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 responsive to the amendment filed on May 29, 2025. As directed by the amendment: claims 1, 8, 13, 15, 22, and 118 have been amended, claims 10, 11, 16-18, 21, 25, 27-31, and 33-115 have been canceled, and no new claims have been added. Thus, claims 1-9, 12-15, 19, 20, 22-24, 26, 32, and 116-118 are presently pending in the application.
Claim Objections
Claim 116 is objected to because of the following informalities:
In claim 116, line 2, “ a flow source” should read -- the . Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
a first sealing mechanism that forms a first seal with a first portion of the second connector when connected (Claim 9, lines 2 and 3), for friction/interference fit with the second connector (Claim 12, lines 2 and 3),
a second sealing mechanism that forms a second seal with a second portion of the second connector when connected (Claim 14, lines 2 and 3), ..for friction/interference fit with the second connector (Claim 19, lines 2 and 3).
The specification describes these limitations as follows:
a first sealing mechanism that forms a first seal with a first portion of the second connector when connected (Claim 9, lines 2 and 3), for friction/interference fit with the second connector (Claim 12, lines 2 and 3) - The specification describes the first sealing mechanism as a seal between the connector and the second connector (T 0013). The first sealing mechanism is described as being a face seal, an O-ring, a lip seal, a wiper seal, or a sealing surface (I 0014). The first sealing mechanism may comprise an internal or external sealing surface for friction/interference fit with the second connector (T 0015). The specification further describes first sealing mechanism in a couple of embodiments: first sealing mechanism (615, Is 0387 and 0388, Figs. 6 and 7) and first sealing mechanism (small O-ring 1115, 1119, Is 0389, Fig. 15). Fig. 18 also shows a first sealing mechanism (1615) that has the same features as first sealing member 615 (T 00406).
a second sealing mechanism that forms a second seal with a second portion of the second connector when connected (Claim 14, lines 2 and 3), for friction/interference fit with the second connector (Claim 19, lines 2 and 3) - The specification describes the second sealing mechanism as a second seal with a portion of the second connector (T 0018). The second sealing mechanism is described as being a face seal, an O-ring, a lip seal, a wiper seal, or a sealing surface (1 0022). The second sealing mechanism may comprise an internal or external sealing surface for friction/interference fit with the second connector (1 0023). The specification further describes second sealing mechanism in a couple of embodiments: second sealing mechanism (619, Is 0387 and 0388, Figs. 6 and 7) and second sealing mechanism (large O-ring 1119, Is 0389, Fig. 15). Fig. 18 also shows a second sealing mechanism (1619) that has the same features as first sealing member 615 (T 00406)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function SO as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 12-15, 19, 20, 22-26, 32, 116-118 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bencke et al. (US 2018/0043125).
As to claim 1, Bencke discloses a connector 9004 (second end 9004, Fig. 6A-6E, paragraphs [0099]-[0100]) configured for use downstream of a pressure relief valve (the pressure relief valve is not positively claimed as part of the structural scope of the claimed connector, thus, since the connector 9004 of Bencke is capable of being installed downstream of a pressure relief valve, the limitation is met), the connector comprising:
a connector body 9004 having an inlet 9018 and an outlet 9006 defining a gas flow passage therebetween (Figs. 6A-6E, paragraphs [0099],[0101],[0107]);
the connector body 9004 configured to removably connect to a downstream side of a second connector 9002 (paragraph [0100]: first end 9004 and second end 9002 may be releasably connected to each other) and having an overlap portion that is overlapped by a portion of the second connector when connected (see Fig. 6E); and
an access passage 9036 extending through the overlap portion to the gas flow passage, the access passage 9036 configured to communicate with a gas bleed line in the pressure relief valve (pressure tap 9036 communicates with port 9032, see Fig. 6E, paragraph [0128]-[0129] and is capable of communicating with a bleed line of a pressure relief valve);
wherein the connector 9004 is configured for gas flow from the inlet 9018 to the outlet 9006, the inlet 9018 being arranged to receive gas flow from a flow source (from RPT device 4000 (see Fig. 6F, paragraph [0099]) and the outlet 9006 being arranged to provide gases to a patient (fluid conduit 9006 is part of air circuit 4170 which connects to patient interface 3000, see Fig. 1A, paragraphs [0099], [0095]).
