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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 12/07/2023 and 04/01/2026 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species (i): Figs. 1-6
Species (ii): Figs. 1-6 and 9
Species (iii): Figs. 7-8
Species (iv): Figs. 7-9
Species (v): Figs. 10-13
The species are independent or distinct because there are mutually claim exclusive drawn to each species and/or there are disclosed patentably distinct species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-3, 9-10 and 14-15 are generic.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
a. the species require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
b. the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Aaron Fishman on 06/17/2026 a provisional election was made without traverse to prosecute the invention of Species (i): Figs. 1-6, claim(s) 1-3, 7-11 and 13-15. Affirmation of this election must be made by applicant in replying to this Office action. Claim(s) 4-6, and 12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
As such, claims 1-3, 7-11 and 13-15 are being examined in the current application.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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, 3, 9 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20160030696 A1) in view of Lewis (US 20070175473 A1).
Regarding claim 1, Klenner teaches a cannula (cannula 14, nasal cannula system 2900, see Figs. 1A-1C and 29A-29B) used in respiratory therapy (Klenner teaches providing gases to patients for respiratory therapy as seen in [0001]), the cannula comprising:
an attachment portion (nasal prongs 20a-20b, see Figs. 1B-1C; nasal cannula system 2900 comprises of nasal prongs as seen in Figs. 29A-29B) configured to be attached in nasal cavities of a subject (nasal prongs 20A-20B are inserted into the nasal cavities of a patient as seen in Figs. 1A-1C and 29A-29B and [0465], to deliver gas to the patient); and
a junction portion (manifold 12/2901, see Figs. 1B-1C and Fig. 29A) configured to be connected to the attachment portion (manifold 12/2901 is connected to nasal prongs 20a-20B as seen in Figs. 1B-1C and 29A-29B),
wherein a first connection portion is provided with a single medical gas flow path for supplying, to the subject, a medical gas from the medical gas supply device (blower/humidifier 2990, see Fig. 29A) (There is a first connection portion where supply tube 2902 connects to manifold 2901, where supply tube 2902 supplies gas from blower/humidifier 2990 as seen in Figs. 29A-29B as seen in [0548] and [0460]), the first connection portion being provided to the junction portion on a side of a medical gas supply device (the first connection portion is connected to manifold 2901 on a side of the blower/humidifier 2990 as seen in Figs. 29A-29B), and
a second connection portion is provided with a single measurement pipe (terminal end 2912, see Fig. 29B) for measuring (There is a second connection portion where terminal end 2912 connects to manifold 2901, where the terminal end 2912 is connected to pressure line 2901 and a pressure gauge to measure the pressure of the flow as seen in Fig. 29A and [0548]-[0549]), the second connection portion being provided to the junction portion on a side of a respiration measurement module (the second connection portion is connected to manifold 2901 on a side of the pressure gauge as seen in Figs. 29A-29B and [0548]).
But does not teach a cannula used in high flow oxygen therapy;
a single measurement pipe for measuring a respiratory condition of the subject. However, Lewis teaches a cannula (cannula 900, see Fig. 2) used in high flow oxygen therapy (Lewis teaches a high flow therapy device 2000 in Fig. 15 used with a non-sealing respiratory interface such as the nasal cannula in Figs. 1-14 for oxygen therapy as seen in [0098], [0005] and [0105]);
a first connection portion (nasal insert 925, see Fig. 9);
a second connection portion (nasal insert 930, see Fig. 9) is provided with a single measurement pipe (tube inlet 972, see Fig. 9; teaches a tube inlet 972 for at least one sensor as seen in [0084]) for measuring a respiratory condition of the subject (Lewis teaches the environment being measured by the sensor reflects the internal portion of the user’s nose and/or the user’s upper airway as seen in [0050], [0101] and [0106]).
Klenner teaches nasal high flow is a non-sealing therapy that delivers high-volume flow to the patient through a nasal cannula as seen in [0801], and further teaches the nasal cannula to deliver gases over a wide range of concentrations and flow rates as seen in [0008] and [0002]- [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner to be used with a high flow therapy device for oxygen as taught by Lewis as they both teach non-sealing cannulas and Klenner further teaches using the cannula to deliver a wide range of concentrations and flow rates (see [0002]- [0003]). Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner to replace the terminal end with the tube inlets and sensors and include the microprocessor as taught by Lewis for an alternative measuring source that can monitor the pressures of the patient in both nostrils and if the pressure is determined to be too low, the microprocessor can adjust the speed of the blower (see [0101]).
