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 .
Response to Amendment
This office action is in response to the amendment filed 07/22/26. Claims 1-3, 11 and 19 have been amended, no new claims have been added, and no claims have been cancelled. Thus, claims 1-19 are presently pending in this application.
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.
Claim(s) 1-5, 8-10, 12-14, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baiko (20180133419).
With respect to claim 1, Baiko discloses a method for determining a degree of degradation of a user interface (14, fig 1) worn by an individual during one or more uses of a respiratory therapy system (see fig 7-8 and claim 6, lines 1-5), the method comprising receiving data associated with the user interface (LLM data and [0048]); determining, based at least in part on the received data, a value of at least one degradation indicator (LLM data monitored and determine if set threshold is reached; [0049]) associated with the user interface (see [0050] and 202/206/208, fig 8), the at least one degradation indicator including a physical characteristic of the user interface (decomposition/wear of the cushion; see [0049-50]) that changes as the user interface is worn by the individual during the one or more uses of the respiratory therapy system (during therapy sessions), revealing a visual degradation indicator (normal wear and tear/decomposition of mask) at a predetermined location on the user interface (see location on mask 14 in fig 1); and determining the degree of degradation (threshold reached or not; 210-212, fig 8) of the user interface based at least in part on the value of the at least one degradation indicator (see [0053]).
With respect to claim 2, Baiko discloses the degradation indicator (52, fig 1) includes at least one audible degradation indicator (see [0043]).
With respect to claim 3, Baiko discloses the at least one visual degradation indicator includes a color of the user interface (see [0045]; LEDs change color of indicator part of interface).
With respect to claim 4, Baiko discloses the at least one audible degradation indicator includes a presence of one or more sounds generated (speaker outputs sound) during use of the user interface (see [0044]).
With respect to claim 5, Baiko discloses at least a portion of the user interface is configured to disintegrate (cushion disintegrates; see [0048]) as the user interface is worn by the individual during the one or more uses of the respiratory therapy system, the disintegration of the portion of the user interface generating one or more openings in the user interface (leak; see [0048-49] where the LLM indicates a leak; i.e. opening).
With respect to claim 8, Baiko discloses at least a portion of the user interface is configured to disintegrate as the user interface is worn by the individual during the one or more uses of the respiratory therapy system (see [0048-49]), the disintegration of the portion of the user interface causing a shape of an exterior surface of the user interface to change (the exterior seal surface changes as degradation occurs).
With respect to claim 9, Baiko discloses the one or more sounds (audible indicator) are generated in response to air flowing along the interior surface of the user interface (leaking; see [0048-50]).
With respect to claim 10, Baiko discloses the air flowing along the interior surface of the user interface or along the exterior surface of the user interface is caused by breathing of the user, a flow of pressurized air generated by the respiratory therapy system, or both (note the air within the interface would be provided from the breathing or pressurized air this the air flowing/leaking from the interface would be from the same).
With respect to claim 12, Baiko discloses the value of the at least one degradation indicator (threshold amount) is indicative of a visibility of the at least one degradation indicator (indicator is activated when the threshold is reached; see [0043] and fig 8)
With respect to claim 13, Baiko discloses the degree of degradation includes an amount of time spent using the user interface (see [0041]; “time wearing patient interface”).
With respect to claim 14, Baiko discloses the at least one degradation indicators includes a measure of a seal (cushion; 30, fig 1) between the user interface and at least a portion of a face of the individual (see [0049] where the LLM value is determined for a cushion and when the threshold of LLM is unacceptable the indicator is activated).
With respect to claim 17, Baiko discloses predicting the degree of degradation of the user interface based on data associated with one or more uses of at least one previous user interface by the individual (see [0048-49] where the cushion is monitored in a testing/learning phase and then determines the degradation based on the data).
With respect to claim 18, Baiko discloses a system (fig 1 and [0002]) for determining a degree of degradation of a user interface (14, fig 1) worn by an individual during one or more uses of a respiratory therapy system (see fig 1 and [0025]), the system including a control system (controller; 22, fig 1) having one or more processors (see [0033]) configured to implement the method of claim 1 (see claim1 above and [0033]).
