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 .
Claim Objections
Claim(s) 14 is/are objected to because of the following informalities:
Claim 14, Ln. 1-2 recites “between outlet” which should read “between the outlet”
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.
Claim(s) 5-6, 8-9 and 13-15 is/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 5 recites the limitation “the second end of the inlet tube and the second end of the outlet tube” in Ln. 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “the outlet of the inlet tube and the inlet of the outlet tube”.
Claim 6 recites the limitation “the patient interface” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 3, which provides the proper antecedent basis.
Claim 8 recites the limitation “the patient interface” in Ln. 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 3, which provides the proper antecedent basis.
Claim 9 recites the limitation “the patient interface” in Ln. 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 3, which provides the proper antecedent basis.
Claim 13 recites the limitation “the inlet of the medicament delivery tube” in Ln. 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the limitation will be interpreted as reading “an inlet of the medicament delivery tube”.
Claim 14 recites the limitation “the patient interface” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 3, which provides the proper antecedent basis.
Claim 15 recites the limitation “the patient interface” in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination the claim will instead be read as dependent on claim 3, which provides the proper antecedent basis.
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) 2-5, 8-11, 14-15 and 18-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,173,269 in view of Mazela et al. (U.S. Pub. 2013/0146053). All requirements of instant claim 2 are found within the overall scope of patent claim 15 with the exception of the specificity of the opening of the pressure tube being at the second end of the respiratory interface adaptor. Patent claim 15 recites a pressure port but fails to recite a specific position for the pressure port.
Mazela teaches a respiratory interface adaptor (Fig. 1A; ¶0104) having a first end (Fig. 1A left, upstream end) and a second end (Figs. 1A & 2B right, downstream end) with a pressure tube (Fig. 1A #24; ¶0104) comprising an opening (Fig. 2B right side opening of #24) at the second end of the respiratory interface adaptor. Mazela teaches pressure sensing at the second end of the adaptor as providing the benefit of detecting pressure proximal to a patient interface and in a flow of aerosol (¶¶0108, 0110).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in patent claim 15 the opening of the pressure tube being at the second end of the respiratory interface adaptor in order to provide the benefit of detecting pressure proximal to a patient interface and in a flow of aerosol in view of Mazela.
A further mapping of dependent claims is as follows:
Instant claim 3 vs. limitations in patent claim 1
Instant claim 4 vs. patent claim 15
Instant claim 5 vs. Mazela (Fig. 2B)
Instant claim 8 vs. Mazela (Fig. 2B)
Instant claim 9 vs. Mazela (Fig. 2B)
Instant claim 10 vs. Mazela (Fig. 2B)
Instant claim 11 vs. Mazela (Fig. 1A)
Instant claim 14 vs. Mazela (Fig. 2B)
Instant claim 15 vs. limitations in patent claim 1 – connection to the patient interface requires a coupling surface
Instant claim 18 vs. limitations in patent claim 1
Instant claim 19 vs. Mazela (¶¶0100, 0104)
Instant claim 20 vs. Mazela (¶¶0101, 0158)
Claim(s) 2-5, 8-11, 14-15 and 18-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,036,369 in view of Mazela et al. (U.S. Pub. 2013/0146053). All requirements of instant claim 2 are found within the overall scope of patent claim 8 with the exception of the specificity of the opening of the pressure tube being at the second end of the respiratory interface adaptor. Patent claim 8 recites a pressure port but fails to recite a specific position for the pressure port.
Mazela teaches a respiratory interface adaptor (Fig. 1A; ¶0104) having a first end (Fig. 1A left, upstream end) and a second end (Figs. 1A & 2B right, downstream end) with a pressure tube (Fig. 1A #24; ¶0104) comprising an opening (Fig. 2B right side opening of #24) at the second end of the respiratory interface adaptor. Mazela teaches pressure sensing at the second end of the adaptor as providing the benefit of detecting pressure proximal to a patient interface and in a flow of aerosol (¶¶0108, 0110).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in patent claim 8 the opening of the pressure tube being at the second end of the respiratory interface adaptor in order to provide the benefit of detecting pressure proximal to a patient interface and in a flow of aerosol in view of Mazela.
A further mapping of dependent claims is as follows:
Instant claim 3 vs. limitations in patent claim 1
Instant claim 4 vs. patent claim 8
Instant claim 5 vs. Mazela (Fig. 2B)
Instant claim 8 vs. Mazela (Fig. 2B)
Instant claim 9 vs. Mazela (Fig. 2B)
Instant claim 10 vs. Mazela (Fig. 2B)
Instant claim 11 vs. Mazela (Fig. 1A)
Instant claim 14 vs. Mazela (Fig. 2B)
Instant claim 15 vs. limitations in patent claim 1 – connection to the patient interface requires a coupling surface
Instant claim 18 vs. limitations in patent claim 1
Instant claim 19 vs. Mazela (¶¶0100, 0104)
Instant claim 20 vs. Mazela (¶¶0101, 0158)
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2-6, 8-11, 13-16 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazela et al. (U.S. Pub. 2013/0146053).
