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.
The factual inquiries 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 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Baecke et al (US 2012/055886), hereinafter Baecke in view of McAuley et al (WO 2010/0131189), hereinafter McAuley.
Regarding claim 1, Baecke teaches a cradle style cushion for a patient interface device (Fig.1, Fig. 2), the cradle style cushion comprising:
a central sealing body portion defining an internal chamber (Fig. 2: bellows 50 with interior chamber Fig. 4), the central sealing body portion comprising:
a front wall (Fig. 3: see below figure),
a rear wall (Fig. 3: opposite front wall),
a bottom wall (see below), and
a top wall including (See below):
a flat or concave central sealing surface (Fig. 3: surfaces 24 and 30, concave surface) structured to engage a septum and a bottom of each nostril of a patient when the patient interface device is donned by the patient (paragraph 14), the central sealing surface having at least one hole defined therethrough (Fig. 3 openings 34 and 40, paragraph 13),
a first stabilizing surface (Fig. 3: 15), and
a second stabilizing surface (Fig. 3:20), the first and second stabilizing surfaces each extending upwardly and outwardly from the central sealing surface (Fig. 3) and a top edge of the front wall in a direction away from the bottom wall (fig. 3),
wherein the first stabilizing surface includes a first front side edge portion (Front side edge of stabilizing portion as seen in Fig. 3) and the second stabilizing surface includes a second front side edge portion (Front side edge of stabilizing portion as seen in Fig. 3), and wherein the top edge of the front wall, the first front side edge portion and the second front side edge portion together define a front opening of the central sealing body portion (Fig. 3) which is structured to expose the front and top of the nose of the patient when the patient interface device is donned by the patient. (Fig. 3)
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Although it appears the nasal cushion of Baecke is structured to wrap around and at portions thereof engage an outer side of a respective one of the nostrils of the patient when the patient interface device is donned by the patient, it is not explicitly stated.
However, McAuley teaches a cradle style mask (figs. 10-12) being structured to wrap around and at portions thereof engage an outer side of a respective one of the nostrils of the patient when the patient device is donned by the patient. (fig. 10: 1006, 1007, paragraph 18 lines 5-11)
It would have been obvious to a person of ordinary skill in the art to modify the mask of Baecke to have portions that are structured to wrap around and engage an outer side of a respective one of the nostrils when donned by the patient as disclosed by McAuley in order to form an additional seal and support the location of the mask. (Page 16: lines 22-24)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,764,107 and claim 1 of US Pat. no. 11,890,417. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of the instant claims are found in the patented claims.
Regarding claim 1, the limitations of claim 1 are found in claim 1 of the patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached between 6:30 am - 3:30 pm MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on 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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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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