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 I, claims 1-6, in the reply filed on 7/31/2026 is acknowledged.
Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/2026. [Note: Applicant’s claim set filed 7/31/2026 improperly lists claims 7-11 as “withdrawn” but also without text. Please see MPEP 714/37 CFR 1.121(c)(3-4), where the full text of withdrawn claims should be present, while no text presented is reserved for cancelled claims. The claims are being treated as withdrawn, but Applicant should confirm the correct status and correct the claim set as appropriate in their response to this Office Action.]
Specification
The disclosure is objected to because of the following informalities:
Para [0024] should read: “The first position is defined as where the bypass valve 30 is sealed against a first wall 35 of the bypass valve 25, thereby allowing air to flow from the inlet 15 to the outlet 20. Meanwhile, the second position is defined as where the bypass valve 30 is sealed against a second wall 37 of the outlet 20, thereby allowing air to flow from the bypass 25 to the outlet 20” because the two described positions in view of e.g. instant Fig. 3 are clearly intended to change the airflow from the inlet to the bypass, not maintain it from the inlet
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 1-6 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.
Regarding claim 1 (and thus its dependent claims 2-6), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II. Moreover, “allowing a bypass of the airflow to the patient” does not appear to be an accurate way of describing the function of the disclosed (3-way/Y-connector) depicted the instant Figures, because the bypass 25/125/225 does not actually bypass “the airflow to the patient,” rather, it provides for a second airflow to the patient from a different source along the same outlet pathway. To address this rejection, Applicant could amend claim 1 to read “the bypass configured to allow
Regarding claim 2, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II. Moreover, it appears that claim 2 contains a typo in light of the specification as originally filed, because the two positions described in instant para [0024] and in light of e.g. instant Fig. 3 both allow airflow to the outlet, while closing one of either the inlet or the bypass; the second position is not understood to allow “the airflow from the inlet to the bypass” (emphasis added) as currently recited by claim 2. To address this rejection, Applicant could amend claim 2 (in conjunction with the suggested amendment for claim 1 above) to read “wherein the first position is configured to allow is configured to allow bypass airflow from the bypass to the outlet.” For purposes of compact prosecution, art will be applied below to address both interpretations.
Regarding claim 5, it is unclear whether “further comprised of” requires two more ports in addition to the at least one port of claim 1 or whether it means there are at least two ports. As best understood, for purposes of examination, it is the latter, such that Applicant could address this rejection by amending the claim to read “is
Claim Interpretation
The Examiner notes that the terms “gas port” and “medicinal port” do not have any established, differentiating structure in the art; any port that is capable of sampling gas and/or medicine reads on the claimed port(s).
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) 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Resca (EP 2319573 A1; hereinafter “Resca”).
Regarding claim 1, Resca discloses a bypass conduit (the Y-piece connector comprising valve V) (Figs. 5-8) for enabling an airflow (along pathway 20), comprising:
an inlet (channel A OR channel 2) configured to connect to a ventilator (Fig. 5; paras [0004], [0020-33], and [0064-67], where either channel A OR channel 2 is fully capable of being/configured to connect to ventilator, because they are both tubular extensions and there is nothing that would preclude this intended use);
an outlet (channel 2 OR channel A, respectively) operatively engaged with the inlet, the outlet configured to allow the airflow from the inlet to a patient (Fig. 5; paras [0004], [0020-33], and [0064-67], where channel 2 is fully capable of being/configured to be connected to a ventilator and channel A connected to a patient, or vice versa as depicted by Resca, because they are both tubular extensions and there is nothing that would preclude this intended use);
a bypass (extending from joint 8) connected to the inlet and the outlet, the bypass allowing a bypass of the airflow [or, as best understood, a bypass airflow, when used in reverse of the flows depicted in Fig. 6 and as discussed in the alternative above] to the patient (Fig. 5; paras [0020-33] and [0064-67]);
a central chamber (within containing means 27) positioned at an intersection of the bypass, the outlet and the inlet (Figs. 5-8);
a bypass valve (valve V) positioned in the central chamber (Figs. 5-8), the bypass valve moveable from a first position (Fig. 7) to a second position (Fig. 8); and,
at least one port (the lower port of the valve housing, for engaging element 11) projecting from the central chamber to provide at least one of: gas sampling and medication delivery (Figs. 5-8; paras [0035-36]).
Regarding claim 2, Resca discloses the bypass conduit of Claim 1 wherein the first position allows the airflow from the inlet (when considered channel A) to the outlet (when considered channel 2) and the second position allows the airflow from the inlet (channel A) to the bypass (extending from joint 8) (Figs. 5-8) OR, as best understood, wherein the first position allows the airflow from the inlet (when considered channel 2) to the outlet (when considered channel A) and the second position allows the airflow from the [bypass] (extending from joint 8) to the [outlet] (channel A).
Regarding claim 3, Resca discloses the bypass conduit of Claim 1 wherein the at least one port is a gas port for the gas sampling (the lower port of the valve housing is fully capable being used for gas sampling, as nothing would prevent this intended use).
Regarding claim 4, Resca discloses the bypass conduit of Claim 1 wherein the at least one port is a medicinal port for the medication delivery (Fig. 5; paras [0035-36]).
Regarding claim 6, Resca discloses the bypass conduit of Claim 1 wherein the at least one port is a tubular member extending from an aperture positioned within the central chamber (Figs. 7-8).
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) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over; Fiorenza (US 2020/0011438 A1; hereinafter “Fiorenza”) in view of Loescher et al. (US 6,209,539; hereinafter “Loescher”).
