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 7/1/2025. As directed by the amendment, claims 1, 3, 4, 7, 8, 10-12, 24 and 28-30 have been amended, and claims 2, 5, 6, 13-23 and 25-27 have been cancelled. As such, claims 1, 3, 4, 7-12, 24 and 28-30 are pending in the instant application.
Applicant has amended the title in response to the previous objection thereof; however, the claims have been amended such that the previously-suggested title is no longer sufficiently descriptive. The objection to the specification is updated below.
Applicant has amended the claims to address the previous objections thereto, which are hereby withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, as Clark’s teaching of an exhalation valve in combination with a dilution valve on a nasal cannula body is not contested.
Applicant's arguments filed 7/1/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Regarding claims 12 and 30 [as the only claims to which Wondka was applied], Applicant argues at the top of page 17 of Remarks that Wondka is not concerned with entrainment of ambient air through FiO2 apertures and that the exhalation ports 270 of Wondka are fixed in diameter, in contrast to the claimed adjustable FiO2 apertures.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant’s arguments against Wondka are not germane to the rejections of claims 12 and 30 (either previous or updated below), because Wondka is not being modified to include an adjustable FiO2 aperture, nor are the exhalation ports of Wondka relied on to teach adjustable FiO2 apertures; rather, they are relied on to teach known locations for valved exhalation ports. The rejections in view of Wondka are updated below.
Regarding claim 24, Applicant alleges at the bottom of page 17 of Remarks that “Boulanger…not only does not maintain a volume of gas in a reservoir at ambient pressure but also directly and explicitly teaches away from doing so.”
The Examiner disagrees with Applicant’s mischaracterization of Boulanger. Boulanger explicitly discloses a volume of gas in a reservoir at ambient pressure (“the internal volume 27a of reservoir 27 equals to atmospheric pressure,” para [0142], emphasis added, see also paras [0126-128] and [0141-143]), and Boulanger also teaches that pressures that deviate from substantially ambient (i.e. over-deflated or over-inflated as shown in Boulanger Figs. 5 and 6, respectively) are to be avoided in order to operate the device in a comfort zone for the patient (Boulanger paras [0129-133] and [0150-154]). Therefore, contrary to Applicant’s assertion of a lack of disclosure and a teaching away, Boulanger is an explicit disclosure as well as an explicit teaching of operating substantially at ambient pressure. As such, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on page 18 of Remarks that Boulanger “does not and cannot maintain the volume of gas in the reservoir substantially at ambient pressure throughout a breathing cycle…doing so would frustrate the operation of the Boulanger system for reasons Boulanger expressly describes.”
The Examiner respectfully disagrees that Boulanger “does not and cannot” maintain the gas in the reservoir at substantially ambient pressure, and the Examiner fails to see where Boulanger “expressly describes” what Applicant asserts. As discussed above, what Boulanger does expressly describe, in para [0142] thereof, is that the pressure within the reservoir as shown in Fig. 3 thereof is equal to ambient pressure at the start of a breathing cycle (“the gas pressure into the internal volume 27a of reservoir 27 equals to atmospheric pressure”), and maintained substantially at ambient pressure throughout the breathing cycle (Boulanger paras [0126-128] and [0142-154]), because even the “slight negative pressure” of -0.2 mbar from ambient that may be present as discussed in Boulanger paras [0128] and [0142], is well within Applicant’s scope of “substantially,” which encompasses 1013.25±50.7 mbar (i.e. ambient±5%) per instant para [0063]. The system of Boulanger is not frustrated by operating substantially at ambient pressure throughout a breathing cycle, because this is what is explicitly disclosed by Boulanger paras [0126-128] and [0142-154], and taught to be desirable by Boulanger paras [0010-16] in order to provide comfortable and easy breathing by avoiding pressures that deviate substantially from ambient within the reservoir. As such, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on page 18 of Remarks that “[r]ather than maintaining a volume of gas at ambient pressure throughout the breathing cycle, Boulanger expressly relies…on the variations from ambient pressure…negative pressure must be provided by the patient to compress the reservoir 27.