DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-16 objected to because of the following informalities:
Regarding claim 1, the period at the end of claim 1 has been deleted with the latest amendment. Claim 1 should be amended to add in the period to the end of the claim.
Regarding claim 2, the limitation “the first and second sensor signals comprise visible light” should read “the detected first and second sensor signals comprise visible light”, or similar phrasing, for consistency with claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13, 36-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "the two or more sensors" in line 1 which renders the claim indefinite. Claim 1 specifically sets forth ‘one or more sensors’ while other dependent claims such as claim 7 are amended to reflect this change, and thus it is unclear if applicant is actually intending in claim 13 to further limit the device to specifically two sensors, or if an amendment to claim 13 was overlooked which would have parity with the other dependent claims. For examination purposes claim 13 will be interpreted as referring to ‘one or more sensors’, as appears to be intended based on amendments to claims 1 and 7, for example.
Claim 36 recites the limitation “the recognized shape of the internal body cavity is changing shape over short periods of time” which renders the claim indefinite. The specification does not provide a definition or any clarity on what constitutes a “short period of time” and thus the claim is unclear. For examination purposes the claim will be interpreted as referring to a timescale on the order of seconds to minutes.
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.
Claims 17-22, 25-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,986,593 B2 in view of Raphael (U.S 2003/0034035 A1) and McKenna (U.S 2010/0261996 A1).
Regarding claim 17, Patent 11,986,593 discloses a method of defining the anatomy of an internal body cavity, the method comprising:
providing a tube, having a proximal end and a distal end, into an internal body cavity (Claim 11);
emitting light from two or more optical outputs supported by the tube (Claim 11, the sensor includes at least one infrared emitter, which is a type of light);
detecting an intensity of reflected light by each of two or more detectors supported by the tube (Claim 11, at least one detector detects the reflected infrared light);
generating a signal in each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors (Claim 11);
transmitting the signals from each of the two or more detectors to a signal processing unit (Claim 11);
receiving and storing signals from each of the two or more detectors in the signal processing unit (Claim 11, the signals must be received and stored for a period of time for determination of the distance); and
determining, using the signal processing unit, a location of the internal body cavity based on the signal (Claim 11).
Patent 11,986,593 is silent regarding determining dimensions of the internal body cavity based on the signal (Claim 11).
However, McKenna teaches an endotracheal tube wherein differences in light reflectance intensity may also be used to provide an indication of distance from adjacent/surrounding tracheal structures (Paragraph 0021-0022, 0032, 0037; Differences in intensity of the backscattered light can provide an indication of distance from certain structures; A reference intensity can be obtained which is then compared to a subsequent intensity to determine the advancement of the ETT based on the differences in intensity and thus the change in distance; see Abstract and Paragraph 0039 regarding location of the ETT relative to the carina and/or vocal cords), for proper localization and placement of the ETT within the airway.
Raphael additionally teaches an endotracheal tube wherein acoustic reflectance is used to determine cross-sectional areas of the trachea adjacent/surrounding the endotracheal tube (Paragraph 0012, 0061, 0064-0067).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to determine dimensions of the trachea through reflectance data, such as that taught by McKenna and Raphael, in order to allow for determination of how far the ETT is advanced relative to structures and to provide indication of proper ETT placement for intubation (Paragraph 0016, 0021 of McKenna) and to help the practitioner identify transition areas of the trachea according to changing tracheal dimensions (Paragraph 0069 of Raphael).
Regarding claim 18, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 further discloses wherein the tube is an endotracheal tube (Claim 11).
Regarding claim 19, Patent 11,986,593 discloses the method of claim 17.
McKenna further teaches generating location data of anatomical features using referential information regarding expected contours of the internal body cavity (Paragraph 0021, 0032; A display in the form of a message/light can indicate when a distance between tracheal structures is within or outside a particular placement range; A green light may indicate proper placement within range from the carina, which is a contour of the bifurcation into the bronchii).
Regarding claim 20, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 further discloses determining a location of the endotracheal tube based on the location data of the anatomical features and a known point on the endotracheal tube (Claim 11; The distance/location of the ETT is determined relative to the vocal cords)
McKenna also teaches determining a location of the endotracheal tube based on the location data of the anatomical features and a known point on the endotracheal tube (Paragraphs 0021-0022, 0032, 0037, 0039; The distance can be obtained from the tip of the ETT to surrounding tracheal anatomy such as vocal cords or carina; This distance from certain landmarks thus allows for determination of precise positioning/location of the ETT).
Regarding claim 21, Patent 11,986,593 discloses the method of claim 19.
Patent 11,986,593 further discloses wherein the anatomical features can be vocal cords (Claim 11).
