DETAILED ACTION
Claims 1-47 are pending in this application.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-35, 45-47) in the reply filed on 07/02/26 is acknowledged.
Claims 36-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/02/26.
Claim Objections
Claim 15 is objected to because of the following informalities: line 1 reads “wherein analyzing data for the individual user provided evaluate anatomical and structural needs further comprises” and should read as--wherein analyzing data for the individual user [[provided]] to evaluate anatomical and structural needs further comprises--. 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.
Claims 12-13 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 12, line 1 recites the limitation "wherein creating a dilator profile comprises". There is insufficient antecedent basis for “a dilator profile” in the claim. For examination purposes, Claim 12 will be read as being dependent on Claim 11 instead of Claim 10, since Claim 11, line 2 recites “creating a dilator profile”.
Claim 13, line 1 recites the limitation "wherein creating a dilator profile comprises". There is insufficient antecedent basis for “a dilator profile” in the claim. For examination purposes, Claim 13 will be read as being dependent on Claim 11 instead of Claim 10, since Claim 11, line 2 recites “creating a dilator profile”.
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.
Claims 1-2, 4, 6, 9, 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrews et al., hereinafter “Andrews” (U.S. Pub. No. 2021/0077292).
Regarding claim 1, Andrews discloses a method for providing a personalized nasal dilator ([0083]), the method comprising:
acquiring data on an individual user's face and/or nasal structure (Id.; via digital scans, MRIs, CT scans, etc.);
analyzing the data to evaluate anatomical and structural needs for the individual user (Id; 3D scan and information is used to produce perfectly customized nasal dilator); and
manufacturing a nasal dilator that is personalized for the individual user wherein the nasal dilator is configured, shaped, and dimensioned for the individual user based on the evaluated anatomical and structural needs of the individual user (Id; customizable dilators are produced through techniques such as injection molding, 3D printing, polymer casting).
Regarding claim 2, Andrews discloses the method further comprising wherein acquiring data on an individual user's face and/or nasal structure comprises using image data to build a three-dimensional (3D) profile of an internal profile of the individual user's nostrils (Id.; a 3D digital model is built by acquiring data of a user’s nasal passages).
Regarding claim 4, Andrews discloses acquiring data on an individual user's face and/or nasal structure comprises using 3D imaging techniques (Id.).
Regarding claim 6, Andrews discloses acquiring data on an individual user's face and/or nasal structure comprises using one or more of X-ray, computed tomography (CT) systems (Id.), and ultrasound imaging.
Regarding claim 9, Andrews discloses acquiring data on an individual user's face and/or nasal structure further comprises extracting one or more landmarks (Id.; “the internal anatomy of the nasal passage is captured”).
Regarding claim 17, Andrews discloses manufacturing a nasal dilator that is personalized for the individual user comprises using additive manufacturing methods (Id.; “3D printing”).
Regarding claim 18, Andrews discloses manufacturing a nasal dilator that is personalized for the individual user comprises: fabricating a mold for the personalized nasal dilator; and using the mold to make a personalized nasal dilator (Id.; via injection molding or polymer casting).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Jansen et al., hereinafter “Jansen” (U.S. Pub. No. 2004/0230199).
Regarding claim 3, Andrews discloses the claimed invention, as discussed above, except does not expressly teach acquiring data on an individual user's face and/or nasal structure comprises using video or photo photogrammetry of one or more of the user's face, exterior of nose and nostrils, and interior of nose and nostrils.
In [0044], Jansen teaches that acquiring data comprises using photogrammetric scans for creating 3D models rapidly.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by using video or photo photogrammetry as claimed, as taught by Jansen, in order to rapidly create 3D models as disclosed in Andrews ([0083]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Nguyen et al., hereinafter “Nguyen” (U.S. Pub. No. 2015/0289945).
Regarding claim 5, Andrews discloses the claimed invention, as discussed above, except for 3D imaging techniques comprise one or more of: LiDAR, depth or Time of Flight (TOF) cameras, infrared (IR) time of flight, structured infrared (IR) light patterns, and multiple cameras.