Regarding claim 3, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches further comprising:
a medical gas conduit (supply tube 2902, see Figs. 29A-29B) configured to be connected to the first connection portion (There is a first connection portion where supply tube 2902 connects to manifold 2901, where supply tube 2902 supplies gas from blower/humidifier 2990 as seen in Figs. 29A-29B as seen in [0548] and [0460]),
wherein the medical gas conduit is connected to the first connection portion such that the medical gas conduit extends in a right direction or a left direction of the junction portion (supply tube 2902 is connected to the first connection portion such that supply tube 2902 extends in a right direction or a left direction of manifold 2901).
Regarding claim 9, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches wherein the attachment portion is softer than the junction portion (Klenner teaches nasal prongs 20a-20b to be formed of thermoplastic, silicone-like material (see [0467]) and the manifold to be formed of relatively hard plastic material that can withstand relatively high loading pressures to protect the manifold as seen in [0469]. Furthermore, Klenner teaches the cannula to include soft material on the side of the cannula facing the patient as seen in [0119] and for prongs to be made of a soft material such as polymer or soft plastic as seen in [0686]. As such, the nasal prongs are softer than the manifold).
Regarding claim 13, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches further comprising:
a medical gas conduit (supply tube 2902, see Figs. 29A-29B) configured to be connected to the first connection portion (There is a first connection portion where supply tube 2902 connects to manifold 2901 as seen in Figs. 29A-29B as seen in [0548] and [0460]); and
a measurement conduit (pressure line 2910, see Figs. 29A-29B) configured to be connected to the second connection portion (pressure line 2910 is connected to the second connection portion as seen in Fig. 29B, on the other side of the terminal end 2912),
wherein a connection direction of the medical gas conduit with respect to the first connection portion, and a connection direction of the measurement conduit with respect to the second connection portion are identical (the connection direction of supply tube 2902 to the first connection portion and the connection direction of pressure line 2910 to the second connection portion are identical as seen in Fig. 29B).
Regarding claim 14, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches wherein an inner diameter of the first connection portion is larger than an inner diameter of the attachment portion (the inner diameter of the first connection portion wherein supply tube 2902 is connected is larger than an inner diameter of the nasal prongs 20a-20b as seen in Figs. 29A-29B, especially as the nasal prongs are to be fitted into a person’s nostrils and the supply tube 2902 are to deliver gas).
Regarding claim 15, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches further comprising:
a fixing portion (strap 40, see Fig. 1A) configured to fix the cannula to the subject (“…the securement mechanism includes a headgear strap 40. The strap 40 can be coupled to the side straps 22 of the cannula 14.” See [0466]),
wherein the fixing portion includes:
a band-shaped portion extending in a left-right direction with a nose of the subject as a reference (strap 40 comprises a band-shaped portion that extends in a left-right direction with a nose of the subject as a reference as seen in Fig. 1A, as it is attached to the side straps 22 of cannula 14 as seen in Figs. 1B-1C)
a medical gas conduit (gas supply tube 50, see Fig. 1A) connected to the first connection portion (gas supply tube 50/2902 is connected to the first connection portion of manifold 12/2901 as seen in Figs. 1A-1C and 29A-29B)
but does not teach conduit mounting portions for mounting, to the fixing portion, a medical gas conduit, and
the conduit mounting portions are provided on left and right sides of the band-shaped portion.
However, Klenner teaches a conduit mounting portion (tube clip 442, see Fig. 5A) for mounting, to the fixing portion, a medical gas conduit (supply tube 450, see Fig. 5A) (Klenner teaches a tube clip 442 coupled to headgear strap 440, wherein tube clip 442 is used to receive supply tube 450 to keep the tube away from the mouth and face of the patient while in use as seen in Fig. 5A and [0480]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner to include the tube clip as taught by Klenner to hold the supply tube to keep the tube away from the mouth and face of the patient while the tube is in use (see [0480]).
With respect to Claim 15, Klenner in view of Lewis does not explicitly teach the conduit mounting portions are provided on left and right sides of the band-shaped portion. However, it has been held that the mere duplication of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a non-obvious change in functionality (see MPEP § 2144.04. VI.B.). In this case, it is unclear why duplicating the tube clip to also be on the other side of the band-shaped portion would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Klenner in view of Lewis to have a tube clip on both the left and right sides of the band-shaped portion, since it has been held that the duplication of parts involves only routine skill in the art. Furthermore, this will allow flexibility in rearranging the tube to enter from the opposite direction or holding a second tube.