McKenna further teaches wherein the anatomical features can be vocal cords (Paragraph 0039).
Regarding claim 22, Patent 11,986,593 discloses the method of claim 19.
Raphael further teaches receiving the location data; and producing an image of the patient anatomy (Fig. 4-6 and Paragraphs 0012-0014, 0034-0036, 0067; The distances and cross-sectional areas are obtained and are displayed in an image which shows the shape of the surrounding anatomy as the ETT is advanced; The changes in cross-sectional area can reflect and show transitional areas such as the carina where cross-sectional area increases due to the bifurfaction).
Regarding claim 25, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is an intravaginal device.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of an intravaginal device, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 26, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is an intrauterine device insertion stylet.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of an intrauterine device insertion stylet, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 27, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is a bladder catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of a bladder catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 28, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is a pleural tube.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of a pleural tube, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 29, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is an intravascular catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of an intravascular catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 30, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is an urethral catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of an urethral catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 31, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding specifically wherein the tube is an intragastric catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included using similar spectroscopy techniques for insertion or positioning of an intragastric catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,986,593 B2 in view of Raphael (U.S 2003/0034035 A1) and McKenna (U.S 2010/0261996 A1), as applied to claim 17, in view of Nawn (U.S 2019/0083728 A1).
Regarding claim 23, Patent 11,986,593 discloses the method of claim 17.
Patent 11,986,593 is silent regarding wherein: the optical output is a light emitting diode (LED); and the detector is a photodiode.
However, Nawn teaches an ETT wherein the surrounding anatomy is detected via optical output, wherein the optical output is a light emitting diode (LED) (Paragraph 0106, white light emitting diode (LED); also see Paragraph 0119); and the detector is a photodiode (Paragraph 0041, 0106, 0109; The receiver is a photodiode).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Patent 11,986,593 to include LED and photodiodes to transmit the light to the surrounding tissue, such as that taught by Nawn, in order to provide a known alternative for detection of airway tissues (Paragraph 0041, 0106, 0109).
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,986,593 B2 in view of Raphael (U.S 2003/0034035 A1) and McKenna (U.S 2010/0261996 A1), as applied to claims 17 and 19, in further view of Cohen (U.S 2021/0393911 A1).
Regarding claim 24, Patent 11,986,593 discloses the method of claim 19.
Patent 11,986,593 is silent regarding wherein the signal processing unit utilizes machine learning to determine generate the location data.
However, Cohen teaches use of machine learning based on images and sensor readouts to determine correct positioning and location of the endotracheal tube (Paragraph 0069).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Patent 11,986,593 to have included utilizing machine learning to generate the location data and determine positioning/location of the endotracheal tube, such as that taught by Cohen, in order to provide automated assessment and guide correction of the positioning of the ETT in use (Paragraph 0069).
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 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nawn (U.S 2019/0083728 A1).
Regarding claim 32, Nawn a method of locating anatomy of an internal body cavity, the method comprising:
emitting, at a first location in an internal body cavity, a first light from a tube (Fig. 1A-B and 15; Abstract, Paragraph 0008, 0059-0067; Light from a light emitting element reflects off surrounding tissue from the tube) having a distal end and a proximal end (Fig. 1A-B and Paragraph 0058, Airway tube 101 has distal end 102, proximal end opposite the distal end, and lumen 107 running along the tube between the two ends);
detecting a first intensity of reflected light from the first light (Fig. 5-6 and Abstract, Paragraph 0008, 0059-0067; The reflectance spectra, with intensities at particular wavelengths, are received after light reflects from the tissue and are processed for spectra analysis);
generating first signals based on the first intensity of the reflected light (Fig. 5-6 and Abstract, Paragraph 0008, 0059-0067, reflectance spectra signals are obtained from the detected reflected light);
generating, a first pattern of a first space in the internal body cavity as a function of the first signals (Fig. 5-6 and Abstract, Paragraph 0008, 0059-0067, the reflectance spectra generated is a pattern of reflectance/absorbance of particular wavelengths of light from the tissue);
emitting, from a second location in the internal body cavity, a second light from the tube (Fig. 15 and Paragraph 0119 regarding simultaneously obtaining multiple discrete wavelengths from the plurality of sensors and thus multiple emissions can be done at once, down the longitudinal length of the tube; Alternatively, another measurement can be taken after advancing of the ETT, or repositioning of the ETT upon accidental placement into the esophagus);
detecting a second intensity of reflected light from the second light (Fig. 15 and Paragraph 0008, 0059-0067, 0119; The second intensity is obtained same as the first, and may be from a second set of emitters/detectors, or alternatively may just be a second instance of spectra obtained after repositioning of the device);
generating second signals as a function on the second intensity of the reflected light (Paragraph 0008, 0059-0067);
generating a second pattern of a second space in the internal body cavity as a function of the second signals (Fig. 5-6, Paragraph 0008, 0059-0067); and
identifying a location of at least a portion of the tube in the internal body cavity as a function of the first pattern and the second pattern (Paragraph 0008, 0059-0067; The position of the tube can be determined according to the spectra obtained compared to a characteristic spectra of the trachea/esophagus; Also, a first location of the ETT may be indicated as in the esophagus according to the first spectra and after attempted re-insertion of the ETT a second location may be in the trachea; The determined location of the ETT can be based on the signals obtained which correspond to esophageal/tracheal/neither).