In [0024], Nguyen teaches 3D imaging techniques comprising multiple cameras (two cameras are used to produce 3D image).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews with a 3D imaging technique including multiple cameras, as taught by Nguyen, since it is a known technique in the art for creating a complete 3D model (Id.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Matthias et al., hereinafter “Matthias” (U.S. Pub. No. 2011/0000483).
Regarding claim 7, Andrews discloses the claimed invention, as discussed above, except for acquiring data on an individual user's face and/or nasal structure comprises using acoustic rhinometry.
In [0048], Matthias teaches acquiring data on an individual user's face and/or nasal structure comprises using acoustic rhinometry.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews with using acoustic rhinometry as claimed, as taught by Matthias, since it is a known technique in the art that is rapid, reproducible, non-invasive, and requires minimal cooperation from the subject (Id.).
Claims 8, 10-13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Magness (U.S. Pub. No. 2021/0085509)
Regarding claim 8, Adams discloses the claimed invention, as discussed above, except for acquiring data on an individual user's face and/or nasal structure further comprises acquiring supplemental posed images or 3D scans of the user
comprising one or more of: an image or 3D scan of the user wrinkling their nose,
an image or 3D scan of the user flaring their nostrils, an image or 3D scan of the user forcefully inhaling through their nose, an image or 3D scan where the user holds one nostril closed and an image or 3D scan where the user holds other nostril closed; and an image or 3D scan where the user holds one nostril open and an image or 3D scan
where the user holds other nostril open.
In the same field of art, namely a method for providing a personalized nasal dilator, Magness teaches in [0047]-[0048], acquiring data on an individual user's face and/or nasal structure comprises acquiring supplemental posed images or 3D scans of the user comprising an image or 3D scan of the user flaring their nostrils (Id.; user’s nose is “in an improved or optimal position for breathing” wherein their nostrils are dilated or flared via inserting filler or packing material, and then digitally scanned to obtain a 3D model).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews such that an image or 3D scan of the user flaring their nostrils is acquired, as taught by Magness, since “an improved or optimal position for breathing” for a user (Id.) facilitates personalizing the nasal dilator for the user.
Regarding claim 10, Adams discloses the claimed invention, as discussed above, except for acquiring data on an individual user's face and/or nasal structure comprises collecting user profile information.
Magness further teaches in [0060], [0075] acquiring data on an individual user's face and/or nasal structure comprises collecting user profile information (via establishing an account on an app).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by collecting user profile information, as taught by Magness, in order to facilitate the personalization method for a user (Id.) and for delivering the device to the user (see abstract).
Regarding claims 11-13, Adams discloses the claimed invention, as discussed above, except for analyzing data for the individual user to evaluate anatomical and structural needs for the individual user comprises creating a dilator profile, and creating a dilator profile comprises a geometric transformation from a 3D Nasal Profile for the user, and wherein creating a dilator profile comprises creating one or
more circumferential radial force profiles.
Magness further teaches in the abstract and [0071]-[0074] analyzing data for the individual user to evaluate anatomical and structural needs for the individual user comprises creating a dilator profile (Id.; a first 3D model can be analyzed by a technician and a second 3D model, or dilator profile, may be created by taking the 3D model and deforming it, including moving selected surfaces outward, to produce the second 3D model for an improved or optimum position for nasal breathing), and creating a dilator profile comprises a geometric transformation from a 3D Nasal Profile for the user (the increase in dimension via moving selected surfaces outward of the nose is considered as a geometric transformation), and wherein creating a dilator profile comprises creating one or more circumferential radial force profiles (the surfaces on the sides of the nose are on the circumference of the nose, and the radial force profile is demonstrated via moving selected surfaces outward of the nose).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by creating a dilator profile as claimed, as taught by Magness, to help produce a nasal dilator that creates an improved or optimum position for nasal breathing (Id.).
