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 .
Claims Pending
Applicant's arguments, filed 10/10/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/10/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant’s previous cancellation of claims 2, 5, 9, 15, and 21 is acknowledged.
Claims 1, 3-4, 6-8, 10-14, 16-20, and 22-23 are the current claims hereby under examination.
Claim Objections - Withdrawn
Applicant’s amendments, filed 10/10/2025, have been fully considered, and the previous objection withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 3-4, 6-8, 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “whereby the handles of the user support interface are for the user to use his or her hands to support the weight of the oscillometry device solely by the hands on the handles when the user has his or her mouth on the user portion and his or her hands on the cheeks, mouth floor and the handles”, which fails to effectively define the metes and bounds of the claim as it is unclear whether the method is positively requiring “user has his or her mouth on the user portion and his or her hands on the cheeks, mouth floor and the handles” as part of the claim itself. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the above being an intended use of the claim.
Claims 3-4, 6-8, and 10-11 are dependent on claim 1 and as such are also rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards an oscillometry device with a casing, a conduit to receive the breath of a user, and handles that project from the sides of the casing.
Claim(s) 1, 3-4, 6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel (US Pub. No. 20170135603) hereinafter Hanewinkel, and further in view of Biener (US Pub. No. 20170049984) hereinafter Biener.
Regarding claim 1, Hanewinkel discloses Use of an oscillometry device for producing oscillometry measurement signals comprising (Par. 41 (“impulse oscillometry system (IOS).”)) (Par. 42 (signals)):
a casing (Fig. 3, Par.42,44, titration tube – 1),
and a user portion forming a conduit entering into the casing (Fig. 2, (dental gauge – 50 inside of tube 1)) (Par. 42, Fig. 2, (“Dental gauge 50 is allowed to move relative to titration tube 1 in the direction of arrow 57 to allow facemask 3 to maintain an airtight seal to face of subject 2 when their mandible is adjusted in the anterior/posterior directions, shown by arrow 55.”)), for receiving a breath of a user (Fig. 2, Par. 42 (measurements of breathing parameters are taken)), and
a user support interface projecting from the casing in a common direction with the user portion (Fig. 1-2, mask - 3), the user support interface being made of a flexible deformable material (Par. 45, (“a soft foam rubber mask”)), the user support interface vertically supporting the oscillometry device relative to a user (Fig. 1 (observable that the user has their mouth on the mask of the device)) (Par. 41, 42, 45 (mask)), and
an oscillometry measurement system operatively connected to the conduit in the casing and for producing oscillometry measurement signals from the breath of the user (Par. 42, “The pressure of bidirectional flow, arrow 22 generated by subject 2 within cylindrical tube 24 is directed by centerline located orifices 61, 65 and coupled to differential pressure sensor 23 by tubing 25, 26. Multiple conductor cable 21 sends electrical signals to a digital controller or computer to determine the volumetric flow rate of breathing in real time.”).
Hanewinkel fails to explicitly disclose the user support interface including a pair of handles projecting from the casing and configured to cover cheeks of the user.
However, Biener teaches the user support interface including a pair of handles projecting from the casing (Par. 202, 203, Fig. 3A, side braces – 3310) and configured to cover cheeks of the user (Fig. 3J (observable that the side braces – 3310 are covering the cheeks of the user)).
Biener and Hanewinkel are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel with that of Biener to include the user support interface including a pair of handles projecting from the casing and configured to cover cheeks of the user through the combination of the references as it would have yielded the predictable result of helping to secure the device to the individuals face.
Modified Hanewinkel fails to explicitly disclose the pair of handles extending from bases each secured to a respective side of the casing to ends, the ends configured to be located at the cheeks of the user, the ends being free and separated from one another, whereby the handles of the user support interface are for the user to use his or her hands to support the weight of the oscillometry device solely by the hands on the handles when the user has his or her mouth on the user portion and his or her hands on the cheeks, mouth floor and the handles.
Hanewinkel does disclose when the user has his or her mouth on the user portion (Par. 42, Fig. 2, (“Dental gauge 50 is allowed to move relative to titration tube 1 in the direction of arrow 57 to allow facemask 3 to maintain an airtight seal to face of subject 2 when their mandible is adjusted in the anterior/posterior directions, shown by arrow 55.”)).
