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
Claim 48 and 53 are objected to because of the following informalities:
Claim 48 “the wall” in line 1 should read “a wall”.
Claim 53 “the gas delivery tubes” in lines 16, 18, 19, 21, 22 should read “the at least two gas delivery tubes”.
Claim 53 recites “the respective cheek region” on page 6, lines 2. This should read “a respective cheek region”.
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 35-45 and 47-49 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 35 recites “the respective valve member”. There is no antecedent basis for this. For purposes of examination it has been interpreted as “the first and the second valve member”. Similarly claim 39 recites “the respective membrane” without antecedent basis. Claim 40 recites “the respective subset” without antecedent basis.
Claims 36-45 and 47-48 are rejected due to their dependencies on claim 35.
Claims 40-45 and 47-48 are rejected due to their dependencies on claim 39.
Claim 47 states that it depends from 39 when dependent on claim 6, however claim 39 is dependent on 37 and there is no claim 6 rendering the claim unclear. For purposes of examination it has been interpreted as dependent on claim 39. Further claim 47 refers to “the plurality of one or more active vent holes” and “the one or more passive vent holes” which both lack antecedent basis and further it is unclear if these vent holes are part of the plurality of vent holes recited in claim 28. For purposes of examination they have been interpreted as part of the plurality of vent holes recited in claim 28.
Claim 48 is rejected due to its dependency on claim 47.
Claim 49 recites “the vent holes”. It is unclear if applicant is referring to the plurality of vent holes recited in claim 28 or just a subset. For purposes of examination it has been interpreted as either.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 53-55 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 53 recites “and extends across the respective cheek region” on page 6, line 2 of the claims which positively recites the respective cheek region. The examiner recommends amending this to read “and configured to extend across the respective cheek region”.
Claims 54-55 are rejected due to their dependency on claim 53.
Claim Rejections - 35 USC § 102
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) 28-31 and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood (US 2003/0116163 A1)
Regarding claim 28, Wood discloses: A vent assembly (components within 32, not including 44) for a patient interface (44) for delivering a flow of breathable gas at a positive pressure to an airway entrance of a patient [0012], the vent assembly comprising:
a vent body (32) at least in part defining a vent chamber configured to contain gas at the positive pressure (as set forth in [0012] the device delivers positive pressure to the patient and thus the chamber is configured to contain gas at the positive pressure), the vent body being configured to define:
a first inlet (where 22 meets 32 on the right side as shown in figure 2) on a first side (right side) of the vent body (32), the first inlet being configured to receive a first inlet flow of breathable gas into the vent chamber (as shown in figure 7);
a second inlet (where 22 meets 32 on the left side as shown in figure 2) on a second side (left side) of the vent body (32), the second side being opposite the first side (see figure 2; left is opposite of right), the second inlet being configured to receive a second inlet flow of breathable gas into the vent chamber (as shown in figure 7, there is flow from the left);
an opening (36) configured to allow exit of the flow of breathable gas from the vent chamber for delivery to the airway entrance and to receive a flow of exhaled gas from the patient into the vent chamber (see figure 7 and 10); and
a plurality of vent holes (54; two exhale apertures as per [0052]) configured to allow a vent flow of exhaled gas from the vent chamber to ambient (see figure 10),
wherein the vent assembly further comprises a valve (60, 66) configured to adopt a first configuration (figure 7) and a second configuration (figure 10), wherein the valve at least partially blocks the plurality of vent holes by a different amount in the first configuration compared to the second configuration (see figure 7 vs figure 10), and
wherein the valve is configured so that the configuration adopted by the valve is based on the positive pressure of gas in the vent chamber (see figure 7 vs 10; the valve moves in response to respiration) [0055]-[0056].
PNG
media_image1.png
680
526
media_image1.png
Greyscale
Regarding claim 29, Wood further discloses: wherein the valve is configured to adopt a plurality of configurations between the first configuration and the second configuration, wherein the amount of blocking of the plurality of vent holes by the valve is different in each of the plurality of configurations (as shown in figure 7 versus figure 10, there are inherently a number of positions that 66, 60 have to move through between those two positions; as such the amount of air (amount of blocking) that can escape from a the positions between figure 7 and 10 is different in each of those intermediary positions).
