (Holman FIG. 3B, sinus ostium 236) leading to the target area through the spray device to increase a positive 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 the opening of the target area such that the drug is sprayed inside the target area while expelling deposits from the target area (Holman paragraph [0072], “One or more fluids can be delivered to the medical device 200. The fluid(s) can include a liquid or a gas. The fluid can include any suitable fluid. For example, the fluid can include saline or air, such as for flushing mucus out of the sinus cavity, for aerating the sinus cavity, for cleansing the sinus cavity, for treating inflammation, and/or for lubricating dry sinus passages, or other cavity in which the medical device 200 can be inserted”; see also Holman FIG. 3B dispenser and Holman paragraph [0077], “dispenser 240 can be shown as being a syringe in FIG. 3B, but can be a gas cylinder, squeeze pump, hand-held dispenser with or without triggers, buttons or other actuators, or any other suitable dispenser in alternate embodiments”. Examiner interprets dispenser 240 as generating positive pressure that exits from medical device 200 into sinus cavity 234 in Holman Fig. 3B; see also Holman paragraph [0084], “The cleansing agent can include a saline liquid or a gas that flows across the walls of the sinus cavity 234 to cleanse the sinus cavity 234. The cleansing agent can flow out of the sinus cavity 234, through the nasal cavity 232, and into a throat or out of a nose.”).
As described above, Holman discloses observing the target area with an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”).
Holman further discloses confirming whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area repeating the spraying of the drug to the target area. That is, Holman further discloses repeating application of the drug to the target area until the target area is sufficiently cured (Holman FIG. 4, operation 268; Holman paragraph [0095], “Operation 268 can include delivering a fluid to the medical device 200 using the dispenser 240…The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug”; Holman paragraph [0093], “Operations 266-272 can be repeated any number of times, (as needed) such as to deliver a fluid to sinus cavity 234.”).
Regarding Claim 11, Holman discloses the features of Claim 1, as described above.
Holman further discloses 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 (Holman Fig. 5G, showing medical device 200 passing through sinus ostium 236; Holman paragraph [0072], “fluid can include saline or air, such as for flushing mucus out of the sinus cavity”).
Regarding Claim 12, Holman discloses the features of Claim 10, as described above.
Holman further discloses 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 the 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 (Holman Fig. 5G, showing medical device 200 passing through sinus ostium 236; Holman paragraph [0072], “fluid can include saline or air, such as for flushing mucus out of the sinus cavity”).
Regarding Claim 21, Holman discloses:
A method for treating rhinosinusitis (Holman paragraph [0065], “Chronic rhinosinusitis (CRS) can be inflammation of paranasal sinuses”), the method comprising:
inserting a tubular spray device (Holman FIG. 3B, medical device 200) up to an opening (Holman FIG. 3B, sinus ostium 236) to a target area of nose and paranasal sinuses or the vicinity thereof (Holman FIG. 3B, sinus cavity 234; Holman FIG. 4, block 256, “positioning the distal end of the delivery device near a sinus ostium”) through a channel in an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”; Holman paragraph [0084], “the cleansing can be performed by delivering the cleansing agent via a working channel of an endoscope”);
inserting the tubular spray device (Holman FIG. 3B, medical device 200) into the opening (Holman FIG. 3B, sinus ostium 236) leading to a target area (Holman FIG. 3B, sinus cavity 234);
sending a gas into the target area through the spray device to increase a positive pressure inside the target area, to generate a flow of gas from the target area toward the opening which spurts the gas out from the opening of the target area and expels deposits from the target area (Holman paragraph [0072], “One or more fluids can be delivered to the medical device 200. The fluid(s) can include a liquid or a gas. The fluid can include any suitable fluid. For example, the fluid can include saline or air, such as for flushing mucus out of the sinus cavity, for aerating the sinus cavity, for cleansing the sinus cavity, for treating inflammation, and/or for lubricating dry sinus passages, or other cavity in which the medical device 200 can be inserted”; see also Holman FIG. 3B dispenser and Holman paragraph [0077], “dispenser 240 can be shown as being a syringe in FIG. 3B, but can be a gas cylinder, squeeze pump, hand-held dispenser with or without triggers, buttons or other actuators, or any other suitable dispenser in alternate embodiments”. Examiner interprets dispenser 240 as generating positive pressure that exits from medical device 200 into sinus cavity 234 in Holman Fig. 3B; see also Holman paragraph [0084], “The cleansing agent can include a saline liquid or a gas that flows across the walls of the sinus cavity 234 to cleanse the sinus cavity 234. The cleansing agent can flow out of the sinus cavity 234, through the nasal cavity 232, and into a throat or out of a nose.”);