However, Biener further teaches the pair of handles (Par. 202,203, Fig. 3A,3B side braces – 3310) extending from bases each secured to a respective side of the casing (Par. 207-208, Fig. 3A,3B, side braces – 3310, front brace - 3320, “In one form, the front brace 3320 may comprise a central portion 3325 and one or more side portions 3327. The central portion 3325 may extend across the patient's face while recessed from the manifold 3200. The one or more side portions 3327 (e.g. a left side portion and a right side portion) may be configured to engage and/or attach with the side brace(s) 3310.”)) to ends (Fig. 3A, 3D, side braces – 3310 (the ends of each side brace 3310 opposite to the end connected to each of the side portions 3327)), the ends configured to be located at the cheeks of the user (Fig. 2K, 3A, 3J, side braces – 3310 (observable that the ends side braces are configured to be located at the Masseter of the user as seen in Fig. 3J and the corresponding Masseter location in Fig. 2K)), the ends being free and separated from one another (Fig. 3C, 3D (observable that the ends of the side braces 3310 as identified above are separated and free from one another)), whereby the handles of the user support interface are for the user to use his or her hands to support the weight of the device solely by the hands on the handles (Par. 202, 203, Fig. 3A, 3D, side braces – 3310)(Examiners note: the side braces 3310 in Fig. 3A, 3D, and 3J are capable for the user to support the weight of the device with their hands) when the user has his or her hands on the cheeks, mouth floor and the handles (Par. 202, 203, Fig. 3A, side braces – 3310) (Examiners Note: the user in Fig. 3J could place their hands on the side braces, their mouth floor, and their cheeks to support the device).
Therefore it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel and Biener with that of Biener to include the pair of handles extending from bases each secured to a respective side of the casing to ends, the ends configured to be located at the cheeks of the user, the ends being free and separated from one another, whereby the handles of the user support interface are for the user to use his or her hands to support the weight of the oscillometry device of Hanewinkel solely by the hands on the handles when the user has his or her mouth on the user portion of Hanewinkel and his or her hands on the cheeks, mouth floor and the handles through the combination of the references as it would have yielded the predictable result of helping to more securely fasten the device to the individuals face.
Regarding claim 3, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches wherein the handles are elongated strips of the flexible deformable material (Biener (Par. 203, Fig. 3A) (Fig. 3B, Par. 241 (“The cover portion may be a silicone overmould (3310om) as shown in FIG. 3B”)(silicone is flexible and deformable))).
Therefore, it would have been further obvious to modify the method of Hanewinkel and Biener with that of Biener to include wherein the handles are elongated strips of the flexible deformable material as it would have yielded the predictable result of allowing for the straps to conform to the users face while also providing flexibility (Par. 202, 203).
Regarding claim 4, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches wherein the elongated strips form loops (Biener (Fig. 3j, side braces – 3310, Par. 244)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel with that of Biener to include wherein the elongated strips form loops as it would have yielded the predictable result of providing more secure means of securing the device to the head of the use by wrapping around the ears.
Regarding claim 6, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches further comprising at least one finger loop on the lateral surfaces of the elongated strips (Biener (Fig. 3j, side braces – 3310, Par. 244 (loop is sized to wrap around the ear))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel and Biener with that of Biener to include further comprising at least one finger loop on the lateral surfaces of the elongated strips as it would have yielded the predictable result of providing more secure means of securing the device to the head of the user by wrapping around the ears.
Regarding claim 9, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches wherein the user support interface includes at least one head strap (Biener (rear strap – 3350)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel and Biener with that of Biener to include wherein the user support interface includes at least one head strap as it would have yielded the predictable result of securing the device to the head of the user.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel in view of Biener as applied to claim 1 above, and further in view of Sun (US Pub. No. 20140276150) hereinafter Sun as referenced by Desiraju, K. et al. (2016, “Impulse oscillometry: The state-of-art for lung function testing.”).
Hanewinkel and Biener the method of claim 1 above.