Claim(s) 2 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20160030696 A1) in view of Lewis (US 20070175473 A1), as applied to claim 1 above, and further in view of Stenzler (US 20190240438 A1).
Regarding claim 2, Klenner in view of Lewis teaches the cannula of claim 1, and further teaches wherein the attachment portion includes:
a first attachment portion (nasal prong 20b, see Figs. 1A-1C and 29A of Klenner) configured to be attached in a right nasal cavity of the subject (nasal prong 20b is to be attached into a right nasal cavity of a user as seen in Fig. 1A of Klenner); and
a second attachment portion (nasal prong 20a, see Figs. Figs. 1A-1C and 29A of Klenner) configured to be attached in a left nasal cavity of the subject (nasal prong 20a is to be attached into a left nasal cavity of a user as seen in Fig. 1A of Klenner),
the junction portion includes:
a branch portion configured to branch the medical gas flow path into the first attachment portion and the second attachment portion (there is a branch portion within the manifold 2901 of Klenner which branches the gas flow from supply tube 2902 into the nasal prongs as seen in Fig. 29A and [0036]),
the first attachment portion includes the medical gas flow path and the measurement pipe (nasal prongs 20b includes a gas flow path to deliver gas to the patient as seen in [0465] of Klenner and a tube inlet (taught by Lewis) to monitor the pressures of the patient as seen in [0101] and [0106] of Lewis), and
the second attachment portion includes the medical gas flow path and the measurement pipe (nasal prongs 20a includes a gas flow path to deliver gas to the patient as seen in [0465] of Klenner and a tube inlet (taught by Lewis) to monitor the pressures of the patient as seen in [0101] and [0106] of Lewis).
But does not teach the branch portion configured to branch the measurement pipe into the first attachment portion and the second attachment portion.
However, Stenzler teaches the branch portion configured to branch the measurement pipe into the first attachment portion and the second attachment portion (Stenzler teaches a monitoring port 118 comprising of a pressure passage 122 that extends into each of the first and second nasal pillow 114, such that a first branch 174 of the pressure passage extends to a first pillow and a second branch 174 of the pressure passage extends into a second pillow as seen in Figs. 3 and 9-10 and [0037] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner in view of Lewis to have the measurement pipe branch into the first attachment portion and the second attachment portion as taught by Stenzler as a known alternative design choice for measurement conduits/pathways within a cannula used within the art.
Regarding claim 7, modified Klenner teaches the cannula of claim 2, and Klenner further teaches wherein the junction portion includes a first mounting portion and a second mounting portion (manifold 12/2901 includes a first mounting portion and second mounting portion where nasal prongs 20a-20b are mounted/attached to the manifold as seen in Figs. 1B-1C and Fig. 29A)
But does not teach a state where the junction portion is connected to the attachment portion is configured to be switched between a first connection state and a second connection state, the first connection state being a state where the first mounting portion is mounted to the first attachment portion and the second mounting portion is mounted to the second attachment portion, the second connection state being a state where the second mounting portion is mounted to the first attachment portion and the first mounting portion is mounted to the second attachment portion.
However, Klenner further teaches a state where the junction portion (manifold 2501, see Figs. 25A-25C) is connected to the attachment portion (prongs 2505, see Figs. 25A-25C) is configured to be switched between a first connection state and a second connection state, the first connection state being a state where the first mounting portion is mounted to the first attachment portion and the second mounting portion is mounted to the second attachment portion, the second connection state being a state where the second mounting portion is mounted to the first attachment portion the first mounting portion is mounted to the second attachment portion (Klenner teaches a lip 2510 and opening 2518 (left) as a first mounting portion and a lip 2510 and opening 2518 (right) as seen in Fig. 25C and [0537]. Klenner further teaches prong insert 2506 which rotates relative to manifold 2501 as seen in Figs. 25A-25C and [0537]. Prong insert 2506 has a pair of prongs 2505 placed on top such that when prong insert 2506 is mounted on and rotatable about a vertical shaft 2508, the prongs 2505 rotate together as seen in [0537]. Therefore, Klenner teaches a first connection state where the first mounting portion (left) is connected to the nasal prong 2505 (left) and the second mounting portion (right) is connected to the nasal prong 2505 (right) and a second connection state, when the prong insert 2506 is rotated such that the prongs 2505 switch openings 2518, wherein the first mounting portion (left) is connected to nasal prong 2505 (right) and the second mounting portion (right) is connected to nasal prong 2505 (left)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by modified Klenner to include the prong insert, vertical shaft and lip taught by Klenner for the rotation of the prongs (see [0537]) that will allow the subject to still use the cannula even in a different position without much movement of the cannula as one will just need to rotate the prong insert.
