DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-14, 18-23, 31 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2007.109837 to Henry (Henry) in view of United States Patent No. 4878491 to McGilvray, III (McGilvray).
McGilvray discloses a tube designed to deliver breathable air to a swimmer (McGilvray, title, abstract), an admittedly different field of endeavor to the CPAP of Henry but relevant to the related problem of configuring an air conduit comfortably along the face of a user.
With regard to claim 11, Henry discloses an air delivery conduit configured to connect a patient interface to a supply of pressurized breathable gas for delivery of the breathable gas to a patient for treatment of sleep disordered breathing (Henry, title, abstract), the air delivery conduit comprising:
a textile layer defining a tubular member (20, fig. 2, paragraph 0024) configured to, in use, convey the breathable gas from the supply to the patient interface (14, paragraphs 0002, 0023 and 0024); and
at least one resilient support structure (230, fig. 3, paragraph 0026) provided to the tubular member and configured to provide form and crush-resistance to the conduit during treatment of sleep disordered breathing (paragraphs 0002-0004),
wherein the tubular member has a substantially non-circular cross-sectional shape (not disclosed).
Henry fails to disclose a conduit having a substantially non-circular cross-sectional shape. McGilvray discloses cross section views of sections of the tubing having a circular, rectangular and D shaped cross section as shown in figs. 4-6 and described at column 4, lines 16-24.
It would have been obvious to one having ordinary skill in the art at the time of filing to provide the tubular member of Henry in the form of a D shaped cross section as shown in fig. 6 of McGilvray, in order to provide the most streamlined fit against a wearer’s face as taught by McGilvray at column 5, lines 65-67.
With regard to claim 12, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses wherein the support structure comprises a plurality of rings positioned along the length of the tubular member to support and provide form to the conduit (as shown in fig. 3 and described in paragraph 0026 “the plastic reinforcing structure 230 that has a spiral/helical shape or a webbing could be used.” Each successive winding of the helical coil of support member 230 defines one of a plurality of rings around the textile tubular member).
With regard to claim 13, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses wherein the support structure is formed on an outer surface of the textile layer (as shown in fig. 3 of Henry)
With regard to claim 14, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and further disclose wherein the support structure is laminated to the textile layer (this limitation is considered to be a product by process limitation that does not further limit the structure of the claimed apparatus absent some evidence of a distinctive characteristic or feature imparted to the apparatus by the process of lamination. As noted in paragraph 0026 the support structure is attached to the tubular member which is functionally equivalent to laminating).
With regard to claim 18, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses wherein the support structure comprises a polymer (Henry, paragraph 0026).
With regard to claim 19, Henry in view of McGilvray discloses the air delivery conduit of claim 18 as set forth above, but does not specifically disclose wherein the polymer comprises nylon, polypropylene, or silicone.
It would have been obvious to one having ordinary skill in the art at the time of filing to provide the conduit of Henry in view of McGilvray and to try various commercially available material as the support layer polymer such as nylon, polypropylene or silicone in order to test the product for suitability in a variety of different applications since those materials are cheap and readily available.
With regard to claim 20, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses wherein the textile layer comprises a textile material that is woven (paragraph 0027), non-woven, braided or three-dimensionally printed.
With regard to claim 21, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses comprising a first cuff attached to a first end of the conduit and a second cuff attached to a second end of the conduit (Henry, paragraph 0024).
With regard to claim 22, Henry in view of McGilvray discloses the air delivery conduit of claim 21 as set forth above, and further discloses wherein the first cuff is configured to facilitate connection of the conduit to the patient interface, and the second cuff is configured to facilitate connection of the conduit to the supply of pressurized breathable gas (Henry, paragraph 0024).
With regard to claim 23, Henry in view of McGilvray discloses the air delivery conduit of claim 21 as set forth above, and further discloses wherein the textile layer is fused to the first and/or second cuff (the device is an air conduit and thus the connections between components are air tight which is a type of fused connection).
With regard to claim 31, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, and Henry further discloses wherein the conduit has an inner surface that is smooth (shown in the figures).
With regard to claim 33, the mask assembly of Henry in view of McGilvray as set forth in the rejection of claim 11 above is configured to interface with the patient’s face to deliver a flow of pressurized gas to the patient’s airways as shown in the figures of Henry.
Claims 15-17, are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2007.109837 to Henry (Henry) in view of United States Patent No. 4878491 to McGilvray, III (McGilvray) in further view of United States Patent Application Publication No. 2007/0267012 to McCarthy (McCarthy).
McCarthy discloses a breathing tube (McCarthy, title, abstract), an analogous field of endeavor to Henry.
With regard to claims 15-17, Henry in view of McGilvray discloses the air delivery duct of claim 14 as set forth above, but fails to further disclose wherein the support structure is laminated as a series of discontinuous lines, wherein the discontinuous lines form a plurality of rings disposed along a length of the tubular member (16), and wherein the discontinuous lines are diagonal lines (17).
