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 12/11/25 Claim(s) 1-2, 4, and 10 have been amended, no new claims have been added, and claims 9, 14, 21-52, and 54-84 have been cancelled. Thus, claims 1-8, 10-13, 15-20, 53 and 85-92 are presently pending in this application.
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: locating features in claim 20.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (2015/0101600).
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Annotated fig 2B of Miller.
With respect to claim 1, Miller discloses connector (200, fig 2A) for a medical tube (gases conduit; 112, fig 2A), wherein the connector comprises a first axial portion (see ‘first portion’ in annotated fig 2B of Miller; note the portion as annotated has three dimensions and thus has an axial direction and is an axial portion) having a first opening (see annotated fig 2B of Miller) configured to receive a flow of gases (204 connects to patient interface which would provide the user with a flow of gases), a second axial portion (see ‘second portion’ in annotated fig 2B of Miller; note the portion as annotated has three dimensions and thus has an axial direction and is an axial portion) having a second opening (see annotated fig 2B of Miller), the second axial portion configured to engage with the medical tube (see second end attached to tube 112 via cuff 118 in fig 2A) and provide a flow of gases to the medical tube through the second opening (see [0017]), a lumen (203, fig 2A) formed by the first axial portion and the second axial portion (see [0026]), the lumen providing a gases flow path between the first opening and the second opening (flow is provided through the lumen of the connector to provide the user the gases), and wherein the first axial portion of the connector comprises a sensor port (212, fig 2B), the sensor port configured to receive a sensor (sensor of sensor module 300, fig 2A), wherein the sensor port is located on a lateral side surface of the connector on the first axial portion of the connector (see location of sensor port in annotated fig 2B; and the location being on a side surface (the top of the first axial portion is a side surface since the portion is 3D and depending on orientation the surface would be lateral) of the first axial portion), wherein the second axial portion of the connector comprises at least one electrical port (214, fig 2B), the electrical port configured to provide an electrical connection to at least one wire (114, fig 2B and [0027]) in the tube, and wherein the electrical port is located on the top of the connector on the second axial portion of the connector (see location of port in annotated fig 2B of Miller), the top surface of the connector being a different surface from the lateral side surface of the connector (note: the tubing is portable so one can orient to be vertical and therefore the top surface would be above the lateral surface).
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.
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) 2-8, 10, 15-20, 53, and 87 is/are rejected under 35 U.S.C. 103 as obvious over Moody (2017/0197055)in view of Bath (WO2014/205513).
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Annotated fig 2 of Moody.
With respect to claim 2, Moody discloses a connector (200, fig 2) for a medical tube (220, fig 2), wherein the connector comprises a first axial portion (see annotated fig 2 of Moody; note the portion as annotated has three dimensions and thus has an axial direction and is an axial portion) having a first opening (see annotated fig 2 of Moody) configured to receive a flow of gases, a second axial portion (see annotated fig 2 of Moody; note the portion as annotated has three dimensions and thus has an axial direction and is an axial portion) having a second opening (see annotated fig 2 of Moody), the second axial portion configured to engage with a medical tube (see connection of second axial portion to tube 220 in fig 2) and provide the flow of gases to the medical tube through the second opening, a lumen (channel formed by connector 200 as seen in fig 3) formed by the first axial portion and the second axial portion with the first axial portion and second axial portion not axially overlapping each other with respect to an axial dimension (note the first and second axial portions are two separate portions of the connector and do not overlap), the lumen providing a gases flow path (channel formed by 200 in fig 3) between the first opening and the second opening, wherein the first axial portion of the connector comprises a sensor port (probe port; 425, fig 2), the sensor port configured to receive a sensor (see [0092]), wherein the second axial portion of the connector comprises at least one electrical port (power adaptor port; 430, fig 2), the electrical port configured to provide an electrical connection to at least one wire in the tube (see [0091]), and wherein the sensor port is offset about 120 to about 75 degrees, or about 110 to about 80 degrees, or about 90 degrees, about a longitudinal axis of the lumen relative to the electrical port (see the probe port and the electrical port offset from one another about 90 degrees in fig 2), but lacks the first axial portion is angled with respect to the second axial portion to form an elbow.
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Annotated fig 4a of Bath.
However, Bath teaches a connector (4106, fig 4a) for a medical tube (4102, fig 4a) with a first axial portion (see annotated fig 4a of Bath) and a second axial portion (see annotated fig 4a of Bath) angled to form an elbow (see fig 4a and [300]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Moody to form an elbow as taught by Bath so as to provide an angle between the portions allowing a well-known orientation of tube connectors.
