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 on 06/11/2026. As directed by the amendment, claim 1 has been amended and claim 30 has been cancelled. As such, claims 1-2, 4-8, 11-13, 16-17, 24-26 and 28-29 are being examined in this application.
Applicant has amended claim 1 to address a 112(b); the 112(b) rejection to claims 1-2, 4-8, 11-13, 16-17, 24-26 and 28-29 has been withdrawn.
Response to Arguments
Applicant's arguments, see pages 5-7 of Remarks, filed 06/11/2026, have been fully considered but they are not persuasive. Applicant recites “…it is respectfully submitted that neither Broborg, Kunz, O'Neill, as evidenced by Huang, nor Cai, either alone or in combination, show or suggest "the tubular gas duct spirally wound inwards toward a center portion of the volume reflector body and folded to include straight and curved portions such that the folded tubular gas duct defines a substantially quadrilateral shape," as recited in amended claim 1.”
The examiner would like to point out that Cai teaches the tubular gas duct (air passages 130, see Fig. 6) spirally wound inwards toward a center portion of the volume reflector body (volume reflector body, see Fig. 6) (Cai teaches air passages 130 to spiral wound inwards towards a center portion of the volume reflector body, in a folded configuration (Fig. 6 of Cai shows air passages 130 folding as the air passages 130 are spirally wounding inwards and further comprises a straight portion and curved portions as seen in Fig. 6), and the volume reflector body is substantially quadrilateral shape as seen in Fig. 6). Furthermore, the examiner would like to state that one of ordinary skill in the art would recognize that both Broborg and Cai teach a quadrilateral shape for the volume reflector body Cai teaches having straight and curved portions when the gas ducts are arranged to be spirally wound inward towards the center portion (see Cai’s Annotated Fig. 6 below). It would be unclear why maximizing the extend of the spiral conduits taught by Cai within the rectangular body taught by Broborg and Cai 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 the tubular gas duct such that the folded tubular gas duct defines a substantially quadrilateral shape since it has been held that the change in shape involves only routine skill in the art. Furthermore, it would have been obvious to one of ordinary skill in the art to provide maximized function in minimized space.
Claim Objections
Claim(s) 26 is/are objected to because of the following informalities:
Claim 26, line 1, recites “…ventilator providing a flow of a driving…” but should recite “…ventilator configured to provide a flow of a driving…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 29 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 29 depends on claim 1 and recites “…wherein the breathing system comprises a ventilator.” However, the breathing system of claim 1 is not a positively recited element, and therefore not further limiting claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 4-8, 11-13, 16-17, 24-26 and 28-29 rejected under 35 U.S.C. 103 as being unpatentable over Broborg (US 20100307490 A1) in view of Kunz (US 20140332005 A1), O'Neill (US 20170216547 A1) and Cai (CN 105517615 A; This reference is translated by machine translation on 11/2/2023) as evidenced by "Plastic Engineering Manual", HUANG Rui, pages 189-190, China Machine Press, April 2000 (hereinafter, known as “Huang”).
Regarding claim 1, Broborg teaches a volume reflector body (volume reflector 330, see Fig. 3 and [0059]; the volume reflector 330 has a body as seen in Fig. 3) comprising:
a tubular gas duct (volume reflector 330 can be a breathing tube as seen in Fig. 3 and [0061]. Alternatively, volume reflector 330 can also be a box comprising folded gas conducting passages (taken as tubular gas ducts) as seen in [0061]) that is configured to convey breathing gas in a breathing system therethrough (volume reflector 330 conveys breathing gas in a breathing system comprising of patient circuit module 302, a ventilator and Y-shaped patient connector as seen in [0054] and [0057]), wherein the tubular gas duct is a single continuous gas duct (volume reflector 330 is a single continuous breathing tube as seen in Fig. 3) having at least two tubular gas duct sections located adjacent to each other (volume reflector 330 shows two tubular gas duct sections located adjacent to each other as seen in Fig. 3);
wherein the volume reflector body has an integrated one-piece structure (volume reflector 330 is a single breathing tube as seen in Fig. 3 and [0061]). Broborg further discloses the volume reflector as being made of plastic ([0061]); and
the volume reflector body has a substantially quadrilateral shape (volume reflector 330 has a substantially quadrilateral shape as seen in Fig. 3).
but does not teach at least two tubular gas duct sections located adjacent to each other and connected to each other by at least one solid portion, the tubular gas duct spirally wound inwards toward a center portion of the volume reflector body, and folded to include straight and curved portions such that the folded tubular gas duct defines a substantially quadrilateral shape;
wherein the volume reflector body, including the tubular gas duct and the at least one solid portion, has an integrated one-piece structure;
molded by blow-molding, and is made of a non-toxic plastic material; and
wherein the plastic material has a melt flow rate (MFR) of 2.5 g/10 min or less, measured according to ISO 1133 with a load of 2.16 kg at a temperature of 230°C, and has a melting point of at least 134°C measured by differential scanning calorimetry according to ASTM D3418-15.
