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 6, 2026. As directed by the amendment: no claims have been amended, claims 8, 11-15, 19-20, 23-25, 27, 28, 30, 33-36, and 39-42 have been canceled, and new claim 43 has been added. Thus, claims 1-7, 9, 10, 16-18, 21, 22, 26, 29, 31, 32, 37, 38, and 43 are presently pending in the application.
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 1 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of copending Application No. 18/021,968. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending claim 1 anticipates the instant claim 1.
Copending claim 17 anticipates the instant claim 16.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 31 of copending Application No. 18/256,566. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending claims 19 and 31 each anticipate the instant claim 1.
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 17, 18, 26, 29, 31, 32, 37, 38 and 43 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 17 recites “an internal chamber” in line 2, “a resiliently deformable enclosing wall” in lines 2-3, “a patient” in line 4, which have already been recited in parent claim 1. Thus, it is not expressly clear if these are new/additional elements being introduced or if they are the same elements recited in claim 1. Examiner suggests the claim be amended to read: --…wherein the sealing member comprises thetheresiliently deformable enclosing wall, the enclosing wall including the the
Claim 17 recites “such that ambient air may enter and exit the internal chamber during use” in line 6. The limitation is indefinite because it is not clear if air being able to enter and exit the internal chamber is a requirement of the claimed structure or if it is an optional limitation. Examiner suggests amending the limitation to read -- such that ambient air is able to
Claim 18 recites “a patient” in line 3, which has already been recited in parent claim 1.
Claim 26 recites the limitation "the mould" in lines 6-7. However, “one or more moulds” has been recited in line 3. Thus, it is unclear if the limitation is limiting to just one mould or if more than one mould reads on “the mould”. Examiner suggests amending the limitation to read –injecting a first polymer through the first polymer injection port into the first cavity of the one or more moulds to form a body portion…--.
Claim 29 recites the limitation "such that the later-formed portion is brought into engagement with the earlier-formed portion, during injection moulding of the later-formed portion, in a manner that fixes the body portion and the sealing member of the respiratory interface device together" in lines 4-7, which is a repeated limitation already recited in claim 26, lines 19-21.
Claim 37 recites the limitation "the mould" in lines 6-7. However, “one or more moulds” has been recited in claim 26, line 3. Thus, it is unclear if the limitation is limiting to just one mould or if more than one mould reads on “the mould”. Examiner suggests amending the limitation to read –wherein the gas inlet port projects relative to a surrounding interior surface of one of the one or more moulds that defines either the first or second cavity…--.
Claim 38 recites the limitation "the respiratory mask" in line 2. There is insufficient antecedent basis for this limitation in the claim since only “a respiratory interface device” has been recited.
Claim 43 recites “a sealing member” in line 7, which has already been recited in line 1. Examiner suggests the limitation be amended to read –the
Claims 31 and 32 are rejected based solely on their dependency to rejected claims.
Allowable Subject Matter
Claims 1 and 16 would be allowable if rewritten to overcome the Double Patenting Rejections set forth in this Office Action, or alternatively, with the filing of a Terminal Disclaimer.
Claims 2-7, 9, 10, 21, and 22 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.
Claims 17 and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 26, 29, 31, 32, 37, 38, and 43 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
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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