DETAILED ACTION
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 .
Response to Amendment
This office action is responsive to the amendment filed on July 29, 2024. As directed by the amendment: no claims have been amended, claims 1-16 have been canceled, and new claims 17-27 have been added. Thus, claims 17-27 are presently pending in the application
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature of claim 25 (a ball and socket type joint that allows relative movement between a frame portion and a mask seal position along a principal axis of the ball and socket joint) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 25-27 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 25, the specification does not describe how a ball and socket type joint can allow relative movement along a principal axis of the ball and socket type joint. Parent claim 1 defines the coupling between the mask seal and the mask frame as the ball and socket type joint. This joint allows rotational movement between the two components, but it is not clear from the specification what the principal axis of such a rotational joint is and how the joint could allow movement along such an axis. The specification only states “the relative movement can be along the principal axis of the ball and socket type joint (i.e., the axis of connection of the ball and socket)”. The description of the principal axis being the axis of connection of the ball and socket does not clarify how a ball can move in a socket along an axis of their connection. For example, Fig. 3 shows a ball and socket type joint where the ball 326 of the frame portion 320 can rotate within the socket of the mask seal portion 310. The movement is defined as rotation movement around center 328. Even if the “principal axis of the ball and socket type joint” is assumed to be the axis running through the centers of the frame inlet 324, frame outlet 326, and seal inlet 314 (which is an assumption made by Examiner and not explicitly described in the specification), then there is still no mechanism shown or described as to how the ball and socket joint allows movement along this axis. The other embodiment of the joint shown in Fig. 2 allows movement in this direction, but it is not a ball and socket joint between the frame 220 and seal 210.
As to claims 26-27, the specification does not describe how a ball and socket type joint allows relative movement that is constrained to a cylindrical boundary. The specification only describes a ball and socket type joint constrained to a spherical boundary (Fig. 3 embodiment, paragraph [0014]). An alternative type of joint is separately described as being constrained to a cylindrical boundary, such as a shaft and bearing type joint (paragraph [0015],[0039]). This type of joint is not shown in the drawings nor is there any description as to how a ball and socket type joint could move in this cylindrically constrained manner.
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 21 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 pre-AIA the applicant regards as the invention.
Claim 21 recites the limitation "the ball joint" in line 1. It is not expressly clear if the ball joint is referring to the ball and socket type joint recited in claim 17 or the ball joint of the connector recited in claim 20. Examiner suggests amending the language to read --the ball joint of the connector-- to clarify.
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 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.
Claims 17-27 are rejected under 35 U.S.C. 103 as being unpatentable over Matula, Jr et al. (US 2007/0044804), in view of Marque et al. (US 2007/0209663).
As to claim 17, Matula discloses a mask interface 450 (Fig. 27-28, paragraphs [0099]-[0101]) comprising:
a mask seal 454 comprising a seal inlet 463, the seal inlet 463 comprising a mask seal female connector portion 463 (the opening 463 is a female connector for receiving neck portion 466 of collar 464, see Fig. 28, paragraphs [0099]-[0100]);
a frame (the frame is considered the faceplate 452 and collar 464 together) comprising a frame inlet (the inlet end of neck portion 466 that receives air/oxygen from conduit 46), the frame inlet 466 comprising a frame connector portion (the inlet end of neck portion 466 connects to conduit 46, see Fig. 27), the frame 452,464 also comprising a frame outlet (the flange 468 defines an outlet end of the collar 464 around neck portion 466), the frame outlet 468 comprising a frame male connector portion 468 (flange 468 of collar 464 connects to the mask seal 454 through opening 463, paragraphs [0099]-[0100]), and the frame 452, 464 further comprising at least one attachment point, the at least one attachment point being configured to connect to headgear (see Fig. 14, paragraph [0082] which describes identical attachment points 266 to those shown in Fig. 27, unlabeled);
a connector (coupling member 46, Fig. 29) that is configured to connect a conduit 34 (sown schematically in Fig. 7) to the mask interface 450, the connector 46 being configured to be connected to the frame inlet 466 (see Fig. 27-28, and paragraph [0102]); and
the frame 452,464 being connectable to the mask seal 454 by a coupling (Figs. 27-28), the coupling comprising a ball and socket type joint 468, 460 (the curved flange 468 of collar 464 acts as the ball of the joint and the curved support 460 act as the socket, see Figs. 27-28, paragraph [0100]), the ball and socket type joint 468, 460 being configured to allow flexing in one direction easier than others (the shape of the opening 463 determines the extent of the movement in each direction, with the elongate shape shown in Fig. 27, it allows the movement more easily in the vertical direction than the horizontal, paragraphs [0100]), the ball and socket type joint 468, 460 comprising the mask seal female connector portion (opening 463) and the frame male connector portion (ball-shaped flange 468 of collar 464 is a male connector portion received by the female socket-like support 460), the coupling 468, 460 being configured to enable independent movement between the frame 452, 468 and the mask seal 454 (when deflectable arm 470 is depressed, paragraph [0101]), the independent movement comprising relative movement between a portion 464 of the frame 452 that is coupled to the mask seal 454 and a portion 460 of the mask seal 454 that is coupled to the frame 452, 464 (Figs. 27-28, paragraph [0100]-[0101]).