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the volume of gas is maintained unvaryingly exactly at ambient pressure throughout a breathing cycle) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). First, the Examiner respectfully notes that claim 24 does not exclude a slight negative pressure, since it recites “substantially at ambient pressure,” where instant para [0063] indicates that “substantially at ambient pressure” can include ambient±5%. Second, the Examiner respectfully notes that Applicant’s own invention depends on slight variations of pressure during operation/does not maintain the volume of gas thereof exactly at ambient pressure throughout operation, because, in the same way as Boulanger, a slight negative pressure from a user’s inhalation is transmitted to the reservoir in order to withdraw the gas from therein, see instant Fig. 13 (cont’d) and instant para [0085]: “[t]he drop in pressure induced by inhalation is used for the transfer of volume from the reservoir 104.” Therefore, Applicant’s arguments against Boulanger are unconvincing, and are not reflective of the claimed (or disclosed) invention. As such, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on page 19 of Remarks that “[b]ecause negative pressure must be provided by the patient to compress the reservoir 27 in Boulanger, a sealed environment must be created.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a non-sealable environment [note: the instant FiO2 apertures are understood to be sealable]) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. However, arguments of counsel cannot take the place of factually supported objective evidence. See MPEP 2145. The Examiner respectfully notes that Boulanger makes no mention of a requirement for a sealed environment, and Applicant has provided no objective evidence that the system of Boulanger cannot function with a cannula as claimed. Given that the instant disclosure also requires a negative pressure to withdraw gas from the reservoir thereof as discussed above yet operates with an unsealed interface, i.e. does not require a sealed environment, the Examiner asserts that, in the same way, a sealed environment is not required in the system of Boulanger, and as such, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on pages 19-20 of Remarks that work must be input by the patient to collapse the reservoir thereof and that the reservoir of Boulanger “exhibits a resilient bias…[b]y virtue of its resilient rubber structure.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., no work is required to be input from the user to withdraw gas from the reservoir, or that the reservoir does not exhibit a resilient bias/is not rubber) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). First, the Examiner again notes that the instant invention also relies on work input from the patient, i.e. inhalation creating a negative pressure, to withdraw gas from and collapse the reservoir thereof as discussed above, see instant Fig. 13 (cont’d) and instant para [0085]. Second, the Examiner notes that no material/functionality requirements for the reservoir are currently recited by the claims that would exclude the reservoir of Boulanger. Therefore, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on page 21 of Remarks that Boulanger includes a differential pressure sensor “configured to measure negative pressures (i.e. compared to atmospheric pressure) down to -5mb.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a pressure sensor is excluded) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also, the Examiner again notes that instant invention also relies on the generation of a slight negative pressure to withdraw gas from the reservoir thereof as discussed above, see instant Fig. 13 (cont’d) and instant para [0085], and that ambient-5 mb is well within the ambient±5% of “substantially at ambient pressure” (i.e. 1013.25±50.7 mbar) according to instant para [0064], and thus even the highest potential pressure deviations registerable by Boulanger’s sensor are within the claimed “substantially at ambient pressure.” Therefore, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on page 21 that “a reservoir exhibiting a resilient resistance to deflation…a tendency to return to its expanded resting state based on its resiliency is critical to the functionality…taught by Boulanger…Boulanger’s system would be inoperable if modified to maintain gas at ambient pressure as disclosed and claimed.”
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the reservoir is not configured to return to its expanded state based on resiliency) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Second, Boulanger’s system expressly maintains the gas at ambient pressure, at least during the rest state, as discussed above and maintained in the rejections below, and it is presumed operable in accordance with MPEP 2121.I. Therefore, the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant argues on pages 21-22 that the claimed system “is elegantly made available for inhalation with no added respiratory work” but then acknowledges that oxygen is withdrawn in the disclosed system “during a natural inspiration phase of a breathing cycle,” yet asserts that this is “in direct opposition to the teachings of Boulanger…[which] teaches a reservoir with walls constantly fighting to achieve an expanded configuration.”
