DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 23, 32 and 46 are objected to because of the following informalities:
Regarding claim 23, the phrase “such that a first stop surface” is repeated in lines 4-5 of the claim.
Regarding claim 32, --to—should be added between “configured” and “convectively”
Regarding claim 46, the limitation “the end portion of the first cuff is constructed from a resilient material and is configured to engage an exterior surface of a tubular connector of a patient interface” should be deleted from the claim since this limitation is already present in claim 21.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-46 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 21, 42, and 43, there is no disclosure of a fixture made from a second material different from the first material. Further there is not disclosure of a base portion constructed from the second material and in one piece with the fixture as claimed in claim 43.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. the limitations in claim 24 are already present in claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 21, 29-36, 39, and 41-44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scardovi (EP 1741462), hereinafter Scardovi in view of Gradon et al (US Pat. No. 6,272,933), hereinafter Gradon, and further in view of Pernetti et al (US Pat. No. 5,762,382), hereinafter Pernetti.
Regarding claim 21, Scardovi teaches an air delivery conduit for use with a positive airway pressure (PAP) system to deliver pressurized breathable air to a patient (Fig. 1, paragraph 14), the air delivery conduit comprising:
a tube having a first tube end and a second tube end (Fig. 1), the tube having spiral ribbing (Fig. 1: 3) and a plurality of wires (Paragraph 17, filament 4, paragraph 18 cable 6);
a first cuff fixedly attached at the first tube end (Fig. 1: end of conduit having probe 9), the first cuff comprising:
an end portion made of first material (Paragraph 17 the duct 1 is comprised of a flexible tubular body), and the end portion is configured to engage an exterior surface of a tubular connector of a patient interface(fig. 1, shows an end portion which would engage with a patient interface, the conduit is designed to deliver an air stream to a patient, Fig. 2, paragraph 3, paragraph 19, probe senses information regarding physical and chemical characteristics of the air stream that reaches the patient);
a fixture protruding radially inward; (Fig. 1:probe 9 protrudes radially inward) and;
a thermistor electrically connected to at least one of the plurality of wires and being enclosed within the fixture so as to be supported within a flow path for pressurized breathable air through the first cuff; protruding radially inwardly from an internal surface of the cuff (Fig. 1: 9, paragraph 19, probe may measure temperature) and electrically connected to a least one of the plurality of wires (paragraph 18-19, connected to probe 9) and supported within a flow path for pressurized breathable air through the first cuff (fig. 1); and
an end portion configured to engage an exterior surface of a tubular connector of a patient interface (fig. 1, shows an end portion which would engage with a patient interface, the conduit is designed to deliver an air stream to a patient, Fig. 2, paragraph 3, paragraph 19, probe senses information regarding physical and chemical characteristics of the air stream that reaches the patient) ; and
a second cuff fixedly attached at the second tube end (Fig. 1: see second cuff connected to 7), the second cuff comprising an electrical connector (Fig. 1: 10) connected to a plurality of wires to provide an electrical connection with the PAP system. (Paragraphs 18- 19, connected to management and control unit 7),
Scardovi does not teach a fixture constructed from a second material that is different from the first material protruding radially inward from an internal surface of the first cuff.
However, Gradon teaches a pap unit with an air conduit (Fig. 5:14) the conduit having a fixture (Fig. 1: 19) protruding radially inward from an internal surface of the conduit; (Fig. 3);
a thermistor being (Col. 9: lines : 5-8) enclosed within the fixture so as to be supported within a flow path for pressurized breathable air through the conduit(Fig. 3: 34, 35, col. 9: lines 1-10), the fixture being made from a second material. (Col. 8: line 58, made of polycarbonate which is different from a flexible material of the tube)
Therefore, the combination of Scardovi and Gradon teaches the first cuff having a fixture protruding radially inward from an internal surface of the first cuff and enclosing the thermistor.