Broborg Annotated Fig. 3
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However, Kunz teaches at least two tubular gas duct sections located adjacent to each other and connected to each other by at least one solid portion (Kunz teaches two breathing tubes 4 located adjacent to each other and connected by a plastically deformable fiber 20 which is located between the tubes as seen in Fig. 8 and [0081]);
Wherein the tubular gas duct and the at least one solid portion has an integrated one-piece structure (Kunz teaches the wire/fiber 20 to be integrated into the material of the breathing tubes as seen in [0049] and further teaches wire/fiber 20 to consist of another material instead of metal as seen in [0079]).
Broborg teaches volume reflector 330 with two tubular gas duct sections located adjacent to each other as seen in Fig. 3. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the volume reflector body taught by Broborg to include a solid portion between two tubular gas ducts adjacent to each other as taught by Kunz for an alternative design within the art which does not affect the functionality of the device.
However, O'Neill teaches fluid supply tubes to be made of a non-toxic plastic material such as polyphenylene sulfide, polyethylene (PE) or polypropylene (PP) (page 8, lines 1-3 of the specification recites “Examples of non-toxic plastic materials suitable for the component are food-grade or medical-grade plastic materials.” O’Neil teaches polyphenylene sulfide, polyethylene (PE) or polypropylene (PP) to be medical grade plastics as seen in [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the volume reflector body taught by Broborg in view of Kunz to change the material of the volume reflector 330 (of Broborg) to be made out of polypropylene as taught by O’Neill as an alternative plastic material that is a medical grade polymer to be used in a medical device and is flexible (see [0041]).
Modified Broborg teaches the volume reflector 330 be made out of polypropylene. As evidenced by Huang, Huang teaches polypropylene to be molded by blow-molding (“Polyethylene, PVC, polypropylene, polystyrene, thermoplastic polyesters, polycarbonates, polyamides, cellulose acetate, and polyoxymethylene are ideal blow molding materials.” See page 189, under section 1.3); and
wherein the plastic material has a melt flow rate (MFR) of 2.5 g/10 min or less, measured according to ISO 1133 with a load of 2.16 kg at a temperature of 230°C (Using the ASTM D1238 standard as an alternative measure shown on page 8, lines 24-30 and page 9, lines 1-3. Huang teaches the melt flow rate of polypropylene used for blow molding typically should be 0.5 to 3.0 g/10 min (see page 190 above the table 3.8-7) and see Table 3.8-7 Properties of typical polypropylene blow molded products on page 190), and has a melting point of at least 134°C measured by differential scanning calorimetry according to ASTM D3418-15 (Table 3.8-3 Properties of typical polypropylene blow molded products, on page 190, shows a melting point of 143-165°C for polypropylene).
However, Cai teaches the tubular gas duct (air passages 130, see Fig. 6) spirally wound inwards toward a center portion of the volume reflector body (volume reflector body, see Fig. 6) (Cai teaches air passages 130 to spiral wound inwards towards a center portion of the volume reflector body, in a folded configuration (Fig. 6 of Cai shows air passages 130 folding as the air passages 130 are spirally wounding inwards and further comprises a straight portion and curved portions as seen in Fig. 6), and the volume reflector body is substantially quadrilateral shape as seen in Fig. 6).
Cai’s Annotated Fig. 6
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the volume reflector body taught by modified Broborg to rearrange the gas duct to be spirally wound inwards towards the center portion of the volume reflector body and have a folded shape in which the free ends of the gas duct are placed adjacent to each other as taught by Cai as a different arrangement of the gas duct that will not affect the function of the device and provides connections that are closer to one another if desired by a user for a particular arrangement of the device.
Modified Borborg in view of Cai teaches the volume reflector body to have a substantially quadrilateral shape (as taught by Broborg above) and wherein further Cai teaches having straight and curved portions when the gas ducts are arranged to be spirally wound inward towards the center portion (see Cai’s Annotated Fig. 6 above). It should further be noted that Broborg teaches a straight and a curved portion as seen in Broborg Annotated Fig. 3 above.