Regarding claim 16, Adams discloses the claimed invention, as discussed above, except for acquiring data on an individual user's face and/or nasal structure comprises collecting and analyzing data about user response to a nasal dilator.
Magness further teaches in [0074] acquiring data on an individual user's face and/or nasal structure comprises collecting and analyzing data about user response to a nasal dilator (Id.; a user may try on various nasal devices and use the one that is most beneficial and order the size that suited them best).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by collecting and analyzing data about user response to a nasal dilator, as taught by Magness, in order to improve customer convenience and satisfaction (Id.).
Claims 14-15, 19-21, 23-24, 27, 30-31, 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139).
Regarding claim 14, Andrews discloses the claimed invention, as discussed above, except for analyzing data for the individual user to evaluate anatomical and structural needs for the individual user further comprises: receiving one or more pro-forma dilator designs, which comprise one or more of: stored templates, one or more stored rules, and one or more stored algorithms; and modifying the one or more pro-forma dilator designs according to data acquired.
In the same field of endeavor, namely a method for personalizing a nasal device, in Figure 18 and [0053]-[0060], Honneger teaches analyzing data (a 3D model acquired by a nose scan is stored in memory to be analyzed by a processing module 13) for an individual user to evaluate anatomical and structural needs for the individual user (the processing module is able to propose a design based on the available data) which further comprises: receiving one or more pro-forma designs (Id. from standard components stored in database 15), which comprise one or more of: stored templates (Id.), one or more stored rules, and one or more stored algorithms; and modifying the one or more pro-forma designs according to data acquired (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by receiving one or more pro-forma designs as claimed, as taught by Honegger in order to facilitate customizing a device for a particular user in a convenient manner in one system 10 (Figure 18). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
Regarding claim 15, Andrews discloses the claimed invention, as discussed above, including analyzing data for the individual user to evaluate anatomical and structural needs for the individual user further comprises: receiving a 3D Nasal Profile for the user (Andrews; [0083]), except for modifying the 3D Nasal Profile for the user using one or more of: one or more stored templates, one or more stored rules, and one or more stored algorithms.
In Figure 18 and [0053]-[0060] Honneger further teaches analyzing data (a 3D model acquired by a nose scan is stored in memory to be analyzed by a processing module 13) for an individual user to evaluate anatomical and structural needs for the individual user (the processing module is able to propose a design based on the available data), and modifying the 3D Nasal Profile for the user using one or more of: one or more stored templates (Id. from standard components stored in database 15), one or more stored rules, and one or more stored algorithms.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by modifying the 3D Nasal Profile for the user using one or more of: one or more stored templates, as taught by Honegger in order to facilitate customizing a device for a particular user in a convenient manner in one system 10 (Figure 18). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
Regarding claim 19, Andrews discloses the claimed invention, as discussed above, except for manufacturing a nasal dilator that is personalized for the individual user comprises modifying an existing dilator to personalize the dilator for the individual user.
In Figure 18 and [0053]-[0060], Honneger further teaches manufacturing a nasal device that is personalized for the individual user comprises modifying (via processing module 13) an existing device (standard components stored in a database 15 can be considered as forming an existing device) to personalize the device for the individual user.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by manufacturing a nasal dilator that is personalized for the individual user comprises modifying an existing dilator to personalize the dilator for the individual user, as taught by Honegger, in order to facilitate customizing a device for a particular user in a convenient manner in one system 10 (Figure 18). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
Regarding claim 20, Andrews discloses a system for providing a personalized nasal dilator; the system configured to receive data on an individual user's facial and nasal structures ([0083]; via digital scans, MRIs, CT scans, etc.), configured to process the data to evaluate nasal characteristics of the individual user (Id; 3D scan and information is used to produce perfectly customized nasal dilator); and configured to fabricate a customized fitting for the nasal dilator based on the evaluated nasal characteristics (Id; using a modified model, customizable dilators are produced through techniques such as injection molding, 3D printing, polymer casting).
