DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. However, it appears applicant may have incorrectly identified the status of the instant application in relation to some of the prior applications. Specifically, the instant application is a continuation of U.S. Appn. 17/388,397. The ‘397 application lists its relationship to the four earlier PCT applications as well as U.S. Appn. 12/753,856; 12/753,851; 12/753,853; 12/753,854; and 12/753,846 all as continuation-in-part. The instant application instead lists its relationship to those same nine earlier applications all as continuation (and not continuation-in-part). Thus, the instant application appears to incorrectly identify its priority benefit claim.
Applicant is reminded of the petition procedures required to correct a priority benefit claim (see MPEP § 211).
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(s) 131-134, 139-140, 142-143, 145-147 and 149-150 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 of U.S. Patent No. 9,132,250 in view of Genger et al. (U.S. Pub. 2004/0016432). Patent claim 1 implies a ventilator in its recitation of a gas source. The gas flow path through the nasal interface of patent claim 1 will obviously be found within a tubular body based upon the standard use of tubular passages to deliver gases and the common use of tubular bodies to deliver gas in nasal interfaces. Patent claims 18-20 variously recite a cross-sectional area of the gas flow path as not decreasing (patent claim 18), uniform (patent claim 19) or increasing (patent claim 20). All three of those claims read on the requirement of instant claim 131 of the cross sectional area not reducing. Patent claim 1 also recites a nozzle with the nasal interface. Patent claim 1 fails to explicitly recite a pair of gas flow paths and a pair of nasal cushions.
Genger teaches a nasal interface (Figs. 3-4; ¶0038) including a pair of gas flow paths (Figs. 3-4 one path through each #21) and a pair of nasal cushions (Figs. 3-4 #24; ¶0038). Genger teaches a pair of gas flow paths as providing the benefit of delivering gas individually to each side of a patient’s nose (¶0038) and teaches a pair of nasal cushions as providing the benefit of ergonomically sealing with the patient’s nostrils during use (¶0038).
It would have been prima facie obvious to one having ordinary skill in the art at the time of the invention to have incorporated in any patent claims 18-20 a pair of gas flow paths and a pair of nasal cushions in order to provide the benefits of delivering gas individually to each side of a patient’s nose and ergonomically sealing with the patient’s nostrils during use in view of Genger.
A further mapping of dependent claims is as follows:
Instant claim 132 vs. patent claim 20
Instant claim 133 vs. patent claim 19
Instant claim 134 as obvious in view of patent claim 1 – one of ordinary skill in the art would have obviously expected a gas flow path through a nasal interface to be round in order to provide laminar flow
Instant claim 139 as obvious in view of patent claims 18-20 – a cross sectional area which is increasing, uniform or not decreasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 140 vs. Genger (Figs. 3-4)
Instant claim 142 is obvious over any of patent claims 18-20 in view of Genger in the same manner discussed above in regard to instant claim 131
Instant claim 143 vs. patent claim 19
Instant claim 145 as obvious in view of patent claims 18-20 – a cross sectional area which is increasing, uniform or not decreasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 146 vs. Genger (Figs. 3-4)
Instant claim 147 is obvious over patent claim 20 in view of Genger in the same manner discussed above in regard to instant claim 131
Instant claim 149 as obvious in view of patent claim 20 – a cross sectional area which is increasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 150 vs. Genger (Figs. 3-4)
Claim(s) 131-134, 139-140, 142-143, 145-147 and 149-150 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 10,265,486 in view of Genger et al. (U.S. Pub. 2004/0016432). Patent claim 1 implies a ventilator in its recitation of a gas source. The gas flow path through the nasal interface of patent claim 1 will obviously be found within a tubular body based upon the standard use of tubular passages to deliver gases and the common use of tubular bodies to deliver gas in nasal interfaces. Patent claims 5-7 variously recite a cross-sectional area of the gas flow path as not decreasing (patent claim 5), uniform (patent claim 6) or increasing (patent claim 7). All three of those claims read on the requirement of instant claim 131 of the cross sectional area not reducing. Patent claim 4 also recites a nozzle with the nasal interface. Patent claim 4 fails to explicitly recite a pair of gas flow paths and a pair of nasal cushions.
Genger teaches a nasal interface (Figs. 3-4; ¶0038) including a pair of gas flow paths (Figs. 3-4 one path through each #21) and a pair of nasal cushions (Figs. 3-4 #24; ¶0038). Genger teaches a pair of gas flow paths as providing the benefit of delivering gas individually to each side of a patient’s nose (¶0038) and teaches a pair of nasal cushions as providing the benefit of ergonomically sealing with the patient’s nostrils during use (¶0038).