Regarding claim 30, Wood further discloses: wherein the configuration adopted by the valve is based on a breathing cycle of the patient in use [0055]-[0056].
Regarding claim 31, Wood further discloses: wherein the configuration adopted by the valve when the patient exhales is different from the configuration adopted by the valve when the patient inhales [0055]-[0056].
Regarding claim 46, Wood further discloses: wherein the vent assembly is configured with the plurality of vent holes on an opposite side of the vent body to the opening (54 is on a side opposite 36 as shown in figures 7 and 10).
Claim(s) 28, 32-38 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allum (US 2012/0325211 A1).
Regarding claim 28, Allum discloses: A vent assembly (112) for a patient interface (100) for delivering a flow of breathable gas at a positive pressure to an airway entrance of a patient [0012] [0014], the vent assembly comprising:
a vent body (see below) at least in part defining a vent chamber (126) configured to contain gas at the positive pressure [0012], the vent body being configured to define:
a first inlet (122a) on a first side of the vent body, the first inlet being configured to receive a first inlet flow of breathable gas into the vent chamber (from 124) [0046];
a second inlet (122b) on a second side of the vent body, the second side being opposite the first side (see figures 8-9), the second inlet being configured to receive a second inlet flow of breathable gas into the vent chamber (from 124) [0046]-[0047];
an opening (through 20a 20b) configured to allow exit of the flow of breathable gas from the vent chamber for delivery to the airway entrance and to receive a flow of exhaled gas from the patient into the vent chamber [0046]; and
a plurality of vent holes (134, 128 and opening between 132a/136a and opening between 132b/136b) configured to allow a vent flow of exhaled gas from the vent chamber to ambient,
wherein the vent assembly further comprises a valve (136a 136b) configured to adopt a first configuration and a second configuration [0051] (closed and open), wherein the valve at least partially blocks the plurality of vent holes by a different amount in the first configuration compared to the second configuration [0051]-[0052], and
wherein the valve is configured so that the configuration adopted by the valve is based on the positive pressure of gas in the vent chamber [0053]-[0054].
PNG
media_image2.png
670
534
media_image2.png
Greyscale
Regarding claim 32, Allum further discloses wherein the valve is configured to be biased to adopt the second configuration (open as per [0052]; meaning 136a and 136b are seated on 130a 130b [0051]), wherein the amount of blocking of the plurality of vent holes by the valve is greater in the first configuration compared to the second configuration [0051]-[0052].
Regarding claim 33, Allum further discloses wherein the plurality of vent holes (134, 128 and opening between 132a/136a and opening between 132b/136b) comprises: one or more active vent holes (opening between 132a/136a and opening between 132b/136b), wherein the vent assembly is configured so that the valve (136a 136b) at least partially blocks the plurality of active vent holes by a different amount when the valve is in the first configuration compared to the second configuration (open vs closed as per [0051]-[-0052]); and one or more passive vent holes (134, 128), wherein the vent assembly is configured so that the amount of blocking of the passive vent holes by the valve is the same when the valve is in the first configuration as when the valve member is in the second configuration (see figures 8 and 9).
Regarding claim 34, Allum further discloses wherein the vent assembly is configured so that the passive vent holes (134, 128) are not blocked by the valve in the first configuration and are not blocked by the valve in the second configuration (see figures 8/9, when 136a/136b move into their open position the vent holes are not blocked).
Regarding claim 35, Allum further discloses wherein the valve comprises a first valve member (136a) and a second valve member (136b), wherein each of the first valve member and the second valve member is configured to adopt a first position when the valve is in the first configuration and to adopt a second position when the valve is in the second configuration, wherein the respective valve member (as per 112b above, this is interpreted as “the first and the second valve member”) at least partially blocks a subset (opening between 132a/136a and opening between 132b/136b) of the plurality of vent holes by a different amount in the first position compared to the second position. (The examiner notes that there are inherently a number of positions that 136a 136b have to move through between the open and closed positions [0051]-[0052]; as such the amount of air (amount of blocking) that can escape is different in each of those intermediary positions).