However, Andrews does not expressly disclose the system comprising a data acquisition subsystem, a data transformation subsystem, and a manufacturing subsystem configured as claimed.
In the same field of endeavor, namely a method for personalizing a nasal device, in Figure 18 and [0053]-[0060], Honneger teaches a data acquisition subsystem (3-dimensional scanner 11), a data transformation subsystem (including server 12 and database 15), and a manufacturing subsystem (machine 16).
It would have been obvious to one of ordinary skill before the effective filing date to modify the system of Andrews with a data acquisition subsystem, a data transformation subsystem, and a manufacturing subsystem as claimed, as taught by Honegger, in order to facilitate customizing a device for a particular user in a convenient manner in one system 10 (Honneger; Figure 18). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar elements for personalizing a nasal dilator.
Regarding claim 21, Andrews as modified teaches the claimed invention, as discussed above, including the data acquisition subsystem is configured to scan an individual user's face and/or nasal structure to build a three-dimensional (3D) profile of an internal profile of the individual user's nostrils (Andrews, [0083]; a 3D digital model is built by acquiring data of a user’s nasal passages).
Regarding claim 23, Andrews as modified teaches the claimed invention, as discussed above, including the data acquisition subsystem is configured to use 3D imaging techniques (Id. and [0053] of Honegger).
Regarding claim 24, Andrews as modified teaches the claimed invention, as discussed above, including the data acquisition subsystem is configured to use one
or more of X-ray, computed tomography (CT) systems (Id.), and ultrasound imaging.
Regarding claim 27, Andrews as modified teaches the claimed invention, as discussed above, including the data acquisition subsystem is configured to extract
one or more landmarks (Id.; “the internal anatomy of the nasal passage is captured” in Andrews).
Regarding claim 30, Andrews as modified teaches the claimed invention, as discussed above, including for the data transformation subsystem is configured to:
receive one or more pro-forma dilator designs, which comprise one or more of: stored
templates, one or more stored rules, and one or more stored algorithms; and
modify the one or more pro-forma dilator designs according to data provided by the
acquisition. In Figure 18 and [0053]-[0060], Honneger further teaches a data transformation subsystem (including a processing module 13 stored on server 12) configured to receive one or more pro-forma designs (Id. from standard components stored in database 15), which comprise one or more of: stored templates (Id.), one or more stored rules, and one or more stored algorithms; and modifying the one or more pro-forma designs according to data acquired (Id.). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar elements for personalizing a nasal dilator.
Regarding claim 31, Andrews as modified teaches the claimed invention, as discussed above, including the data transformation subsystem is configured to:
receive a 3D Nasal Profile for the user (Andrews; [0083]), and configured to modify the 3D Nasal Profile for the user using one or more of: one or more stored templates, one or more stored rules, and one or more stored algorithms. In Figure 18 and [0053]-[0060], Honneger further teaches a data transformation subsystem (including a processing module 13 stored on server 12) configured to modify the 3D Nasal Profile for the user (the processing module is able to propose a design based on the available data) using one or more of: one or more stored templates (Id. from standard components stored in database 15), one or more stored rules, and one or more stored algorithms. It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
Regarding claim 33, Andrews as modified teaches the claimed invention, as discussed above, including the manufacturing subsystem uses additive manufacturing methods (Andrews, [0083]; “3D printing”).
Regarding claim 34, Andrews as modified teaches the claimed invention, as discussed above, including the manufacturing subsystem is configured to:
fabricate a mold for the personalized nasal dilator; and use the mold to make a personalized nasal dilator (Id.; via injection molding or polymer casting).
Regarding claim 35, Andrews as modified teaches the claimed invention, as discussed above, including the manufacturing subsystem is configured to modify
an existing dilator to personalize the dilator for an individual user. In Figure 18 and [0053]-[0060], Honneger further teaches manufacturing a nasal device that is personalized for the individual user comprises modifying (via processing module 13) an existing device (standard components stored in a database 15 can be considered as forming an existing device) to personalize the device for the individual user. It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139), as applied to claim 20 above, and further in view of Jansen (U.S. Pub. No. 2004/0230199).
