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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/676456 (hereinafter ‘456), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Fig. 6 in ‘456 appears to illustrate the mask frame comprising multiple holes, but does not disclose the holes are configured to washout exhaled air as recited in currently presented claim 21. The limitation to washout of exhaled air is disclosed in AU 2012903504 (hereinafter ‘504, filing date 08/15/2012). It is additionally noted that ‘456 discloses a plenum chamber having a shape this is complementary to a shape of the frame connection region, and ‘504 discloses the frame removably detached from the plenum chamber. The frame of ‘504 must require a retaining structure to enable removable attachment to the plenum chamber as illustrated in Fig. 6 of ‘456.
Examiner therefore considers the effective filing date as 08/15/2012.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 27 is 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 27 recites the limitation "Positioning and stabilizing structure" in line 1. It appears that the preamble intends to rely on the limitations of claim 21 and merely refers to further features of the positioning and stabilizing structure within the patient interface device. However, this is not clear from the claims. As such, the examiner recommends inserting “The patient interface device comprising the” at the beginning of the claim for proper reference to claim 21, consistent with the remaining dependent claims. Examiner will interpret the claim accordingly for the purposes of examination.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 – 22, 27 – 34, and 36 – 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20120204878) in view of Rummery (US 20100229868) in view of Radney (US 7296575).
21. Smith discloses a patient interface device for delivery of a supply of pressurised air or breathable gas to an entrance of a patient's airways (Fig. 1, [0003]), the patient interface device comprising: a frame (4) comprising a connection port (16), wherein the frame further comprises a frame connection region (see [0021], Figs. 1 – 2, the frame is detachably connected to the plenum via the frame connection region), and wherein the connection port is formed in one piece with the frame (see Fig. 2); a plenum chamber with a plenum connection region which comprises a retaining structure removably attachable to the frame (plenum chamber 12 is removably attached to receive gas as per [0021], and therefore must require a connection region retaining structure for the removable attachment; see also discussion in the “Priority” section above) and having a shape and/or configuration that is complementary to a shape and/or configuration of the frame connection region (see complementary shape of plenum chamber in Fig. 1; it is noted that the frame connection region may be interpreted to include the edges of frame 10, which are shaped to connect to the plenum chamber as illustrated in Fig. 1); a seal-forming structure disposed on the plenum chamber (14 illustrated with sealing cones in Fig. 1; see also [0021], [0006], the seal may be a nasal mask, and [0006 – 0007], an unbroken seal is required in the invention) and arranged to surround an entrance to the airways of the patient so as to facilitate the supply of air at positive pressure to the airways (the sealing cones 14 would surround the respective naris, as would the nasal mask disclosed in [0021]), the seal-forming structure being configured to leave the patient's mouth uncovered in use (see Fig. 1, [0006], the nasal mask would leave the mouth uncovered as illustrated), a positioning and stabilising structure (6 and 8) comprising: a strap comprising a pair of pocketed ends (28, see Fig. 1, [0023]), a pair of side strap portions (24) and a back strap portion (22, see [0023]); and a pair of rigidiser arms, each of the rigidiser arms including a protruding end configured to retain a corresponding pocketed end of the strap (8, see [0024, 0025], where the protruding end is considered inclusive of loop 20; in an alternative interpretation, rigidizer structure distal to the loop is considered to retain the corresponding pocketed end in an upward position along the patient) wherein the positioning and stabilising structure is arranged to position the strap and the pair of rigidiser arms with regard to one another such that each of the rigidiser arms imparts a predetermined shape to the strap at a rigidised portion of corresponding ones of the side strap portions of the strap (see Fig. 1, [0024 – 0025]) and allowing at least the rigidised portion of corresponding ones of the side strap portions to move relative to the rigidiser arms ([0026]).