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 Scardovi with the fixture of Gradon to provide a protection for the thermistor by providing a housing that encases or encapsulates the thermistor. (Col. 9: lines 14-15)
If Applicant does not agree that Scardovi teaches an end portion that is constructed from a resilient material, Pernetti teaches an air delivery conduit (Fig. 2) wherein the end portion of the first cuff (Fig. 2: 32) is constructed from a resilient material (Col. 1: lines 42-43) and is configured to engage an exterior surface of a tubular connector of a patient interface. (Gradon teaches that the connector may be to a patient interface, Fig. 5)
It would have been obvious to a person of ordinary skill in the art to have substituted the material of Scardovi in view of Gradon with the resilient material as taught by Pernetti since the resilient material is suitable for use as a cuff material and the courts have held that the use of material suitable for its intended use is not inventive.
Regarding claim 29, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Scardovi further teaches wherein the plurality of wires include a heated wired configured to generate heat. (paragraph 17, heating filament 4)
Regarding claim 30, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Gradon further teaches wherein the fixture of the first cuff is molded around the thermistor. (Col. 9: lines 14-16)
Regarding claim 31, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Gradon further teaches wherein the fixture is longer in a direction parallel to a flow direction of pressurized breathable air through the first cuff than in a direction perpendicular to the flow direction of pressurized breathable air through the first cuff. (Figs. 1 and 2, Col. 10, Lines 8-20, lines 37-40, the projecting tab is parallel to flow and therefore in cross section the fixture is longer in a direction parallel to a flow direction)
Regarding claim 32, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Gradon further teaches wherein the fixture is configured convectively transfer from pressurized breathable air flowing through the first cuff to the thermistor over a range of flow rates. (Col 10: lines 35-40, since Gradon teaches a similar wing shape to that of the instant invention, the convective performance throughout a range of flow rates should perform in a similarly to the instant invention)
Regarding claim 33, Scardovi in view of Gradon and Pernetti further teaches the air delivery conduit according to claim 21, wherein the first cuff further comprises lead frames that electrically connect the thermistor to the plurality of wires. (Fig. 3: leads 48, are held in fixture portion 30 via 32 and 33 and through cuff at 41, Col. 9:1-17 lines Figs. 1-3)
Regarding claim 34, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 33, and Gradon teaches wherein the lead frames are partially enclosed by the fixture. (Fig. 3: leads 48, are held in fixture portion 30 via 32 and 33 and through cuff at 41, Col. 9:1-17 lines Figs. 1-3)
Regarding claim 35, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 33, and the combination of Scardovi with Gradon and Pernetti teaches wherein the lead frames are partially enclosed by the end portion of the first cuff. (Fig. 1 of Scardovi teaches that the probe is in the end portion of the cuff and Gradon teaches the lead frames are partially enclosed by the end portion of the cuff, Figs. 1-3, leads 48 held in fixture via 32 and 33, enclosed by cuff at 41)
Regarding claim 36, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim21, and Gradon teaches wherein one of the plurality of wires is configured to transmit a signal based on a temperature sensed by the thermistor to a controller of the PAP system. (Col. 9: lines 10-15, 20-30, Col. 12: lines 25-30)
Regarding claim 39, Scardovi in view of Gradon, and Pernetti teaches the air delivery conduit according to claim 21, and Pernetti further teaches wherein the second cuff comprises a sealing lip structured to engage and resiliently deform against an exterior surface of a tubular connector of the PAP system. (Fig. 4: annular bead 48, Col. 3: lines 50-58 and 63-66) (This is current claim 39)
It would have been obvious to a person of ordinary skill in the art to have provided Scardovi as modified with the sealing lip as taught by Pernetti to form a seal between the two components.