Regarding claim 22, Andrews as modified teaches the claimed invention, as discussed above, except for the data acquisition subsystem is configured to use
video or photo photogrammetry of one or more of a user's face, exterior of nose and nostrils, and interior of nose and nostrils.
In [0044], Jansen teaches a data acquisition subsystem configured to use photogrammetric scans for creating 3D models rapidly.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified by using video or photo photogrammetry as claimed, as taught by Jansen, in order to rapidly create 3D models as disclosed in Andrews ([0083]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139), as applied to claim 20 above, and further in view of Matthias (U.S. Pub. No. 2011/0000483).
Regarding claim 25, Andrews as modified teaches the claimed invention, as discussed above, except for the data acquisition subsystem is configured to use acoustic rhinometry.
In [0048], Matthias teaches a data acquisition subsystem is configured to use acoustic rhinometry.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified with using acoustic rhinometry as claimed, as taught by Matthias, since it is a known technique in the art that is rapid, reproducible, non-invasive, and requires minimal cooperation from the subject (Id.).
Claims 26, 28, 29, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139), as applied to claim 20 above, and further in view of Magness (U.S. Pub. No. 2021/0085509).
Regarding claim 26, Andrews as modified teaches the claimed invention, as discussed above, except for the data acquisition subsystem is configured to acquire
supplemental posed images or 3D scans of the user comprising one or more of:
an image or 3D scan of the user wrinkling their nose, an image or 3D scan of the user flaring their nostrils, an image or 3D scan of the user forcefully inhaling through their nose, an image or 3D scan where the user holds one nostril closed and an image or 3D scan where the user holds another nostril closed; and an image or 3D scan where the user holds one nostril open and an image or 3D scan where the user holds other nostril open.
In the same field of art, namely a personalized nasal dilation system, Magness teaches in [0047]-[0048] a data acquisition subsystem configured to acquire supplemental posed images or 3D scans of the user comprising an image or 3D scan of the user flaring their nostrils (Id.; user’s nose is “in an improved or optimal position for breathing” wherein their nostrils are dilated or flared via inserting filler or packing material, and then digitally scanned to obtain a 3D model).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified such that an image or 3D scan of the user flaring their nostrils is acquired, as taught by Magness, since “an improved or optimal position for breathing” for a user (Id.) facilitates in personalizing the nasal dilator for the user.
Regarding claim 28, Andrews as modified teaches the claimed invention, as discussed above, except for the data transformation subsystem is further configured
to collect user profile information.
Magness further teaches in [0060], [0075] a data transformation subsystem further configured to collect user profile information (via establishing an account on an app).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified by collecting user profile information, as taught by Magness, in order to facilitate the personalization method for a user (Id.) and for delivering to the user (see abstract).
Regarding claim 29, Andrews as modified teaches the claimed invention, as discussed above, except for processing the data to evaluate nasal characteristics of
the user comprises creating a dilator profile.
Magness further teaches in the abstract and [0071]-[0074] processing the data to evaluate nasal characteristics of the user comprises creating a dilator profile (Id.; a first 3D model can be analyzed by a technician and a second 3D model, or dilator profile, may be created by taking the 3D model and deforming it, including moving selected surfaces outward, to produce the second 3D model for an improved or optimum position for nasal breathing).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified by creating a dilator profile as claimed, as taught by Magness, to help produce a nasal dilator that creates an improved or optimum position for nasal breathing (Id.).
Regarding claim 32, Andrews as modified teaches the claimed invention, as discussed above, except for the data transformation subsystem is further configured
to collect and analyze data about user response to a nasal dilator.
