DETAILED ACTION
This Office Action in response to the amendment, filed on July 27, 2026. Primary Examiner acknowledges Claims 21-40 are pending in this application, with Claims 21 and 35 having currently amended, and Claims 1-20 having been cancelled by preliminary amendment on January 29, 2024.
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 Rejections - 35 USC § 112 (a) or 1st Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, independent claims, Claims 21 and 35, now recite the limitation “water fill opening”; however, the breadth and scope of this limitation is not supported by the original specification as filed.
The original specification as filed provides no discussion of a “water fill opening”.
Regarding the word “fill” and its variants, this term is only utilized twice (2) within the original specification as filed. The first (1st) instance is in relation to “the maximum water fill level of the humidifier” as disclosed in original paragraph 0064 – “The seal, or seals, between the housing 88 and the humidifier 96 may be provided above the maximum water fill level of the humidifier.” The second (2nd) instance is in relation to “The process of humidifier refilling without interrupting treatment is simplified” as disclosed in original paragraph 0071 – “The process of humidifier refilling without interrupting treatment is simplified, since there's no pressure gradient above atmosphere.” Yet, neither of these instances positively disclose the concept of “a water fill opening”.
Clearly, water must be provided to the interior of the humidifier tub to retain the liquid to be vaporized and supplied to the patient for the delivery of humidified gas; yet, the concept of an opening that is specific for the purpose/functionality to support the act of “water fill” is not provided in the original disclosure as filed.
Even if Applicant were to argue any opening within the humidifier tub to including the perimeter of the humidifier tub constitutes a “water fill opening”; then, the question becomes what is the difference between the “water fill opening” and the “outlet”? If Applicant were to allege they are the same, when does the “water fill opening” become the “outlet”? Is it a “water fill opening” at a disconnected state of the humidifier tub to the flow generator – and a “outlet” at the connected state of the humidifier tub to the flow generator? If so, then returning to Applicant’s disclosure of “refilling” to occur “without interrupting treatment” – then how can you “refill” water into the “water fill opening” – “without interrupting treatment” – when the act of separating the humidifier tub and the flow generator will in fact interrupt treatment?
Continuing in a different direction, how is the water add added to the humidifier tub – e.g. what is the methodology, what are the steps/actions/considerations made to permit this activity? Applicant hints at the concept of a “maximum water fill level” and that “refilling” is possible, but there is no disclosure as to how the water gets into the humidifier tub to reach the “maximum water fill level” at the initial filling nor how does “refilling” occur. For example: for “refilling” to occur “without interrupting treatment” – does that mean refilling can occur without separating the stacked configuration of the flow generator and the humidifier tub? If so, does the health care professional inject a syringe of fluid down the “air delivery tube” that will bypass the water vapor headed to the patient, to be received within the humidifier tank? How does the health care professional know how much water should/could be added without exceeding the “maximum water fill level”? What happens if the “maximum water fill level” is exceeded?
The answers and even discussion of the aforementioned concepts is explicitly missing from the original disclosure as filed.
Therefore, Primary Examiner maintains the concept of “a water fill opening” is not supported by the original specification as filed – and thus is considered new matter. Applicant is reminded, no amendment may introduce new matter into the disclosure of an application after its filing date, pursuant to MPEP 608.04. Dependent claims, Claims 22-34 and 36-40 incorporate the new matter from which they depend. Appropriate correction and clarification is required.
Specifically, independent claims, Claims 21 and 35, now recite the limitation “the flow generator is configured to receive water vapor from the humidifier tub through the inlet opening on the bottom of side of the housing” (Claim 21) and “the blower is configured to receive water vapor from the humidifier tub through the inlet on the bottom side of the housing” (Claim 35); however, the breadth and scope of this limitation is not supported by the original specification as filed.
There is no disclosure within the original specification as filed which permits “water vapor” to engage with the flow generator/blower through the inlet opening on the bottom side of the housing (of the flow generator/blower).
Primary Examiner notes Applicant’s disclosure of Figures 1B states “The air flow 54 passes over the surface 70 of a supply of water 68 provided in the humidifier 60 and the air flow 54 is humidified. As shown in Fig. 3B, the air flow 58 is delivered by the airway connector 44 to the channel inlet 46 generally near the center of the humidifier 60. As the air flow 54 spirals from about the center of the humidifier 60 to the channel outlet 50, the amount of water that the air flow 54 contacts is maximized to improve the humidification of the air flow 54. The humidified air flow 54 is directed by the channel 49 to the channel outlet 50 and exits the humidifier 60 through an outlet 62.” (Para 0052). This disclosure is excluded as water vapor is not received from the humidifier tub through the inlet on the bottom side of the (flow generator/blower) housing, but rather at a side outlet 62 of the humidifier tub (60).