Regarding claim 1, Fiorenza discloses a bypass conduit (bypass conduit 65) for enabling an airflow (in direction X) (Fig. 5B; para [0014]), comprising:
an inlet (the upper right branch/inlet for flow in direction X in Fig. 5B) configured to connect to a ventilator (as a tubular extension, the upper right branch is configured/fully capable of being connected to a ventilator, as nothing would preclude this intended use);
an outlet (the upper left branch/outlet for flow in both the X and Y directions) operatively engaged with the inlet, the outlet configured to allow the airflow from the inlet to a patient (Fig. 5B, where the upper left branch is configured/fully capable of being connected to a patient, as nothing would preclude this intended use);
a bypass (the lower branch/inlet for flow in the Y direction in Fig. 5B) connected to the inlet and the outlet, the bypass allowing, as best understood, a bypass airflow (in direction Y) to the patient (Fig. 5B, para [0014], where the upper left branch is fully capable of being connected to a patient, such that airflow in the Y direction would be to the patient);
a central chamber (the chamber in which valve 10 is positioned) positioned at an intersection of the bypass, the outlet and the inlet (Fig. 5B);
a bypass valve (valve 10) positioned in the central chamber, the bypass valve moveable from a first position to a second position (Fig. 5B; para [0014]).
Fiorenza is silent regarding at least one port projecting from the central chamber to provide at least one of: gas sampling and medication delivery. However, Loescher teaches that it was known in the respiratory connector art before the effective filing date of the claimed invention for a Y-piece connector (adapter 10) (Fig. 1) to include at least one port (port 18 and/or port 22) projecting from the central chamber (Figs. 1-2) to provide at least one of: gas sampling and medication delivery (col. 2, lines 44-52; wherein gas is fully capable of being withdrawn for sampling through either port, and medication is fully capable of being delivered through either port, as nothing would preclude either intended use). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Fiorenza to include at least one port projecting from the central chamber to provide at least one of: gas sampling and medication delivery as taught by Loescher, in order to place ports(s) in a known location to provide the predictable result(s) of allowing monitoring of delivered gases using the same port(s) regardless of which inlet branch is being used and/or to provide medicament to a patient using the same port(s) regardless of which inlet branch is being used (Loescher col. 2, lines 44-52).
Regarding claim 2, Fiorenza in view of Loescher teaches the bypass conduit of Claim 1 wherein modified Fiorenza further discloses wherein the first position allows the airflow (X) from the inlet to the outlet and the second position allows, as best understood, the [bypass] airflow (Y) from the [bypass] to the [outlet] (Fiorenza Fig. 5B; para [0014]).
Regarding claim 3, Fiorenza in view of Loescher teaches the bypass conduit of Claim 1 wherein the at least one port is a gas port for the gas sampling (gas is fully capable of being withdrawn for sampling through either of the ports taught by Loescher, as nothing would preclude this intended use, such that said port comprehends a gas port as claimed).
Regarding claim 4, Fiorenza in view of Loescher teaches the bypass conduit of Claim 1 wherein the at least one port is a medicinal port for the medication delivery (medication is fully capable of being delivered through either of the ports taught by Loescher, as nothing would preclude this intended use, such that said port comprehends a medicinal port as claimed).
Regarding claim 5, Fiorenza in view of Loescher teaches the bypass conduit of Claim 1 wherein the at least one port is further comprised of a gas port and a medicinal port (gas is fully capable of being withdrawn for sampling through either port, and medication is fully capable of being delivered through the other port, as nothing would preclude this intended use, such that the two ports taught by Loescher comprehend a gas port and medicinal port as claimed, and including both the ports of Loescher in modified Fiorenza would have been obvious to an artisan before the effective filing date of the claimed invention in order to provide both the functionalities taught by Loescher col. 2, lines 44-52, or any other two port functionalities simultaneously and/or without having to switch components, e.g. the instantly-claimed intended uses).
Regarding claim 6, Fiorenza in view of Loescher teaches the bypass conduit of Claim 1 wherein Loescher educates modified Fiorenza to include wherein the at least one port is a tubular member extending from an aperture positioned within the central chamber (Loescher Figs. 1-2 in view of Fiorenza 5B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references available to reject at least claim 1 under 35 USC 102: Rich (US 6,123,674); Thompson (US 3,301,255); Bird (US 5,165,398); Milliken (EP 0700687 A1); Wright (US 5,720,282); Burk et al. (US 2008/0210242 A1); Gallem et al. (US 2011/0146670 A1); Chui (US 2011/0155135 A1); Cavendish (US 2013/0081617 A1; Fig. 2); Shin et al. (WO 2013/122326 A1); Bayron et al. (US 8,656,915 B2); Rusher (US 2014/0150801 A1). Additional references teaching port(s) in the central chamber of a 3-way connector: Meech (US 2021/0138176 A1); Wallace (US 5,036,840); DeVries (US 6,102,038); Faram et al. (US 2002/0058879 A1); Remmerswaal et al. (US 2012/0123208 A1); Fischer, Jr. (US 2013/0204082 A1); Fisher et al. (US 2015/0083121 A1); Martin et al. (US 2015/0352310 A1); Shau et al. (US 2016/0346491 A1); Jiang et al. (CN 110237382 A). Additional references teaching a flap valve as disclosed in the central chamber of a 3-way connector: Weikert et al. (US 2019/0336718 A1); Hansen (US 2003/0015200 A1); Dwyer (US 2010/0071688 A1); Lurie et al. (US 2010/0319691 A1; Fig. 13B); Fiorenza (US 2015/0202398 A1); Schmidt (US 2007/0017516 A1). Additional references regarding ports for respiratory gas connectors: Poole, Jr. (US 5,181,508 and US 4,953,547).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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