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the reservoir does not have walls constantly fighting to achieve an expanded configuration) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Second, the Examiner yet again notes that instant invention relies on the generation of a negative pressure to withdraw gas from the reservoir thereof as discussed above, see instant Fig. 13 (cont’d) and instant para [0085], with the instant specification indicating at paras [0058-59] that the reservoir therein maintains its expanded shape/does not significantly collapse on its own due to the weight of the walls, which belies Applicant’s arguments regarding not needing some degree of work/negative pressure to collapse the walls, which are otherwise fighting to stay in the expanded state. As such, Applicants arguments are unconvincing and not reflective of the claims or the disclosed invention, and the rejections in view of Boulanger are maintained/updated below.
Further regarding claim 24, Applicant asserts on page 22 of Remarks that use “at rest…but also in times of extreme exertion” are not “practically possible under Boulanger…designed for a basically different purpose, namely, the administration of procedural sedation.”
First, the Examiner respectfully notes that the instant claims are not method claims. Because the instant claims are apparatus claims, the claimed invention must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2114. The system of modified Boulanger meets all of the instantly claimed limitations as discussed in the updated rejections below; therefore, the instant claims stand rejected under 35 USC 103. Second, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the gas is a non-sedative gas) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, even if the claims were amended to require a non-sedative gas, the Examiner notes that Boulanger does not require the use of the system for sedation, as Boulanger teaches that the gas can be any respiratory gas (e.g. Boulanger para [0176]), and Boulanger teaches benefits (e.g. gas conservation, reduced respiratory effort, fast response time, synchronized operation, paras [0004-16]) that would have been obvious to an artisan before the effective filing date of the claimed invention as applicable to any respiratory gas therapy in order to gain the benefits described by Boulanger paras [0004-16].
Further regarding claim 24, Applicant argues on pages 22-23 of Remarks that “under Applicant’s claimed invention, the process for refilling the reservoir is decoupled from the patient inspiration process…Boulanger, however, teaches relying on a negative pressure indication…Applicant’s reservoir being automatically refilled prior to any negative pressure trigger…based on a detection of the state of inflation.”
The Examiner respectfully notes that both Boulanger and the instantly claimed system function by monitoring the state of deflation of a reservoir due to negative pressure generated by inhalation/gas from the reservoir being inhaled and withdrawn from the reservoir and triggering re-inflation thereof once a certain degree of deflation occurs, as discussed above and maintained in the updated rejections below. The Examiner fails to see a differentiation between the claimed invention and Boulanger in this regard.
Further regarding claim 24, Applicant states on page 23 that “Boulanger requires a closed system,” and argues that “Applicant’s system has no such requirement and can be open to the environment.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a non-closable system [note: the instant FiO2 apertures are understood to be closable]) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. However, arguments of counsel cannot take the place of factually supported objective evidence. See MPEP 2145. The Examiner respectfully notes that Boulanger makes no mention of a requirement for a closed system, and Applicant has provided no objective evidence that the system of Boulanger cannot function with a cannula as claimed. Given that the instant disclosure also requires a negative pressure to withdraw gas from the reservoir thereof as discussed above yet operates with an open interface, i.e. does not require a closed system, the Examiner asserts that a closed system is similarly not required in the system of Boulanger. As such, the rejections in view of Boulanger are maintained/updated below.
Regarding claims 3-4, Applicant argues on page 24 of Remarks that “the independently operable FiO[2] adjustment apertures are different than the “plurality of ribs” discussed in In re Harza…as cited in MPEP § 2100.04(VI)(B),” asserting that “[p]roviding individual FiO[2] adjustment…is nowhere contemplated in the cited art and is in purpose and effect a step beyond merely duplicating a part…is exactly the “new and unexpected result” contemplated by the Court of Customs and Patent Appeals.”
The Examiner respectfully inquires as to what “new and unexpected result” Applicant believes has been provided by duplicating the FiO2 adjustment aperture of Clark, as Applicant has not indicated the nature of the asserted new and unexpected result, nor have they provided any objective evidence to demonstrate the alleged new and unexpected result. If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. However, arguments of counsel cannot take the place of factually supported objective evidence. See MPEP 2145. Regardless, in response to applicant's argument that some “new and unexpected result” is provided by the claimed structure, which is taught by the prior art as discussed in the updated rejections below, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). An artisan before the effective filing date of the claimed invention would readily predicted the results provided by such a duplication parts as discussed in the previous rejection and maintained below, and Martin teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to align FiO2 adjustment apertures with nasal prongs, such that the rejections of claims 3 and 4 have been updated below.
