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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-7, in the reply filed on 6/22/2026 is acknowledged.
Priority
Acknowledgement is made to Applicant's claim to priority to U.S. Provisional App. No. 63/381,287 filed 10/27/2022.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1 and 6 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1 and 6 recites at least one step or instruction for evaluating the seal between a user’s face and a user interface, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). The claimed limitations involve observing the seal between the user’s face and the user interface, evaluating whether there is a leak, and making a judgment regarding a new user interface based on the location of the leak, which are all concepts performed in the human mind in MPEP 2106.04(a)(2)(III).
Accordingly, each of Claims 1 and 6 recites an abstract idea.
Specifically, Claim 1 recites:
A method comprising:
generating seal information associated with a seal region between a face of a user and a current user interface donned on the face of the user (observation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
analyzing the seal information to determine whether a leak exists in the seal region (evaluation and judgment, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
and if the leak exists: analyzing the seal information to determine a location of the leak within the seal region (evaluation and judgment, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
and determining a new user interface to replace the current user interface based on the current user interface and the location of the leak (evaluation and judgment, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
Further, dependent Claim 6 merely includes limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 (and dependent Claims 6) is not integrated into a practical application under MPEP 2106.04(d) because there are no additional elements recited in the claims.
Accordingly, independent Claim 1 (and dependent claim 6) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claim 1 and dependent claim 6 include additional elements.
Therefore, none of the Claims 1 and 6 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 and 6 are not patent eligible and rejected under 35 U.S.C. 101.
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)(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.
Claim(s) 1-2, 4, and 6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hendriks et al. (US 20220344026 A1), hereafter Hendriks.
Regarding claim 1, Hendriks discloses a method comprising: generating seal information associated with a seal region between a face of a user and a current user interface donned on the face of the user (relative position data of mask and patient face is obtained and a skin pressure distribution, slip/shear distribution, and/or gap distribution is determined; Fig. 2, par. 0032); analyzing the seal information to determine whether a leak exists in the seal region (the skin pressure, shear, and gap distribution, is interpreted in terms of skin comfort, leakage and mask stability, par. 0040); and if the leak exists: analyzing the seal information to determine a location of the leak within the seal region (a gap along the circumference of the contact between the seal or cushion and the face is analyzed to determine if there is an unintentional leakage for example near the eyes, par. 0040; when the unintended leak is above a certain threshold, a virtual sensor is activated to search for the leak location, par. 0051; sensing arrangement can include microphones, cameras, thermal sensors to locate leak, par. 0052); and determining a new user interface to replace the current user interface based on the current user interface and the location of the leak (actionable information to improve seal is provided based on analysis, par. 0018, 0033; actionable information provided by analysis unit may include a suggestion to replace mask with another like mask or with a different mask likely better suited for patient with different size, style, arrangement for securing, par. 0031; if leakage near eyes, consider a replacement mask that avoids leakage near eyes, par. 0042-0046).
Regarding claim 2, Hendriks discloses the method of claim 1 (shown above), further comprising: scanning, with at least one microphone, the seal region between the face of the user and the current user interface donned on the face of the user while positive airway pressure is being supplied to the user through the current user interface (a sensing arrangement obtains real-time relative position data regarding the relative position of the mask relative to face of the patient during pressure therapy, par. 0010; sensing arrangement can include microphones, par. 0014; a stereo microphone or multiple microphones are used to localize the sound created by the air turbulences of leaking air, par. 0052), wherein the seal information is generated by the at least one microphone during the scanning the seal region (sensing arrangement can include microphones, par. 0014; a stereo microphone or multiple microphones are used to localize the sound created by the air turbulences of leaking air, par. 0052).
Regarding claim 4, Hendriks discloses the method of claim 1 (shown above), further comprising: scanning, with at least one camera, the seal region between the face of the user and the current user interface donned on the face of the user, wherein the seal information is generated by the at least one camera during the scanning of the seal region (sensing arrangement detects leaks in the sealing portion of the mask and the location of leaks; the sensing arrangement can include cameras to provide this function; par. 0052; examiner notes: it can be understood that in order to detect and localize leaks in the seal, the camera would need to scan the seal region).