Primary Examiner notes Applicant’s disclosure of Figure 4A is similar to disclosure of Figure 1B and is also excluded as the water vapor is not received from the humidifier tub through the inlet on the bottom side of the (flow generator/blower) housing, but rather at a side outlet (26) of the humidifier tub (via 48).
Primary Examiner notes Applicant’s disclosure of Figures 8 is also similar to the disclosures of 1B and 4A, and is still excluded as the water vapor is not received from the humidifier tub through the inlet on the bottom side of the (flow generator/blower) housing, but rather at a side outlet (124) of the humidifier tub (96) – “The air moves in a circular fashion around the chamber 104 of the blower motor assembly housing 100 and over the water 68 and out through outlet 124, where it then passes into a hose, tube, or conduit 128 that is connected the outlet 124 by a connector 126.” (Para 0070).
Primary Examiner notes Applicant’s disclosure of Figures 9 and 10A-C states “The air flow 148 enters the humidifier 96 through the inlet 108 and passes through the apertures 114 and passes over the water 68. The humidified air flow 168 then exits the humidifier 96 through the outlet 110 into the outlet tube 142.” (Para 0077) and “The air flow 148 then flows around the chamber 104 of the housing 100 and passes over the water 68 and is humidified. The humidified air flow 164 passes through an outlet 110 and into an outlet tube 142 that is connected to the outlet 110 of the housing 100. The humidified air flow 164 is conducted out of the device 10 through the outlet tube 142 which extends through the lid 146.” (Para 0075). By the italicized disclosure, this is the ONLY disclosure which meets the configuration of water vapor received from the humidifier tub through the inlet on the bottom side of the (flow generator/blower) housing. Yet, this disclosure remains problematic because the water vapor DOES NOT engage the “flow generator” NOR “blower”. Rather the water vapor ONLY engages the “housing” of the flow generator/blower as a passthrough to the outlet tube 142.
Thus, it appears the limitations of “the flow generator is configured to receive water vapor from the humidifier tub through the inlet opening on the bottom of side of the housing” (Claim 21) and “the blower is configured to receive water vapor from the humidifier tub through the inlet on the bottom side of the housing” (Claim 35) is a mischaracterization of the functionality of the operational capacity as disclosed. The water vapor DOES NOT ever engage or reengage the flow generator/blower, the air from the flow generator/blower is directed into the humidifier tub (via 108) to be humidified and then ONLY goes to the housing of the flow generator/blower (via 110, at the “inlet on a bottom side of the housing”) before passing through the entire housing of the flow generator/blower to exit via the “outlet tub 142” as connected to an air delivery tube to support the flow of vaporized air to the patient. There is no discussion of any engagement or reengagement of the vaporized air to the flow generator/blower, and furthermore this functionality would be customarily avoided to prevent failure of the flow generator/blower and its components by being exposed to rusting from condensation/rainout.
Therefore, Primary Examiner maintains the limitation of “the flow generator is configured to receive water vapor from the humidifier tub through the inlet opening on the bottom of side of the housing” (Claim 21) and “the blower is configured to receive water vapor from the humidifier tub through the inlet on the bottom side of the housing” (Claim 35) is new matter. Applicant is reminded, no amendment may introduce new matter into the disclosure of an application after its filing date, pursuant to MPEP 608.04. Dependent claims, Claims 22-34 and 36-40 incorporate the new matter from which they depend. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 112 (b) or 2nd Paragraph
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 21-40 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.
Specifically, independent claims, Claims 21 and 35, now recite the limitation “water fill opening”; however, the breadth and scope of this limitation is indefinite. There is no disclosure in the original specification as filed to the limitation of a “water fill opening”. Primary Examiner is unsure - what is the difference between the “water fill opening” and the “outlet”? If Applicant were to allege they are the same, when does the “water fill opening” become the “outlet”? Is it a “water fill opening” at a disconnected state of the humidifier tub to the flow generator – and a “outlet” at the connected state of the humidifier tub to the flow generator? Dependent claims, Claims 22-34 and 36-40 incorporate the new matter from which they depend. Appropriate correction and clarification is required.