simultaneously with the sending of the gas into the target area through the spray device (Holman paragraph [0095], “The fluid can be a cleansing agent used to cleanse the sinus cavity 234, including a saline or gas. The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug.”), spaying a drug to the target area with the gas as the deposits are expelled from the target area (Holman paragraph [0072], “One or more fluids can be delivered to the medical device 200. The fluid(s) can include a liquid or a gas. The fluid can include any suitable fluid. For example, the fluid can include saline or air, such as for flushing mucus out of the sinus cavity, for aerating the sinus cavity, for cleansing the sinus cavity, for treating inflammation, and/or for lubricating dry sinus passages, or other cavity in which the medical device 200 can be inserted”; see also Holman FIG. 3B dispenser and Holman paragraph [0077], “dispenser 240 can be shown as being a syringe in FIG. 3B, but can be a gas cylinder, squeeze pump, hand-held dispenser with or without triggers, buttons or other actuators, or any other suitable dispenser in alternate embodiments”. Examiner interprets dispenser 240 as generating positive pressure that exits from medical device 200 into sinus cavity 234 in Holman Fig. 3B; see also Holman paragraph [0084], “The cleansing agent can include a saline liquid or a gas that flows across the walls of the sinus cavity 234 to cleanse the sinus cavity 234. The cleansing agent can flow out of the sinus cavity 234, through the nasal cavity 232, and into a throat or out of a nose.”);
As described above, Holman discloses observing the target area with an endoscope (Holman paragraph [0083], “An endoscope can be inserted in the nostril 230 to visualize the nasal cavity 232, the sinus cavity 234, and/or the sinus ostium 236, or other structure around the medical device 200.”).
Holman further discloses determining whether sufficient deposits are expelled from the target area; if it is observed that the deposits are not sufficiently expelled from the target area, repeating the sending of the gas into the target area to continue to expel the deposits from the target area (Holman FIG. 4 block 252; Holman paragraph [0084]; Holman paragraph [0085], “The operations 250 and 252 can be repeated (e.g., as needed for cleaning of the sinus cavity 234).”).
Holman further discloses confirming whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area repeating the spraying of the drug to the target area. That is, Holman further discloses repeating application of the drug to the target area until the target area is sufficiently cured (Holman FIG. 4, operation 268; Holman paragraph [0095], “Operation 268 can include delivering a fluid to the medical device 200 using the dispenser 240…The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug”; Holman paragraph [0093], “Operations 266-272 can be repeated any number of times, (as needed) such as to deliver a fluid to sinus cavity 234.”).
Claim Rejections - 35 USC § 103
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 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Guest et al. (US PGPUB 2005/0085790 – “Guest”).
Regarding Claim 13, Holman discloses the features of Claim 1, as described above.
Holman does not explicitly disclose withdrawing the spray device from the target area while spraying the drug.
Guest is analogous art in the field of endoscopic procedures that teaches withdrawing the spray device from the target area while spraying the drug (Guest FIG. 4C, syringe 46 and catheter 40 treating subarachnoid space 50 of a spinal column; Guest paragraph [0009], “The injection member may be at least partially withdrawn from the spinal cord while injecting the therapeutic substance to thereby form a trail of therapeutic substance.”).
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 Guest’s trail of therapeutic substance with the method disclosed by Holman . 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 provides additional therapeutic coverage of a target area.
Regarding Claim 14, Holman in view of Guest teaches the features of Claim 13, as described above.
Guest further teaches wherein the spray device is configured to spray the drug on multiple locations simultaneously (Guest FIG. 4C, showing catheter 40 treating multiple locations within subarachnoid space 50).
Regarding Claim 15, Holman discloses the features of Claim 10, as described above.
Holman does not explicitly disclose withdrawing the spray device from the target area while spraying the drug.
Guest is analogous art in the field of endoscopic procedures that teaches withdrawing the spray device from the target area while spraying the drug (Guest FIG. 4C, syringe 46 and catheter 40 treating subarachnoid space 50 of a spinal column; Guest paragraph [0009], “The injection member may be at least partially withdrawn from the spinal cord while injecting the therapeutic substance to thereby form a trail of therapeutic substance.”).
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 Guest’s trail of therapeutic substance with the method disclosed by Holman . 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 provides additional therapeutic coverage of a target area.
Regarding Claim 16, Holman in view of Guest teaches the features of Claim 15.