With respect to claim 4, the modified Moody shows the angle between the first axial portion and the second axial portion is about 90 degrees to about 170 degrees (see elbow formed by the electrical port and the sensor port extending from the connector when viewing through the annotated plane of fig 2 of Moody, the elbow would form about 90 degrees, alternatively, ‘elbow having an angle of about 90 degrees’, see [300] of Bath).
With respect to claim 5, the modified Moody shows the first axial portion provides for a taper fit connection (see [0086] of Moody).
With respect to claim 6, the modified Moody shows the sensor port provides an aperture (port configured to receive) for the sensor to be inserted so as to be in contact with a flow of gases in the first axial portion of the connector (see [0092] of Moody).
With respect to claim 7, the modified Moody shows the sensor is configured to measure flow rate of the flow of gases in the first axial portion of the connector and/or measure temperature of the flow of gases in the first axial portion of the connector (‘temperature probe or a flow probe’; see [0092])
With respect to claim 8, the modified Moody shows said sensor is comprised as part of a probe (a sensor probe), the probe for being received by the sensor port (see [0092]).
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Annotated fig. 2 of Moody.
With respect to claim 15, the modified Moody shows the electrical port is offset from a longitudinal central axis of the second axial portion of the connector (see annotated fig 2 of Moody above; where the port 430 is offset from the axis substantially perpendicular).
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Annotated fig 5 of Moody.
With respect to claim 10, the modified Moody shows the first axial portion is angled with respect to the second axial portion to form an elbow (see elbow formed by the electrical port and the sensor port extending from the connector when viewing through the annotated plane of fig 2 of Moody) wherein opposite sides of the elbow define internal (inside of connector 200) and external (outside surface of connector 200, labeling of overmold 240, fig 2 of Moody) elbow surfaces, and wherein the electrical port is located on the external elbow surface (see electrical port on the outer surface of the connector and extending from the surface, fig 2 of Moody).
However, if there is any question that Moody forms an elbow, Bath teaches a connector (4106, fig 4a) for a medical tube (4102, fig 4a) with a first axial portion (see annotated fig 4a of Bath) and a second axial portion (see annotated fig 4a of Bath) angled to form an elbow (see fig 4a and [300]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Moody to form an elbow as taught by Bath so as to provide an angle between the portions allowing a well-known orientation of tube connectors.
With respect to claim 16, the modified Moody shows the sensor port having a longitudinal axis (see annotated fig 5 of Moody above), the sensor port allowing communication with an interior of the connector (see [0092]).
With respect to claim 17, the modified Moody shows the longitudinal axis of the sensor port is oriented substantially perpendicularly to the flow of gases through the first axial portion of the connector (note the flow of gas runs substantially perpendicular to the sensor port as seen in annotated fig 5 of Moody above).
With respect to claim 18, the modified Moody shows the longitudinal axis of the sensor port substantially intersects a corresponding longitudinal axis of the first axial portion of the connector from which the sensor port depends (see annotated fig 5 above where the axes intersect one another near the sensor port).
With respect to claim 19, the modified Moody shows the sensor port comprises a substantially cylindrical cross-section (see cross section of 425 in figs 3 and 5; a cylindrical cross-section).
With respect to claim 20, the modified Moody shows a terminal surface of the sensor port (see annotated fig 5 of Moody) distal of an outer surface of the first axial portion (see the sensor port 425 extending from the connector in fig 2 of Moody) comprises one or more locating features (see annotated fig 5 of Moody above where the locating features are the extensions and ends of 425 and 430).
With respect to claim 53, the modified Moody shows the electrical port is configured to extend in a direction upward and away from the humidifier (see the electrical port 430 extending upward from the connector in fig 2) when the connector is connected to a humidification chamber (150, fig 1).
With respect to claim 85, the modified Moody shows the electrical port comprises at least one connection point (440, [0122]), the connection point configured to provide for connection of the electrical port to the at least one wire (note the electrical port connects to a power source to provide power to the heating wire, see [0091]).
With respect to claim 86, the modified Moody shows a pin (440, [0122]) connected to said at least one wire (note the electrical port connects to a power source to provide power to the heating wire, see [0091]).
With respect to claim 87, the modified Moody shows a medical tube assembly (205, fig 2) comprising a medical tube (220, fig 2) and the connector (200, fig 2).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moody in view of Bath as applied to claim 2 above, further in view of Moody (2017/0197055).