Regarding claim 7, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Sun teaches further comprising at least one pressure sensor on the handles for producing a signal indicative of a pressure applied thereon (Par. 5 (sensor able to be applied to both handles)).
Biener, Hanewinkel, and Sun are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel and Biener with the sensors of Sun to include further comprising at least one pressure sensor on the handles for producing a signal indicative of a pressure applied thereon as impulse Oscillometry requires a certain level of force to be applied to the handles (Desiraju (Page 411, Col. 2, Par. 1)) and including a sensor would help the user determine if they have sufficient placed on the cheeks.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel in view of Biener as applied to claim 1 above, and further in view of Morrison (US Pat. No. 10905356).
Hanewinkel and Biener teach the method of claim 1 above.
Regarding claim 8, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Morrison teaches further comprising at least one inertial sensor on the casing for producing a signal indicative of an orientation of the oscillometry device (Col. 4, lines 4-7)(Col. 13, lines 30-40).
Biener, Hanewinkel, and Morrison are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Hanewinkel and Biener with that of Morrison to include further comprising at least one inertial sensor on the casing for producing a signal indicative of an orientation of the oscillometry device through the combination of references as it would have yielded the predictable result of determining if the device is in the proper orientation.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel in view of Biener as applied to claim 1 above, and further in view of Amarasinghe (US Pub. No. 20040067333) hereinafter Amarasinghe.
Hanewinkel and Biener teach the method of claim 1 above.
Regarding claim 10, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Amarasinghe teaches wherein the handles have a height of at most 4.0 cm in a face contacting end (Par. 12, (“Each strap is approximately 2 cm wide”) (straps are equivalent to handles)).
Biener, Hanewinkel, and Amarasinghe are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the dimensions of the handles of Hanewinkel and Biener with that of Amarasinghe to include wherein the handles have a height of at most 4.0 cm in a face contacting end as this is a design variation known in the art and would have yielded the predictable result of fitting around the user’s head.
Regarding claim 11, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Amarasinghe further teaches wherein a height to thickness ratio for the face contacting end of the handles is of at least 10 (Par. 12, “approximately 2 cm wide and approximately 3 mm thick” (approximately 3mm))(Par. 33 (“thickness of the composite is approximately 2 mm”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the dimensions of the handles of Hanewinkel, Biener, and Amarasinghe with that of Amarasinghe to include wherein a height to thickness ratio for the face contacting end of the handles is of at least 10 as this is a design variation known in the art and would have yielded the predictable result of ensuring the straps are not too thick and heavy on the face of the user.
Claim(s) 12-14,16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel, and further in view of Biener and Meng (US Pub. No. 20120029376) hereinafter Meng.
Regarding claim 12, Hanewinkel discloses an oscillometry device (Par. 41 (“impulse oscillometry system (IOS).”)) comprising:
a casing (Fig. 3, Par. 44, titration tube – 1),
a user portion projecting in a user direction (Fig. 2, (dental gauge – 50 inside of tube 1)) and forming a conduit entering into the casing (Par. 42, Fig. 2, (“Dental gauge 50 is allowed to move relative to titration tube 1 in the direction of arrow 57 to allow facemask 3 to maintain an airtight seal to face of subject 2 when their mandible is adjusted in the anterior/posterior directions, shown by arrow 55.”)), the conduit adapted to receive a breath of a user (Fig. 2, Par. 42 (measurements of breathing parameters are taken)), the user portion having a central axis (as indicated in modified Fig. 2 below), the central axis being normal to a reference plane of the user portion (as indicated in modified Fig. 2 below), the reference plane being at an end of the user portion in the user direction (reference plane as indicated in modified Fig. 2 below),
an oscillometry measurement system operatively connected to the conduit in the casing and adapted to produce oscillometry measurement signals from the breath of the user (Par. 42, “The pressure of bidirectional flow, arrow 22 generated by subject 2 within cylindrical tube 24 is directed by centerline located orifices 61, 65 and coupled to differential pressure sensor 23 by tubing 25, 26. Multiple conductor cable 21 sends electrical signals to a digital controller or computer to determine the volumetric flow rate of breathing in real time.”), and
a user support interface projecting from the casing (Fig. 1-2, mask - 3), the user support interface vertically supporting the oscillometry device relative to a user (Fig. 1 (observable that the user has their mouth on the device and there is no other support present)) (Fig. 1-2 (mask -3)), the user support interface being made of a flexible deformable material (Par. 45, (“a soft foam rubber mask”)).
