DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicants’ arguments, with respect to the restriction of claims 19 and 35 are persuasive. However, upon further consideration, a new ground(s) of rejection is made over Van Beurden et al (US 2006/0266359), hereinafter Van Beurden in view of Gunaratnam et al (US 2005/0241644), hereinafter Gunaratnam.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) 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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 15-16, 22-24, 26-27, 29-32, 38, 40, 41, 43-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Beurden et al (US 2006/0266359), hereinafter Van Beurden in view of Gunaratnam et al (US 2005/0241644), hereinafter Gunaratnam.
Regarding claim 15, Van Beurden teaches a patient interface configured to deliver a flow of breathable gas to a patient (Fig. 1: patient interface 2, paragraph 25 used with a respiratory system for providing gas to a patient), the patient interface comprising:
a frame (Figs. 2-3:25) with a central region and a pair of wings extending laterally outward from the central region (See annotated figure below), each wing comprising a headgear attachment point at which headgear is attachable to the patient interface (See annotated figure below), the central region comprising:
a superior base portion (Figs. 1-3: 21);
a pair of nasal prongs extending from a first side of the superior base portion (Fig. 2: nasal prongs 22, 23 extend from 21); and
a mounting boss extending from a second side of the superior base portion (Fig. 4: mounting boss 26 extends from the bottom of 21, paragraph 44) ; and
a connector attached to the frame (Fig. 4: 24, connected to frame via the mounting boss 26), the connector comprising:
an inferior base portion configured to be attached to the superior base portion (Fig. 4: 27, end portion of 24 inserts into mounting boss 26);
a tube connection structure configured to attach to an air delivery tube (See annotated figure below); and
a conduit connecting the inferior base portion to the tube connection structure to form an airflow path from the tube connection structure to the inferior base portion (See annotated figure below, paragraph 44 forms an airflow passage with air delivery tube), wherein the mounting boss is configured to receive and support the inferior base portion against the superior base portion (paragraph 44, tubular recess 26 is capable of receiving a gas flow manifold part 24), and
wherein the superior base portion and the inferior base portion are configured to form a plenum when the superior base portion and the inferior base portion are secured together. (Paragraph 44, opening 28 acts as an exit for gases received from the conduit 3, gases flowing through conduit 3 and into the gases flow manifold part 24 exit through the opening 28 and into the nasal prongs)
a posterior side configured to engage the patient’s face in use; (Fig. 4: side facing towards face)
an anterior side opposite the posterior side, (fig. 4: opposite side, side facing outward)
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Van Beurden does not teach wherein each wing of the frame comprises:
a superior intermediate side extending from the posterior side to the anterior side, and
an inferior intermediate side opposite the superior intermediate side and extending from the posterior side to the anterior side, and
wherein each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend.
However, Gunaratnam teaches a similar patient interface device (Fig. 2) which has a posterior side configured to engage the patient’s face in use (Fig. 1, Fig. 16, Fig. 24: side towards face);
an anterior side opposite the posterior side, (Fig. 1,fig. 16, Fig. 24, side facing outwards away from face)
a superior intermediate side extending from the posterior side to the anterior side (Figs. 1, 24: top surface of 608), and
an inferior intermediate side opposite the superior intermediate side and extending from the posterior side to the anterior side (Figs. 1,24: Bottom surface of 608), and
wherein each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend. (See annotated fig. 24 below)
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It would have been obvious to a person of ordinary skill in the art to modify the shape of the wing so that each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend as taught by Gunaratnam so that the frame follows the contours of the patient’s face.