With respect to Claim 1, modified Broborg in view of Cai does not explicitly teach the tubular gas duct folded to include straight and curved portions such that the folded tubular gas duct defines a substantially quadrilateral shape. However, it has been held that the mere change in shape does not constitute a patentable improvement in the art when said change in shape does not result in a non-obvious change in functionality (see MPEP § 2144.04. IV. B.). In this case, it is unclear why maximizing the extend of the spiral conduits taught by Cai within the rectangular body taught by Broborg and Cai 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 the tubular gas duct such that the folded tubular gas duct defines a substantially quadrilateral shape since it has been held that the change in shape involves only routine skill in the art. Furthermore, it would have been obvious to one of ordinary skill in the art to provide maximized function in minimized space.
Regarding claim 2, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein the melt flow rate (MFR) is from 0.6 g/10 min to 1.0 g/10 min, measured according to ISO 1133 with a load of 2.16 kg at a temperature of 230°C (Using the ASTM D1238 standard as an alternative measure shown on page 8, lines 24-30 and page 9, lines 1-3. Huang teaches the melt flow rate of polypropylene used for blow molding typically should be 0.5 to 3.0 g/10 min (see page 190 above the table 3.8-7), in which the range of 0.6 to 1.0 g/10 min lies within).
Regarding claim 4, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein the plastic material has a melting point adapted to be above a sterilization temperature of the volume reflector body and the melting point is from 140 to 220°C, measured by differential scanning calorimetry according to ASTM D3418-15 (Table 3.8-3 Properties of typical polypropylene blow molded products, on page 190, shows the melting point of polypropylene to be 143-165°C).
Regarding claim 5, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein a flexural modulus of the plastic material is from 900 to 2000 MPa, measured at 23°C and according to ISO 178 (Table 3.8-3 Properties of typical polypropylene blow molded products, on page 190, shows the flexural modulus of polypropylene to be 1445 MPa for homopolymer).
Regarding claim 6, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein a density of the plastic material is from 0.8 g/mL to 1.0 g/mL at 25 °C (Table 3.8-3 Properties of typical polypropylene blow molded products, on page 190, shows the density of polypropylene to be 0.9 to 0.905 g/cm3 (g/mL = g/cm3)).
Regarding claim 7, modified Broborg teaches a volume reflector body according to claim 1, and O’Neil further teaches wherein the plastic material is polyolefin-based (page 4, lines 20-23 of the specification recites “Suitably, the polyolefin-based material may be polyethylene, polypropylene or a copolymer thereof.” O’Neil teaches the plastic material to be polypropylene (see [0041])).
Regarding claim 8, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein the polyolefin- based material is polyethylene, polypropylene or a copolymer thereof (O’Neil teaches the polyolefin-based material to be polypropylene (see [0041])).
Regarding claim 11, modified Broborg teaches a volume reflector body according to claim 1, and further teaches wherein the tubular gas duct comprises free ends (first free end and second free end, see Cai’s Annotated Fig. 6), wherein at one free end is formed a first port and at a second free end is formed a second port (Cai teaches one free end to from a first port and a second free end to form a second port as seen in Fig. 6 by the two free ends and ports), and teach of the first port and the second port comprises a connector to connect the volume reflector body to the breathing system (Modified Borborg teaches the first port and second port of Cai to be connected to common line portions 328 and 332 to connect volume reflector 330 to the patient circuit module 302 as seen in Fig. 3 and [0061] of Broborg).
Regarding claim 12, modified Broborg teaches a volume reflector body according to claim 11, and Cai further teaches wherein the gas duct has a folded shape (gas passage 130 is in a shape of a folded tube see Fig. 6) in which the free ends of the gas duct are placed adjacent to each other (the free ends of the gas passage 130 are placed adjacent to each other as seen in Fig. 6) so that at least two adjacent gas duct portions run side-by-side (two adjacent gas passages 130 run side by side as seen in Fig. 6).
Regarding claim 13, modified Broborg teaches a volume reflector body according to claim 12, and further teaches wherein a folded end of the tubular gas duct is arranged so that two central loops are formed in the center portion of the volume reflector body (Modified Broborg teaches wherein a folded end of the volume reflector body 330 (taught by Broborg) is arranged so that there are two central loops formed in the center portion of the volume reflector body (taught by Cai) as seen in Cai’s Annotated Fig. 6).