It would have been prima facie obvious to one having ordinary skill in the art at the time of the invention to have incorporated in any patent claims 5-7 a pair of gas flow paths and a pair of nasal cushions in order to provide the benefits of delivering gas individually to each side of a patient’s nose and ergonomically sealing with the patient’s nostrils during use in view of Genger.
A further mapping of dependent claims is as follows:
Instant claim 132 vs. patent claim 7
Instant claim 133 vs. patent claim 6
Instant claim 134 as obvious in view of patent claim 4 – one of ordinary skill in the art would have obviously expected a gas flow path through a nasal interface to be round in order to provide laminar flow
Instant claim 139 as obvious in view of patent claims 5-7 – a cross sectional area which is increasing, uniform or not decreasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 140 vs. Genger (Figs. 3-4)
Instant claim 142 is obvious over any of patent claims 5-7 in view of Genger in the same manner discussed above in regard to instant claim 131
Instant claim 143 vs. patent claim 6
Instant claim 145 as obvious in view of patent claims 5-7 – a cross sectional area which is increasing, uniform or not decreasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 146 vs. Genger (Figs. 3-4)
Instant claim 147 is obvious over patent claim 7 in view of Genger in the same manner discussed above in regard to instant claim 131
Instant claim 149 as obvious in view of patent claim 7 – a cross sectional area which is increasing, uniform or not decreasing through a nasal interface would have been obviously expected to not include abrupt angles or corners
Instant claim 150 vs. Genger (Figs. 3-4)
Allowable Subject Matter
Claims 131-150 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 131, the prior art fails to teach or suggest a ventilator system including a nasal interface of the type recited by the claim. Specifically, the claim requires a nasal interface including a pair of gas flow paths which terminate respectively in a pair of distal gas flow openings and which also each include a respective entrainment aperture. The claim further specifies that between the respective entrainment aperture and the respective distal gas flow opening a cross sectional area does not reduce. The instant application indicates this configuration as maximizing the flow rate capable of being delivered by the system into the patient, and also reduces the inhalation and exhalation resistance when compared to typical jet pump systems which include a reduction in cross section (¶000114). Additionally, the claim recites a pair of nasal cushions.
Closest prior art to the instant claim includes: Genger et al. (U.S. Pub. 2004/0016432), Matarasso (U.S. Pub. 2006/0011198), Matarasso (U.S. Pub. 2006/0180149), Duquette et al. (U.S. Pub. 2007/0074724) and Pierro et al. (U.S. Pub. 2007/0125379).
Genger (e.g. Fig. 3), Matarasso ‘198 (e.g. Figs. 3 & 7D-8B) and Matarasso ‘149 (e.g. Figs. 3, 7D & 8D-9B) each clearly include a constriction between an entrainment aperture and a distal gas flow opening, as is common when using a venturi design. Genger and both Matarasso references thus fail to teach or suggest the requirement of the instant claim that a cross sectional area does not reduce.
Pierro (e.g. Figs. 2B, 4C, 8A & 10A-10C) teaches nozzles 50a, 50b as projecting into a flow path between a distal gas flow opening (e.g. Fig. 2B #46a) and an entrainment aperture (e.g. Fig. 2B top end of #60). Thus, Pierro fails to teach or suggest the requirement of the instant claim that a cross sectional area does not reduce.
Duquette (e.g. Figs. 2 & 4A) teaches a flow path between an entrainment aperture (Fig. 4A bottom end of #64) and a distal gas flow opening (Fig. 4A #36). However, Duquette specifically intends exhalation passageway 64 to include taper portion 78 having an angle of at least 0.5 degrees (¶0058). That intended taper angle in Duquette will thus result in a reducing cross sectional area from the respective entrainment aperture and the respective distal gas flow opening, which is in contradiction to the requirements of the instant claim. It is specifically noted that the claim specifies the direction in which the prohibition of cross sectional area reduction is to be consider, i.e. from the respective entrainment aperture to the respective distal gas flow opening.
It is thus found that one having ordinary skill in the art at the time of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 142, the claim is found allowable for the same reasons discussed above in regard to claim 131.
Regarding claim 147, the claim is found allowable for the same reasons discussed above in regard to claim 131.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additionally 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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