Regarding claims 12 and 30, Applicant argues on page 25 of Remarks “by virtue of their disposition in alignment with the first and second nasal prongs, the second and third one-way expiratory valves achieve synergistic benefits beyond a mere duplication of parts.”
Applicant has not indicated the nature of said synergistic benefits, nor have they provided any objective evidence to demonstrate the alleged synergistic benefits. If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. However, arguments of counsel cannot take the place of factually supported objective evidence. See MPEP 2145. Modified Kooij in view of Wondka teaches locating two one-way expiratory valves in alignment with first and second nasal prongs; therefore, the claims remain rejected under 35 USC 103 as discussed in the updated rejections below.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Nasal Cannula With -Way Expiratory Valve and FiO2 Adjustment Aperture.
Claim Objections
Claims 1, 12, 24 and 30 are objected to because of the following informalities:
Claim 1, line 19 should read “by the second body member”
Claim 12, line 3 should read “prongs, respectively” for clarity in light of the specification
Claim 24, line 16 should read “the compartmented volume of gas” because it is clearly intended to refer to that of line 3
Claim 24, line 39 should read “by the second body member”
Claim 30, line 3 should read “prongs, respectively” for clarity in light of the specification
Appropriate correction is required.
Claim Interpretation
As best understood in view of the instant specification, e.g. para [0089] and Figs. 7-8 and 10-11, the newly claimed “at least one opening [of the first body member] opposite the first and second nasal prongs” corresponds to the open area under the nasal platform that is between the rings depicted on either side of the nasal platform in Figs. 7-8 OR the open areas under the nasal platform that are depicted on either side of the ring/reception structure 28 in Fig. 10.
Per para [0064] of the instant application, “substantially at ambient pressure” is understood to encompass “within five percent of ambient pressure.”
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 10 and 28 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 claims 10 and 28, claims 1 and 24 have been amended to recite the second body member comprising “at least one opening disposed to align with the first and second nasal prongs,” which is understood in light of the specification, e.g. Fig. 10 and para [0095], to correspond to the top opening that is bounded by the upper platform/ring depicted on the second body member in Fig. 10, such that claims 10 and 28 are now unclear, because claims 10/28 do not clearly connect the opening recited thereby with the at least one opening of claims 1/24, rendering it unclear if another opening is being recited, or if, as best understood, the platform is further limiting the at least one opening recited in claims 1/24. Applicant could address this rejection by amending claims 10/28 to read “wherein the at least one opening of the second body memberis bounded by a platform”.
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.
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) 1, 3, 4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kooij et al. (US 10,092,720 B2; hereinafter “Kooij”) in view of Hobson et al. (US 2010/0192957 A1; hereinafter “Hobson”), Clark (US 853,439; hereinafter “Clark”) and Martin et al. (US 2022/0072255 A1; hereinafter “Martin”).
Regarding claim 1, Kooij discloses a nasal cannula (Figs. 24a-b) for use with a gas dispensing system with tubing (tube 1100) for providing gas to an individual (e.g. Figs. 1 and 36; col. 1, lines 17-24), the nasal cannula comprising:
a nasal cannula body (patient interface 1000) with an inner volume (within barrel 1005) (Fig. 24a), wherein the nasal cannula body is formed from a first body member (sleeve 1001) assembled with a second body member (barrel 1005), wherein the first body member has a central portion that defines a reception cavity (the cavity through sleeve 1001), wherein the second body member at least partially defines the inner volume of the nasal cannula body (Fig. 24a), wherein the second body member is configured to be received into the reception cavity of the first body member (Fig. 24b);
first and second nasal prongs (nasal prongs 1010) that extend from the first body member of the nasal cannula body (Fig. 24a), wherein the first body member of the nasal cannula has at least one opening opposite the first and second nasal prongs (the opening between edges 1001a) (Fig. 24a), wherein the second body member of the nasal cannula has at least one opening (aperture 1061) disposed to align with the first and second nasal prongs that extend from the first body member (Figs. 24a-b; aperture 1061 that is configured to be aligned with the nasal prongs 1010, col. 17, lines 61-64), wherein the first and second nasal prongs are in fluidic communication with the inner volume of the nasal cannula body (Figs. 24a-b; col. 17, lines 55-64 in view of e.g. col. 1, lines 17-24);
a gas reception aperture (the opening into barrel 1005 to the left in Figs. 24a-b) in the second body member of the nasal cannula body in fluidic communication with the inner volume of the nasal cannula body for receiving gas from the tubing of the gas dispensing system (Figs. 24a-b; col. 17, lines 55-64 in view of e.g. col. 1, lines 17-24 and e.g. Fig. 36).