Matula does not expressly disclose that the frame connector portion of the frame inlet is a female connector portion (Matula’s frame inlet/neck portion end 466 appears to be a male connector that is inserted into connector 46 in this embodiment) and does not expressly disclose whether the connector 46 is configured to rotatably connect the frame inlet 466.
However, Marque teaches a mask interface (Fig. 1) having a connector assembly 18 including a female frame inlet connector portion (female ball and socket joint 19, Fig. 5) receiving a male portion 22 of a connector 21 (male spherical element 22 of coupling sleeve 21, Fig. 5), wherein the connector 21 is rotatable relative to the frame inlet 19 (see Fig. 5, paragraphs [0045]-[0046]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the mask interface of Matula so that the connection between the frame inlet (neck portion 466) and the connector 46 is a ball and socket type joint (with the frame inlet 466 forming the female connector portion and the connector 46 forming the male connector portion), as taught by Marque, in order to provide a suitable known type of connection that allows improved articulation of the patient circuit relative to the mask interface for ease of maneuvering components.
As to claim 18, modified Matula discloses the mask interface of claim 17, wherein the connector 46 is configured to swivel (see Marque’s ball and socket joint 18, Figs. 5-7, paragraphs [0023],[0045]-[0046]).
As to claim 19, modified Matula discloses the mask interface of claim 17, wherein the connector 46 is an elbow (see Figs. 26, 26, and 29 of Matula).
As to claim 20, modified Matula discloses the mask interface of claim 17, wherein the connector 46 comprises a ball joint (see Marque, Figs. 5-7, paragraphs [0023],[0045]-[0046]).
As to claim 21, modified Matula discloses the mask interface of claim 20, wherein the ball joint is connected to the frame inlet (see Marque, Figs. 5-7, paragraphs [0023],[0045]-[0046]).
As to claim 22, modified Matula discloses the mask interface of claim 17, wherein the seal inlet 463 and the frame outlet 464,468 comprise a common rotational center (see Figs. 27-28 of Matula, paragraph [0099]-[0101]).
As to claim 23, modified Matula discloses the mask interface of claim 17, wherein the relative movement is between mounting locations of the coupling (see Figs. 27-28 of Matula, paragraph [0099]-[0101]).
As to claim 24, modified Matula discloses the mask interface of claim 17, wherein the relative movement is constrained to a generally spherical boundary with a common rotational center (see Figs. 27-28 of Matula, paragraph [0099]-[0101]).
As to claim 25, modified Matula discloses the mask interface of claim 17, but does not expressly disclose that the relative movement is along a principal axis of the ball and socket type joint. However, Marque teaches a ball and socket type joint 18, 19, 20 (Figs. 5-7) that allows relative movement along an axis of the joint (the funnel shaped ball and socket can be connected and disconnected forcibly nesting, paragraph [0046]-[0047]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the mask interface of Matula so thathe ball and socket joint allows movement along the axis of the joint (in the connecting/disconnecting direction), as taught by Marque, in order to allow the components to be disconnected and re-connected to replace or interchange the components as desired.
As to claim 26, modified Matula discloses the mask interface of claim 17, wherein the relative movement is rotational but does not expressly disclose that the movement is constrained to a generally cylindrical boundary (the movement is constrained by the shape of the opening 463, see Matula, paragraph [0100]).
As to claim 27, modified Matula discloses the mask interface of claim 26, but does not expressly disclose that the relative movement is permitted along an axis of the generally cylindrical boundary. However, Marque teaches a ball and socket type joint 18, 19, 20 (Figs. 5-7) that allows relative movement along an axis of the joint (the funnel shaped ball and socket can be connected and disconnected by forcibly nesting, paragraph [0046]-[0047]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the mask interface of Matula so that the ball and socket joint allows movement along the axis of the joint (in the connecting/disconnecting direction), as taught by Marque, in order to allow the components to be disconnected and re-connected to replace or interchange the components as desired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McCall et al. (US 5,921,239), Eifler et al. (US 2005/0150497), and Schulz et al. (US 2008/0210241), and Hoffman (US 2007/0163600) each disclsoe a mask interface with a ball and socket type joint.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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 supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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