Regarding claim 41, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Pernetti further teaches wherein the end portion of the first cuff includes an entry surface that is curved or chamfered from an axially outward edge of the end portion such that a diameter of the end portion decreases in an axial direction into the first cuff from the axially outward edge of the end portion. (Fig. 4: taper surface 52 at distal end 34)
It would have been obvious to a person of ordinary skill in the art to have provided Scardovi in view of Gradon with the entry surface that is curved or chamfered as taught by Pernetti to provide a transition surface leading to the end of the cuff. (Col. 3: lines 30-35)
Regarding claim 42, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, and Gradon teaches wherein a base portion (Fig. 3: portion 40)that partly forms the flow path for pressurized breathable air. (the flow path of air would be around the protruding portion 40 and so would form part of the flow path)
Therefore, the first cuff comprises a base portion that partly forms the flow path for pressurized breathable air through the first cuff flows from the combination of Scardovi and Gradon.
Regarding claim 43, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 42, and Gradon further teaches wherein the base portion is constructed from the second material and in one piece with the fixture. (See Fig. 1)
Regarding claim 44, Scardovi in view of Gradon and Pernetti teaches a PAP system for treatment of sleep disordered breathing (Scardovi, paragraph 2, Gradon, Fig. 5, Col. 7: lines 50-55) the PAP system comprising:
a PAP device configured to pressurize breathable air (Gradon, Col. &: line 55, a gases supply or blower);
a humidifier (Scardovi, paragraph 3, Gradon Fig. 1: 4, Col. 7: lines 56-58) pneumatically connected to the PAP device to humidify pressurized breathable air(Fig. 1); and the air delivery conduit of claim 21. (see rejection of claim 21)
Claims 22-24, 26, and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scardovi (EP 1741462), hereinafter Scardovi in view of Gradon et al (US Pat. No. 6,272,933), hereinafter Gradon, further in view of Pernetti, and further in view of Sheppard et al (US 20070040378), hereinafter Sheppard.
Regarding claim 22, Scardovi in view of Gradon and Pernetti teaches the air delivery conduit according to claim 21, but does not teach wherein the end portion of the first cuff has a retention bead that extends radially inward therefrom and is configured to engage an exterior surface of a tubular connector of a patient interface.
However, Sheppard teaches a two piece quick connect retainer for a conduit (Fig. 2, paragraphs 2, 4)) having a first cuff (Fig. 2:14 ) wherein the end portion of the first cuff has a retention bead that extends radially inward therefrom and is configured to engage an exterior surface of a tubular connector of a patient interface. (Fig. 2: 62, paragraph 52 )
It would have been obvious to a person of ordinary skill in the art to have modified the air delivery conduit of Scardovi in view of Gradon so that an end portion of the first cuff had a retention bead as taught by Shepperd in order to retain the connecting component (paragraph 52,) and provide a secure, reliable, and durable connection that can be connected and disconnected with ease. (paragraph 4)
Regarding claim 23, Scardovi in view of Gradon, Pernetti and Sheppard teaches the air delivery conduit according to claim 22, and Shepperd further teaches wherein the first cuff comprises a first stop positioned between the fixture and the retention bead in an axial direction relative to the first cuff, the first stop surface extending radially inward to form a first hole having a smaller diameter than the retention bead such that the first stop surface is configured to contact an end of the tubular connector of the patient interface. (Fig. 2: 58, paragraph 54,annular shoulder 66, further insertion is prevented by contact of the connecting end with annular shoulder 66)
It would have been obvious to a person of ordinary skill in the art to have provided Scardovi in view of Gradon with the stop as taught by Shepperd to provide a limit to the insertion depth. (paragraph 54)
Regarding claim 24, Scardovi in view of Gradon, Pernetti and Sheppard teaches the air delivery conduit according to claim 22, and Shepperd states that the cuff may be made from a variety of materials (paragraph 46) but does not explicitly state wherein an end portion of the first cuff is constructed of a resilient material. (This limitation is in the independent claim)
However, Pernetti teaches an air delivery conduit (Fig. 2) wherein the end portion of the first cuff (Fig. 2: 32) is constructed from a resilient material (Col. 1: lines 42-43) and is configured to engage an exterior surface of a tubular connector of a patient interface. (Gradon teaches that the connector may be to a patient interface, Fig. 5)
It would have been obvious to a person of ordinary skill in the art to have substituted the material of Scardovi in view of Gradon and Shepperd with the resilient material as taught by Pernetti since the resilient material is suitable for use as a cuff material.