With respect to claim 11, the modified Moody shows the sensor port is oriented substantially perpendicular to the first axial portion (see the location of the sensor port 425 being perpendicular to the first axial portion in fig 2 of Moody).
Moody is silent regarding the sensor port being perpendicular to the first axial portion, however, the claimed orientation is provided as preferred configuration(s) of the invention and provide no inherent advantage. Limitations drawn to the orientation or arrangement of the sensor port to the first axial portion would have been a matter of obvious design choice to one of ordinary skill in the art at the time of invention, absent criticality or unexpected results, as the skilled artisan would have chosen from various orientations or arrangements based on suitability for the intended results. See MPEP § 2144.04(I).
With respect to claim 12, Moody discloses the sensor port is oriented substantially perpendicular to a longitudinal axis of the first axial portion (see the location of the sensor port 425 being perpendicular to the first axial portion in fig 2 of Moody).
Moody is silent regarding the sensor port being perpendicular to the first axial portion, however, the claimed orientation is provided as preferred configuration(s) of the invention and provide no inherent advantage. Limitations drawn to the orientation or arrangement of the sensor port to the first axial portion would have been a matter of obvious design choice to one of ordinary skill in the art at the time of invention, absent criticality or unexpected results, as the skilled artisan would have chosen from various orientations or arrangements based on suitability for the intended results. See MPEP § 2144.04(I).
With respect to claim 13, Moody discloses the electrical port is oriented substantially perpendicular to the first axial portion (see the location of the electrical port 430 being perpendicular to the first axial portion in fig 2 of Moody).
Moody is silent regarding the sensor port being perpendicular to the first axial portion, however, the claimed orientation is provided as preferred configuration(s) of the invention and provide no inherent advantage. Limitations drawn to the orientation or arrangement of the sensor port to the first axial portion would have been a matter of obvious design choice to one of ordinary skill in the art at the time of invention, absent criticality or unexpected results, as the skilled artisan would have chosen from various orientations or arrangements based on suitability for the intended results. See MPEP § 2144.04(I).
Claim(s) 88-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moody in view of Bath as applied to claim 20 above, and further in view of Welsh (WO2004/108218).
With respect to claim 88, the modified Moody shows the locating features (see claim 20 above) but is silent regarding the one or more locating features comprise one or more notches of the terminal surface of the sensor port.
However, Welsh shows a tube (40, fig 6) with a port (44, fig 6) comprising a terminal surface (end portion of 55 near 55 in fig 6) wherein the one or more locating features (complimentary shaped aperture; 45, fig 6) comprise one or more notches of the terminal surface of the port (see fig 6 and pg. 7, lines 1-7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the terminal surface of the sensor port of Moody to include notches as taught by Welsh so as to easily and correctly position mating of two structures (see pg. 7, lines 3-4 of Welsh).
With respect to claim 89, the modified Moody shows the one or more notches extend along a direction parallel to a longitudinal axis of the sensor port (see apertures 45 extending from a top to a center in fig 6 of Welsh).
With respect to claim 90, the modified Moody shows the one or more notches extend toward a center of the connector (see apertures 45 extending from a top to a center in fig 6 of Welsh).
With respect to claim 91, the modified Moody shows the one or more notches are spaced apart about a perimeter of the terminal surface (see two notches spaced around the surface of the port 44 in fig 6 of Welsh).
With respect to claim 92, the modified Moody shows the one or more notches are substantially V-shaped (see fig 6 and complimentary shaped aperture 45 to fit triangular protrusion; pg. 7, lines 1-7 of Welsh).
Response to Arguments
The arguments to the newly added claim limitations in claims 1, 2-8, 10, 15-20, 53, and 87 have been addressed in the above rejections.
Applicant's arguments to claims filed 12/11/25 have been fully considered but they are not persuasive. On pg. 7, Applicant argues that "any modification of Moody that introduces the bend required for an elbow would render Moody unstable for its intended purpose of providing a reusable conduit which results from the smooth continuous internal wall". This is not persuasive since the elbow of Bath is still a smooth continuous wall between the tube and connector and the choice of angle would still provide the function of Moody to be reusable and allow for proper cleaning. .
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Forrester (20180214657) is cited to show an additional breathing tube.
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 KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY E BALLER/Examiner, Art Unit 3785
/TU A VO/Primary Examiner, Art Unit 3785