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
Claims 59 and 67 objected to because of the following informalities:
Claim 59 recites “that in fluid” in line 2. This should read “that is in fluid”.
Appropriate correction is required.
Claim 67 recites “defines a cavity to form” in line 2. This should read “forms”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “flow directing member” in claims 57-68, 71-72, 75, 77-78, 86, 103 and 104; “first nasal element” and “second nasal element” in claim 78.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 86, 103 and 104 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ronayne (WO 2018/042355 A1)
Regarding claim 86, Ronayne discloses: A patient interface (figures 1 and 2) for respiratory therapy comprising:
a cannula body (2, 4) comprising a first nasal element (2) and a second nasal element (4); and
a cannula manifold (manifold connected to 2, 4), the cannula manifold comprising a manifold inspiratory lumen (through flow path 3), a manifold expiratory lumen (through flow path 5), and a flow directing member (partition 7 which can be a valve 6 as shown in figure 2; [0358]), wherein the flow directing member is arranged to direct gas flow from the manifold inspiratory lumen to the first nasal element and to direct gas flow from the second nasal element to the manifold expiratory lumen (see flow as shown in figure 1).
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Regarding claim 103, Ronayne further discloses wherein the cannula manifold comprises a pressure monitoring port [0397].
Regarding claim 104, Ronayne further discloses wherein the pressure monitoring port is configured to provide a gas flow for pressure monitoring (claim 28) [0397], the gas flow comprising an average of the inspiratory gas flow and expiratory gas flow (claim 29).
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) 57-61, 63-64, 66-68, 71-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (CA 3147682) in view of Anderson (WO 2008019294 A2)
Regarding claim 57, White discloses: A patient interface (see figure 4) for respiratory therapy comprising:
a cannula body (32, 33, 34) comprising a first nasal element (33) and a second nasal element (34); and
a cannula manifold (35), the cannula manifold being reconfigurable relative to the cannula body in a first configuration (figure 6) and in a second configuration (figure 5).
White does not explicitly disclose the cannula manifold comprising a manifold inspiratory lumen, a manifold expiratory lumen, and a flow directing member.
However, Anderson teaches it is known to have a manifold (152) comprising a manifold inspiratory lumen (156) coupled to an inspiratory conduit (159), a manifold expiratory lumen (158) coupled to an expiratory conduit (160) and a flow directing member (partition shown in figure 18 between 158 and 156) [154]. The examiner also notes that based on [154] the inspiratory lumen/conduit can alternatively be 158/160 and the expiratory lumen/conduit can be 156/159.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified White such that the cannula manifold comprising a manifold inspiratory lumen coupled to an inspiratory conduit, a manifold expiratory lumen coupled to an expiratory conduit, and a flow directing member as taught by Anderson for the benefit of being able to provide oxygen and sample fluid being exhaled [154].
Therefore, White as modified discloses wherein in a first configuration (figure 6 of White) the flow directing member is arranged to direct gas flow from the manifold inspiratory lumen to the first nasal element (as modified by Anderson, the flow directing member would direct gas from 156 of Anderson into the first nasal element 34 of White; or alternatively 158 or Anderson into 33 of White) and to direct gas flow from the second nasal element (33 of White; or alternatively 34 of White) to the manifold expiratory lumen (158 of Anderson; or alternatively 156 of Anderson), and in a second configuration (figure 5 of White) the flow directing member is arranged to direct gas flow from the manifold inspiratory lumen to the second nasal element (as modified by Anderson, the flow directing member would direct gas from 156 of Anderson into the second nasal element 33 of White; or alternatively from 158 into 34 of White) and to direct gas flow from the first nasal element (34 of White; or alternatively 33 of White) to the manifold expiratory lumen (158 of Anderson; or alternatively 156 of Anderson).
Regarding claim 58, White as modified discloses the claimed invention substantially as claimed. White further discloses wherein the cannula manifold is configured for insertion into the cannula body (see figures 4-6 of White).
Regarding claim 59, White as modified discloses the claimed invention substantially as claimed. White as modified discloses comprising or coupled to an inspiratory conduit (159 of Anderson) that is in fluid communication with the inspiratory lumen (see figure 18 of Anderson), and comprising or coupled to an expiratory conduit (160 of Anderson) that in fluid communication with the expiratory lumen (see figure 18 of Anderson).
Regarding claim 60, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the inspiratory conduit (159 of Anderson) and the expiratory conduit (160 of Anderson) are coaxial or substantially parallel (see figure 17 and 18 of Anderson).
