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 statements (IDS) dated 10/20/2023 has been received and considered. The documents previously lined through were reviewed in parent application 16/966690. The examiner thanks the applicant for pointing to the locations of the cited references in the parent application, as this was not apparent on the IDS as received.
Response to Amendment
The amendment filed 07/07/2023 has been entered. Claims 21-23 and 26-42 remain pending in the application.
Response to Arguments
Applicant's arguments filed 07/07/2026 (“Remarks”) have been fully considered but they are not persuasive.
Regarding the argument on page 7 of “Remarks”, the rejection of amended claim 21 has been updated in light of the amendment incorporating now-canceled claims 24 and 25. Please refer to the rejection over Goldspink of claim 21.
The rejection over Dravitzki has been withdrawn in light of the amended claims; however, please refer to the updated rejection below in view of Goldspink.
The double patenting rejection has been updated, since the conflicting patent recites the newly amended limitations in claim 21. Please see below for the maintained double patenting rejection.
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.
Claims 40-41 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 40 recites “wherein the clip member is configured to provide a non-removable or permanent connection with the elbow member”, when parent claim 21 has been amended to recite that the elbow member and the clip member are separable. It is not clear how the clip member and elbow member may both be separable and non-removable or permanently connected.
Similarly, Claim 41 recites “wherein one or more portions of the clip member is welded or bonded to the elbow member to permanently connect the clip member to the elbow member”. It is unclear how the two components can be required to fulfill both conditions of being separable and permanently connected.
In order to advance prosecution, the permanent connection between the elbow and the clip members is interpreted to be an alternative construction to the separable configuration.
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 (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 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.
Claims 21-23, 26-39, and 42 are rejected under 35 U.S.C. 102(a)(1) as unpatentable over Goldspink et al. (US 2018/0236200 A1), hereafter Goldspink.
Regarding Claim 21, Goldspink discloses an elbow assembly (fig. 4, 6600 [0172]) for a patient interface (fig. 4, 6000 [0172]), the elbow assembly comprising: an elbow member (fig. 8, 6620 [0175]) including an exterior surface arranged outside an air flow path formed by the elbow member ([0175]); and a clip member provided to the elbow member (fig. 8, 6650 [0191]), wherein the clip member includes a separate and distinct structure from the elbow member (fig. 8 shows that the clip member 6650 is an identifiable distinct member from the elbow), wherein the elbow member and the clip member are separable (fig. 19, elbow assembly 6620 is separable from the clip member 6650 by the swivel component 6612 [0175]) and comprise separately molded components that are subsequently connected to one another (fig. 19, elbow component 6620 has a first end 6660 that is shown as a separate component joined to clip member 6650 by swivel member 6612 [0200]),
wherein the clip member includes a pair of resilient, quick release pinch arms (fig. 8, two pinch arms 6650 are shown [0191]), and a connecting portion that interconnects the resilient, quick release pinch arms (fig. 8, 6610, abstract [0229]),
wherein the exterior surface of the elbow member includes a recess configured and arranged to receive at a least a portion of the clip member (fig. 17 shows a flattened area recessed from the rest of the elbow where the ends of clips 6650 are pinched [0193]), wherein the clip member is configured and arranged to releasably connect the elbow assembly to the patient interface ([0191]), wherein the clip member is configured to form a swivel connection to allow 360° free rotation of the elbow assembly relative to the patient interface ([0228]), and
wherein the elbow member is configured and arranged to form a seal with the patient interface when the elbow assembly and the patient interface are connected to one another (end of [0072] the swivel connector portion of the clip and elbow connector assembly forms a diametric seal with the patient interface).
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Regarding Claim 22, Goldspink discloses an elbow assembly according to claim 21, further comprising a swivel connector (fig. 19, 6625 [0175]) provided to the elbow member (fig. 19 shows the exploded assembly in which 6625 connects to elbow assembly 6620), wherein the swivel connector is configured and arranged to releasably connect the elbow assembly to an air circuit ([0175]), and wherein the swivel connector is configured to allow 360° free rotation of the swivel connector and the air circuit connected thereto relative to the elbow member ([0377]).
Regarding Claim 23, Goldspink discloses an elbow assembly according to claim 22, wherein the clip member and the swivel connector provide decoupling of the air circuit from the patient interface ([0200] the swivel connector 6625 is permanently couple to the elbow, and thus is understood to be able to decouple from the air circuit).