Guest further teaches wherein the spray device is configured to spray the drug on multiple locations simultaneously (Guest FIG. 4C, showing catheter 40 treating multiple locations within subarachnoid space 50).
Regarding Claim 17, Holman discloses the features of Claim 1, as described above.
Holman does not explicitly disclose wherein the spray device comprises a connector on a proximal side.
Guest is analogous art in the field of endoscopic treatment that teaches wherein the spray device (Guest FIG. 4C, catheter 40) comprises a connector on a proximal side (Guest FIG. 4C, connection between catheter 40 and syringe 46; Guest paragraph [0040], “A syringe 46 containing cells and/or other therapeutic agent(s) is placed in fluid communication with the catheter 40 and needle 42”).
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 or substitute Guest’s catheter 40 for Holman’s medical device 200. A person having ordinary skill in the art would be motivated to make this combination/substitution according to known methods to yield the predictable result of a method that has a source of therapeutic agents for treating an endoscopic area of interest.
Regarding Claim 18, Holman in view of Guest teaches the features of Claim 17, as described above.
Guest further teaches wherein the connector is configured to connect to a drug supply source (Guest FIG. 4C, syringe 46; Guest paragraph [0040], “A syringe 46 containing cells and/or other therapeutic agent(s) is placed in fluid communication with the catheter 40 and needle 42”).
Regarding Claim 19, Holman discloses the features of Claim 10, as described above.
wherein the spray device comprises a connector on a proximal side.
Holman does not explicitly disclose wherein the spray device comprises a connector on a proximal side.
Guest is analogous art in the field of endoscopic treatment that teaches wherein the spray device (Guest FIG. 4C, catheter 40) comprises a connector on a proximal side (Guest FIG. 4C, connection between catheter 40 and syringe 46; Guest paragraph [0040], “A syringe 46 containing cells and/or other therapeutic agent(s) is placed in fluid communication with the catheter 40 and needle 42”).
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 or substitute Guest’s catheter 40 for Holman’s medical device 200. A person having ordinary skill in the art would be motivated to make this combination/substitution according to known methods to yield the predictable result of a method that has a source of therapeutic agents for treating an endoscopic area of interest.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Kojo (US PGPUB 2019/0336733 – “Kojo”).
Regarding Claim 5, Holman discloses the features of Claim 1, as described above.
Holman does not explicitly disclose after continuing to spray the drug, withdrawing the spray device from the target area; and withdrawing the spray device from the nose and paranasal sinuses.
Kojo is analogous art in the field of endoscopic treatment that teaches after continuing to spray 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 disclosed by Holman. 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 Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Tanigami et al. (US PGPUB 2021/0386270 – “Tanigami”).
Regarding Claim 6, Holman discloses the features of Claim 1, as described above.
Holman further discloses before continuing to spray the drug (Holman FIG. 4, block 270; Holman paragraph [0096], “Operation 270 can include delivering the fluid in the medical device 200 to the sinus cavity 234”), and positioning the spray device with respect to the site of inflammation (Holman Fig. 4, block 258; advancing the delivery device 280 into the sinus cavity 234).
Holman does not explicitly disclose confirming a site of inflammation in the target area with an endoscopic image captured by the endoscope.
Tanigami is analogous art in the field of endoscopic treatment that teaches confirming a site of inflammation in the target area with an endoscopic image (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; 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 Holman. 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 Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Tanigami et al. (US PGPUB 2021/0386270 – “Tanigami”) and Uemori et al. (US PGPUB 2021/0037173 – “Uemori”).
Regarding Claim 7, Holman in view of Tanigami teaches the features of Claim 6, as described above.
Holman in view of 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 is analogous art in the field of endoscopic operations that 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 Holman in view of 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 Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Maeda et al. (US PGPUB 2012/0176486 – “Maeda”).
Regarding Claim 8, Holman discloses the features of Claim 1, as described above.
Holman does not explicitly teach before sending the gas, aspirating the deposits inside the target area with an aspirating device.
Maeda is analogous art in the field of endoscopic operations that 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 disclosed by Holman. 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 before it is visualized by an endoscope (Maeda paragraph [0108] “irrelevant objects are physically eliminated from the target site during the special inspection mode, in order to obtain image data G from the target site before…the physical elimination of irrelevant objects”. That is, it would be obvious to a person having ordinary skill in the art to remove distracting/irrelevant objects when taking an image, so that the image 1) shows the target area without visual interference from the irrelevant objects, and 2) the user’s attention is not distracted by the irrelevant objects.