As to claim 2, Bencke discloses the connector according to claim 1, wherein the access passage 9036 comprises an aperture 9036 that fluidly communicates with the gas flow passage to sense pressure in the gas flow passage (Fig. 6E, paragraph [0128]-[0129]: pressure tap 9036 communicates with the internal passage and with pressure port 9032, which may be used to determine a pressure of the air in the second opening 9018).
As to claim 3, Bencke discloses the connector according to claim 2, wherein the gas flow passage is defined at least in part by a wall (internal wall of opening 9018, see Fig. 6E) of the connector 9004, and the aperture 9036 is in the wall of the connector 9004 (see Fig. 6E, paragraphs [0128]-[0129]).
As to claim 4, Bencke discloses the connector according to claim 1, further comprising a cavity forming portion 9034 that forms a cavity with the second connector 9002 when connected (see annotated Fig. 6E below).
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As to claim 5, Bencke discloses the connector according to claim 4, wherein the cavity forming portion comprises an arcuate surface (the outer surface of the tubular end 9034 is an arcuate surface, see Fig. 6H and Fig. 6E).
As to claim 6, Bencke discloses the connector according to claim 4, wherein the cavity forming portion is a recess in a surface of the connector body 9004 (see annotated Fig. 6E below).
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As to claim 7, Bencke discloses the connector according to claim 4, wherein the cavity forming portion is in fluid communication with the gas flow passage 9018 via the access passage 9036 (see Fig. 6E).
As to claim 8, Bencke discloses the connector according to claim 4, wherein the cavity forming portion has a longitudinal dimension that is parallel to a direction of gas flow in the gas flow passage (see annotated Fig. 6E below).
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As to claim 9, Bencke discloses the connector according to claim 4, further comprising a first sealing mechanism (sealing surface 9016) that forms a first seal with a first portion (seal portion 9008) of the second connector 9002 when connected (see Fig. 6E, paragraph [0108]).
As to claim 12, Bencke discloses the connector according to claim 9, wherein the first sealing mechanism 9016 comprises an internal or external sealing surface for friction/interference fit with the second connector (see Fig. 6E and paragraph [0114] which describes friction that must be overcome to connect the connectors 9004,9002; thus, the fit is a friction fit).
As to claim 13, Bencke discloses the connector according to claim 9, wherein at least one of the access passage 9036 is arranged upstream of the first sealing mechanism 9016 (see Fig. 6E).
As to claim 14, Bencke discloses the connector according to claim 9, further comprising a second sealing mechanism that forms a second seal with a second portion of the second connector when connected (see annotated Fig. 6E below).
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As to claim 15, Bencke discloses the connector according to claim 14, wherein the access passage 9036 is between the first sealing mechanism 9016 and the second sealing mechanism (see annotated Fig. 6E above).
As to claim 19, Bencke discloses the connector according to claim 14, wherein the second sealing mechanism comprises an internal or external sealing surface for friction/interference fit with the second connector 9002 (see annotated Fig. 6E below and paragraph [0114] which describes friction that must be overcome to connect the connectors 9004,9002; thus, the fit is a friction fit).
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As to claim 20, Bencke discloses the connector according to claim 1, wherein a portion (complimentary latching portion 9014) of the connector 9004 is tapered (see Fig. 6E, paragraph [00111]).
As to claim 22, Bencke discloses the connector according to claim 2, wherein the aperture 9036 is arranged perpendicular to a direction of gas flow in the gas flow passage 9018 (see Fig. 6E).
As to claim 23, Bencke discloses the connector according to claim 2, wherein the aperture 9036 is radially arranged about the gas flow passage 9018 (see Fig. 6E).
As to claim 24, Bencke discloses the connector according to claim 2, wherein the connector further comprises a stepped portion (overhang portion 9034 is stepped inward from the seal portion 9016, as shown in annotated Fig. 6E below) and the aperture 9036 is arranged on the stepped portion 9034 (see Fig. 6E).
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As to claim 32, Bencke discloses the connector according to claim 1, further comprising a stop (end of overhang portion 9034 provides a stop which engages stop 9030 on second connector/first end 9002, see Fig. 6E, paragraph [0109]).