Regarding claim 16, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches wherein the mounting boss is a looped structure (Fig. 4, paragraph, open tubular recess), and the inferior base portion is configured to be received through an opening formed by the looped structure. (paragraph 44, capable of receiving gases flow manifold 24)
Regarding claim 22, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches wherein the superior base portion extends in an anterior direction from the wings of the frame. (See Figs. 2-4)
Regarding claim 23, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches, wherein each headgear attachment point comprises a slot configured to receive a connecting member of a headgear assembly. (See figs. 1-4, headgear attachment point 25 is shown as a slot)
Regarding claim 24 Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches wherein mounting boss is configured to receive the inferior base portion in a lateral direction. (See Figs. 1-4, the manifold 24 is designed to be laterally inserted into mounting boss 26)
Regarding claim 26, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches wherein the wings of the frame are resiliently flexible. (paragraphs 42, 43, made of soft silicone, paragraph 44 due to the flexible nature of the material)
Regarding claim 27, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden further teaches wherein the wings and the central region of the frame are integrally formed and are made of silicone. (Paragraph 42, the face mount 21, nasal prongs are integrally molded, paragraph 43, strap or strap attachment means 24 may be integrally formed to face mount 21)
Regarding claim 29, Van Beurden in view of Gunaratnam teaches a patient interface system comprising:
the patient interface of claim 15 (figs. 1-4); and
headgear attachable to the patient interface at the headgear attachment points on the wings of the frame. (Fig. 1: shows headgear attached)
Regarding claim 30, Van Beurden in view of Gunaratnam teaches the patient interface of claim 29, and Van Beurden further teaches comprising an air delivery tube attachable to the tube connection structure of the patient interface connector. (See Fig. 1: air delivery tube 3)
Regarding claim 31, Van Beurden teaches a patient interface configured to deliver a flow of breathable gas to a patient (Fig. 1: patient interface 2, paragraph 25 used with a respiratory system for providing gas to a patient), the patient interface comprising:
a plenum base (Figs. 2-3, Paragraph 44, opening 28 acts as an exit for gases received from the conduit 3, gases flow through conduit 3 and into the gases flow manifold part 24 exit through the opening 28 and into the nasal prongs) comprising a superior base portion (Fig. 4: 21), an inferior base portion (Fig. 4: 24), and a retainer configured to hold the superior base portion and the inferior base portion together (Fig. 4: 26, paragraph 44, tubular recess 26 is capable of receiving a gas flow manifold part 24 and connect to portion 21);
a pair of nasal prongs extending from the superior base portion; (Fig. 2: nasal prongs 22, 23 extend from 21)
a first headgear connector extending laterally from the superior base portion in a first direction (Figs. 1-4: headgear connector 25), the first headgear connector comprising a first headgear attachment point at which the patient interface is connectable to headgear (Figs 1-4: headgear attachment point at end of connector 25);
a second headgear connector extending laterally from the superior base portion in a second direction opposite the first direction (Figs. 104: headgear connector 25 extends in both directions), the second headgear connector comprising a second headgear attachment point at which the patient interface is connectable to the head gear;(Figs. 1-4: headgear attachment at end of 25, connectable to headgear, see Fig. 1) and
a conduit attached to the inferior base portion. (Fig. 4: conduit portion of manifold 24 extending laterally, see below) a posterior side configured to engage the patient’s face in use; (Fig. 4: side facing towards face)
an anterior side opposite the posterior side, (fig. 4: opposite side, side facing outward)
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Van Beurden does not teach wherein each wing of the frame comprises:
a superior intermediate side extending from the posterior side to the anterior side, and
an inferior intermediate side opposite the superior intermediate side and extending from the posterior side to the anterior side, and
wherein each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend.
However, Gunaratnam teaches a similar patient interface device (Fig. 2) which has a posterior side configured to engage the patient’s face in use (Fig. 1, Fig. 16, Fig. 24: side towards face);
an anterior side opposite the posterior side, (Fig. 1,fig. 16, Fig. 24, side facing outwards away from face)
a superior intermediate side extending from the posterior side to the anterior side (Figs. 1, 24: top surface of 608), and
an inferior intermediate side opposite the superior intermediate side and extending from the posterior side to the anterior side (Figs. 1,24: Bottom surface of 608), and
wherein each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend. (See annotated fig. 24 below)
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It would have been obvious to a person of ordinary skill in the art to modify the shape of the wing so that each wing bends toward the superior direction so that the superior intermediate side is concave at the bend and the inferior intermediate side is convex at the bend as taught by Gunaratnam so that the frame follows the contours of the patient’s face.
Regarding claim 32, Van Beurden in view of Gunaratnam teaches the patient interface of claim 31, and Van Beurden further teaches wherein the retainer is a looped structure (Fig. 4, paragraph 44, open tubular recess), and the inferior base portion is configured to be received through an opening formed by the looped structure. (paragraph 44, capable of receiving gases flow manifold 24)
Regarding claim 38, Van Beurden in view of Gunaratnam teaches the patient interface of claim 31, and Van Beurden further teaches wherein the superior base portion extends in an anterior direction from the first and second headgear connectors. (See Figs. 2-4)
Regarding claim 40, Van Beurden in view of Gunaratnam teaches the patient interface of claim 31, and Van Beurden further teaches wherein the first and second headgear connectors are resiliently flexible. (paragraphs 42, 43, made of soft silicone, paragraph 44 due to the flexible nature of the material)
Regarding claim 41, Van Beurden in view of Gunaratnam teaches the patient interface of claim 31, and Van Beurden further teaches wherein the first headgear connector, the second headgear connector, the superior base portion, and the nasal prongs are integrally formed and are made of silicone. (Paragraph 42, the face mount 21, nasal prongs are integrally molded, paragraph 43, strap or strap attachment means 24 may be integrally formed to face mount 21)
Regarding claim 43, Van Beurden in view of Gunaratnam teaches a patient interface system and comprising:
the patient interface of claim 31 (Figs. 1-4 of Van Beurden); and
headgear attachable to the patient interface at the headgear attachment points on the first and second headgear connectors.(Fig. 1: shows headgear attached to headgear attachments points)
Regarding claim 44, Van Beurden in view of Gunaratnam teaches the patient interface system of claim 43, and Van Beurden further teaches comprising an air delivery tube attachable to the conduit. (Fig. 1: air delivery tube 3)
Regarding claim 45, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and Van Beurden appears to teach wherein a width of the frame in the central region is less than a width of the frame at the pair of wings. (See Fig. 4, where the frame central region appears wider than the wings)
The examiner notes that the courts have held that mere changes of shape is an obvious matter of choice which a person or ordinary skill in the rt would have found obvious absent persuasive evidence that the particular configuration was significant.