Kooij is silent regarding the materials of the cannula of Figs. 24a-b, such that Kooij is silent regarding wherein the first body member is formed from a resilient and substantially flexible material, and wherein the second body member is formed from a substantially rigid material. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Hobson teaches that it was known in the two-body nasal cannula art before the effective filing date of the claimed invention to include wherein the first body member (part 32) (Figs. 4-5) is formed from a resilient and substantially flexible material (part 32…manufactured out of a flexible polymer material or silicone, preferably a soft thermoplastic elastomer, para [0142]), and wherein the second body member (part 35) is formed from a substantially rigid material (part 35 is manufactured from a hard plastic material, para [0137]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Kooij to include wherein the first body member is formed from a resilient and substantially flexible material, and wherein the second body member is formed from a substantially rigid material as taught by Hobson, in order to provide the predictable results of a soft material provided to contact the user for comfort and harder material forming the air passage to prevent unintended collapse thereof.
Modified Kooij is silent regarding a one-way expiratory valve retained by [the] second body member of the nasal cannula body wherein the one-way expiratory valve is in fluidic communication with the inner volume of the nasal cannula body;
an FiO2 adjustment aperture in the second body member of the nasal cannula body in fluidic communication with the inner volume of the nasal cannula body, wherein the FiO2 adjustment aperture is positioned to align with the at least one opening in the first body member of the nasal cannula opposite the first and second nasal prongs, wherein the FiO2 adjustment aperture is selectively adjustable in size whereby the size of the FiO2 adjustment aperture can be adjusted to provide a desired entrainment of atmospheric air with gas inhaled through the first and second nasal prongs;
whereby gas provided by the tubing can be inhaled through the nasal prongs and whereby, during expiration, expired breath can be discharged through the one-way expiratory valve.
However, Clark teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include a one-way expiratory valve (check valve formed by disk 13 and cage 14) (Figs. 1-2) retained by a tubular manifold defining an inner volume (casing 1) of the nasal cannula body wherein the one-way expiratory valve is in fluidic communication with the inner volume of the nasal cannula body (Fig. 2; page 1, lines 75-83);
an FiO2 adjustment aperture (the open area of opening 18) in the tubular manifold defining the inner volume (casing 1) of the nasal cannula body in fluidic communication with the inner volume of the nasal cannula body (Figs. 2 and 4; page 1, lines 98-110), wherein the FiO2 adjustment aperture is selectively adjustable in size whereby the size of the FiO2 adjustment aperture can be adjusted to provide a desired entrainment of atmospheric air with gas inhaled through the first and second nasal prongs size (Fig. 4; disk 17…adapted to control an opening 18 communicating between the interior of the case and the atmosphere…patient may thus be given pure air, or diluted gas, page 1, lines 98-110; where rotation of disk 17 around pivot 19 allows the open area of opening 18 to be adjusted);
whereby gas provided by the tubing can be inhaled through the nasal prongs (Figs. 2-4; page 1, lines 45-49) and whereby, during expiration, expired breath can be discharged through the one-way expiratory valve (Fig. 2; page 1, lines 75-83), and Martin teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include wherein the FiO2 adjustment aperture (either of air entrainment ports 28) is positioned to align opposite the first and second nasal prongs (ports 28) (Figs. 20-24).
Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kooij to include a one-way expiratory valve retained by [the] second body member of the nasal cannula body, wherein the one-way expiratory valve is in fluidic communication with the inner volume of the nasal cannula body; an FiO2 adjustment aperture in the second body member of the nasal cannula body in fluidic communication with the inner volume of the nasal cannula body, wherein the FiO2 adjustment aperture is positioned to align with the at least one opening in the first body member of the nasal cannula opposite the first and second nasal prongs, wherein the FiO2 adjustment aperture is selectively adjustable in size whereby the size of the FiO2 adjustment aperture can be adjusted to provide a desired entrainment of atmospheric air with gas inhaled through the first and second nasal prongs; whereby gas provided by the tubing can be inhaled through the nasal prongs and whereby, during expiration, expired breath can be discharged through the one-way expiratory valve as taught by Clark and Martin and because it has been held that positioning of known parts on an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, in order to provide the predictable results of a standard means by which to prevent exhaled gas from being rebreathed (Clark page 1, lines 75-83) and known means by which to allow the patient the option to inhale ambient air after the gas has been shut off (thus preventing asphyxiation) and/or to inhale gas diluted with a selectable amount of ambient air (Clark page 1, lines 98-110) as desired/required for treatment, where locating both the exhalation valve and the dilution valve on the barrel/second body member in locations not overlapped by the sleeve/first body member of Kooij, e.g. in the opening between edges 1001a for central positioning of the dilution valve as taught by Clark, would have been obvious to an artisan before the effective filing date of the claimed invention in order to predictably provide direct pathways between the inner volume and ambient without having to go through both the first and second bodies for simplified manufacturing and use, i.e. to avoid having to form valve openings in both the first and second bodies and ensure that said valve openings are aligned during use.
Regarding claim 3, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 1, wherein it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for modified Kooij to include first and second FiO2 adjustment apertures (i.e. by providing two of apertures 18 of Clark Fig. 4 with their corresponding open areas below the two nasal prongs as taught by Martin) in the second body member of the nasal cannula body positioned to align with the least one opening in the first body of the nasal cannula opposite the first and second prongs (i.e. positioned in the opening between edges 1001a of Kooij Figs. 24a-b) in fluidic communication with the inner volume of the nasal cannula body wherein the first and second FiO2 adjustment apertures are individually and selectively adjustable in size (i.e. by providing each aperture 18 with a corresponding disk 17 on pivot 19 of Clark Fig. 4) whereby the sizes of the FiO2 adjustment apertures can be individually adjusted to provide a desired entrainment of atmospheric air with gas inhaled through the first and second nasal prongs (Clark Fig. 4; page 1, lines 98-110), in order to provide the predictable result of tailorable ambient air access and/or entrainment for each nostril, e.g. to allow a nostril dried by dry oxygen delivery to have more access to humid ambient air than a moisturized nostril, which would allow a more comfortable user experience without having to over-dilute the delivered gas by unnecessarily opening both dilution apertures.
Regarding claim 4, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 3, wherein Clack further educates modified Kooij to include wherein each of the first and second FiO2 adjustment apertures has a moveable cover (disk 17) (Clark Fig. 4; page 1, lines 98-110) and wherein the first and second FiO2 adjustment apertures are individually and selectively adjustable in size by operation of the movable cover of the respective first and second FiO2 adjustment aperture, in order to provide the individual control over the ambient air access discussed above regarding claim 3.
Regarding claim 7, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 1, wherein Kooji further teaches first and second straps (on either side of the cannula body in Fig. 28 and comprising slots 642) that extend laterally in opposite directions from the central portion of the first body member (Kooij Figs. 24a-b in view of e.g. Fig. 28), because it would have been obvious to an artisan before the effective filing date of the claimed invention for the embodiment of Kooij 24a-b to include first and second straps that extend laterally in opposite directions from the central portion of the first body member as taught by e.g. Kooji Fig. 28, in order utilize a known means to predictably allow the cannula to interface with standard headgear for holding the cannula against the wearers face (Kooij Fig. 28, col. 18, lines 3-7) .
Regarding claim 8, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 1, wherein Kooji further discloses wherein the first body member has a central strap portion that defines the reception cavity for receiving the second body member and wherein the second body member passes through the reception cavity (Kooij Figs. 24a-b).