McCarthy discloses the use of either helical support members (28, fig. 25) or axially spaced rings (4, fig. 1). McCarthy further discloses discontinuous diagonal lines (160, figs. 45-46) that can be configured to create a plurality of rings disposed along a length of the tubular member. It would have been obvious to one having ordinary skill in the art at the time of filing to provide the support structure of McCarthy to the configuration of Henry in view of McGilvray in order to provide a breathing tube that can bend around a patient as needed but still remain open to the gas being transported to the patient as taught by McCarthy.
Claims 24-30 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2007.109837 to Henry (Henry) in view of United States Patent No. 4878491 to McGilvray, III (McGilvray) in further view of WO 2005/075186 to Nasarczyk (Nasarczyk)
With regard to claim 24, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, but fails to further disclose a laminate layer provided to the textile layer.
Nasarczyk discloses a textile air delivery conduit comprising air impermeable film layers on page 3, lines 15-33. The layers are adhered together as described at page 4, lines 18-21 with an adhesive forming a longitudinal seam that is welded together as the film is folded over and adhered to itself as described at page 4, lines 11-16. The film can be composed of one or more polymer compositions as described at page 3, lines 17-25.
It would have been obvious to one having ordinary skill in the art at the time of filing to provide the conduit of Henry in view of McGilvray with the laminated structure of Nasarczyk and provide a thin protective film of material to provide additional protection to the fabric of the conduit and to extend the functional life of the conduit.
With regard to claim 25, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 24 as set forth above, and further discloses wherein the laminate layer is formed on the textile layer (as described in the rejection of claim 24 above).
With regard to claim 26, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 25 as set forth above, and further discloses wherein the laminate layer is glued, melted, or sprayed on the textile layer (this limitation is considered a product by process limitation that does not further define the claimed apparatus absent some evidence of a distinctive characteristic imparted to the structure of the conduit as a result of the claimed processes of glued, melted or sprayed. Nasarczyk discloses the use of a hot melt method).
With regard to claim 27, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 24 as set forth above, and further discloses wherein the laminate layer is formed on an inner surface of the textile layer (Nasarczyk discloses the application of the protective laminate layer to the inner and/or outer sides of the conduit).
It would have been obvious to one having ordinary skill in the art at the time of filing to provide protective film to both the inside and outside surfaces of the conduit to extend to the protective characteristics of the layer to the entire conduit in order to extends the useful life of the air delivery conduit.
With regard to claim 28, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 24 as set forth above, and further discloses wherein the laminate layer is formed on an outer surface of the textile layer (as set forth in the rejection of claim 27 above, the laminate layer is applied to the outer surface of the textile layer).
With regard to claim 29, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 24 as set forth above, and Nasarczyk further discloses wherein the laminate layer comprises a flexible, air impermeable material (col. 5, lines 20-26).
With regard to claim 30, Henry in view of McGilvray in further view of Nasarczyk discloses the air delivery conduit of claim 29 as set forth above, but does not further disclose wherein the flexible, air impermeable material comprises polyurethane, silicone or nylon .
PU, silicone and nylon are known to provide air impermeable barriers in addition to other mechanical properties. These materials are relatively cheap and easy to acquire and form into sheets for use in the above type applications. It would have been obvious to one having ordinary skill in the art the time of filing to make the device of Henry in view of McGilvray in further view of Nasarczyk with a PU, silicone or nylon laminate protective layer in order to test the suitability of those materials for use in the field of intended use of the air delivery conduit.
With regard to claim 32, Henry in view of McGilvray discloses the air delivery conduit of claim 11 as set forth above, but does not further disclose comprising: an air impermeable laminate layer provided to the textile layer (if would have been obvious to one having ordinary skill in the art at the time of filing to provide an air impermeable laminate layer as taught by Nasarczyk for the same reasons set forth in the rejection of claim 24 above); and a first cuff attached to a first end of the conduit and a second cuff attached to a second end of the conduit, wherein the first cuff is configured to facilitate connection of the conduit to the patient interface, and the second cuff is configured to facilitate connection of the conduit to the supply of pressurized breathable gas (Henry, paragraph 0024), wherein the support structure comprises a plurality of rings positioned along the length of the textile to support and provide form to the conduit, wherein the support structure is formed on an outer surface of the textile layer (as set forth in the rejection of claim 12 above and for the same reasons), wherein the support structure comprises a polymer, wherein the air impermeable laminate layer comprises polyurethane, silicone or nylon (as set forth in the rejection of claim 30 above and for the same reasons), and wherein the conduit has a length of between 200 mm and 700 mm (not disclosed).
It would have been obvious to one having ordinary skill in the art at the time of filing to provide the conduit in a length between 200 and 700 mm in order to provide enough hose to connect a patient interface with a supply of breathable gas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R DEAL whose telephone number is (469)295-9216. The examiner can normally be reached M-F generally 8-4 pm CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors can be reached at: Craig M Schneider (571) 272-3607 and Ken Rinehart (571) 272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID R DEAL/Primary Examiner
Art Unit 3753
Prosecution Insights