With respect to claim 19, Baiko discloses a system (fig 1 and [0002]) for determining a degree of degradation of a user interface (14, fig 1) worn by an individual during one or more uses of a respiratory therapy system (see fig 1 and [0025]), the system including an electronic interface configured (14, fig 1) to receive data (see [0035]; over short range wireless network); a memory storing machine-readable instructions (see [0033]); and a control system (controller; 22, fig 1) having one or more processors (see [0033]) configured to execute the machine-readable instructions to receive data associated with the user interface (see [0033]); determine, based at least in part on the received data, a value of at least one degradation indicator (52, fig 1 which monitors and then indicates if a threshold is reached and provides feedback) associated with the user interface (see [0050] and 202/206/208, fig 8), the at least one degradation indicator including a physical characteristic of the user interface (decomposition/wear of the cushion; see [0049-50]) that changes as the user interface is worn by the individual during the one or more uses of the respiratory therapy system (during therapy sessions), revealing a visual degradation indicator (normal wear and tear/decomposition of mask) at a predetermined location on the user interface (see location on mask 14 in fig 1), the visual indicator including a shape of the user interface (cushion decomposes from normal wear and compresses down to change shape); and determine the degree of degradation (threshold reached or not; 210-212, fig 8) of the user interface based at least in part on the value of the at least one degradation indicator (see [0053]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baiko in view of Wilkerson (2022/0126056).
With respect to claim 6, Baiko discloses all the elements as claimed above but lacks the one or more sounds are generated in response to air flowing through at least one of the one or more openings in the user interface.
However, Wilkerson teaches an interface (100, fig 1) comprising a portion of the user interface (seal) is configured to disintegrate as the user interface is worn by the individual during the one or more uses of the respiratory therapy system (see [0028] where the seal loosens), the disintegration of the portion of the user interface generating one or more openings in the user interface (note the loosening of the seal creates openings of the interface from the user’s face) and lacks the one or more sounds are generated in response to air flowing through at least one of the one or more openings in the user interface (see fig 4 and [0055]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient interface of Baiko to disintegrate to form openings as taught by Wilkerson so as to
With respect to claim 7, the modified Baiko shows the air flowing through the at least one of the one or more openings in the user interface is caused by breathing of the user (see [0054-55] of Wilkerson).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baiko in view of Klee (CN106030586).
With respect to claim 15, Baiko discloses all the elements as claimed above but lacks the data associated with the user interface includes image data reproducible as one or more images of the user interface, and wherein determining the value of the at least one degradation indicator includes analyzing at least a portion of the image data.
However, Klee teaches a respiratory system (10, fig 1) receiving data (image from camera; 60, fig 3) associated with a user interface (12, fig 1) wherein the data associated with the user interface includes image data reproducible as one or more images of the user interface (see [0109] of translation), and wherein determining the value of at least one degradation indicator includes analyzing at least a portion of the image data (degraded below a predetermined level; see [0109] of translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Baiko to receive image data as taught by Klee so as to monitor the degradation of the interface seal so as to maintain efficiency of treatment (see [0082] of Klee translation).
With respect to claim 16, the modified Baiko shows transmitting a request to the individual to generate the image data (see Klee translation “the presentation component 56a' to remind the patient to take a picture of the patient interface” [0109]).
Allowable Subject Matter
Claim 11 is allowable over the prior art.
Response to Arguments
Applicant argues on pg. 12 in remarks that “Applicant respectfully submits that such cracks or deformations in Baiko’s patient interface would occur at random and unpredictable locations.” This is not persuasive since the cracks or deformation would occur on the seal and therefore would be at a predictable location. Further, the cracks and wear of the seal would be visible to the user and/or medical professional providing the visual degradation indicator. Thus, the rejection stands.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Klee (10,751,495) is cited to show a mask with a degradation indicator.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/Primary Examiner, Art Unit 3785
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