Alternatively, Nawn discloses obtaining multiple discrete wavelengths simultaneously from a plurality of emitters/sensors (Fig. 15 and Paragraph 0119, multiple discrete wavelengths can be obtained at once, such as 3). And thus each pattern from the discrete wavelengths are used for consensus on the characteristic pattern matching the obtained spectras, and thus the determined location is a function of each of the obtained patterns.
Regarding claim 33, the method of Nawn discloses the method of claim 32.
Nawn further discloses emitting, at a third location in the internal body cavity, a third light from the tube; detecting a third intensity of reflected light from the third light; generating third signals as a function on the third intensity of the reflected light; generating a third pattern of a second space in the internal body cavity as a function of the third signals; and identifying a location of at least a portion of the tube in the internal body cavity as a function of the first pattern, the second pattern, and the third pattern (see rejection of claim 1 above and Figs. 15 and Paragraph 0119; A third instance of spectra analysis may be performed in trying to correctly position the ETT; There also may be multiple discrete wavelengths obtained at the same time, for example three, and thus each of the three discrete wavelengths will have intensities that can be mapped onto the characteristic spectra for tracheal/esophageal tissue in order to determine the location of the ETT next to either tissue).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 11, 13-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nawn (U.S 2019/0083728 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1).
Regarding claim 1, Nawn discloses an endotracheal system comprising:
an endotracheal tube having a proximal end, a distal end, and a lumen between the proximal end and the distal end (Fig. 1A-B and Paragraph 0058, Airway tube 101 has distal end 102, proximal end opposite the distal end, and lumen 107 running along the tube between the two ends);
a signal processing unit (Fig. 2-3 and Paragraph 0010-0011, signal processor and/or spectrum analyzer; also see Paragraph 0078 regarding passing the data to externally run software);
one or more sensors positioned on the endotracheal tube (Fig. 1A-B and Paragraph 0059, sensing element 109), the one or more sensors configured to:
produce one or more sensor signals, the produced one or more sensor signals interact with a surrounding patient anatomy, the surrounding patient anatomy comprising an internal body cavity (Abstract, Paragraph 0008, 0059-0067; Light from a light emitting element 108/202 reflects off surrounding tissue such as internal esophageal or tracheal tissue, which is then received by the photo-sensing element);
detect the produced one or more sensor signals that have interacted with the surrounding patient anatomy (Abstract, Paragraph 0008, 0059-0067; The reflectance spectra are received after light reflects from the tissue and are processed for spectra analysis); and
transmit the one or more detected sensor signals to the signal processing unit (Paragraph 0010-0011 and 0059-0067, the signal processer receives the signals from the photo-sensing element; also see Claims 3-4);
and the signal processing unit in signal communication with the one or more sensors and configured to:
receive the one or more detected sensor signals (Paragraph 0010-0011 and 0059-0067, the signal processor receives the reflectance data);
produce a first pattern from a first detected sensor signal (Fig. 4, 6; A reflectance spectra pattern is generated from the reflected light, this first pattern can be obtained from insertion into the esophagus which yields esophageal characteristic spectra);
produce a second pattern from a second detected sensor signal (Abstract, Paragraph 0057, 0081, the endotracheal tube can then, in response to the first pattern indicating incorrect insertion into the esophagus, re-seated into the trachea, from which a new spectra is obtained);
determine location data for at least a portion of the tube in the internal body cavity as a function of changes between the first pattern and the second pattern (Paragraph 0057 and 0059-0067; In use, if the attempted placement of the ETT is back into the esophagus, it will indicate that the ETT is still improperly in the esophagus from no changes in reflectance spectra; Alternatively, reseating ETT into the trachea will generate the appropriate characteristic tracheal spectra and thus determines that the tube is located in the trachea).
Alternatively, Nawn is silent regarding specifically determine location data for at least a portion of the tube in the internal body cavity as a function of changes between the first pattern and the second pattern.