Regarding claim 8, modified Klenner teaches the cannula of claim 7, and Klenner further teaches wherein the first mounting portion and the second mounting portion have a shape that is 180 degrees rotationally symmetrical about a middle point between the first mounting portion and the second mounting portion (Klenner teaches the lips 2510 and openings 2518 of the manifold to have a shape that is 180 degrees rotationally symmetric about a middle point between the first mounting portion and second mounting portion as seen in Fig. 25C as the lips 2510 and openings 2518 are circular in shape).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20160030696 A1) in view of Lewis (US 20070175473 A1), as applied to claim 1 above, and further in view of Matsubara (US 20150335847 A1).
Regarding claim 10, Klenner of Lewis teaches the cannula of claim 1, and Klenner further teaches further comprising:
a medical gas conduit (supply tube 2902, see Figs. 29A-29B) configured to be connected to the first connection portion (There is a first connection portion where supply tube 2902 connects to manifold 2901 as seen in Figs. 29A-29B as seen in [0548] and [0460])
but does not teach wherein the medical gas conduit is softer than the junction portion.
However, Matsubara teaches wherein the medical gas conduit (gas supply tube 36, see Fig. 1) is softer than the junction portion (second connector 32 and third connector 35, see Fig. 1) (Matsubara teaches the first to fourth connectors to be molded from a hard synthetic resin such as hard vinyl chloride and the gas supply tube 36 to be molded from a soft synthetic resin such as soft vinyl chloride as seen in [0030]).
Klenner teaches the manifold to be formed of relatively hard plastic material that can withstand relatively high loading pressures to protect the manifold as seen in [0469]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner in view of Lewis to have the medical gas conduit be made out of soft synthetic resin as taught by Mastubara as a known tube material used within the art that is used to connect with a harder material.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klenner (US 20160030696 A1) in view of Lewis (US 20070175473 A1), as applied to claim 1 above, and further in view of Kazuhiko (JP S63161973 A).
Regarding claim 11, Klenner in view of Lewis teaches the cannula of claim 1, and Klenner further teaches a measurement conduit (pressure line 2910, see Figs. 29A-29B) and medical gas conduit (supply tube 2902, see Figs. 29A-29B) but does not teach wherein the second connection portion is located inside the first connection portion, and
a measurement conduit connected to the second connection portion is located inside a medical gas conduit connected to the first connection portion.
However, Kazuhiko teaches wherein the second connection portion is located inside the first connection portion (Kazuhiko teaches a main pipe 4 wherein there is a first connection portion between main pipe 4 and introduction tube 5 and a second connection portion between main pipe 4 and respiration sensor passage 7 as seen in Fig. 3, wherein the second connection portion is located inside the first connection portion), and
a measurement conduit (respiration sensor passage 7, see Fig. 3) connected to the second connection portion is located inside a medical gas conduit (introduction tube 5, see Fig. 3) connected to the first connection portion (the respiration sensor passage 7 is connected to the second connection portion located inside the introduction tube 5 connected to the first connection portion as seen in Fig. 3).
Klenner teaches a variety of embodiments of nasal cannula assemblies with pressure measurement capability as seen in Figs. 29A-29L and [0393]-[0394]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the cannula taught by Klenner in view of Lewis to have the second connection portion located inside the first connection portion, and the measurement conduit connected to the second connection portion is located inside the medical gas conduit connected to the first connection portion as taught by Kazuhiko as an alternative design for a nasal cannula assembly with pressure measurement capability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Curti (US 20130211275 A1) and Carter (US 4989599 A) teaches a cannula with a divided nare, wherein a section of the nare is for sensor/measurement.
Spence (US 10610653 B2) further teaches a cannula with a divided nares for negative and positive flows of gas.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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, 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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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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