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 .
Information Disclosure Statement
The information disclosure statement filed 10 Apr 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the foreign patent documents listed as citations 33 and 39 both fail to include any information in the column for “Name of Patentee or Applicant of cited Document.” It has been placed in the application file, but the information referred to therein has not been considered as to the merits for those two citations. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim(s) 1-17 is/are objected to because of the following informalities:
Claim 1, Ln. 3 recites “comprising first strap end” which should read “comprising a first strap end”
Claim 1, Ln. 15 recites “a sub-nasal ridge formed as a sealing boundary about both nares” which should read “a sub-nasal ridge configured to form a sealing boundary about both nares” in order to avoid inadvertently positively claimed the nares of the patient
Claim 7, Ln. 1 recites “enable” which should read “enables”
Claim 16, Ln. 1 recites “a respiratory treatment apparatus” which should read “the respiratory treatment apparatus” following after claim 1
Appropriate correction is required.
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(s) 2-4 and 16 is/are 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 2 recites the limitation “the mask apparatus comprises a plenum chamber structure defined at least in part by the cushion, wherein the plenum chamber structure comprises a first vent and a second vent” in Ln. 1-3 which deems the claim indefinite. The claimed first vent and second vent are best understood as generally referring to vents 3400 shown in Figs. 11-12. Notably, those vents 3400 are located in frame 3500. The present claim has recited the first vent and second vent as in the plenum chamber structure but have only recited the plenum chamber structure as specifically being defined by the cushion. The claim is thus indefinite as a plain reading of the claim and its positive recitations would appear to locate the first vent and the second vent as in the cushion, which is not accurate. The claim is thus overly broad by defining the first vent and the second vent as in the plenum chamber structure without more specifically further defining the plenum chamber structure as including the frame of claim 1. This leads to confusion in the claim as the claim appears to recite a possibility of the first vent and the second vent being located somewhere other than the frame, which does not appear accurate. It is suggested to amend the introduction of the plenum chamber structure to further specify it is also at least partly defined by the frame (such as is done in claim 3). This interpretation will be applied to the below examination.
In claim 16 the scope of the claimed subject matter is unclear due to inconsistencies between the language of the claim preamble and certain portions of the body of the claim. The preamble of claim 16 sets forth the of a mask apparatus. However, line 1 of the claim recites [the] respiratory treatment apparatus which sets forth a positive relationship between the respiratory treatment apparatus and the mask apparatus, and thus the claim appears to claim the combination a respiratory treatment system. The respiratory treatment apparatus is not disclosed as part of the mask apparatus and one of ordinary skill in the art would consider it unreasonably broad to call the respiratory treatment apparatus part of the mask apparatus. Applicant needs to amend the language of the claim to be consistent either as a combination or subcombination claim. For the purposes of examination the claim will be interpreted as the combination of the mask apparatus of claim 1 and the respiratory treatment apparatus, in the form of a respiratory treatment system.
Claim 16 recites the limitation “a gas delivery conduit” in Ln. 3 which deems the claim indefinite. Claim 1 has previously introduced “an air circuit” which appears to correspond to the same structure presently recited as the gas delivery conduit. Using different language for the same part creates confusion. One of claims 1 and 16 should be amended so the same terminology is used to refer to the conduit/circuit in the two claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-7 and 10-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barlow et al. (WO Pub. 2012/040791 A1).
Regarding claim 1, Barlow discloses a mask apparatus (e.g. Fig. 48) for delivering a respiratory treatment to a patient comprising: a headgear (Fig. 45 #30; ¶0069) comprising a plurality of headgear vectors (Fig. 45 left and right pairs of #32, 35; ¶0069), the plurality of headgear vectors comprising a first strap end (Fig. 45 right side #33), a second strap end (Fig. 45 right side #39), a third strap end (Fig. 45 left side #33) and a fourth strap end (Fig. 45 left side #39); a frame (Figs. 45 & 48 #21; ¶0067) adapted to couple with a respiratory treatment apparatus so as to permit communication of a pressurized gas to a respiratory system of a patient from the respiratory treatment apparatus (¶¶0003, 0065), wherein the frame comprises a set of fasteners (Fig. 48 left and right pairs of #26, 27; ¶¶0069-0070) for removably coupling the headgear to the frame, the set of fasteners comprising first and second fasteners (Fig. 48 right side #26, 27) and third and fourth fasteners (Fig. 48 left side #26, 27), the first and second fasteners configured for fastening and positioning respectively the first and second strap ends of the headgear on a first side of the frame (Figs. 45 & 48), and the third and fourth fasteners configured for fastening and positioning respectively the third and fourth strap ends of the headgear on a second side of the frame (Figs. 45 & 48), and wherein the frame comprises a connection port (Fig. 48 #45 or opening in #21 to receive #45; ¶00127) for receiving an air circuit (e.g. Fig. 15 #11; ¶00116); and a cushion (Fig. 48 #24; ¶0067) including a cushion support structure (¶0082 – cushion clip; see also Fig. 136 #400; ¶00109) to which the cushion is adhered, wherein the cushion support structure is adapted to removably couple with the frame (¶0082 – snap together; ¶¶0096, 0098 – clip together), the cushion configured as a substantially under nose seal portion (Fig. 79 #242; ¶0092) and a mouth seal portion (Fig. 79 #23 with #232; ¶00108), the under nose seal portion comprising a sub-nasal ridge (Fig. 79 #242) configured to form a sealing boundary about both nares of the patient for achieving a seal in a sub-nasal region of the patient's nose (Fig. 79 #242, wherein the cushion is capable of rolling inwards to close around a periphery of the nares (¶0092 – unsupported central portion 242 will be able to roll inwards when a force is applied against it). It is noted that the terminology headgear “vectors” is understood to relate to what are commonly termed headgear straps.