Hanewinkel fails to explicitly disclose having handles extending beyond the reference plane in the user direction, the handles configured to cover the cheeks of the user.
Biener teaches having handles extending beyond the reference plane in the user direction (Fig. 3A (braces -3310)(Fig. 3J, (observable that the handles extend through to the ear, which is beyond the reference plane)), the handles being positioned laterally of the central axis (Fig. 3A,J (observable that the handles are on the left and right sides of the sagittal plane)), the handles configured to cover the cheeks of the user (Fig. 3J (observable that the side braces – 3310 are covering the cheeks of the user)).
It would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel with that of Biener to include having handles extending beyond the reference plane in the user direction, the handles being positioned laterally of the central axis, the handles configured to cover the cheeks of the user through the combination of references as it would have yielded the predictable result of securing the device to the user’s head.
Modified Hanewinkel fails to explicitly disclose the handles extending from bases each secured to a respective side of the casing to ends, the ends configured to be located at the cheeks of the user, the ends being free and separated from one another enabling the user to use his or her hands to support the weight of the oscillometry device solely by the hands on the handles when the user has his or her mouth on the user portion and his or her hands on the cheeks, mouth floor and the handles.
Hanewinkel does disclose when the user has his or her mouth on the user portion (Par. 42, Fig. 2, (“Dental gauge 50 is allowed to move relative to titration tube 1 in the direction of arrow 57 to allow facemask 3 to maintain an airtight seal to face of subject 2 when their mandible is adjusted in the anterior/posterior directions, shown by arrow 55.”)).
However, Biener further teaches the handles (Par. 202, 203, Fig. 3A,3B side braces – 3310) extending from bases each secured to a respective side of the casing (Par. 207-208, Fig. 3A,3B, side braces – 3310, front brace - 3320, “In one form, the front brace 3320 may comprise a central portion 3325 and one or more side portions 3327. The central portion 3325 may extend across the patient's face while recessed from the manifold 3200. The one or more side portions 3327 (e.g. a left side portion and a right side portion) may be configured to engage and/or attach with the side brace(s) 3310.”)) to ends (Fig. 3A, 3D, side braces – 3310 (the ends of each side brace 3310 opposite to the end connected to each of the side portions 3327)), the ends configured to be located at the cheeks of the user (Fig. 2K, 3A, 3J, side braces – 3310 (observable that the ends side braces are configured to be located at the Masseter of the user as seen in Fig. 3J and the corresponding Masseter location in Fig. 2K)), the ends being free and separated from one another (Fig. 3C,3D (observable that the ends of the side braces 3310 as identified above are separated and free from one another)) enabling the user to use his or her hands to support the weight of the device solely by the hands on the handles (Par. 202, 203, Fig. 3A, 3D, side braces – 3310) (Examiners note: the side braces 3310 in Fig. 3A, 3D, and 3J are configured to enable the user to support the weight of the device with their hands) when the user has his or her hands on the cheeks, mouth floor and the handles (Par. 202, 203, Fig. 3A, side braces – 3310) (Examiners Note: the user in Fig. 3J could place their hands on the side braces, their mouth floor, and their cheeks).
Therefore it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel and Biener with that of Biener to include the handles extending from bases each secured to a respective side of the casing to ends, the ends configured to be located at the cheeks of the user, the ends being free and separated from one another enabling the user to use his or her hands to support the weight of the oscillometry device of Hanewinkel solely by the hands on the handles when the user has his or her mouth on the user portion of Hanewinkel and his or her hands on the cheeks, mouth floor and the handles through the combination of the references as it would have yielded the predictable result of helping to more securely fasten the device to the individuals face.
Modified Hanewinkel fails to explicitly disclose the handles being positioned laterally of the central axis and vertically located at least partially in a range of +5 cm to -5.0 cm of the central axis.