However, McKenna teaches an endotracheal tube wherein differences in light reflectance intensity may also be used to provide an indication of distance from tracheal structures (Paragraph 0021-0022, 0032, 0037; Differences in intensity of the backscattered light can provide an indication of distance from certain structures; A reference intensity can be obtained which is then compared to a subsequent intensity to determine the advancement of the ETT based on the differences in intensity and thus the change in distance; see Abstract and Paragraph 0039 regarding location of the ETT relative to the carina and/or vocal cords), for proper localization and placement of the ETT within the airway.
It is also noted that while McKenna specifically discusses light intensity, reflectance spectra such as that of Nawn necessarily already has reflectance intensity data, as the height of the peaks indicate a particular intensity of reflected light at a given wavelength, which will change according to distance as the amount of light returned via backscattering will vary.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to have included comparing first and second intensities of the reflectance spectra to determine a change in distance/distances from tracheal structures, such as that taught by McKenna, in order to allow for determination of how far the ETT is advanced relative to structures and to provide indication of proper ETT placement for intubation (Paragraph 0016, 0021).
Regarding claim 2, the device of Nawn discloses the device of claim 1.
Nawn further discloses wherein: the first and second sensor signals comprise visible light or infrared light (Paragraph 0014, the light may be in the visible spectrum); the interaction of the first and second sensor signals signal with the surrounding patient anatomy comprises reflection (Paragraph 0016-0017; The obtained signals are reflectance spectra); and the produced first and second sensor signals signal is are detected by a photodiode (Paragraph 0041, 0106, 0109; The receiver is a photodiode).
Regarding claim 3, the device of Nawn discloses the device of claim 2.
Nawn further discloses wherein: the visible light is produced by an LED (Paragraph 0106, white light emitting diode (LED); also see Paragraph 0119).
Regarding claim 5, the device of Nawn discloses the device of claim 1.
Nawn is silent regarding specifically wherein the one or more sensors extend longitudinally along at least a portion of a length of the endotracheal tube.
However, Nawn teaches that a plurality of diodes and photodiodes may be used and are disposed longitudinally along at least a portion of a length of the endotracheal tube (Paragraph 0119 and Fig. 15; A plurality of receiving photodiodes 605/606 may be disposed longitudinally along the ETT to receive the reflectance along a length of the tissue).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to include the sensors extending longitudinally along the ETT, such as that taught by Nawn, in order to provide several discrete wavelengths of light that can all be measured simultaneously (Paragraph 0119).
Regarding claim 11, the device of Nawn discloses the device of claim 1.
Nawn is silent regarding specifically wherein the surrounding patient anatomy includes a larynx.
However, the larynx is disposed adjacent to the trachea and esophagus (Paragraph 0072) and in use the ETT may be advanced through the larynx and thus reflectance spectrometry can be obtained from the larynx. If the pattern of the larynx matches neither the trachea nor esophagus then it can be assumed that the ETT is in the larynx and needs to be advanced.
Thus, in use, the larynx will be a surrounding tissue to the ETT when advanced through the airway towards the trachea.
Regarding claim 13, the device of Nawn discloses the device of claim 1.
Nawn further discloses wherein the two or more sensors configured to detect the surrounding patient anatomy are configured to detect at least one of visible light characteristic of the surrounding patient anatomy (Paragraph 0014-0017; Visible light reflectance is obtained from surrounding tissue).
Regarding claim 14, the device of Nawn discloses the device of claim 1.
Nawn further discloses a flex circuit disposed on the endotracheal tube between the two or more sensors and the endotracheal tube, the flex circuit provides signal communication between the two or more sensors and the signal processing unit (see Fig. 15 and Paragraph 0119 and 0140; A flexible printed circuit board may hold the diodes and include circuitry such as wires 608/607 to transmit the electrical signals obtained from the light reflectance; Paragraph 0010-0011, the diodes are connected to signal processor to interpret the voltages/signals).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) or Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1), as applied to claim 1, in further view of Schaner (U.S 2011/0030694 A1).
Regarding claim 4, the device of Nawn discloses the device of claim 1.
Nawn is silent regarding a display modality configured to: receive the location data; produce an image of the surrounding patient anatomy; and display a visual representation of a distance between an anatomical referent and a known point on the endotracheal tube.
However, Schaner discloses an endotracheal tube with a display modality (Paragraph 0007, display) configured to: receive location data (see Fig. 5-6 and Paragraph 0008, 0013-0014, 0028; The display may receive data about differences between surrounding trachea/esophageal tissue and converts the measurements into contours/indicated distance relative to the ETT); produce an image of the surrounding patient anatomy (Fig. 5-6 and Paragraph 0008, 0013-0014, 0028; Contour and color coding are indicated to identify the anatomy).