Regarding claim 9, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 8, wherein Kooji further discloses wherein the reception cavity of the first body member is generally tubular and wherein the second body member has a corresponding generally tubular portion (Kooij Figs. 24a-b).
Regarding claim 10, Kooij in view of Hobson, Clark and Martin teaches the nasal cannula of claim 1, wherein Kooji further discloses/teaches, as best understood, wherein the second body member has an opening (1061) bounded by a platform/raised ring (Kooij Fig. 24a), wherein the first body member has a nasal prong platform (the top of sleeve 1001) (Kooij Figs. 24a-b), wherein the nasal prongs extend from the nasal prong platform of the first body member (Kooij Figs. 24a-b), and wherein the nasal prong platform of the first body member establishes a sealing engagement with the platform of the second body member when the first and second body members are assembled (Kooij col. 17, lines 55-64), because a sealing engagement between the two platforms would have been reasonably inferred by an artisan before the effective filing date of the claimed in invention in order to avoid unintended leakage between the two platforms and/or noise caused by such leakage.
Claim(s) 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Boulanger (US 2020/0269007 A1; hereinafter “Boulanger”) in view of Kooij, Hobson, Clark and Martin.
Regarding claim 24, Boulanger discloses an ambient pressure gas dispensing system for providing gas at ambient pressure to an individual (abstract; the internal volume 27a of reservoir 27 equals to atmospheric pressure, para [0142], see also paras [0126-128] and [0141-143]), the ambient pressure gas dispensing system comprising:
a donor reservoir (reservoir 27) (Fig. 2) configured to retain a compartmented volume of gas substantially at ambient pressure wherein the donor reservoir has a fully inflated condition (Fig. 3; paras [0126] and [0142-143]);
a supply valve (proportional valve 22) in fluidic association with the donor reservoir (Fig. 2; para [0145]), the supply valve with an open condition wherein gas is allowed to flow into the donor reservoir and with a closed condition wherein gas is not allowed to flow into the donor reservoir (para [0109]);
an inflation detection system (comprising distance sensor 26) configured to detect when the donor reservoir is inflated to within a predetermined range of the fully inflated condition (Figs. 2-6; paras [0121-134]), wherein the inflation detection system is configured to detect a first condition when the donor reservoir is inflated to within the predetermined range of the fully inflated condition (Fig. 3; para [0126]), wherein the inflation detection system is configured to detect a second condition when the donor reservoir is inflated below the predetermined range of the fully inflated condition (Figs. 4-5; paras [0128-132]), wherein the inflation detection system is configured to actuate the supply valve to the open condition when the donor reservoir is inflated below the predetermined range of the fully inflated condition (paras [0160-161]), and wherein the inflation detection system is configured to retain [the] compartmented volume of gas substantially at ambient pressure waiting to be drawn from the reservoir by the individual (the internal volume 27a of reservoir 27 equals to atmospheric pressure, para [0142], see also paras [0126-128] and [0141-143]);
ambient pressure tubing (tube 13) with a first end (to the left in Fig. 1) and a second end (to the right in Fig. 1), wherein the first end of the ambient pressure tubing is in fluidic communication with the donor reservoir (Figs. 1-2; para [0103]);
a patient interface (10) comprising a body with an inner volume (Fig. 1; para [0090])
a gas reception aperture (inhalation port 12) in fluidic communication with the inner volume of the nasal cannula body for receiving gas from the donor reservoir through the ambient pressure tubing (Fig. 1; para [0103]), and a one-way expiratory valve (exhalation valve 11) retained by the patient interface body wherein the one-way expiratory valve is in fluidic communication with the inner volume of the patient interface body whereby gas provided by the tubing can be inhaled through the patient interface and whereby, during expiration, expired breath can be discharged through the one-way expiratory valve (Fig. 1; para [0103]).