Regarding claim 5, Barlow discloses the cushion is made from a silicone material (¶0080).
Regarding claim 6, Barlow discloses the headgear vectors are positioned to enforce the seal at the periphery of both of the nares (Fig. 1).
Regarding claim 7, Barlow discloses flexibility of the cushion enables the cushion to align to an alar angle and to a nasolabial angle of the patient's nose (Fig. 79; ¶0080).
Regarding claim 10, Barlow discloses the cushion is foam (¶¶0081, 0089).
Regarding claim 11, Barlow discloses the cushion support structure comprises a clip (¶0082) configured to couple with the frame.
Regarding claim 12, Barlow discloses the cushion support structure comprises a nasal plateau region and a mouth periphery region (Fig. 79).
Regarding claim 13, Barlow discloses the nasal plateau region is approximately perpendicular to the mouth periphery region (Figs. 77-81).
Regarding claim 14, Barlow discloses the cushion comprises a generally flat sealing surface (e.g. Fig. 79 flat along #232). Flap 232 is read as generally flat as it does not provide a bumpy or otherwise roughly textured surface.
Regarding claim 15, Barlow discloses the cushion comprises a generally curved sealing surface (Fig. 79 – cushion has curves where sealing will occur).
Regarding claim 16, Barlow discloses the respiratory treatment apparatus configured to generate a controlled supply of a breathable gas at a pressure above atmospheric pressure (¶0003 – CPAP), the respiratory treatment apparatus including a gas delivery conduit (e.g. Fig. 15 #11; ¶00116) coupled with the frame to direct the breathable gas to the frame.
Regarding claim 17, Barlow discloses the cushion support structure is inwardly concave (Fig. 79).
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al. (WO Pub. 2012/040791 A1).
Regarding claim 2, Barlow discloses the mask apparatus comprises a plenum chamber structure defined at least in part by the cushion (e.g. interior space of Fig. 77), wherein the plenum chamber structure comprises a first vent (e.g. Fig. 84 right edge #25; ¶00129) and a second vent (e.g. Fig. 84 left edge #25; ¶00129), the first vent comprising a first plurality of holes (Fig. 84 right edge #25) and the second vent comprising a second plurality of holes (Fig. 84 left edge #25), wherein the first plurality of holes are spaced apart from the second plurality of holes at least by a central area of the plenum chamber (Fig. 84).
Barlow fails to disclose in the cited embodiment of Fig. 84 the central area includes an opening for the connection port.
However, Barlow teaches various possible locations for the connection port on front plate 21, to include a central area (e.g. any of Figs. 97-99; ¶¶0094-0096). The overall disclosure of Barlow those teaches as obvious an opening for the connection port which is in a central area of front plate 21 which would be located between the right and left edge vent holes 25 of Fig. 84.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Barlow an opening for the connection port based upon an obvious use together of the vent hole arrangement of Fig. 84 of Barlow with the tube connection arrangement of any of Figs. 97-99 of Barlow.
Regarding claim 3, Barlow further teaches the cushion and the frame form the plenum chamber for sealing about the nares and mouth (Figs. 79 & 84).
Regarding claim 4, Barlow further teaches the cushion is configured to permit a generated gas pressure from a flow generator coupled to the mask apparatus to accumulate inside the plenum chamber to push the cushion outwards to thereby ensure an opening up of an air passage to the patient's nostrils and compress the cushion upwardly towards the patient's sub-nasal region, thereby generating sealing pressure around the nares (Fig. 79; ¶0003 – CPAP usage).
Allowable Subject Matter
Claim(s) 8-9 is/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 following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, Barlow fails to teach or suggest the cushion comprises a triangular ring having a common nasal and mouth aperture. Barlow fails to teach both a triangular ring (e.g. Fig. 80 of Barlow is not triangular) and a common nasal and mouth aperture (Fig. 79 has separate nasal and mouth apertures).
Another prior art readable on claim 1 is Ho et al. (U.S. Pub. 2007/0125385; Figs. 25-36). However, Ho also fails to teach both a triangular ring (e.g. Fig. 25 of Ho is not triangular) and a common nasal and mouth aperture (Figs. 25-26 & 32-36 have separate nasal and mouth apertures).
The use of a triangular shaped cushion having a common nasal and mouth aperture is known in the prior art (e.g. Geist – U.S. Pub. 2006/0042629; e.g. Figs. 1-2D). However, that prior art form of cushion fails to accurately read on claim 1 with its specific requirement of an under nose seal portion comprising a sub-nasal ridge formed as a sealing boundary about both nares. Instead, Geist and other related prior art seal higher on the nose and do not include the required under nose seal portion with a sub-nasal ridge.
One of ordinary skill in the art would not have considered it prima facie obvious to have mixed and matched the different teachings of the prior art in order to have arrived at the instantly claimed invention without improper hindsight reasoning at least because of how the different prior art apply unique shapes and designs for particular purposes which are not interchangeable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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