McKenna additionally teaches displaying a visual representation of a distance between an anatomical referent and a known point on the endotracheal tube (Paragraph 0021, 0032; A display in the form of a message/light can indicate when a distance between tracheal structures is within or outside a particular placement range; A green light may indicate proper placement within range).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to have included a display modality to produce a visual representation of, and distance to, surrounding tracheal and/or esophageal anatomy, such as that taught by Schaner and McKenna, in order to allow practitioner identification and verification of ETT placement relative to anatomy of the patient (Paragraph 0007-0008 and Claim 15-16 of Schaner; Paragraph 0032 of McKenna).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) or Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1), as applied to claim 1, in further view of Rowbottom (U.S 2013/0281885 A1).
Regarding claim 6, the device of Nawn discloses the device of claim 1.
Nawn further discloses an inflatable airway occlusion cuff located closer to the distal end of the endotracheal tube than the proximal end (Fig. 1A-B and Paragraph 0063; Balloon cuff 115);
Nawn is silent regarding specifically one or more additional sensors positioned on the endotracheal tube; and wherein the one or more additional sensors are positioned proximally of the airway occlusion cuff.
However, Nawn teaches use of multiple LEDs and sensors to allow simultaneous collection of multiple discrete wavelengths (Paragraph 0119).
Rowbottom teaches an endotracheal tube with inclusion of sensors placed proximal to the occlusion cuff in order to allow for monitoring and confirmed positioning between vocal cords (Fig. 1 and Paragraph 0037; The pressure sensors are disposed at the distal end but also are provided proximal to the inflatable cuff 20; The proximal pressure sensors allow for monitoring of vocal cords and placement therebetween). Additionally, sensors may be placed at the proximal portion 14 of the ETT to allow for monitoring of blood flow in tongue/microvascular networks for oxygenation of the patient (Paragraph 0040).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to have placed additional sensors proximal to the occlusion cuff such as that taught by Rowbottom, in order to provide continual monitoring of placement relative to the vocal cords (Paragraph 0037) and/or to measure and provide oxygenation information about the patient measured in the airway (Paragraph 0040).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) or Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1), as applied to claim 1, in further view of Cohen (U.S 2021/0393911 A1).
Regarding claim 10, the device of Nawn discloses the device of claim 1.
Nawn is silent regarding wherein the signal processing unit utilizes machine learning to determine generate the location data.
However, Cohen teaches use of machine learning based on images and sensor readouts to determine correct positioning and location of the endotracheal tube (Paragraph 0069).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Nawn to have included utilizing machine learning to generate the location data and determine positioning/location of the endotracheal tube, such as that taught by Cohen, in order to provide automated assessment and guide correction of the positioning of the ETT in use (Paragraph 0069).
Claims 17-23, 25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1) and Raphael (U.S 2003/0034035 A1).
Regarding claim 17, Nawn teaches a method of defining the anatomy of an internal body cavity, the method comprising:
providing a tube, having a proximal end and a distal end, into an internal body cavity (Fig. 1A-B and Paragraph 0058, Airway tube 101 has distal end 102, proximal end opposite the distal end, and lumen 107 running along the tube between the two ends);
emitting light from two or more optical outputs supported by the tube (Fig. 1A-B and 15; Abstract, Paragraph 0008, 0059-0067; Light from a light emitting element reflects off surrounding tissue such as internal esophageal or tracheal tissue, which is then received by the photo-sensing element; There can be two LEDs providing the white light);
detecting an intensity of reflected light by each of two or more detectors supported by the tube (Fig. 5-6 and Abstract, Paragraph 0008, 0059-0067; The reflectance spectra, with intensities at particular wavelengths, are received after light reflects from the tissue and are processed for spectra analysis);
generating a signal in each of the two or more detectors based on the intensity of the reflected light detected by each of the two or more detectors (Fig. 5-6 and Abstract, Paragraph 0008, 0059-0067, reflectance spectra signals are obtained from the detected reflected light; also see Paragraph 0119 regarding simultaneously obtaining multiple discrete wavelengths from the plurality of sensors);
transmitting the signals from each of the two or more detectors to a signal processing unit (Paragraph 0010-0011 and 0059-0067, a signal processer receives the signals from the photo-sensing element; also see Claims 3-4);
receiving and storing signals from each of the two or more detectors in the signal processing unit (Paragraph 0010-0011 and 0059-0067, the signal processor receives the reflectance data; The data is stored at least temporarily in order to generate the spectra and to analyze it to determine surrounding tissue type); and
determining, using the signal processing unit, a location of the internal body cavity based on the signal (Paragraph 0057 and 0059-0067; A location of the ETT in either the trachea or esophagus can be distinguished based on characteristic reflectance spectra and comparison to the obtained spectra).