Specifically, independent claims, Claims 21 and 35, now recite the limitation “the flow generator is configured to receive water vapor from the humidifier tub through the inlet opening on the bottom of side of the housing” (Claim 21) and “the blower is configured to receive water vapor from the humidifier tub through the inlet on the bottom side of the housing” (Claim 35); however, the breadth and scope of this limitation is unclear. There is no disclosure within the original specification as filed which permits “water vapor” to engage with the flow generator/blower through the inlet opening on the bottom side of the housing (of the flow generator/blower). From a review of the original disclosure as filed Paragraphs 0075 and 0075, it appears the limitations of “the flow generator is configured to receive water vapor from the humidifier tub through the inlet opening on the bottom of side of the housing” (Claim 21) and “the blower is configured to receive water vapor from the humidifier tub through the inlet on the bottom side of the housing” (Claim 35) is a mischaracterization of the functionality of the operational capacity as disclosed. The water vapor DOES NOT ever engage or reengage the flow generator/blower, the air from the flow generator/blower is directed into the humidifier tub (via 108) to be humidified and then ONLY goes to the housing of the flow generator/blower (via 110, at the “inlet on a bottom side of the housing”) before passing through the entire housing of the flow generator/blower to exit via the “outlet tub 142” as connected to an air delivery tube to support the flow of vaporized air to the patient. Dependent claims, Claims 22-34 and 36-40 incorporate the new matter from which they depend. Appropriate correction and clarification is required.
Response to Arguments
Applicant’s arguments, filed July 27, 2027 with respect to Deming et al. (4,399,349) have been fully considered and are persuasive, in light of the amendments to the claim listing. Thus, the rejection of the claims under 35 U.S.C. 102(a)(1) as being anticipated by Deming et al. (4,399,349) have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in light of the new rejections under 35 U.S.C. 112 (a) or 1st Paragraph – new matter; and under 35 U.S.C. 112 (b) or 2nd Paragraph – indefiniteness.
It is noted, Demings does not disclose teach or fairly suggest the configuration by which the “humidifier tub [is] configured to be removably secured to the housing [of the flow generator].” Rather, Demings teaches away from “removably secured” by the configuration of a “sealed” seam connecting the humidifier tub (1) and the flow generator housing (2). (Column 4, Lines 1-15).
Nevertheless, it should be noted in the absence of this “removably secured” limitation, and in light of the new rejections under 35 U.S.C. 112 (a) or 1st Paragraph – new matter; and under 35 U.S.C. 112 (b) or 2nd Paragraph – indefiniteness, a rejection under Demings would still be applicable as the other newly added limitations appear to be disclosed, taught, or fairly suggested by the configuration of Demings.
Demings clearly discloses “a water fill opening” (15 via 17, “The water fill tube 15 is sealed, after the sauna is filled, by a screw plug 17. The tube 15 and plug 17 are made of moldable heat resistant plastic with a coefficient of expansion such that the plug will not loosen when cold and not bind when hot. The fill tube 15 passes through a hole in the base plate 39 of the lower water tank 9 and is sealed against water leakage through the tank base plate 39 by a plastic grommet 14 such as one made from, for example, ethylene-propylene.” Column 4, Lines 15-30) whereby the flow generator/blower (29) as retained in the housing (2) is covered by/when the flow generator/blower (29) as retained in the housing (2) is lowered onto the humidifier tub (1).
Demings clearly discloses the configuration of a flow generator (Claim 21 – “blower” Claim 35) is configured to receive water vapor (via arrows of 13 in the humidifier tub 1 heading towards the flow generator 29 within the housing 2 at the chamber 22) from the humidifier tub (1) through the inlet (10 via 2) on the bottom side of the housing (2); and the flow generator /blower (29) inlet (10 via 2) on the bottom side of the housing (2) is configured to connect (via arrows of 13 in the humidifier tub 1 heading towards the flow generator 29 within the housing 2 at the chamber 22) to the outlet (via 8 of 1) of the humidifier tub (1) by the lowering of the flow generator/blower (29 as retained in the housing 2) onto the humidifier tub (1).
Nevertheless, in light of the aforementioned reasoning, the non-final rejection of the claims has been maintained and made FINAL.
Although Applicant has obviated all prior art rejections, Applicant is now subject to overcome the rejections under 35 U.S.C. 112 (a) or 1st Paragraph – new matter; and under 35 U.S.C. 112 (b) or 2nd Paragraph – indefiniteness as imparted by Applicant’s amendments to the claims. Appropriate correction and clarification is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huang (2008/0111257) discloses a PAP device including a flow generator located within a housing positioned in a stacked configuration upon a humidifier tub; yet, does not expressly disclose the configuration of the outlet of the flow generator being connected to an air delivery tube.
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 ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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