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
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 19-34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McAuley et al. (2005/0166927) in view of Falco (2003/0172938).
Regarding claim 19, McAuley discloses a nasal pillow (40) for use as part of a system for delivering a stream of gases to a user, the system produces the stream of gases to a patient interface (2) that is configured to deliver the gases to the nares, said nasal pillow section (40) forming part of the patient interface, said nasal pillow section comprising: a stalk (i.e. branching portions) having an upper end and lower end, the lower end (31) adapted to receive the stream of gases to be delivered to the patient interface (2), a cap (41) connected to an upper end of said stalk, an outer surface of said cap 41 adapted to substantially seal against the nares of the user, said caps 41 and said stalks forming an airway that acts as a path for the stream of gases to flow through said pillow portion to the user (fig. 2, 5, 6; par. 45, 48), wherein said cap 41 having a flange portion (fig. 6 shows a flange) extending outwardly from the upper end of the stalk, (par. 37-40, 45, 48; fig. 1, 2).
McAuley substantially teaches the claimed invention but is silent as to a plurality of ribs located below the flange and providing support to the flange. However, Falco teaches providing at least one rib (42) running between an outer surface (12) of said stalk (13) and an underside of said flange portion (18), said at least one rib 42 adapted to support said flange portion (par. 44-45; fig. 3A, 3B). Falco further teaches that ribs 42 provide an added degree of stiffness to the flanges to prevent undesired wrinkling while at the same time allowing the flanges to compress sufficiently when the device is inserted into a bodily orifice to provide desired fit and comfort for the user (par. 45). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the flange of McCauley with at least one rib running between an outer surface of said stalk and an underside of said flange portion, said at least one rib adapted to support said flange portion, as taught by Falco, to provide an added degree of stiffness to the flanges to prevent undesired wrinkling while at the same time allowing the flanges to compress sufficiently when the device is inserted into a bodily orifice to provide desired fit and comfort for the user.
Regarding claim 20, the modified McCauley discloses in figs. 6 and 17 the ribs (42, 302, 202) extend from an outer surface of the stalk towards an outer edge of the flange (as shown, the ribs extend outward).
Regarding claim 21, the modified McAuley discloses said at least one rib comprises four ribs arranged around said flange portion and running radially outwards from said outer surface of said stalk (fig. 18 of Falco disclose the ribs running radially outward).
Regarding claim 22, the modified McAuley discloses a lower edge or surface of said at least one rib (302) does not extend downwards further than a lower edge of said flange portion 18 (fig. 18).
Regarding claim 23, McAuley discloses in figs. 6-10 wherein the airway defines an enlarged internal cavity (center region widest about the flange 51, 52) having a greater width than a portion of the airway above the enlarged internal cavity (as shown, the neck is narrower than the center) and a portion of the airway below the enlarged internal cavity (as shown, the flange tapers to a narrower neck region). However, Falco teaches in figs. 7, 13, and 14 a tapered stalk narrower at the bottom than the center. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have manufactured the airway of McCauley with a bottom taper, as taught by Falco, to provide the advantage for enhanced comfort to fit various users.
Regarding claim 23, McAuley discloses in figs. 6-10 wherein the airway defines an enlarged internal cavity (center region widest about the flange 51, 52) having a greater width than a portion of the airway above the enlarged internal cavity (as shown, the neck is narrower than the center) and a portion of the airway below the enlarged internal cavity (as shown, the flange tapers to a narrower neck region).
Regarding claim 24, McCauley discloses the enlarged internal cavity is defined by a curved portion of an internal wall surface that forms the airway of the nasal pillow portion (as shown in figs. 8-10, the internal walls are curved).
Regarding claim 25, McCauley discloses the enlarged internal cavity is located closer to the aperture of the cap (top opening) than the lower end of the stalk (as shown, the enlarged cavity Is at the top near the flange).
Regarding claim 26, McCauley discloses in figs. 6-10, the portion of the airway below the enlarged internal cavity is defined by a straight portion of an internal wall surface that defines the airway (as shown, the lower walls are relatively straight).
Regarding claim 27, the modified McCauley discloses top and bottom tapers but does not specifically disclose a width of the portion of the airway above the enlarged internal cavity is equal to a width of the portion of the airway below the enlarged internal cavity. However, such a shape would be considered a design choice easily implemented by one having ordinary skill in the art and able to perform equally well. In addition, it has been held that where the general conditions of a claim are known it is not inventive to determine optimum or workable ranges by routine experimentation.
Regarding claim 28, the modified McCauley discloses each of the plurality of ribs (42, 302, 202; figs. 13-18 of Falco) extends from a lower surface of the flange portion (as shown, the ribs extend from a lower surface).
Regarding claim 29, the modified McCauley discloses each of the plurality of ribs (42, 302, 202; figs. 13-18 of Falco) has a width that is equal to or greater than a wall thickness of the cap (as shown, the thickness of the ribs is substantially equal to the cap).
Regarding claims 30-32, the modified McCauley discloses the width of each of the plurality of ribs (42, 302, 202; figs. 13-18 of Falco) is equal to one another being identical to one another in shape and dimensions and equally spaced around the flange portion (as shown, the ribs are identical and evenly spaced)
Regarding claim 33 the modified McCauley discloses wherein each of the plurality of ribs (42, 302, 202; figs. 8-18 of Falco) has a thickness and a length, the thickness measured in a direction from a lower surface of the flange portion towards a lower surface of each of the plurality of ribs, wherein the thickness varies along the length (i.e. as shown in fig. 8, the ribs are curved as a sem0circle or arc. Thus the width varies along the semi-circle).
Regarding claim 34, McCauley discloses in figs 7-11 internal wall surface of the nasal pillow portion (40) that forms the airway is straight between the lower end of the stalk and the aperture of the cap (as shown, at least lower portions are substantially straight).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785
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