Magness further teaches in [0074] a data transformation subsystem is further configured to collect collecting and analyzing data about user response to a nasal dilator (Id.; a user may try on various nasal devices and use the one that is most beneficial and order the size that suited them best).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified by collecting and analyzing data about user response to a nasal dilator, as taught by Magness, in order to improve customer convenience and satisfaction (Id.).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139) and Magness (U.S. Pub. No. 2021/0085509).
Regarding claim 45, Andrews discloses a method for providing a personalized nasal dilator ([0083]), the method comprising:
scanning an individual user's face and/or nasal structure (Id.; via digital 3D scans, MRIs, CT scans, etc.), the scanning comprising:
scanning an individual user's photogrammetry or 3D imaging (Id.);
extracting landmarks from the scanning (Id.; “the internal anatomy of the nasal passage is captured”);
analyzing data for the individual user provided by the scanning to evaluate anatomical and structural needs for the individual user (Id; 3D scan and information is used to produce perfectly customized nasal dilator); and
manufacturing a nasal dilator that is personalized for the individual user wherein the nasal dilator is configured, shaped, and dimensioned for the individual user based on the evaluated anatomical and structural needs of the individual user from the dilator profile (Id.).
However, Andrews does not disclose the analyzing comprising: selecting a pro-forma dilator design based on the landmarks; modifying the pro-forma dilator design based on the landmarks to address anatomical and structural needs for the individual user; and generating a dilator profile.
In Figure 18 and [0053]-[0060], Honneger teaches analyzing data (a 3D model acquired by a nose scan is stored in memory to be analyzed by a processing module 13) selecting a pro-forma device design (the processing module is able to propose a design based on the available data) modifying the pro-forma design based on the data to address anatomical and structural needs for the individual user (Id. from standard components stored in database 15).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by selecting a pro-forma dilator design as claimed, as taught by Honegger in order to facilitate customizing a device for a particular user in a convenient manner in one system 10 (Figure 18). It is noted that Honegger does not teach a dilator design, but in combination with Andrews, a skilled artisan would apply the similar method steps for personalizing a nasal dilator.
In the same field of art, namely a method for providing a personalized nasal dilator, Magness teaches in the abstract and [0071]-[0074] analyzing data for the individual user to evaluate anatomical and structural needs for the individual user comprises creating a dilator profile (Id.; a first 3D model can be analyzed by a technician and a second 3D model, or dilator profile, may be created by taking the 3D model and deforming it, including moving selected surfaces outward, to produce the second 3D model for an improved or optimum position for nasal breathing).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by creating a dilator profile as claimed, as taught by Magness, to help produce a nasal dilator that creates an improved or optimum position for nasal breathing (Id.).
Regarding claim 46, Andrews as modified teaches the claimed invention, as discussed above, except for analyzing the data further comprises collecting user profile data for the individual user.
Magness further teaches in [0060], [0075] acquiring data on an individual user's face and/or nasal structure comprises collecting user profile information (via establishing an account on an app).
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews by collecting user profile information, as taught by Magness, in order to facilitate the personalization method for a user (Id.) and for delivering to the user (see abstract).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Andrews (U.S. Pub. No. 2021/0077292) in view of Honegger (U.S. Pub. No. 2010/0042139) and Magness (U.S. Pub. No. 2021/0085509), as applied to claim 45 above, and further in view of Lucey et al., hereinafter “Lucey” (U.S. Pub. No. 2017/0173289).
Regarding claim 47, Andrews as modified teaches the claimed invention, as discussed above, except for analyzing the data is performed using machine learning.
In [0025], [0040], Lucey teaches a method for providing a personalized device including analyzing data for an individual user’s face is performed using machine learning.
It would have been obvious to one of ordinary skill before the effective filing date to modify Andrews as modified by analyzing the data performed using machine learning, as taught by Lucey, in order to enhance an analyzing system’s algorithm ability to learn from the training dataset and help classify and recognize points or landmarks on a user’s face (Lucy; [0128], [0129]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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