Regarding claim 2, Mazela discloses a respiratory interface adaptor (Fig. 1A; ¶0104) for delivering medical gases to a patient, the respiratory interface adaptor comprising: an inlet tube (Fig. 1A horizontal tube with #20; ¶0104) comprising an inlet port (Fig. 1A #20; ¶0104) at a first end of the respiratory interface adaptor (Fig. 1A left, upstream end) and an outlet (Figs. 1A & 2A opening downstream from #20 into #17) at a second end of the respiratory interface adaptor (Figs. 1A & 2B right, downstream end), the inlet port configured to connect to an inspiratory conduit (e.g. Fig. 8); an outlet tube (Fig. 1A horizontal tube with #22; ¶0104) comprising an outlet port (Fig. 1A #22; ¶0104) at the first end of the respiratory interface adaptor and an inlet port (Figs. 1A & 2A opening upstream from #22 coming out of #17) at the second end of the respiratory interface adaptor, the outlet port configured to connect to an expiratory conduit (e.g. Fig. 8); a medicament delivery tube (Fig. 2B #12; ¶0104) comprising an outlet (Fig. 2B #30; ¶0106) at the second end of the respiratory interface adaptor; and a pressure tube (Fig. 1A #24; ¶0104) comprising an opening (Fig. 2B right side opening of #24) at the second end of the respiratory interface adaptor, wherein the opening is configured to be in fluid communication with a pressure sensor (¶0104 – pressure sensor port).
It is noted that the claim is understood to require a broad reading of the term “end” as none of the disclosed embodiments have both the inlet tube and the outlet tube extending fully to the literal second end of the adaptor where the adaptor connects to the patient interface (e.g. Figs. 4C-4E, 5C, 6C, 6H, 7C, 7F, 8D-8E & 9A-9D). As the claim language is original claim language from the originally filed claims in the originating parent application the limitations regarding “ends” are interpreted as broadly recited and not as new matter lacking written description support. Thus, based upon the claim language where the inlet tube and the outlet tube terminate along the length of the adaptor may be read as the second end of the adaptor.
Regarding claim 3, Mazela discloses the second end of the respiratory interface adaptor is configured to be connected to a patient interface (¶0104 – patient interface port 16 is connected directly to a patient interface).
Regarding claim 4, Mazela discloses the pressure tube comprises a pressure port (Fig. 1A left end of #24) at the first end of the respiratory interface adaptor and the pressure port is configured to connect to the pressure sensor (¶0104).
Regarding claim 5, Mazela discloses the outlet of the medicament delivery tube is positioned below the outlet of the inlet tube and the inlet of the outlet tube and in close proximity to a patient interface (Fig. 2B).
Regarding claim 6, Mazela discloses the opening of the pressure tube lies on a plane perpendicular to an inlet of the patient interface (Figs. 1A & 2A-2B).
Regarding claim 8, Mazela discloses the outlet of the medicament delivery tube is configured to be substantially in alignment with an inlet of the patient interface (Fig. 2B).
Regarding claim 9, Mazela discloses the outlet of the medicament delivery tube is positioned directly above and in line with an opening of the patient interface (Fig. 2B).
Regarding claim 10, Mazela discloses the outlet of the medicament delivery tube extends past the opening of the pressure tube (Fig. 2B).
Regarding claim 11, Mazela discloses the pressure tube is located between the inlet tube and the outlet tube (Fig. 1A).
Regarding claim 13, Mazela discloses the medicament delivery tube extends above the inlet tube and the outlet tube (Fig. 2B extends up to #14) such that an inlet of the medicament delivery tube is directed away from the face of the patient.
Regarding claim 14, Mazela discloses there is a gap between the outlet of medicament delivery tube and an inlet of the patient interface (Fig. 2B).
Regarding claim 15, Mazela discloses the respiratory interface adaptor has a coupling surface for engaging the patient interface (¶0104 –direct connection to a patient interface requires a coupling surface to form the connection).
Regarding claim 16, Mazela discloses a nozzle disposed about the medicament delivery tube (Fig. 2B tapering from #17 into #12 is readable as a nozzle).
Regarding claim 18, Mazela discloses a respiratory humidification system (e.g. Figs. 1A & 8; ¶0104) for delivering medical gases to a patient, the respiratory humidification system comprising: the respiratory interface adaptor of claim 2 (see above); a patient interface (¶0104 – patient interface) configured to be connected to the second end of the respiratory interface adaptor (¶0104 – patient interface port 16 is connected directly to a patient interface).
Regarding claim 19, Mazela discloses the patient interface is a sealing interface (¶¶0100, 0104 – mask providing “adequate seal”).
Regarding claim 20, Mazela discloses a flow generator (e.g. ¶0101 – CPAP) and/or a humidifier (¶0158).
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 2, 7 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kemps et al. (WO 2014/116122 A1) in view of Pierre (U.S. Pub. 2011/0284007).
Regarding claim 2, Kemps discloses a respiratory interface adaptor (Fig. 2; ¶0046) for delivering medical gases to a patient, the respiratory interface adaptor comprising: an inlet tube (Fig. 2 beginning from #124; ¶0046) comprising an inlet port (Fig. 2 #124; ¶0046) at a first end of the respiratory interface adaptor (Fig. 2 left, upstream end) and an outlet (Figs. 9 & 11 opening downstream around #150) at a second end of the respiratory interface adaptor (Figs. 2 & 11 right, downstream end), the inlet port configured to connect to an inspiratory conduit (Fig. 1; ¶0046); an outlet tube (Fig. 2 beginning from #126; ¶0046) comprising an outlet port (Fig. 2 #126; ¶0046) at the first end of the respiratory interface adaptor and an inlet port (Figs. 9 & 11 opening upstream around #150) at the second end of the respiratory interface adaptor, the outlet port configured to connect to an expiratory conduit (Fig. 1; ¶0046); a medicament delivery tube (Fig. 2 & 10 #154; ¶0051) comprising an outlet (Figs. 10-11 into #146; ¶0051) at the second end of the respiratory interface adaptor; and a probe tube (Fig. 2 #152; ¶0051) comprising an opening (Figs. 4 & 9 downward through #152) at the second end of the respiratory interface adaptor.
It is noted that the claim is understood to require a broad reading of the term “end” as none of the disclosed embodiments have both the inlet tube and the outlet tube extending fully to the literal second end of the adaptor where the adaptor connects to the patient interface (e.g. Figs. 4C-4E, 5C, 6C, 6H, 7C, 7F, 8D-8E & 9A-9D). As the claim language is original claim language from the originally filed claims in the originating parent application the limitations regarding “ends” are interpreted as broadly recited and not as new matter lacking written description support. Thus, based upon the claim language where the inlet tube and the outlet tube terminate along the length of the adaptor may be read as the second end of the adaptor.
Kemps fails is silent as to whether the opening is configured to be in fluid communication with a pressure sensor. Kemps does not specifically discuss what type of probe is intended for use. Further, it is noted that the pressure sensor is not read as positively recited by the claim.
Pierre teaches a respiratory wye adaptor (Fig. 1 #1; ¶0011) including a pressure monitor port (Fig. 1 #3; ¶0011). Pierre teaches a connection to a pressure sensor as providing the benefit of detecting pressure changes caused by inhalation and exhalation flows during positive pressure therapy (¶0014).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Kemps the opening is configured to be in fluid communication with a pressure sensor in order to provide the benefit of detecting pressure changes caused by inhalation and exhalation flows during positive pressure therapy in view of Pierre.
Regarding claim 7, Kemps further teaches at least a portion of the pressure tube lies perpendicular to a plane of the inlet tube and a plane of the outlet tube (Fig. 2 #152 extends upwards, which is perpendicular to both the inlet and the outlet tubes).
Regarding claim 12, Kemps further teaches the pressure tube extends above the inlet tube and the outlet tube (Fig. 2 #152 extends upwards) such that the pressure port is directed away from the face of the patient.
Regarding claim 13, Kemps further teaches the medicament delivery tube extends above the inlet tube and the outlet tube (Fig. 2 #154 extends upwards) such that an inlet of the medicament delivery tube is directed away from the face of the patient.
Allowable Subject Matter
Claim(s) 17 is/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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 17, none of Mazela, Kemps or Pierre teaches or suggests the medicament delivery tube comprises a bifurcated portion that allows the medicament delivery tube to fluidly connect to a pair of nostril lumens of nasal prongs. None of the above cited references has any consideration of a bifurcated portion that allows the medicament delivery tube to fluidly connect to a pair of nostril lumens of nasal prongs. There is not found to be a preponderance of the evidence that one of ordinary skill in the art would have obviously sought to have made that specific type of modification in any of Mazela, Kemps or Pierre.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional 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
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