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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 18/213,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all elements in Claim 1 of the present patent application are claimed in Claim 1 of copending Application No. 18/213,394, such that this is an anticipation-type nonstatutory double patenting rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
A comparison of Claim 1 of current patent Application 18/774,115 and Claim 1 of pending parent patent Application 18/213,394 is shown in the table below:
Current patent Application 18/774,115
Parent patent Application 18/213,394
Claim 1.
Claim 1. (As amended on August 10)
A method for treating rhinosinusitis, the method comprising:
A method for treating rhinosinusitis, the method comprising:
inserting a tubular spray device into a target area of nose and paranasal sinuses;
Inserting a tubular spray device up to an opening to a target area of nose and paranasal sinuses or the vicinity thereof through a channel in an endoscope; inserting the tubular spray device into the opening leading to the target area;
sending a gas into the target area through the spray device to expel deposits from the target area; and
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;
spraying a drug into the target area through the spray device.
spraying a drug into the target area through the spray device;.
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.
Dependent Claims 2-17 are further rejected based on their dependence of Claim 1 of the present patent Application 18/774,115.
Claim Interpretation
Dependent Claim 11, and thus Claims 12-17 that depend therefrom, is interpreted as claiming subject matter that is eligible under 35 U.S.C. 101 (Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014); Mayo, 566 U.S. at 79-80, 86-87,
101 USPQ2d at 1968-69, 1971)), for reciting “calculating an index value for each pixel in at least a partial region of the acquired white light image by normalizing a sum of a red pixel value and a green pixel value of the each pixel by twice a blue pixel value”. That is, this feature normalizes (creates a combination color) by adding a red pixel value and a green pixel value of a pixel, and then adjusting that sum by twice the blue pixel value for that pixel by a mathematical manipulation (such as division). This process cannot be performed with a pencil and paper or within a human mind, since it is not feasible for a human to tell what the specific pixel values (hue/wavelength) of the red pixel value, the green pixel value, and the blue pixel value are, particularly since twice the blue pixel value is required to adjust the pixel value. Rather, these determinations must be made by an electronic sensor and a processor. As such, this feature passes Prong One of an Alice/Mayo analysis and is not directed to a judicial exception under 35 U.S.C. 101. See MPEP 2106.04(a)(2)(III)(A).
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.
Claims 1-3 and 10 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”; Holman paragraph [0005], “treat a chronic condition (e.g., CRS). The medical device can be removably connectable to a delivery system. Such systems and methods can be beneficial for treating patients”), the method comprising:
inserting a tubular spray device (Holman FIG. 3B, medical device 200) into a target area (Holman FIG. 3B, sinus ostium 236) of nose and paranasal sinuses (Holman FIG. 3B, sinus cavity 234; see also Holman paragraph [0084], “A lumen of the cleaning device can be inserted into the sinus cavity 234”);
sending a gas into the target area through the spray device to expel deposits from the target area (Holman FIG. 4, block 252; Holman paragraph [0084], “Operation 252 can include cleansing the sinus cavity 234. The sinus cavity 234 can be cleansed by flushing a cleansing agent (e.g., saline or air) into the sinus cavity 234”); and
spraying a drug into the target area through the spray device (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”; Holman paragraph [0095], “The fluid can also be a therapeutic fluid, for example a therapeutic fluid including a therapeutic drug.”).
Regarding Claim 2, Holman discloses the features of Claim 1, as described above.
Holman further discloses before inserting the spray device into the target area (Holman FIG. 4, block 252, “cleansing a sinus cavity”), inserting the spray device up to an opening to the target area or the vicinity thereof while observing the nose and paranasal sinuses with an endoscope (Holman FIG. 4, block 250, “visualizing a sinus cavity’’; Holman paragraph [0083], “Operation 250 can include visualizing the sinus 234. 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 3, Holman discloses the features of Claim 2, as described above.
Holman further discloses 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.” Examiner interprets Holman paragraph [0083] as teaching that medical device 200 is inserted into the target area while being observed by the endoscope.)
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) into a target area of nose and paranasal sinuses (Holman FIG. 3B, sinus cavity 234); and
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 the target area through the spray device to spray the drug 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”).
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.
Claim 4 is 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 4, Holman discloses the features of Claim 2, as described above.