Regarding claim 6, Hendriks discloses the method of claim 1 (shown above), wherein the generating the seal information occurs after a period of time has elapsed from when the current user interface was donned on the face of the user so that the current user interface is fully settled on the face of the user [seal information is generated throughout a session of PAP therapy (par. 0010) so it can be understood that a period of time has elapsed since donning the user interface and the user interface is fully settled on the face of the user].
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.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Lawrenson et al. (US 20170203071 A1), hereafter Lawrenson.
Regarding claim 3, Hendriks discloses the method of claim 2 (shown above), further comprising: scanning the seal region with the at least one microphone such that the seal information is generated as a function of a position along the seal region (a stereo microphone or multiple microphones are used to localize the sound of air leaking from the seal; par. 0052).
Hendriks does not explicitly disclose tracing the seal region with the at least one microphone during the scanning of the seal region.
Lawrenson teaches a method of using a microphone to detect the location of a leak in a mask seal (par. 0064, 0102) comprising: tracing the seal region with the at least one microphone (a microphone is moved in a loop fully circumnavigating the patient interface and the signals of the microphone are used to determine the position and magnitude of the leak; par. 0065, 0102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hendriks to generate the seal information by tracing the seal region with a microphone as taught by Lawrenson since Lawrenson teaches that this is a known method of localizing air leakage from the seal of a patient interface (Lawrenson par. 0102). This method would also provide the benefit of requiring only a single microphone while still being able to accurately determine a position and magnitude of the leak (Lawrenson par. 0065).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Znamenskiy et al. (US 20140373374 A1), hereafter Znamenskiy.
Regarding claim 5, Hendriks discloses the method of claim 4 (shown above) wherein the seal information is generated by the at least one camera (par. 0052).
Hendriks does not disclose placing a dye on a surface of the current user interface that makes contact with the face of the user when the current user interface is donned on the face of the user, wherein the scanning of the seal region includes scanning the dye left on the face of the user around the seal region after removing the current user interface from being donned on the face, and the seal information is generated by the at least one camera during the scanning of the dye.
Znamenskiy teaches a device for determining the fit of a user interface (abstract) comprising: placing a dye on a surface of a user interface that makes contact with the face of the user when the user interface is donned on the face of the user (a visualizing material, such as ink, is dispersed around the perimeter of the ring and produces an imprint on the patient's face; par. 0021), wherein the scanning of the seal region includes scanning the dye left on the face of the user around the seal region after removing the current user interface from being donned on the face, and the seal information is generated during the scanning of the dye (visual inspection of ink imprint to see where the sizing gauge has a correct contact to the patient's face and where not; par. 0021) for the purpose of easing the visual inspection by providing a visualizing material (par. 0021).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hendriks to comprise placing a dye on a surface of a user interface that makes contact with the face of the user when the user interface is donned on the face of the user, wherein the scanning of the seal region includes scanning the dye left on the face of the user around the seal region after removing the current user interface from being donned on the face, and the seal information is generated during the scanning of the dye as taught by Znamenskiy for the purpose of easing the visual inspection by providing a visualizing material (Znamenskiy par. 0021).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Lin (US 20210316166 A1).
Regarding claim 7, Hendriks discloses the method of claim 1 (shown above).
Hendriks does not disclose wherein the current user interface includes a dye that is time-activated, moisture activated, photochromic, ultraviolet light sensitive, or a combination thereof.
Lin teaches a mask (abstract) wherein the user interface includes a dye that is time-activated, moisture activated, photochromic, ultraviolet light sensitive, or a combination thereof (mask includes a relative humidity sensitive material for visualizing leaks, par. 0096, 0111-0115; examiner notes: humidity is moisture in the air so a humidity sensitive material can be identified as moisture activated) for the purpose of visually identifying the location of leaks in the mask seal (par. 0002).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hendriks to include a dye that is time-activated, moisture activated, photochromic, ultraviolet light sensitive, or a combination thereof as taught by Lin for the purpose of visually identifying the location of leaks in the mask seal (Lin par. 0002).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haas (US 20120240933 A1) discloses a system for locating a leak in the seal of a mask.
Oestenstad et al. ("Identification of faceseal leak sites on a half-mask respirator” vol. 51, no. 5, 1990) discloses using a photosensitive material to detect leak sites on a face mask.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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