As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the use of Maeda’s pre-cleaning providing an improved image of the target area described by Holman). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Holman et al. (US PGPUB 2020/0406012 – “Holman”) in view of Hunt (US PGPUB 2006/0135846 – “Hunt”).
Regarding Claim 9, Holman discloses the features of Claim 1, as described above.
Holman does not explicitly disclose wherein a first operator operates the endoscope, and a second operator different from the first operator operates the spray device.
Hunt is analogous art in the field of endoscopic treatment that 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 disclosed by Holman. 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, see pages 7-10, filed August 10, 2026, with respect to the rejection(s) of Claims 1, 10, and 21, have been fully considered but they are not persuasive. Specifically, Applicant asserts that Holman et al. (US PGPUB 2020/0406012 – “Holman”) fails to teach or suggest “determining, by observation with the endoscope, whether sufficient deposits are expelled from the target area; if it is observed that the deposits are not sufficiently expelled from the target area, repeating the sending of the gas into the target area to continue to expel the deposits from the target area”, and/or “confirming by observation with the endoscope whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area, repeating the spraying of the drug to the target area.” As described in the rejections of Claims 1, 10, and 21 under 35 U.S.C. 102/103 presented above, Holman discloses determining whether sufficient deposits are expelled from the target area; if it is observed that the deposits are not sufficiently expelled from the target area, repeating the sending of the gas into the target area to continue to expel the deposits from the target area (Holman FIG. 4 block 252; Holman paragraph [0084]; Holman paragraph [0085], “The operations 250 and 252 can be repeated (e.g., as needed for cleaning of the sinus cavity 234).”). Holman further discloses confirming whether the drug is sufficiently sprayed in the target area; and if it is observed that the drug is not sufficiently sprayed in the target area repeating the spraying of the drug to the target area. That is, Holman further discloses repeating application of the drug to the target area until the target area is sufficiently cured (Holman FIG. 4, operation 268; Holman paragraph [0095], “Operation 268 can include delivering a fluid to the medical device 200 using the dispenser 240…The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug”; Holman paragraph [0093], “Operations 266-272 can be repeated any number of times, (as needed) such as to deliver a fluid to sinus cavity 234.”).
On page 10, Applicant asserts that only impermissible hindsight would result in combining Holman with Maeda et al. (US PGPUB 2012/0176486 – “Maeda”) to reject Claim 8. Examiner respectfully disagrees. As described above, 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 disclosed by Holman. 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 before it is visualized by an endoscope (Maeda paragraph [0108] “irrelevant objects are physically eliminated from the target site during the special inspection mode, in order to obtain image data G from the target site before…the physical elimination of irrelevant objects”. That is, it would be obvious to a person having ordinary skill in the art to remove distracting/irrelevant objects when taking an image, so that the image 1) shows the target area without visual interference from the irrelevant objects, and 2) the user’s attention is not distracted by the irrelevant objects.
As such, the rejection of Claims 1, 3, 5-19, and 21 under 35 U.S.C. 102/103 are maintained.
Conclusion
The prior art made of record and not relied upon but still considered pertinent to applicant's disclosure includes the following:
Carlson, Jennifer, "Spray Coverage Testing", Cleaning Compliance Forum, Spring 2011, Vol. 15, Number 2, file:///C:/Desktop/Applications%20-%20patents/18213394%20Treating%20rhinosinusitis/spray-coverage-testing-20121.pdf (Carlson”), which teaches on page 45 “Spray coverage testing provides assurance that spray devices used during cleaning for a particular piece of equipment are able to reach and rinse all interior process contacting surfaces.”
Firas H Al-Kawas, "Chromoendoscopy", Gastroenterology & Hepatology Journal, 2006 Feb; 2(2): 101-103 (“Al-Kawas”), which teaches on page 3 that spraying contrast dyes on mucosa are sufficient to enhance/highlight the appearance of the mucosa.
Goldfarb (US PGPUB 2012/0265094 – “Goldfarb”), which teaches in Goldfarb paragraph [0138] that a view of a target area provide by an endoscope can confirm that the target area has been cleaned out.
Wei (US PGPUB 2015/0265752 – “Wei”), which teaches in Wei paragraph [0138] that a patient can repeat applications of a drug to a target area until it is determined that the target area has been sufficiently covered to achieve a desired therapeutic effect.
Drinan et al. (US PGPUB 2003/0145849 – “Drinan”), which teaches in Drinan paragraph [0056] that a therapeutic agent can be repeatedly delivered to a nasal cavity until a determination is made that sufficient amounts of the therapeutic agent have been delivered to the nasal cavity.
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.
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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/08/2026