Regarding Claim 26, Goldspink discloses an elbow assembly according to claim 25, wherein each of the pinch arms includes a catch portion (fig. 9, 6652 [0191]) and a button portion (see annotated fig. 7 below [0192]; see also fig. 33 7657 [0194]), each catch portion including a catch configured to provide a snap joint assembly with the patient interface ([0194]).
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Regarding Claim 27, Goldspink discloses an elbow assembly according to claim 25, wherein the recess of the elbow member includes an upper recessed portion configured to receive the connecting portion (see annotated fig. 19, the recess which engages swivel member 6612 [0200]) and side recessed portions configured to receive respective pinch arms (see annotated fig. 19 below).
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Regarding Claim 28, Goldspink discloses an elbow assembly according to claim 27, wherein each of the side recessed portions includes a lug (see annotated fig. 17 below) configured and arranged to interact with a respective one of the pinch arms to facilitate retention of the clip member on the elbow member and operation of the pinch arms (the pinch arm 6650 is retained to the swivel component via the indicated lug; the swivel component connects to the elbow [0175]) .
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Regarding Claim 29, Goldspink discloses an elbow assembly according to claim 21, wherein the elbow member includes a 90° bend (fig. 14 appears to show an oblique angle between the upper and lower portions of the elbow; however [0367] states that the elbow may be approximately 90 degrees).
Regarding Claim 30, Goldspink discloses an elbow assembly according to claim 21, wherein the elbow member includes a plurality of vent holes to permit the exit of exhaust gases from the patient interface (fig. 17, vent holes 6640 [0179]).
Regarding Claim 31, Goldspink discloses an elbow assembly according to claim 21, wherein the elbow member is comprised of a material that is more rigid than a material of the clip member ([0195] the elbow may be polycarbonate and the swivel and spring arms may be more flexible; see also [0191]).
Regarding Claim 32, Goldspink discloses an elbow assembly according to claim 21, further comprising a retaining arrangement configured to connect the clip member to the elbow member (fig. 19, 6635 provides a socket for ball and socket joint between elbow 6660 and swivel 6612 [0197])
Regarding Claim 33, Goldspink discloses an elbow assembly according to claim 32, wherein the retaining arrangement comprises a snap joint assembly ([0203] the ball joint is a snap-fit joint).
Regarding Claim 34, Goldspink discloses an elbow assembly according to claim 21, wherein the clip member is configured and arranged to provide a separable snap joint assembly with a ring member provided to the patient interface ([0203] fig. 19, clip members 6650 with ring member 6612 provide a separable snap joint to a patient interface [0191]).
Regarding Claim 35, Goldspink discloses an elbow assembly according to claim 34, wherein the elbow member includes a tubular end portion (fig. 21, 6662 [0202]) configured to extend through the ring member (fig. 11, and fig. 21, the tubular end portion 6662 extends through the ring member 6612 [0197]) and into engagement with a seal member (fig. 10, 6200 [0172] is a seal structure engaged with the tubular end portion of the elbow member) to provide a sealed air flow path for delivery of pressurized gas through the elbow assembly to the patient interface (fig. 10, 6200 is a seal-forming structure [0172]).
Regarding Claim 36, Goldspink discloses an elbow assembly according to claim 34, wherein the clip member includes catches configured to matingly engage within a clip channel formed by the ring member (fig. 11, 6120 [0219]).
Regarding Claim 37, Goldspink discloses a patient interface to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient's airways including at least the entrance of a patient's nares while the patient is sleeping (figs. 1A-C, patient interface 3000 [0078-0080]), to ameliorate sleep disordered breathing ([0015]), the patient interface comprising: a seal-forming structure configured to form a seal with a region of a patient's face surrounding the entrance to the patient's airways (fig. 3A, 3100 [0171]); a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient's head (fig. 3A, 3300 [0171]); and the elbow assembly according to claim 21 (see claim 21 above), the elbow assembly configured and arranged to releasably connect the elbow assembly to an air circuit ([0175] and [0367]).
Regarding Claim 38, Goldspink discloses a CPAP system used for treatment of sleep disordered breathing (figs. 1A-C, [0261]), the CPAP system comprising: a CPAP device configured to supply a flow of air at a positive pressure (fig. 1A, 4000 [0078]); the patient interface according to claim 37 (see claim 37 above); and an air circuit connected between the CPAP device and the patient interface to deliver the flow of air at the positive pressure from the CPAP device to the patient interface (fig. 1A-C, 4170 [0078]).