However, Meng teaches handles vertically located at least partially in a range of +5 cm to -5.0 cm of the central axis (Par. 8 (“central longitudinally-extending axis of the air flow tube is substantially coplanar with the central longitudinally-extending axes of the handgrips”).
Biener, Hanewinkel, and Meng are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the handle starting position of Hanewinkel and Biener with that of Meng to include handles vertically located at least partially in a range of +5 cm to -5.0 cm of the central axis as this is a design variation and would have yielded the predictable result of ensuring that the device is more compact with the parts closer together.
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Hanewinkel modified Fig. 2
Regarding claim 13, Hanewinkel fails to disclose the limitations of the claim.
However, Biener further teaches wherein the handles are elongated strips of the flexible deformable material (Biener (Par. 203, Fig. 3A) (Fig. 3B, Par. 241 (“The cover portion may be a silicone overmould (3310om) as shown in FIG. 3B”)(silicone is flexible and deformable))).
Therefore, it would have been further obvious to modify the device of Hanewinkel, Biener, and Meng with that of Biener to include wherein the handles are elongated strips of the flexible deformable material as it would have yielded the predictable result of allowing for the straps to conform to the users face while also providing flexibility (Par. 202, 203).
Regarding claim 14, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches wherein the elongated strips form loops (Biener (Fig. 3j, side braces – 3310, Par. 244)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel, Biener, and Meng with that of Biener to include wherein the elongated strips form loops as it would have yielded the predictable result of providing more secure means of securing the device to the head of the use by wrapping around the ears.
Regarding claim 16, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches further comprising at least one finger loop on the lateral surfaces of the elongated strips (Biener (Fig. 3j, side braces – 3210, Par. 244 (loop is sized to wrap around the ear))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel, Biener, and Meng with that of Biener to include further comprising at least one finger loop on the lateral surfaces of the elongated strips as it would have yielded the predictable result of providing more secure means of securing the device to the head of the use by wrapping around the ears.
Regarding claim 19, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Biener further teaches wherein the handles are part of a head strap (Biener (Fig. 3J, rear strap – 3350 (handles with the rear strap make up a head strap))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel, Biener, and Meng with that of Biener to include wherein the user support interface includes wherein the handles are part of a head strap as it would have yielded the predictable result of securing the device to the head of the user.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel, Biener, and Meng as applied to claim 13 above, and further in view of Sun as referenced by Desiraju.
Modified Hanewinkel, Biener, and Meng teach the device of claim 13 above.
Regarding claim 17, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Sun teaches further comprising at least one pressure sensor on the handles producing a signal indicative of a pressure applied thereon (Par. 5 (sensor able to be applied to both handles)).
Biener, Hanewinkel, Sun, and Meng are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel, Biener, and Meng with the sensors of Sun to include further comprising at least one pressure sensor on the handles producing a signal indicative of a pressure applied thereon as impulse Oscillometry requires a certain level of force to be applied to the handles (Desiraju (Page 411, Col. 2, Par. 1)) and including a sensor would help the user determine if they have sufficient placed on the cheeks.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel, Biener, and Meng as applied to claim 13 above, and further in view of Morrison.
Modified Hanewinkel, Biener, and Meng teach the device of claim 13 above
Regarding claim 18, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Morrison teaches further comprising at least one inertial sensor on the casing producing a signal indicative of an orientation of the oscillometry device (Col. 4, lines 4-7)(Col. 13, lines 30-40).
Biener, Hanewinkel, Meng, and Morrison are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Hanewinkel, Biener, and Meng with that of Morrison to include further comprising at least one inertial sensor on the casing producing a signal indicative of an orientation of the oscillometry device through the combination of references as it would have yielded the predictable result of determining if the device is in the proper orientation.
Claim(s) 20, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanewinkel, Biener, and Meng as applied to claim 13 above, and further in view of Amarasinghe.
Hanewinkel and Biener teach the device of claim 13 above.
Regarding claim 20, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Amarasinghe teaches wherein the handles have a height of at most 4.0 cm in a face contacting end (Par. 12, (“Each strap is approximately 2 cm wide”) (straps are equivalent to handles)).