Nawn is silent regarding determining dimensions of the internal body cavity based on the signal.
However, McKenna teaches an endotracheal tube wherein differences in light reflectance intensity may also be used to provide an indication of distance from adjacent/surrounding tracheal structures (Paragraph 0021-0022, 0032, 0037; Differences in intensity of the backscattered light can provide an indication of distance from certain structures; A reference intensity can be obtained which is then compared to a subsequent intensity to determine the advancement of the ETT based on the differences in intensity and thus the change in distance; see Abstract and Paragraph 0039 regarding location of the ETT relative to the carina and/or vocal cords), for proper localization and placement of the ETT within the airway.
It is also noted that while McKenna specifically discusses light intensity, reflectance spectra such as that of Nawn necessarily already has reflectance intensity data, as the height of the peaks indicate a particular intensity of reflected light at a given wavelength, which will change according to distance as the amount of light returned via backscattering will vary.
Additionally, Raphael teaches an endotracheal tube wherein acoustic reflectance is used to determine cross-sectional areas of the trachea adjacent/surrounding the endotracheal tube (Paragraph 0012, 0061, 0064-0067) and generation of an image to adjust placement of the ETT based on the surrounding cross-sectional area/shape of the portion of the trachea (Paragraph 0012, 0061). It is noted that McKenna similarly uses returning reflections to determine the distance to surrounding tissue and thus similarly can gauge distances of tracheal walls or landmarks.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have determining dimensions of the trachea through reflectance data, such as that taught by McKenna and Raphael, in order to allow for determination of how far the ETT is advanced relative to structures and to provide indication of proper ETT placement for intubation (Paragraph 0016, 0021 of McKenna) and to help the practitioner identify transition areas of the trachea according to changing tracheal dimensions (Paragraph 0069 of Raphael).
Regarding claim 18, the method of Nawn discloses the method of claim 17.
Nawn further discloses wherein the tube is an endotracheal tube (Paragraph 0058, Airway tube 101).
Regarding claim 19, the method of Nawn discloses the method of claim 17.
McKenna further teaches generating location data of anatomical features using referential information regarding expected contours of the internal body cavity (Paragraph 0021, 0032; A display in the form of a message/light can indicate when a distance between tracheal structures is within or outside a particular placement range; A green light may indicate proper placement within range from the carina, which is a contour of the bifurcation into the bronchii).
Regarding claim 20, the method of Nawn discloses the method of claim 17.
Nawn further discloses determining a location of the endotracheal tube based on the location data of the anatomical features and a known point on the endotracheal tube (Paragraph 0057 and 0059-0067; Reflectance spectra matching characteristic spectra can determine relative location of the end of the ETT being in the trachea or esophagus).
McKenna also teaches determining a location of the endotracheal tube based on the location data of the anatomical features and a known point on the endotracheal tube (Paragraphs 0021-0022, 0032, 0037, 0039; The distance can be obtained from the tip of the ETT to surrounding tracheal anatomy such as vocal cords or carina; This distance from certain landmarks thus allows for determination of precise positioning/location of the ETT).
Regarding claim 21, the method of Nawn discloses the method of claim 19.
McKenna further teaches wherein the anatomical features can be vocal cords (Paragraph 0039).
Regarding claim 22, the method of Nawn discloses the method of claim 19.
Raphael further teaches receiving the location data; and producing an image of the patient anatomy (Fig. 4-6 and Paragraphs 0012-0014, 0034-0036, 0067; The distances and cross-sectional areas are obtained and are displayed in an image which shows the shape of the surrounding anatomy as the ETT is advanced; The changes in cross-sectional area can reflect and show transitional areas such as the carina where cross-sectional area increases due to the bifurfaction).
Regarding claim 23, the method of Nawn discloses the method of claim 17.
Nawn further discloses wherein: the optical output is a light emitting diode (LED) (Paragraph 0106, white light emitting diode (LED); also see Paragraph 0119); and the detector is a photodiode (Paragraph 0041, 0106, 0109; The receiver is a photodiode).
Regarding claim 25, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is an intravaginal device.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of an intravaginal device, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 26, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is an intrauterine device insertion stylet.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of an intrauterine device insertion stylet, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 27, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is a bladder catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of a bladder catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 28, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is a pleural tube.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of a pleural tube, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 29, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is an intravascular catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of an intravascular catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 30, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is an urethral catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of an urethral catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Regarding claim 31, the method of Nawn discloses the method of claim 17.
Nawn is silent regarding specifically wherein the tube is an intragastric catheter.
