DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Species 4, Figs. 85a-85j in the reply filed on 12/29/25 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because as stated in the original each of the different species requires a different field of search requiring different search term to find the adjustable nasal prongs, opposing forces, as well as a different search for the different geometries of the different species of nasal masks.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-21, 28, 35-37 and claim 42 will not be examined as they do not correspond to the species shown in figs. 85a-85j. The examiner notes that the frame in Figs. 85a-85j does not show a compound bend as claimed.
Instead this shape is shown as part of the embodiment of Figs. 39-40 and described in paragraph 29 of the instant specification. This embodiment is directed to a rigidizer and is different from the wings of the frame of Species 4 (Figs. 8a-85j).
Therefore, Claims 15-18, 22-27, 29-34, 38-41, and 43-44 will be examined as the elected species 4.
Claim Objections
Claims 19 and 24 are objected to because of the following informalities:
Claim 19 should have –an—before “anterior” in line 3 of the claim
Claim 24 should have –the—before “mounting boss”
Appropriate correction is required.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 15-16, 22-24, 26-27, 29-32, 38, 40, 41, 43-44 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Van Beurden et al (US 2006/0266359), hereinafter Van Beurden.
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)
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Regarding claim 16, Van Beurden teaches the patient interface of claim 15, and 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 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 teaches the patient interface of claim 15, 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 teaches the patient interface of claim 15, and 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 teaches the patient interface of claim 15, and 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 teaches the patient interface of claim 15, and 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 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 teaches the patient interface system of claim 29, 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)
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Regarding claim 32, Van Beurden teaches the patient interface of claim 31, and 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 teaches the patient interface of claim 31, and 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 teaches the patient interface of claim 31, and 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 teaches the patient interface of claim 31, and 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 teaches a patient interface system comprising:
the patient interface of claim 31 (Figs. 1-4); 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 teaches the patient interface system of claim 43, further teaches comprising an air delivery tube attachable to the conduit. (Fig. 1: air delivery tube 3)
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 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 White et al (US 2004/0261797), hereinafter White.
Regarding claim 17, Van Beurden 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 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 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 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 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 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 34, Van Beurden in view of 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 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 Gray (US 2004/0079371), hereinafter Gray.
Regarding claim 25, Van Beurden 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 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 - 3:30 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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