However, Smith does not disclose the frame comprising a multi-hole vent configured to washout exhaled air including exhaled carbon dioxide, and the seal-forming structure being constructed from a silicone material. Nonetheless, Rummery discloses the frame comprising a multi-hole vent configured to washout exhaled air including exhaled carbon dioxide (see Fig. 2, vent 28, [0024]) and the seal-forming structure being constructed from a silicone material (see [0009]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the frame and seal of Smith with vent holes and silicone, respectively, for the benefit of washing out excess CO2 from the user’s exhalations to prevent rebreathing of the CO2, and for the benefit of a soft conforming structure that effects sealing.
While Smith discloses that the strap comprises a fastening system that may use forms of connection such as snaps or buckles, Smith does not disclose the strap comprising a pair of button-holes. Nonetheless, Radney discloses a strap (see for example Fig. 4, 38’ as well as 70 and 62, though other embodiments may apply as well) comprising a pair of button-holes (receiving holes to protrusions/buttons, see c. 8: 47 – 58, Figs. 4 - 6, wherein the button-holes comprise a pair of holes located on the right and left sides of the strap; Fig. 5 illustrates surface-to-surface contact by inserting the protrusions/buttons into the receiving holes). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to substitute the hook and loop fastening surfaces of Smith (or alternatively the loop system 20 of Smith) with a pair of receiving button-holes on the strap as taught in Radney for the predictable result of flexibility in size while securely fastening the strap once the size adjustment has been made (see c. 8: 6 – 7).
22. Smith discloses the patient interface device of claim 21, wherein the seal-forming structure comprises: a pair of nasal pillows, each of the nasal pillows being constructed and arranged to form a seal with a respective naris of the nose of a patient (see Fig. 1, 14); or a nasal cushion constructed and arranged to form a seal against the patient's airways that surrounds both nares without being partially located inside the nose (see [0006]).
27. Smith discloses the positioning and stabilising structure according to claim 21, wherein an end portion of each of the rigidiser arms is affixed to the strap (proximal end portion is affixed to the strap via loops 20, see [0025]).
28. Smith discloses the patient interface device according to claim 21, wherein each of the rigidiser arms is incapable of stretching and is relatively more rigid than the strap (see [0021]).
29. Smith discloses the patient interface device according to claim 21, wherein each of the rigidiser arms is completely removable from the strap (see [0026], Fig. 1, Fig. 2, the fasteners are fully capable of being detached and the rigidizer removed).
30. Smith discloses the patient interface device according to claim 21, wherein each of the side strap portions is arranged to extend from a corresponding one of the rigidiser arms along a corresponding side of the patient's head, and the back strap portion further comprises two back strap portions arranged to extend along the back of the patient's head (see Fig. 1).
31. Smith discloses the patient interface device according to claim 30, wherein the two back strap portions are not adjustable except through the elasticity of the back strap portions or through increasing the back strap portions in tightness equally by shortening the total length of the strap (see Fig. 1, [0026]).
32. Smith discloses the patient interface device according to claim 30, wherein the two back straps comprise a first back strap adapted to engage the patient proximal to the crown of the head of the patient and a second back strap adapted to engage the patient proximal to the rear of the head (see Fig. 1, the straps would be fully capable of meeting the configuration on a patient).
33. Smith discloses the patient interface device according to claim 30, wherein each of the two back straps are non-independently adjustable such that the two back straps naturally center on respective sides of the crown of the head of a patient (see Fig. 1, the back straps are fully capable of natural centering).
34. Smith discloses the patient interface device according to claim 21, wherein the protruding end of each of the rigidiser arms is positioned proximal to the frame (protruding end is interpreted to include loops 20 and thereby located proximal to the end; examiner alternatively notes that the entire rigidizer arm may be interpreted as the protruding end, since no other end is claimed).
36. Smith discloses the patient interface according to claim 21, further comprising a short tube configured to be connected to an additional gas delivery tube (18, see [0021]).
37. Smith discloses the patient interface according to claim 36, wherein the short tube comprises a rotatable cuff configured to rotatably connect the short tube to the additional gas delivery tube (see [0021]).
38. Smith discloses the patient interface according to claim 36, wherein the short tube is removably and movably connected to the frame at the connection port (see Figs. 1 – 2, [0021]).