However, McKenna teaches that light reflectometry techniques as in tracheal tubes may also be employed to facilitate placement of other medical devices such as stents, catheters, implants, feeding tubes, etc. (Paragraph 0039).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have included using similar spectroscopy techniques for insertion or positioning of an intragastric catheter, such as that taught by McKenna, in order to provide the spectroscopy techniques to aid in positioning of known alternative medical devices (Paragraph 0039) and because they are recited as known modifications and alternatives (Paragraph 0039).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1) and Raphael (U.S 2003/0034035 A1), as applied to claims 17 and 19, in further view of Cohen (U.S 2021/0393911 A1).
Regarding claim 24, the method of Nawn discloses the method of claim 19.
Nawn is silent regarding wherein the signal processing unit utilizes machine learning to determine generate the location data.
However, Cohen teaches use of machine learning based on images and sensor readouts to determine correct positioning and location of the endotracheal tube (Paragraph 0069).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Nawn to have included utilizing machine learning to generate the location data and determine positioning/location of the endotracheal tube, such as that taught by Cohen, in order to provide automated assessment and guide correction of the positioning of the ETT in use (Paragraph 0069).
Claims 34-39, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1), as applied to claims 32-33, in view of McKenna (U.S 2010/0261996 A1) and Raphael (U.S 2003/0034035 A1).
Regarding claim 34, the method of Nawn discloses the method of claim 33.
Nawn is silent regarding recognizing a shape of the internal body cavity dimensions of the internal body cavity based on changes between the first pattern, the second pattern, and the third pattern.
However, McKenna teaches an endotracheal tube wherein differences in light reflectance intensity may also be used to provide an indication of distance from adjacent/surrounding tracheal structures (Paragraph 0021-0022, 0032, 0037; Differences in intensity of the backscattered light can provide an indication of distance from certain structures; A reference intensity can be obtained which is then compared to a subsequent intensity to determine the advancement of the ETT based on the differences in intensity and thus the change in distance; see Abstract and Paragraph 0039 regarding location of the ETT relative to the carina and/or vocal cords), for proper localization and placement of the ETT within the airway.
It is also noted that while McKenna specifically discusses light intensity, reflectance spectra such as that of Nawn necessarily already has reflectance intensity data, as the height of the peaks indicate a particular intensity of reflected light at a given wavelength, which will change according to distance as the amount of light returned via backscattering will vary.
Additionally, Raphael teaches an endotracheal tube wherein acoustic reflectance is used to determine cross-sectional areas of the trachea adjacent/surrounding the endotracheal tube (Paragraph 0012, 0061, 0064-0067) and generation of an image to adjust placement of the ETT based on the surrounding cross-sectional area/shape of the portion of the trachea (Paragraph 0012, 0061). It is noted that McKenna similarly uses returning reflections to determine the distance to surrounding tissue and thus similarly can gauge distances of tracheal walls or landmarks.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Nawn to have determining the shape of the trachea through reflectance data of the received patterns as the ETT is advanced, such as that taught by McKenna and Raphael, in order to allow for determination of how far the ETT is advanced relative to structures and to provide indication of proper ETT placement for intubation (Paragraph 0016, 0021 of McKenna) and to help the practitioner identify transition areas of the trachea according to changing tracheal dimensions (Paragraph 0069 of Raphael).
Regarding claim 35, the method of Nawn discloses the method of claim 34.
Raphael further discloses wherein the recognized shape of the internal body cavity is at least one of: irregular; asymmetrical; or discontinuous (see Fig. 5 and Paragraph 0066; The cross-sectional area/shape of the trachea as the ETT is advanced is shown, which is irregular down the length of the trachea and especially at the carina at 46 where bifurcations increase the cross-sectional area).
Regarding claim 36, the method of Nawn discloses the method of claim 34.
Raphael further discloses wherein the recognized shape of the internal body cavity is changing shape over short periods of time (see Fig. 5 and Paragraph 0066; The cross-sectional area of the trachea is determined as the ETT is advanced in order to determine its location and thus the recognized shape of the body will change over short periods of time as it is advanced through the trachea; Additionally, the sensor feedback of Nawn and McKenna can provide continuous measurements or measurements repeatedly over a short time scale and thus provide the recognition of the recognized shape of the internal body as it is advanced through the airways).
Regarding claim 37, the method of Nawn discloses the method of claim 36.
Raphael further discloses wherein the recognition of the changing shape of the internal body cavity is continuous (Paragraph 0066 and rejection of claim 36 above; The measurements provided by the sensor are continuously generated on a short time scale and thus the recognized shape will change as it is moved along the airway).
Regarding claim 38, the method of Nawn discloses the method of claim 36.