Biener, Hanewinkel, Meng, and Amarasinghe are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the dimensions of the handles of Hanewinkel, Biener, and Meng with that of Amarasinghe to include wherein the handles have a height of at most 4.0 cm in a face contacting end as this is a design variation known in the art and would have yielded the predictable result of fitting around the user’s head.
Regarding claim 22, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Amarasinghe teaches wherein ends of the handles extend beyond the reference plane by at least 3.0 cm (Par. 12 (the strap length is 19cm))(Fig. 1 (the strap that extends to the ear would at least have to be 3.0 cm long))
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the dimensions of the handles of Hanewinkel, Biener, and Meng with that of Amarasinghe to include wherein ends of the handles extend beyond the reference plane by at least 3.0 cm as this is a design variation known in the art and would have yielded the predictable result of ensuring the straps are adjustable for use and long enough to be secured. Regarding claim 23, modified Hanewinkel fails to explicitly disclose the limitations of the claim.
However, Amarasinghe teaches wherein ends of the handles extend are located at a distance from 3.0 cm to 12.0 cm beyond the reference plane. (Par. 12 (the strap length is 19 cm)) (Fig. 1 (the strap that extends to the ear would at least have to be 3.0 cm long) (Par. 11 (the headgear can be adjusted)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the dimensions of the handles of Hanewinkel, Biener, and Meng with that of Amarasinghe to include wherein ends of the handles extend are located at a distance from 3.0 cm to 12.0 cm beyond the reference plane as this is a design variation known in the art and would have yielded the predictable result of ensuring the straps are adjustable for use and customizable for individual use.
Response to Arguments
Applicant's amendments, filed 10/10/2025, have been fully considered, and the previous 112 rejections have been withdrawn. However, a new 112(b) rejection has been put forth as a result of the applicant’s amendments to the claim.
Applicant's arguments filed 10/10/2025, regarding the previous 103 rejection have been fully considered and are deemed as not persuasive.
The applicant’s arguments, on page 6, that Biener explicitly requires additional straps and not including those straps would render the device as inoperable for its intended purpose, have been fully considered and deemed as not persuasive. Biener indicates the headgear as potential structures, stating “the headgear may comprise a rear strap 3350 and atop strap 3340, which could be engaged to the frame using one of a number of known methods, such as adhesives, stitching, over-moulding and so on. In other forms, the headgear may be formed integrally with the frame.” (Biener(Par. 243)) and further identifies additional types of headgear that are not entirely around the head “Some forms of headgear (not shown) may engage the patient's ears for support, such as with one or more headgear portions, each of which loops or hooks around a base of the ear. Some forms of headgear (not shown) may include a single strap, such as to only include a rear strap. Yet other forms of headgear (not shown) may comprise one or more straps, each which may be for example bifurcated.” (Biener (Par. 244)). As such, Biener does not explicitly require the existence of straps 3340 and 3350.
Applicant’s argument that there is no indication in Biener regarding the use of a system as supported by the hands on the cheeks and mouth and is instead directed towards sleep, has been fully considered and deemed as not persuasive. As previously indicated, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, a person could place their hand on the handle in the indicated location of modified Fig. 3J of Biener (Modified Fig. 3J of Biener as shown below, but without strap 3340 and 3350 as shown in Fig. 3D of Biener), and touch all three of the cheek, handle, and mouth floor. As the claim solely requires “his or her hands on the cheeks, mouth floor and the handles”, it is observable in modified Fig. 3J of Biener below, that the distance covered would solely need to be from the bottom of the nose of the user to the mouth floor. Additionally, Biener does not preclude the user from more securely holding the side braces during the use of the device. As such, the applicant’s arguments are deemed as not persuasive and the rejection is maintained.
In response to applicant's argument that Biener is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Biener and Hanewinkel are considered to be analogous art to the claimed invention as they are involved with respiratory devices.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have yielded the predictable result of helping to more securely fasten the device to the individuals face.
The applicant’s arguments, regarding the dependent claims, rely on the arguments related to the independent claims, and as such are also deemed as not persuasive.
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Biener Modified Fig. 3J
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 ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791