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 in response to the preliminary amendment filed 9/17/2024. As directed by the amendment, claims 1-39 have been cancelled, and claims 40-65 have been added. As such, claims 40-65 are pending in the instant 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.
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Claims 40-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,905,843 in view of Jackson et al. (WO 2015/038014 A1; hereinafter “Jackson”). The patented claims recite all of the limitations of the instant claims, except patented claim 1 is silent regarding the controller is configured to control the set point also based on “the type of therapy.” However, Jackson teaches that it was known in the respiratory humidifier art before the effective filing date of the claimed invention to control a temperature set point associated with a humidifier heater based on the type of therapy (the targeted temperature of the gas…can be about 37 ˚C for an invasive mode or an OptiflowTM mode and about 31 ˚C for a non invasive mode, para [0268]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify patented claim 1 to include wherein the controller is configured to control the set point also based on the type of therapy as taught by Jackson, in order to provide the predictable result of providing temperature control in the system based on a suitable delivery temperature depending on the needs of the patient, which vary based on mode/type of therapy/delivery interface.
Claims 40-43 and 45-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5 and 8 of U.S. Patent No. 12,029,585 in view of Jackson. Patented claim 1 anticipates the limitations of instant claims 40-42 and 46, except patented claim 1 is silent regarding the controller is also configured to “control the set point based on the type of therapy.” However, Jackson teaches that it was known in the respiratory humidifier art before the effective filing date of the claimed invention to control a temperature set point associated with a humidifier heater based on the type of therapy (the targeted temperature of the gas…can be about 37 ˚C for an invasive mode or an OptiflowTM mode and about 31 ˚C for a non invasive mode, para [0268]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify patented claim 1 to include wherein the controller is configured to control the set point based on the type of therapy as taught by Jackson, in order to provide the predictable result of providing temperature control in the system based on a suitable delivery temperature depending on the needs of the patient, which vary based on mode/type of therapy/delivery interface. The patented claims lack the structure of the humidifier recited in instant claim 43; however, Jackson Fig. 1 demonstrates that this was a well-known respiratory humidifier structure before the effective filing date of the claimed invention; therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to include in the patented claims in order to recite a common respiratory humidifier structure for providing the patented humidification functionality. The patented claims lack the details of instant claim 45 regarding how the set point is controlled; however, Jackson paras [0155] and [0266-267] in combination with general knowledge would have rendered the claimed process obvious in order to predictably change a setpoint on a processor. Patented claim 8 anticipates/renders obvious instant claim 47 because rooms/the ambient atmosphere of earth contain/comprise air, and patented claim 5 renders obvious instant claim 48 because it would have been obvious to an artisan before the effective filing date of the claimed invention to generate and provide an indicator corresponding the set point temperature for communication to a user when requesting the patented user confirmation of setpoint adjustment, in order to predictable allow the user to know/see what change(s) are being made.
Claim Objections
Claims 52 and 65 are objected to because of the following informalities:
Applicant may have intended claim 52, line 2 to read “expiratory circuit or the expiratory conduit” in order to encompass both of the alternatives of claim 51
Claim 65, lines 2-3 should read “non-air-entraining” and “air-entraining”
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.
Claims 40-65 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.
Regarding claim 40 (and thus its dependent claims 40-65), lines 6 and 8 recite “respiratory gases,” wherein it is unclear in the claim whether these are the same or different, and whether they are the same or different from the respiratory gases of line 4. As best understood, for purposes of examination, they are all the same, such that Applicant could address this rejection by amending claim 40, lines 6 and 8 to read each “the respiratory gases” (two instances total).
Further regarding claim 40 (and thus its dependent claims 40-65), line 7 recites “gases source,” wherein it is unclear in the claim whether this is the same gases source as line 2 or different. As best understood, for purposes of examination, they are the same, such that Applicant could address this rejection by amending claim 40, lines 7 to read “the gas source”.
Claim 40 (and thus its dependent claims) recites the limitation "the type of therapy" in the last two lines. There is insufficient antecedent basis for this limitation in the claim. As best understood, in light of the specification, claim 40 will be considered to read “a type of therapy to be delivered to the patient by the respiratory assistance system.”
Regarding claims 41-43, the claims recite “further comprising a patient interface/an inspiratory conduit/a humidification chamber,” wherein it is unclear in the claims if these are in addition to those recited in the preamble of claim 40 or are intended to be positively reciting those same elements. As best understood, for purposes of examination, it is the latter, such that Applicant could amend claims 41-43 to read “further comprising the patient interface/the inspiratory conduit/the humidification chamber, the patient interface/the inspiratory conduit/the humidification chamber configured/comprising” to address these rejections.
Further regarding claim 41, it is unclear in the claim whether the flow of gases and gases source in line 2 are the same or different from that of claim 40. As best understood, for purposes of examination, they are the same, such that Applicant could address this rejection by amending claim 41, line 2 to read “the flow…the gases source”.
Claims 55, 56 and 60-63 recite the limitations “the detection of the breathing pattern/bias flow/rebreathing” in lines 1-2 of each claim. There is insufficient antecedent basis for these limitations in the claims. Applicant could amend claims 55, 56 and 60-63 to depend from claim 54 (rather than claim 53), which would provide the requisite antecedent basis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reference teaching taking into account gas source type (e.g. air entraining and/or dry gas supply) when controlling a respiratory humidifier: Becker et al. (US 8,100,124 B2; col. 1, lines 61-62, col. 2, lines 21-32, col. 4, lines 10-17 and 42-59). Additional references teaching taking into account an operating mode and/or patient interface type when controlling a humidifier setpoint: Ghalib et al. (US 2014/0116433 A1); Arcilla et al. (US 2013/0263851 A1; para [0060]); Andrieux et al. (US 2010/0078017 A1; paras [0301], [0306]). References teaching gas source identification in respiratory devices: Acker et al. (WO 2015/172160 A1); de Silva et al. (US 2003/0106554 A1); Desilva (CA 2915686). References teaching known humidifier temperature set point control: Huddart et al. (US 2006/0113690 A1); Hunt et al. (US 2004/0221844 A1); Kock (US 2008/0190426 A1); Muller (US 2010/0132707 A1); Pujol et al. (US 2008/0307100 A1); Seakins et al. (US 2001/0050080 A1); Tatkov et al. (US 2014/0166005 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M 7:30a-3:30p, Tu-Th 8a-2p, F 7:30-11:30a ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785
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