Regarding claim 61, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the inspiratory conduit (159 of Anderson) and the expiratory conduit (160 of Anderson) are on a single limb (left limb as shown in figures 17 and 18 of Anderson), such that the inspiratory element and the expiratory element both extend in one direction from the cannula body (see figures 17 and 18 of Anderson).
Regarding claim 63, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the flow directing member (Anderson: wall between 158 and 156 as shown in figure 18) is arranged such that a distal one (furthest from left side of manifold: 154 of Anderson/34 of White) of the first and second nasal elements relative to a manifold inlet and a manifold outlet (both inlet and outlet are on left side of Anderson/White as shown in figure 18 of Anderson and figure 6 of White) is an inspiratory nasal element (34 of White) for directing gas flow to the patient and a proximal one (155 of Anderson/33 of White) of the first and second nasal elements relative to the manifold inlet and the manifold outlet (both inlet and outlet are on left side of Anderson/White) is an expiratory nasal element (33 of White) for directing a flow of expiratory gases away from the patient (Anderson [154]).
Claim 64 is based on: The examiner also notes that based on [154] of Anderson the inspiratory lumen/conduit can alternatively be 158/160 and the expiratory lumen/conduit can be 156/159 as set forth for claim 57 above.
Regarding claim 64, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the flow directing member (Anderson: wall between 158 and 156 as shown in figure 18) is arranged such that a proximal one (closest to left side of manifold: 155 of Anderson, 33 of White) of the first and second nasal elements relative to a manifold inlet and a manifold outlet (both inlet and outlet are on left side of Anderson/White as shown in figure 18 of Anderson and figure 6 of White) is an inspiratory nasal element (33 of White) for directing gas flow to the patient and a distal one (154 of Anderson, 34 of White) of the first and second nasal elements relative to the manifold inlet and the manifold outlet is an expiratory nasal element (34 of White) for directing a flow of expiratory gases away from the patient (Anderson [154]).
Regarding claim 66, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the cannula manifold comprises a body portion (body of 35 of White), and wherein the flow directing member comprises a proximal portion that extends substantially in a longitudinal direction of a body portion and a distal portion that extends transversely from a distal end of the proximal portion to meet the body portion (see annotated figure below of Anderson).
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Regarding claim 67, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein a cavity defined between the proximal portion, the distal portion, and the body portion defines a cavity to form one of an expiratory gases receipt opening and an inspiratory gas delivery opening (see annotated figure below).
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Regarding claim 68, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein an other of the inspiratory gas delivery opening and the expiratory gases receipt opening is provided on an opposite side of the distal portion of the flow directing member from the cavity (see annotated figure below).
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Regarding claim 71, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the cannula manifold is configured to be inserted into the cannula body in the first configuration and in the second configuration (see figures 4-6 of White).
Regarding claim 72, White as modified discloses the claimed invention substantially as claimed. White as modified discloses wherein the first configuration corresponds to the cannula manifold being inserted into the cannula body from a first side of the cannula body (figure 6 of White), and wherein the second configuration corresponds to the cannula manifold being inserted into the cannula body from a second side of the cannula body (figure 5 of White).
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (CA 3147682) in view of Anderson (WO 2008019294 A2) in further view of Ronayne (WO 2018/042355 A1).
Regarding claim 75, White as modified discloses the claimed invention substantially as claimed. White as modified does not explicitly disclose wherein the cannula manifold comprises a pressure monitoring port, wherein the pressure monitoring port is in fluid communication with the manifold inspiratory lumen and the manifold expiratory lumen.
However, Ronayne teaches that it is known to provide a pressure monitoring port, wherein the pressure monitoring port is in fluid communication with the manifold inspiratory lumen and the manifold expiratory lumen [0048].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified White such that the cannula manifold comprises a pressure monitoring port, wherein the pressure monitoring port is in fluid communication with the manifold inspiratory lumen and the manifold expiratory lumen as taught by Ronayne for the benefit of ensuring appropriate flow/pressure during treatment.
Claim(s) 57 and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (CA 3147682) in view of McAuley et al. (US 2017/0239438 A1)
Regarding claim 57, White discloses: A patient interface (see figure 4) for respiratory therapy comprising:
a cannula body (32, 33, 34) comprising a first nasal element (33) and a second nasal element (34); and
a cannula manifold (35), the cannula manifold being reconfigurable relative to the cannula body in a first configuration (figure 6) and in a second configuration (figure 5).