Regarding Claim 39, Goldspink discloses an elbow assembly according to claim 21, wherein the clip member is configured to provide a releasable connection with the elbow member (fig. 19, the ball and socket snap fit connection is described in a way that is releasable [0201]).
Regarding Claim 42, Goldspink discloses a patient interface to deliver a flow of air at a positive pressure with respect to ambient air pressure to an entrance to the patient's airways including at least the entrance of a patient's nares while the patient is sleeping figs. 1A-C, patient interface 3000 [0078-0080], to ameliorate sleep disordered breathing ([0015]), the patient interface comprising: a positioning and stabilising structure configured to provide a force to hold a seal- forming structure in a therapeutically effective position on a patient's head (fig. 3A, 3300 [0171]); and the elbow assembly according to claim 21 (see claim 21), the elbow assembly configured and arranged to releasably connect the elbow assembly to an air circuit ([0175] and [0367]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Goldspink in view of Dravitzki et al. (US 2012/0138061 A1), hereafter Dravitzki.
Regarding Claim 40, Goldspink discloses an elbow assembly according to claim 21, but is silent on wherein the clip member is configured to provide a non-removable or permanent connection with the elbow member.
Dravitzki teaches an elbow for a patient interface (fig. 51, elbow 3000 [0313]) which has a clip member (fig. 47, button 3100 having catch 34040 [0314]) configured to connect the elbow to the patient interface ([0314]), where the clip member is non-removable and permanently connected to the elbow member (fig. 47, buttons are overmolded onto the elbow [0317] and are thus permanently connected to the elbow).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alternatively make the clip member non-removable or permanently connected to the elbow member, as Dravitzki teaches that this alternative construction would work equally well at connecting an elbow to a patient interface ([0313]).
Regarding Claim 41, Goldspink discloses an elbow assembly according to claim 40, wherein one or more portions of the clip member is welded or bonded to the elbow member to permanently connect the clip member to the elbow member (as modified by Dravitzki, the clip is button 3100, which is bonded to the elbow member 3000 by overmolding [0317]).
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.
Claims 21 and 26-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-11, 14, 16, and 19-21 of U.S. Patent No. 1833307 B2.
Regarding Claim 21, the conflicting patent recites an elbow assembly for a patient interface (claim 1, line 53), the elbow assembly comprising: an elbow member including an exterior surface arranged outside an air flow path formed by the elbow member (claim 1 lines 62-64); and a clip member provided to the elbow member (claim 1 line 56), wherein the clip member includes a separate and distinct structure from the elbow member (claim 1 lines 56-57), wherein the elbow member and the clip member are separable and comprise separately molded components that are subsequently connected to one another (claim 1 lines 59-61), wherein the clip member includes a pair of resilient, quick release pinch arms and a connecting portion that interconnects the pair of resilient, quick release pinch arms (claim 5) wherein the exterior surface of the elbow member includes a recess configured and arranged to receive at a least a portion of the clip member (claim 1 lines 65-67), wherein the clip member is configured and arranged to releasably connect the elbow assembly to the patient interface (claim 1, col. 44 lines 1-3 and claim 1 lines 50-52, the clip member is claimed to be attached to a ring member, which is attached to a patient interface), wherein the clip member is configured to form a swivel connection to allow 360° free rotation of the elbow assembly relative to the patient interface (claim 16), and wherein the elbow member is configured and arranged to form a seal with the patient interface when the elbow assembly and the patient interface are connected to one another (claim 1, col. 44 lines 3-6).
The following table lists additional conflicting claims that are patentably indistinct from the conflicting patent.
Instant application 18/382108
Conflicting patent 11833307
Claim 26
Claim 6
Claim 27
Claim 7
Claim 28
Claim 8
Claim 29
Claim 3
Claim 30
Claim 10
Claim 31
Claim 11
Claim 32
Claim 19
Claim 33
Claim 20
Claim 34
Claim 2
Claim 35
Claim 9
Claim 36
Claim 14
Claim 37
Claim 1
Claim 38
Claim 21
Claim 39
Claim 1, col. 44 lines 1-2
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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, Brandy S. 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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/SARA K TOICH/ Examiner, Art Unit 3785
/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785
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