Regarding claim 16, modified Broborg teaches a volume reflector body according to claim 1, but does not teach wherein the length of the tubular gas duct of the volume reflector body is from 0.5 m to 4 m.
However, Cai further teaches wherein the length of the gas duct of the volume reflector body is from 0.5 m to 4 m (the length of gas passageway 130 is from 1m to 4m as seen on page 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the volume reflector body taught by modified Broborg to have the length of the gas duct be from 1m to 4m as taught by Cai which is good for patient breathing as it improves the comfort to the patient (see page 5). Furthermore, Broborg teaches volume reflector 330 to be a variable length and volume (see [0061] and [0077]).
Regarding claim 17, modified Broborg teaches a volume reflector body according to claim 16, but does not teach wherein a total gas duct volume is from 0.1 liters to 2 liters.
However, Cai teaches wherein a total gas duct volume is from 0.1 liters to 2 liters (the total volume of the air passage 130 is from 1000 ml to 1500 ml as seen on the bottom of page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the volume reflector body taught by modified Broborg to have a total gas duct volume of 0.1 liters to 0.15 ml as taught by Cai to have a volume greater than the exhaled tidal volume of a patient to prevent overflow (see last paragraph of page 4 and first two paragraphs of page 5). Furthermore, Broborg also teaches tailoring the volume reflector so that the chosen volume is slightly bigger than the tidal volume of the patient (see [0059]).
Regarding claim 24, modified Broborg teaches a volume reflector unit (volume reflector 330, see Fig. 3) comprising the volume reflector body of claim 1 (volume reflector 330, see Fig. 3 and [0059]; the volume reflector 330 has a body as seen in Fig. 3) and a carrier having a shape adapted to the shape of the volume reflector body (Broborg teaches the volume reflector 330 to include a plastic box with a folded gas conducting passage as seen in [0061], and the plastic box is in the shape of the folded gas passage as seen in Fig. 3).
Regarding claim 25, modified Broborg teaches a volume reflector unit according to claim 24, and Broborg further teaches wherein the carrier has edges adapted to at least partially surround the volume reflector body (Broborg teaches the volume reflector 330 to include a plastic box with a folded gas conducting passage as seen in [0061], and therefore the plastic box will have edges to surround the volume reflector 330 as seen in Fig. 3 and [0061]).
Regarding claim 26, modified Broborg teaches a breathing system (the breathing system will consist of a patient circuit module 302 is connected to a drive circuit which includes a ventilator and an inhalation and exhalation branch of a Y-shaped patient connector as seen in [0054]) comprising a ventilator providing a flow of a driving gas (patient circuit module 302 is connected to a drive-acting ventilator as seen in [0054] and [0056]), a patient circuit comprising an inhalation line and an exhalation line connectable to a patient (“The patient cassette 306 has a first inlet 308 arranged to be connected to a drive circuit (not shown), such as a manual bag, a ventilator operated bag-in-bottle, or a direct-acting ventilator, and two second inlets 314a-b arranged to be connected to a an inhalation and exhalation branch, respectively, of a Y-shaped patient connector (not shown).” See [0054]), a fresh gas supply inlet connectable to the inhalation line (“…a fresh gas inlet 344 which is pneumatically connected to the inspiratory leg 338 via a fresh gas supply line 348 for delivering additional fresh gas, typically oxygen, nitrous oxide and anesthetic, to the gas flow passing there through.” See [0055]), and an arrangement that separates the driving gas provided by the ventilator from patient breathing gases in the patient circuit (patient circuit module 302 separates the ventilator which is connected to inlet 308 (see [0057]) from the patient circuit which would be connected to outlets 314a/b as seen in Fig. 3 and [0056]), wherein the breathing system comprises the breathing system component volume reflector body according to claim 1 (the breathing system includes the patient circuit module 302 with volume reflector 330 as seen in Fig. 3).
Regarding claim 28, modified Broborg teaches a volume reflector body according to claim 1, and Huang further teaches wherein a flexural modulus of the plastic material is from 1000-1500 MPa, measured at 23°C and according to ISO 178 (Table 3.8-3 Properties of typical polypropylene blow molded products, on page 190, shows the flexural modulus of polypropylene to be 1445 MPa for homopolymer.).
Regarding claim 29, Broborg teaches a volume reflector body according to claim 1, and Broborg further teaches wherein the breathing system comprises a ventilator (the breathing system includes a ventilator as seen in [0054]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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