Regarding claim 36, Allum further discloses wherein the first valve member (136a) is positioned in a path of the first inlet flow of breathable gas from the first inlet and the second valve member (136b) is positioned in a path of the second inlet flow of breathable gas from the second inlet (see figures 8-9).
Regarding claim 37, Allum further discloses wherein the first valve member (136a) comprises a first membrane (136a is a flapper as per [0054]) mounted to the vent body (see figures 8-9) and the second valve member (136b) comprises a second membrane (136b is a flapper as per [0054]) mounted to the vent body (see figures 8-9).
Regarding claim 38, Allum further discloses wherein the first membrane and the second membrane are pivotally mounted to the vent body [0053]-[0054].
Regarding claim 49, Allum further discloses wherein the vent assembly is configured so that, in use, a vent flow rate (from 134 to 128) of the flow of exhaled air from the vent chamber through the vent holes (134 and 128) to ambient is substantially constant for a range of pressures inside the vent chamber [0054].
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). It is the examiner’s position that the prior art discloses all the structural limitations of the claimed invention.
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.
Claim(s) 50-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 2012/0325211 a1) in view of Richardson et al. (WO 2014/129913 A1)
Regarding claim 50, Allum discloses the claimed invention substantially as claimed as set forth for claim 28 above. Allum does not explicitly state wherein the vent assembly further comprises a diffuser to diffuse the vent flow of exhaled gas from the vent chamber to ambient.
However, Richardson teaches it is known for a vent assembly (vents through 514 as shown in figure 15) to comprise a diffuser (570+566) to diffuse the vent flow of exhaled gas from the vent chamber to ambient [00118] (see figures 13 and 15).
It would have been obvious to have modified Allum to include a diffuser to diffuse the vent flow of exhaled gas from the vent chamber to ambient as taught by Richardson for the benefit of reducing entrainment of surrounding air [00118].
Regarding claim 51, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above. Allum as modified further discloses wherein the diffuser (Richardson: 570+ 566) comprises a diffuser member (570) mounted to the vent body so that the diffuser member is positioned in the path of the vent flow of exhaled gas through the plurality of vent holes (see figures 13 and 15 of Richardson) and so that a surface (interior surface facing 514) of the diffuser member facing the vent body is spaced apart from the vent body (see figure 15).
Regarding claim 52, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 51 above. Allum as modified further discloses wherein the diffuser (570+566) comprises a diffusing body (566) positioned in a space between the vent body (body where 514 is located) and the diffuser member (570) (see figure 15).
Claim(s) 53-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 2012/0325211 a1) in view of Kwok et al. (US 2017/0312465 A1)
Regarding claim 53, Allum discloses: A patient interface (100) for delivering a flow of breathable gas at a positive pressure to an airway entrance of a patient [0008], the patient interface comprising:
a vent assembly as claimed in claim 28 (see claim 28 above);
a plenum chamber (chamber within 100) pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure [0008] [0014], the plenum chamber comprising the vent body of the vent assembly (see annotated figure below);
a structure (120a 120b) having a hole (see figures 8, 9) therein such that the flow of breathable gas at said therapeutic pressure is delivered to the airway entrance [0046] [0053], the structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use [0053]-[0054]; and
at least two gas delivery tubes (124 see figures 8-9)
Allum further does not explicitly disclose a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising:
the at least two gas delivery tubes (124 of Allum) to receive the flow of breathable gas from a connection port configured to be positioned on top of the patient's head in use and to deliver the flow of breathable gas to the airway entrance via the plenum chamber, the gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head and the gas delivery tubes being constructed and arranged so that, in use, at least one of the gas delivery tubes is positioned in use on each side of the patient's head and extends across the respective cheek region, wherein one of the gas delivery tubes fluidly connects to the first inlet of the vent assembly and another of the gas delivery tubes fluidly connects to the second inlet of the vent assembly.