Regarding claim 26, Scardovi in view of Gradon, Pernetti, and Shepperd teaches the air delivery conduit according to claim 24, and Pernetti further teaches wherein an external surface of the end portion of the first cuff comprises finger grip portions to facilitate manual attachment and detachment of the first cuff to and from the tubular connector of the patient interface.(Fig. 4: 42, col. 3: lines 17-22, an enlarged portion is provided)
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 the cuff of Scardovi in view of Gradon and Shepperd with the finger grips as taught by Pernetti to aide in connecting and disconnecting the cuff, Col. 3: lines 17-22)
Regarding claim 38, the air delivery conduit according to claim 21, wherein the plurality of wires are supported by the spiral ribbing. (Fig. 2, Fig. 3, Fig. 5)
Regarding claim 40, Scardovi in view of Gradon, Pernetti teaches the air delivery conduit according to claim 39, but does not teach a stop surface position inward of the sealing lip.
However, Shepperd Sheppard teaches a two piece quick connect retainer for a conduit (Fig. 2, paragraphs 2, 4)) having a first cuff (Fig. 2:14 ) which has a stop surface positioned inward of the sealing lip in an axial direction relative to the second cuff, the second stop surface extending radially inward to form a second hole such that the second stop surface is configured to contact the tubular connector of the PAP system. (Fig. 2: 58, paragraph 54,annular shoulder 66, further insertion is prevented by contact of the connecting end with annular shoulder 66)
Therefore, the combination of Scardovi, Gradon, Pernetti and Shepperd teaches wherein the second cuff includes a second stop. (Scardovi and Gradon both teach first and second cuffs)
It would have been obvious to a person of ordinary skill in the art to have provided Scardovi in view of Gradon with the stop as taught by Shepperd to provide a limit to the insertion depth. (paragraph 54)
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scardovi in view of Gradon, Pernetti and Shepperd, and further in view of Walter et al (US 2007/0218734), hereinafter Walter.
Regarding claim 27, Scardovi in view Gradon, Pernetti and Shepperd teaches the air delivery conduit according to claim 26, but does not teach wherein each of the finger grip portions is a U-shaped projection extending radially outward from the end portion of the first cuff.
However, Walter teaches a cuff for a conduit (Figs. 1 and 9) which has a finger grip portion which is a U-shaped projection extending radially outward from the end portion of the first cuff. (Figs. 1 and 9)
It would have been obvious to a person of ordinary skill in the art to have modified the finger grip of Scardovi in view of Gradon, Pernetti and Shepperd to have a U-Shaped portion in order to provide a better gripping surface.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scardovi in view of Gradon, Pernetti and Shepperd, and further in view of Matlock et al (US 2007/0255258), hereinafter Matlock.
Regarding claim 28, Scardovi in view of Gradon, Pernetti and Shepperd teaches the air delivery conduit according to claim 24, but does not teach wherein the first cuff further comprises a pre-block constructed from a different material than the resilient material of the end portion, the end portion being molded onto the pre-block.
However, Matlock teaches that overmolding is a common manufacturing process and may be used to provide the desired shape and characteristics of the connector. (paragraph 56)
Therefore, it would have been obvious to a person of ordinary skill in the art to provide Scardovi in view of Gradon, Pernetti and Shepperd with a pre-block constructed from a different material than the resilient material of the end portion, the end portion being molded onto the pre-block in order to provide the desired shape of the connector. (paragraph 56)
Allowable Subject Matter
Claims 25, 37, 45 and 46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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