Raphael further discloses wherein the recognition of the changing shape of the internal body cavity is in real time (Paragraph 0066 and rejection of claim 36 above; The measurements provided by the sensor immediately provide the generation of the cross-sectional area data and additionally an indication of the location of the ETT in the airways and thus the recognition is in real time; Additionally, as the ETT is advanced it will move according to the model in real time, as it is tracking it’s position continuously).
Regarding claim 39, the method of Nawn discloses the method of claim 34.
Nawn further discloses wherein the changes between the first pattern, the second pattern, and the third pattern correspond to a particular pattern (It is first noted that the ‘particular pattern’ is recited very broadly and without any specifics as to what the pattern entails; The subsequent measurements obtained after movement of the ETT within the airway can correspond to movement between any known anatomy; For example, first ETT pattern not in either trachea/esophagus, second ETT pattern in esophagus, third pattern in neither trachea/esophagus, fourth pattern in trachea; This overall shows a pattern indicative of attempted intubation and subsequent successful reintubation; Alternatively, 3 patterns of the same trachea indicate retention of the ETT within the trachea and thus remainder in the correct area).
Regarding claim 41, the method of Nawn discloses the method of claim 39.
Raphael further teaches wherein the particular pattern corresponds to an hourglass spatial shape, a concave shape, a symmetrical shape, or a triangular shape (see Fig. 5 and Paragraph 0066; The cross-sectional area/shape of the trachea as the ETT is advanced is shown and thus the pattern as the ETT is advanced may show a concave/symmetrical/triangular shape as the ETT is advanced and withdrawn; In other words, the shape of the graph may show a symmetrical shape as it is advanced and withdrawn, since the cross-sectional area will increase at the bifurcation and then decrease as it is withdrawn).
Claims 40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Nawn (U.S 2019/0083728 A1) in view of McKenna (U.S 2010/0261996 A1) and Raphael (U.S 2003/0034035 A1), as applied to claims 32-34, in further view of Rowbottom (U.S 2013/0281885 A1).
Regarding claim 40, the method of Nawn discloses the method of claim 34.
Nawn is silent regarding wherein the particular pattern is used to infer the location of the vocal cords.
However, Nawn teaches the importance of locating and passing the ETT through the vocal cords for proper intubation (Paragraph 0006).
Additionally, Rowbottom teaches that the unique anatomy of the vocal cords may generate a pattern that can be used to identify them (Paragraph 0037).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to include detecting the vocal cords based on the detected spectra/cross-sectional area/shape, such as that taught by Rowbottom, in order to ensure proper ETT placement (Paragraph 0006 of Nawn and Paragraph 0037 of Rowbottom).
Regarding claim 42, the method of Nawn discloses the method of claim 39.
Nawn is silent regarding wherein the particular pattern is identified as unique to passage of the tube through the vocal cords.
However, Nawn teaches the importance of locating and passing the ETT through the vocal cords for proper intubation (Paragraph 0006).
Additionally, Rowbottom teaches that the unique anatomy of the vocal cords may generate a pattern that can be used to identify them (Paragraph 0037).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Nawn to include detecting the passage through the vocal cords based on the detected spectra/cross-sectional area/shape, such as that taught by Rowbottom, in order to ensure proper ETT placement (Paragraph 0006 of Nawn and Paragraph 0037 of Rowbottom).
Allowable Subject Matter
Claims 7-9, 15-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Nawn (U.S 2019/0083728 A1) and McKenna (U.S 2010/0261996 A1) and Raphael (U.S 2003/0034035 A1) and Rowbottom (U.S 2013/0281885 A1) and Schaner (U.S 2011/0030694 A1) and Talbert (U.S 2020/0404146 A1) and Stopek (U.S 2015/0073268 A1).
Regarding claim 7, none of the prior art teaches or suggests the required interpenetrating array of emitters and detectors in alternating rows and columns. Schaner and Rowbottom discloses arrays of pressure sensing electrodes which are arranged in a grid-like pattern (see Fig. 4 and Paragraph 0026-0027 of Schaner in particular) but these are specific to non-emitting sensor arrays. The other ETT sensors using light have simplistic arrangements of emitters relatively near detectors, but are not arranged close to the required structure of alternating rows/columns of emitters and detectors and additionally sensor arrangements are not disposed in this manner circumferentially around the tube, requiring much more density than is taught by the prior art.
Regarding claim 15, similarly, none of the prior art teaches an outer case around the sensors and flex circuit to provide encasement. While sensors generally may teach use of reflective glass to divert the reflected light into a photodiode (see Fig. 15 of Nawn for example), the sensors are merely disposed adjacent the ETT tube on a flexible circuit but are not disclosed as within an outer case. The prior art is either silent regarding the encasement of the sensors or merely discloses them as embedded in the ETT.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights