DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made to Applicant’s claim for priority to Non-Provisional App. No. 16/924,071 filed July 8, 2020 now Pat. No. 11,730,913; to Non-Provisional App. No. 15/436,479 filed February 17, 2017 now Pat. No. 10,744,294; to Non-Provisional App. No. 13/643,763 filed February 8, 2013 now Pat. No. 9,572,951; to National Stage App. No. PCT/NZ2011/000059 filed on April 27, 2011; and to provisional Application No. 61/328,521 filed on April 27, 2010.
Status of Claims
This Office Action is responsive to the amendment filed on September 26, 2025. As directed by the amendment: claims 2-5, 7-9, 11-12, 14-15, and 18-19 have been amended. Thus, claims 2-21 are presently pending in this application.
Applicant’s amendments to claim 18 obviate the previous objection made thereto. Applicant’s amendment to claim 18 obviate the previous Drawing objections. Claims 2 and 19, and claims 3-18 and 20-21 by dependency, are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. The rejection of claims 2 and 19 under 35 U.S.C. 101 has been maintained. Claim 18 was previously rejected under 35 U.S.C. 112(a) and 112(b). Applicant’s amendment to claim 18 obviate the previous rejection under 35 U.S.C. 112(a) and 112(b). Claims 2 and 6 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9,572,951.
Claims 2-6, 8-13, 15, 16, 19, and 20 were previously rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Radomski et al. (U.S. Pub. No. 2009/02550055) in view of Smith et al. (U.S. Publication No. 2002/0100320). Claims 7, 14, 17, and 21 were previously 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
101 Rejections
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2 and 19, and claims 3-18 and 20-21 by dependency, are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 2 recites “a gases supply passage downstream of the humidified gases supply, and upstream of a patient,”, ln 4-5 where the gases supply passage is directly defined the patient (i.e. human). Thus, the invention of claim 2 is directed to a human organism.
Similar rationale is applied to independent claim 19.
Examiner suggests amending the claims to functional claim the location of the gases supply passage in relationship to the humidified gases supply and the patient. For example: --a gases supply passage configured to be downstream of the humidified gases supply and upstream of a patient,--.
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 2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9,572,951 (hereinafter: “Patent’951”).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the instant application independent claim 2 are found in Patent’951 claim 12. Since the instant application independent claim 2 is fully encompassed by Patent’921 claim 12, the difference between the application claim and the Patent’951 claim lies in the fact that the Patent’951 claim includes more elements and is thus more specific. Accordingly, the invention of Patent’951 claim is a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. Since the application claims are anticipated by the Patent’951 claim, it is not patentably distinct from the patent claim
Furthermore:
Instant claim 6 is unpatentable over claim 12 of Patent '951 because they recite the same limitations.
Allowable Subject Matter
Claims 7, 14, 17, and 21 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.
The following is a statement of reasons for the indication of allowable subject matter: Prior art of Radomski et al. (U.S. Pub. No. 2009/02550055) discloses an apparatus for a supply of humidified gases to a patient, the apparatus comprising: a humidified gases supply (2, 24, 27, 28; Fig. 3, 4), a gases supply passage (4, 16, 26; Fig. 1, 3; ¶¶ 0036, 0039) downstream of the humidified gases supply (Fig. 3), and upstream of a patient (¶ 0041), a first temperature sensor (6; Fig. 1, 3, 5) and a second sensor (7; Fig. 1, 3, 5) embedded in or located on an outside of a wall (11; Fig 1, 3, 5) of the gases supply passage (¶¶ 0038-0043; Fig. 3, 5), , and a controller (5; Fig. 1) receiving an output of each of the first and second sensors (¶¶ 0038-0043) and adapted to derive from the output of each of the first and second sensors, an estimation of a property of gases flowing through the gases supply passage (“temperature” and “humidity”; ¶¶ 0038, 0040) and to provide a control output to the humidified gases supply according to the output of each of the first and second temperature sensors (¶¶ 0040-0043); wherein the wall of the gases supply passage divides the first and second temperature sensors from a flow of gases in the gases supply passage [Fig. 1, 3; ¶¶ 0036-0039; Examiner notes: Radomski discloses a sensor housing (23) comprising a sensor block (15) containing a plurality of sensors including the first and second sensors (Fig. 3). Radomski discloses the sensor housing as being embedded into the wall of the conduit (4; Fig. 1; ¶ 0038) such that a portion of the wall (11; Fig. 1, 3) is between the flow of humidified gas and the second sensor (¶¶ 0036-0039).] and the first sensor and the second sensor are provided at spaced apart locations (Fig. 3-5).
Prior art of record Radomski et al. and Smith et al. alone or in combination fails to disclose or render obvious the apparatus:
“wherein one of the first sensor and the second sensor being located in a location where liquids may accumulate in the gases supply passage and the other being located in a location where liquids will not accumulate in the gases supply passage, the controller being adapted to calculate an estimate of relative humidity of gases flowing through the gases supply passage based on the outputs of the first and second sensor”, as recited in dependent claims 7 and 14.
“wherein the first temperature sensor is positioned at a location that is an upward leg of the elbow and the second temperature sensor is positioned at a horizontal leg of the elbow”, as recited in dependent claims 17 and 21.
Response to Arguments
Applicant's arguments filed September 26, 2025 have been fully considered but they are not persuasive. Applicant’s asserts that amendments to independent claims 2 and 19 obviate the previous rejection under 35 U.S.C. 101, Pg. 8-9.
Examiner respectfully disagrees. Applicant’s amendments to independent claims 2 and 19 fail to address the limitation “a gases supply passage downstream of the humidified gases supply, and upstream of a patient,” being directed to or encompassing a human organism. As such, the previous rejection under 35 U.S.C. 101 has been maintained. Examiner suggests amending the claims to functional claim the location of the gases supply passage in relationship to the humidified gases supply and the patient. For example: “a gases supply passage configured to be downstream of the humidified gases supply and upstream of a patient,”.
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 ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785