However Kwok teaches a patient interface (see figure 1-6) wherein a positioning and stabilising structure (30) to provide a force to hold a seal-forming structure (20) in a therapeutically effective position on the patient's head (as shown in figures 1-4 and 1-5), the positioning and stabilising structure comprising:
the at least two gas delivery tubes (42) to receive the flow of breathable gas from a connection port (70) configured to be positioned on top of the patient's head in use (see figure 1-4) and to deliver the flow of breathable gas to the airway entrance via the plenum chamber (as modified Allum would receive the gas from the connector and deliver it to the plenum chamber), the gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (see figure 1-4) and the gas delivery tubes being constructed and arranged so that, in use, at least one of the gas delivery tubes is positioned in use on each side of the patient's head and extends across the respective cheek region (see figure 1-5), wherein one of the gas delivery tubes fluidly connects to the first inlet of the vent assembly and another of the gas delivery tubes fluidly connects to the second inlet of the vent assembly (see figures 1-5 and 1-6 wherein the tubes connect to the right and left sides of the patient interface 20).
Therefore it would have been obvious to have modified Allum to include a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising:
the at least two gas delivery tubes (124 of Allum) to receive the flow of breathable gas from a connection port configured to be positioned on top of the patient's head in use and to deliver the flow of breathable gas to the airway entrance via the plenum chamber, the gas delivery tubes being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head and the gas delivery tubes being constructed and arranged so that, in use, at least one of the gas delivery tubes is positioned in use on each side of the patient's head and extends across the respective cheek region, wherein one of the gas delivery tubes fluidly connects to the first inlet of the vent assembly and another of the gas delivery tubes fluidly connects to the second inlet of the vent assembly for the benefit of providing a sleek and elegant patient interface that is soft, comfortable, lightweight, functional, therapy enhancing, fashionable, easy and intuitive to fit and adjust with little or no adjustment, shape holding, low impact, low profile, continuity of form, individualized or customized, and/or are more appealing and much less objectionable by patients and bed partners alike [0098].
Allum does not explicitly state the structure (120a 120b) is seal forming to form a seal with a region of the patient's face surrounding the airway entrance.
However Allum discloses that other direct nasal interface masks are disclosed such nasal cradle masks [0028], which provide a seal with a region of the patient’s face surrounding the airway entrance. Kwok provides an example of a nasal cradle (20) (shown in 2-1) [0200]-[0201].
Therefore it would have been obvious to have modified Allum’s figures 8-9 to include a nasal cradle as shown in Kwok thus providing a seal forming structure as this was contemplated by Allum in [0028]. This provides a comfortable fit as set forth in Kwok [0201].
PNG
media_image2.png
670
534
media_image2.png
Greyscale
Regarding claim 53, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 54 above. Allum as modified further discloses wherein the positioning and stabilising structure comprises a bendable strap (60 of Kwok).
Regarding claim 55, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 53 above. Allum as modified further discloses wherein the seal-forming structure is configured to seal around an inferior periphery of the nose (Kwok: figure 1-5 and [0201]).
Allowable Subject Matter
The examiner notes a call was made to Paul Bowen on 11/21/2025 and a voicemail was left regarding an examiner’s amendment to incorporate claim 39 (and dependents) into the independent claim, however the examiner was not able to reach applicant’s representative.
Claim 39 is 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.
Claims 40-45 depend from claim 39 and thus also contain allowable subject matter.
Claims 47-48 appear to depend from claim 39 (see 112b issue above) and if this is the case also contains allowable subject matter.
The prior art of Allum contains the valve seat portions (either 132a/132b or the seat at 130a/130b) as required by claim 39, however the plurality of vent holes are not provided in the first and second seat portions. 132a/132b only contain a subset of the plurality of vent holes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm.
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.
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785