As to claim 116, Bencke discloses the connector according to claim 1, wherein the inlet 9018 receives gas flow from a flow source (from RPT device 4000, Fig. 6F) and wherein the gas flow travels through the gas flow passage from the inlet 9018 to the outlet 9006 (see Figs. 6E, 6G, 6H, paragraphs [0100]-[0101]).
As to claim 117, Bencke discloses the connector according to claim 1, further comprising an inlet end (at overhang portion 9034, Fig. 6E) and an outlet end (at 9026/9028, see Fig. 6E) opposite the inlet end 9034, wherein the inlet end 9034 is smaller than the outlet end 9026/9028 (see Fig. 6E).
As to claim 118, Bencke discloses a connection assembly 9000 (Fig. 6A-6E, paragraphs [0099]-[0100]) configured for use downstream of a pressure relief valve (the pressure relief valve is not positively claimed as part of the structural scope of the claimed connection assembly; thus, since the connector 9000 of Bencke is capable of being installed downstream of a pressure relief valve, the limitation is met), the connection assembly 9000 comprising:
A first connector 9004 (second end 9004, Fig. 6D) comprising a connector body 9004 having an inlet 9018, an outlet 9006, a gas flow passage between the inlet 9018 and the outlet 9006 (Figs. 6A-6E, paragraphs [0099],[0101],[0107]), and an overlap portion (see Fig. 6E where portions of connector 9004 are overlapped by portions of connector 9002 when assembled), wherein the first connector 9004 is configured for gas flow from the inlet 9018 to the outlet 9006, the inlet 9018 being arranged to receive gas flow from a flow source (from RPT device 4000 (see Fig. 6F, paragraph [0099]) and the outlet 9006 being arranged to provide gases to a patient (fluid conduit 9006 is part of air circuit 4170 which connects to patient interface 3000, see Fig. 1A, paragraphs [0099], [0095]);
a second connector (first end 9002, Fig. 6D) comprising a connector body 9002 having an inlet 9010, an outlet 9008, a gas flow passage between the inlet 9010 and the outlet 9008 of the connector body of the second connector 9002 (see Figs. 6D, 6E, 6H, paragraph [0107]), and an overlap portion (see Fig. 6E where portions of connector 9002 overlap portions of connector 9004, when assembled), wherein the first and second connectors 9004, 9002 are removably connectable to one another such that the overlap portion of the first connector 9004 is received by the overlap portion of the second connector 9002 thereby forming an assembly gas flow passage (see Fig. 6E, paragraph [0100]);
an access passage 9036 extending through the overlap portion of the connector body 9004 of the first connector 9004 to the assembly gas flow passage, the access passage 9036 configured to communicate with a gas bleed line in the pressure relief valve (pressure tap 9036 communicates with port 9032, see Fig. 6E, paragraph [0128]-[0129] and is capable of communicating with a bleed line of a pressure relief valve).
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 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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Bencke et al. (US 2018/0043125), in view of Choncholas et al. (US 2011/0087123).
As to claim 26, Bencke discloses the connector according to claim 1, but does not expressly disclose that the connector further comprises a flow restriction. However, Choncholas teaches a patient circuit connector (patient limb 38) having a flow restriction (flow restrictor 64) along patient limb 38 as part of a respiratory and metabolic gas module 40, for measuring pressure and flow measurements in the patient limb 38, see Fig. 1, Fig. 2, paragraph [0024]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the connector of Bencke to include a flow restriction (at patient limb 9006, for example) as part of a pressure/flow measuring module, as taught by Choncholas, in order to provide flow measurement feedback to the respiratory device for better control of the ventilation support to the patient.
Response to Arguments
Applicant’s arguments, see pages 10-14 of the remarks, filed May 29, 2025, with respect to the Drawing Objections, Specification objections, and claim objections have been fully considered and are persuasive. The objections have been withdrawn.
Applicant’s arguments, see pages 14-15 of the remarks, filed May 29, 2025, with respect to the rejection of claims 12 and 19 under 35 USC 112(a) have been fully considered and are persuasive. The rejection has been withdrawn.
Applicant’s arguments, see page 15 of the remarks, filed May 29, 2025, with respect to the rejections of claims 1-9, 12-15, 19-20, 22-24, 26, 32, and 116-117 under 35 USC 112(b) have been fully considered and are persuasive. The rejection has been withdrawn.
Applicant’s arguments with respect to claims 1-9, 12-15, 19, 20, 22-26, 32, and 116-118 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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