39. Smith discloses the patient interface according to claim 36, wherein the short tube is permanently and fixedly connected to the frame at the connection port (see [0021]).
40. Smith discloses the patient interface according to claim 21, wherein the positioning and stabilising structure does not include a buckle connected to the strap for length adjustment of the strap (see Fig. 1).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20120204878) in view of Rummery (US 20100229868) in view of Radney (US 7296575) in view of Johnson (US 5438979) in view of Belluye (US 20060169004).
23. Smith discloses the patient interface device according to claim 21, but does not disclose wherein the strap is made of an elastic material and the positioning and stabilising structure is arranged such that the at least one strap is substantially free to move by elastically expanding and/or contracting , relative to the pair of rigidiser arms, and along a longitudinal axis of the strap and/or the pair of rigidiser arms. Nonetheless, Johnson discloses a respiratory interface having a rigidizer with straps, wherein the straps are made entirely from elastic, see c. 4: 16 – 26. Upon combination, Smith in view of Johnson disclose that the positioning and stabilising structure is arranged such that the at least one strap is substantially free to move by elastically expanding and/or contracting , relative to the pair of rigidiser arms, and along a longitudinal axis of the strap and/or the pair of rigidiser arms. It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the entire headgear of Smith with the elasticity of Johnson so that, upon adjustment, the headgear and its strap gently contracts around the head of the patient to hold the patient interface in place.
However, Smith in view of Johnson do not disclose an elastic textile. Nonetheless, in the reasonably pertinent art of elastic fabric materials in the medical field, Belluye discloses a fabric material for applying compression, wherein the material is an elastic textile, see [0002]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the elastic fabric strap of Smith in view of Johnson with the elastic textile of Belluye for the benefit of providing a well-known, flexible, elastic, comfortable strap.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20120204878) in view of Rummery (US 20100229868) in view of Radney (US 7296575) in view of Johnson (US 5438979).
24. Smith discloses the patient interface device according to claim 21, but does not disclose wherein the strap is able to stretch along its substantially entire length. Nonetheless, Johnson discloses a respiratory interface having a rigidizer with straps wherein the straps are made from elastic, see c. 4: 16 – 26. It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the entire headgear of Smith with the elasticity of Johnson so that, upon adjustment, the headgear and its strap gently contracts around the head of the patient to hold the patient interface in place. Upon modifying the entire headgear of Smith with the single elastic material of Johnson, the combined references disclose that the strap is able to stretch along its substantially entire length.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20120204878) in view of Rummery (US 20100229868) in view of Radney (US 7296575) in view of McAuley (US 20090241961).
35. Smith discloses the patient interface device according to claim 21, but does not disclose further comprising a pair of flexible joints each extending from a respective lateral side of the frame and each of the rigidiser arms being permanently connected to a corresponding one of the flexible joints. Nonetheless, McAuley discloses a patient interface having a pair of rigidizers and further comprising a pair of flexible joints each extending from a respective lateral side of the frame and each of the rigidiser arms being permanently connected to a corresponding one of the flexible joints (see Fig. 2, [0076], [0079], rigidizer 41, flexible joints 39). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the rigidizer arms of Smith with flexible joints as taught in McAuley for the benefit of allowing bending of the arms to better fit the contours of the patient’s face.
Allowable Subject Matter
Claims 25 and 26 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.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose or suggest all the features of claim 25. Smith in view of Rummery in view of Radney, the closest prior art of record, fails to disclose wherein each of the side strap portions comprises a hollow sleeve for receiving a corresponding one of the rigidiser arms in place, and a corresponding one of the button-holes for receiving each of the rigidiser arms into corresponding ones of the hollow sleeve. Furthermore, it would not have been obvious to one of ordinary skill in the art to modify Smith with such feature since the modified pair of button holes of Radney are not for receiving each of the rigidizer arms into the corresponding strap hollow sleeve with pocketed end.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 6119694 – protrusions with protrusion receiving holes
EP 2140902 – movable strap over rigidizer
US 20120067349 – uniform strap over rigidizer, see Fig. 90
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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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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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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