White does not explicitly disclose the cannula manifold comprising a manifold inspiratory lumen, a manifold expiratory lumen, and a flow directing member.
However, McAuley teaches it is known to have a manifold (figure 26b) [0250] comprising a manifold inspiratory lumen (path from 63 to 62), a manifold expiratory lumen (86) and a flow directing member (partition shown in figure 26b between 63 and 86.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified White such that the cannula manifold comprising a manifold inspiratory lumen, a manifold expiratory lumen, and a flow directing member as taught by McAuley for the benefit of being able to provide oxygen without expiratory gases interfering with them [0249].
Therefore, White as modified discloses wherein in a first configuration (figure 6 of White) the flow directing member is arranged to direct gas flow from the manifold inspiratory lumen to the first nasal element (as modified by McAuley, the flow directing member would direct gas from 63 of McAuley into the first nasal element 33 of White) and to direct gas flow from the second nasal element (34 of White) to the manifold expiratory lumen (86 of McAuley), and in a second configuration (figure 5 of White) the flow directing member is arranged to direct gas flow from the manifold inspiratory lumen to the second nasal element (as modified by McAuley, the flow directing member would direct gas from 63 of McAuley into the second nasal element 34 of White) and to direct gas flow from the first nasal element (33 of White) to the manifold expiratory lumen (86 of McAuley).
Regarding claim 77, White as modified discloses the claimed invention substantially as claimed. White as modified further discloses a filter (120) in fluid communication with the manifold expiratory lumen (see figure 26b), the filter configured to filter the flow of gas from the patent interface before passage of the flow of expiratory gases from the patient interface into ambient air (see figure 26b; [0250]).
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (CA 3147682) in view of Anderson (WO 2008019294 A2) in further view of McAuley et al. (US 2017/0239438 A1)
Regarding claim 65, White as modified discloses the claimed invention substantially as claimed. White as modified does not explicitly disclose a gases port for entrainment of expiratory gases from a patient's nose and/ or a patient's mouth that are not directed into the expiratory nasal element.
However, McAuley teaches it is known to provide a gases port (72) for entrainment of expiratory gases from a patient's nose and/ or a patient's mouth that are not directed into the expiratory nasal element [0245].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified White to include a gases port for entrainment of expiratory gases from a patient's nose and/ or a patient's mouth that are not directed into the expiratory nasal element as taught by McAuley for the benefit of allowing exhaled gases to pass via the channel and exit below the cannula [0245] and to suppress noise [0250] via a filter within the channel.
Claim(s) 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ronayne (WO 2018/042355 A1) in view of Anderson (WO 2008019294 A2)
Regarding claim 78, Ronayne discloses: A patient interface (figures 1 and 2) for respiratory therapy comprising:
a cannula body (2, 4) comprising a first nasal element (2) configured to direct gas into a nare of the patient and a second nasal element (4) configured to direct gas from another nare of the patient (see figure 1); and
a cannula manifold (manifold connected to 2, 4), the cannula manifold comprising a manifold inspiratory lumen (through flow path 3) for inspiratory gas flow in fluid communication with a manifold inlet (see annotated figure below), a manifold expiratory lumen (through flow path 5) for expiratory gas flow in fluid communication with a manifold outlet (see annotated figure below), and a flow directing member (partition 7 which can be a valve 6 as shown in figure 2) that is arranged to direct gas flow from the manifold inspiratory lumen to the first nasal element (see figure 1) and to direct gas flow from the second nasal element to the manifold expiratory lumen (see figure 1) [0356] [0359], and a pressure monitoring port [0397] in fluid communication with the manifold inspiratory lumen and the manifold expiratory lumen [0397] (claim 28).
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Ronayne does not explicitly disclose wherein the manifold inlet and the manifold outlet are on a single limb, such that the manifold inlet and the manifold outlet both extend in one direction from the patient interface in use.
However, Anderson (figure 18) teaches it is known for a manifold inlet (where 160 attaches to nasal interface) and a manifold outlet (where 159 attaches to nasal interface) are on a single limb (left limb), such that the manifold inlet and the manifold outlet both extend in one direction from the patient interface in use (see figure 18).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ronayne wherein the manifold inlet and the manifold outlet are on a single limb, such that the manifold inlet and the manifold outlet both extend in one direction from the patient interface in use such that tubing is only on one side of the patient, thereby allowing a patient to lay comfortably on one side without the risk of laying on tubing extending from the cannula manifold. [13]-[14] also discuss improved stability and comfort to the patient.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785