Regarding claim 46 Van Beurden in view of Gunaratnam teaches the patient interface of claim 31, and Van Beurden appears to show wherein a width of the first headgear connector at the superior base portion is less than a width of the first headgear connector at an end furthest from the superior base portion (See fig. 4), and
wherein a width of the second headgear connector at the superior base portion is less than a width of the second headgear connector at an end furthest from the superior base portion. (See Fig. 4)
The examiner notes that the courts have held that mere changes of shape is an obvious matter of choice which a person or ordinary skill in the rt would have found obvious absent persuasive evidence that the particular configuration was significant.
Claims 17-18 and 33-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over van Beurden in view of Gunaratnam, and further in view of White et al (US 2004/0261797), hereinafter White.
Regarding claim 17, Van Beurden in view of Gunaratnam teaches the patient interface of claim 16, but does not teach wherein the inferior base portion comprises a circumferential groove and the mouthing boss is configured to be received in the circumferential groove when the inferior base portion is received by the mounting boss.
However, White teaches a breathing assistance apparatus (Figs. 4-6) wherein an inferior base portion (Fig. 5: 35) comprises a groove (Fig. 5: 60) and the mounting boss (Fig. 5: 38) is configured to be received in groove. (paragraph 58)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the device of Van Beurden in view of Gunaratnam so that it includes a groove as taught by White in order to retain the inferior base portion in the mouthing boss. (paragraph 58)
Van Beurden, in view of White does not specify the groove is circumferential. However, the courts have held that mere changes in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant.
Regarding claim 18, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, and White further teaches wherein the inferior base portion comprises a circumferential lip configured to be received by the superior base portion. (Fig. 5: lips 58, 59, paragraph 58)
Van Beurden in view of Gunaratnam and White does not specify the lip is circumferential. However, the courts have held that mere changes in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant.
Regarding claim 33, Van Beurden in view of Gunaratnam teaches the patient interface of claim 32, but does not teach wherein the inferior base portion comprises a circumferential groove and the retainer is configured to be received in the circumferential groove when the inferior base portion is received by the retainer.
However, White teaches a breathing assistance apparatus (Figs. 4-6) wherein an inferior base portion (Fig. 5: 35) comprises a groove (Fig. 5: 60) and the mounting boss (Fig. 5: 38) is configured to be received in the groove. (paragraph 58)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified the device of Van Beurden in view of Gunaratnam so that it includes a groove as taught by White in order to retain the inferior base portion in the mouthing boss. (paragraph 58)
Van Beurden, in view of Gunaratnam and White does not specify the groove is circumferential. However, the courts have held that mere changes in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant.
Regarding claim 34, Van Beurden in view of Gunaratnam and White teaches the patient interface of claim 31, and White further teaches wherein the inferior base portion comprises a circumferential lip configured to be received by the superior base portion. (Fig. 5: lips 58, 59, paragraph 58)
Van Beurden in view of Gunaratnam and White does not specify the lip is circumferential. However, the courts have held that mere changes in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant.
Claims 25 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over van Beurden in view of Gunaratnam, and further in view of Gray (US 2004/0079371), hereinafter Gray.
Regarding claim 25, Van Beurden in view of Gunaratnam teaches the patient interface of claim 15, but does not teach wherein the conduit of the connector comprises a helical rib mounted on an exterior surface of the conduit.
However, Gray teaches a breathing circuit (Abstract) with a connector (Figs. 6-8, paragraph 75, connector 23) which comprises a helical rib mounted on an exterior surface of the conduit. (Fig. 6: helical rib 28)
Therefore, the combination of Van Beurden and Gray teaches the conduit of the connector comprises a helical rib mounted on an exterior surface of the conduit.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Van Beurden with the exterior helical thread as taught by Gray to cooperate with helical reinforcing bead of an air delivery conduit. (paragraph 75)
Regarding claim 39, Van Beurden in view of Gunaratnam and Gray teaches the patient interface of claim 31, but does not teach wherein the conduit comprises a helical rib mounted on an exterior surface of the conduit.
However, Gray teaches a breathing circuit (Abstract) with a connector (Figs. 6-8, paragraph 75, connector 23) which comprises a helical rib mounted on an exterior surface of the conduit. (Fig. 6: helical rib 28)
Therefore, the combination of Van Beurden and Gray teaches the conduit of the connector comprises a helical rib mounted on an exterior surface of the conduit.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Van Beurden with the exterior helical thread as taught by Gray to cooperate with helical reinforcing bead of an air delivery conduit. (paragraph 75)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:00 pm MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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