Holman further discloses that cleansing air is provided through a working channel of an endoscope (Holman paragraph [0084], “The sinus cavity 234 can be cleansed by flushing a cleansing agent (e.g., saline or air) into the sinus cavity 234. In an embodiment, the cleansing can be performed by delivering the cleansing agent via a working channel of an endoscope.”). While a reasonable interpretation of this passage from Holman would be that the spray device is also within the working channel of the endoscope, for purposes of compact prosecution Examiner further cites Guest, which is analogous art in the field of endoscopic treatment that explicitly teaches the spray device (Guest FIG. 2, injection catheter 40 with a needle 42; Guest paragraph [0009], “inserting an injection member through the skin puncture site and into the spinal cord and injecting the therapeutic substance through an aperture of the injection member”) is inserted through a channel in the endoscope (Guest paragraph [0035], “introducing a flexible catheter with an attached needle into a working channel or lumen of the endoscope”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilizes Guest’s working channel to position Holman’s medical device 200. 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 utilizes a working channel in an endoscope to position the medical device. 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 cleansing air is provided through a working channel, as taught by Guest, would result in the predictable result of supplying aspirating air in the method disclosed 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 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 spraying 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 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 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, since it is no longer needed to clean the sinus. 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 removing the spray device after use (as taught by Kojo) would be anything but a predictable step to take after the sinus is cleared using the method disclosed 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 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 2, as described above.
Holman further discloses before spraying 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.
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. 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 using Tanigami’s method for identifying an inflammation site and positioning the treatment device thereupon would be anything but a predictable step to take in order to ensure that the sinus is cleared using the method disclosed 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 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]). 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 using Uemori method for highlighting a target would be anything but a predictable step to take in order to ensure that the target is cleaned using the method taught by Holman in view of Tanigami). 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 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 more thoroughly than a single-pass cleaning. Examiner further cites Holman paragraph [0085], which states that operation “252 can be repeated (e.g., as needed for cleaning of the sinus cavity 234)”. As such, Holman does not teach that the cleansing operation in block 252 of Holman FIG. 4 is a “one and done” cleansing operation, but rather may require several iterations. As such, it would be obvious to a person having ordinary skill in the art to utilize the suction/aspiration taught by Maeda with the air injection/flushing disclosed by Holman when performing the multiple cleansing iterations taught in Holman paragraph [0085]. 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 using Maeda’s pre-op cleaning of the target using aspiration with the method disclosed by Holman would be anything but a predictable step to take in order to ensure that the target is thoroughly cleaned when combined with the method taught 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 2, 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. 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 using Hunt’s method of using a two-member surgical team would be anything but a predictable step to take in order to ensure that the target is cleaned using the method taught by Holman, such that no single person is not overburdened by having to use two instruments simultaneously). 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.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base Claim 1, but would be allowable 1) if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and 2) the double-patenting rejection of Claim 1 were to be overcome (e.g., with a Terminal Disclaimer).
The following is a statement of reasons for the indication of allowable subject matter: the claimed invention is allowable over the prior art of record for not disclosing or fairly suggesting a method for treating rhinosinusitis that includes calculating an index value for each pixel in at least a partial region of the acquired white light image by normalizing a sum of a red pixel value and a green pixel value of the each pixel by twice a blue pixel value, and discriminating a symptom level of a lesion corresponding to the each pixel by using the index value recorded in advance and a threshold value indicating the symptom level. The closest identified prior art is Hsiao et al. (US PGPUB 2022/0133171 – “Hsiao”). Hsiao teaches a method for identifying diseased tissue based on pixel values in an image. More specifically, paragraph [0041] of Hsiao teaches “with the disease diagnosing method and the disease diagnosing system in the disclosure, the skin images of a patient are obtained and a time domain signal is generated according to the pixel value of the skin images…The second feature is mapped to another high dimensional feature space and a hyperplane classifies the second feature as one of the multiple categories of the disease.” However, neither Hsiao nor any combination of the identified prior art teaches or suggests identifying/discriminating a symptom level of a lesion/tissue based on an index value that is derived from a blue pixel value that is doubled. Furthermore, there is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Dependent Claims 12-17 are also deemed allowable based on their dependence on Claim 11, subject to the conditions for allowability of Claim 11 as described above.
Conclusion
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
Prosecution Insights