Boulanger is silent regarding wherein the patient interface is a nasal cannula comprising the limitations of claim 1. However, Kooij in view of Hobson, Clark and Martin teaches that such a nasal cannula would have been obvious in the gas therapy art before the effective filing date of the claimed invention as discussed above regarding claim 1, such that it would have been obvious to an artisan before the effective filing date of the claimed invention to implement the claimed nasal cannula as taught by Kooij in view of Hobson, Clark and Martin as the patient interface in the system of Boulanger, in order to provide the predictable result of an interface that allows access to the mouth during use, for user comfort and/or convenience, and/or to utilize a lower-profile interface for aesthetic reasons, as well as to provide for anti-asphyxia and/or dilution with ambient air functionality as discussed above regarding claim 1.
Regarding claim 28, Boulanger in view of Kooij, Hobson, Clark and Martin teaches the ambient pressure gas dispensing system of claim 24, wherein modified Kooij teaches wherein the second body member has an inner volume with an opening bounded by a platform, wherein the first body member has a nasal prong platform, wherein the nasal prongs extend from the nasal prong platform of the first body member, and wherein the nasal prong platform of the first body member establishes a sealing engagement with the platform of the second body member when the first and second body members are assembled as discussed above regarding claim 10.
Claim(s) 11 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kooij in view of Hobson, Clark and Martin as applied to claim 1 above and Boulanger in view of Kooij, Hobson, Clark and Martin as applied to claim 24 above, and further in view of Guichard (US 3,902,486; hereinafter “Guichard”).
Regarding claims 11 and 29, Kooij in view of Hobson, Clark and Martin teaches nasal cannula of claim 1 and Boulanger in view of Kooij, Hobson, Clark and Martin teaches the ambient pressure gas dispensing system of claim 24, wherein Kooij further discloses wherein the gas reception aperture (the opening into barrel 1005 to the left in Figs. 24a-b) is disposed at a first end of the second body member (Figs. 24a-B), but modified Kooij/Boulanger is silent regarding wherein the one-way expiratory valve comprises a first one-way expiratory valve disposed at a second end of the second body member. However, Kooij further teaches that the second end of the second body member is not covered by the sleeve/first body (Figs. 24a-b), it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and Guichard teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include wherein a gas reception aperture (at valve 4) (Fig. 2) is disposed at a first end (to the right) of a tubular manifold and wherein the one-way expiratory valve (valve 3) comprises a first one-way expiratory valve disposed at a second end (to the left) of the tubular manifold (Fig. 2). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Kooij to include wherein the one-way expiratory valve comprises a first one-way expiratory valve disposed at a second end of the second body member as taught by Guichard, in order to locate the exhalation valve on the barrel/second body member in a known location and one that is not overlapped by the sleeve/first body member of Kooij, in order to predictably provide a direct pathway between the inner volume and ambient without having to go through both the first and second bodies for simplified manufacturing, i.e. to avoid having to form valve openings in both the first and second bodies.
Claim(s) 12 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kooij in view of Hobson, Clark, Martin and Guichard as applied to claim 11 above and Boulanger in view of Kooij, Hobson, Clark, Martin and Guichard as applied to claim 29 above, and further in view of Wondka (US 2009/0183739 A1; hereinafter “Wondka”).
Regarding claims 12 and 30, Kooij in view of Clark, Martin and Guichard teaches the nasal cannula of claim 11 and Boulanger in view of Kooij, Clark, Martin and Guichard teaches the ambient pressure gas dispensing system of claim 29, but modified Kooij/Boulanger is silent regarding second and third one-way expiratory valves disposed on the second body member in general alignment with the first and second nasal prongs, respectively. However, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B., Kooij teaches providing one-way expiratory valves (release flaps 1096R) in general alignment with the first and second nasal prongs (Figs. 5a-5b), and Wondka teaches that it was known in the nasal cannula art before the effective filing date of the claimed invention to include second and third one-way expiratory valved openings (Fig. 6; exhalation exhaust ports 270 may have a one-way valve feature to allow flow in the exhaled direction, but restrict flow in the inspired direction, para [0085]) disposed on a cylindrical body member in general alignment with at least one of the first and second nasal prongs (Fig. 6). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for modified Kooij/Boulanger to include second and third one-way expiratory valves disposed on the second body member in general alignment with the first and second nasal prongs, respectively, as taught by Kooij and Wondka, in order to provide the predictable result of providing as many additional exhalation valves as needed/desired to ensure adequate and