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 .
Preliminary Amendment
This office action is responsive to the preliminary amendment filed on 5/26/23. As directed by the amendment: no claims have been amended, claims 1-30 have been canceled, and new claims 31-50 have been added. Thus, claims 31-50 are presently pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1 in fig. 13A. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 39-40 are objected to because of the following informalities:
Claim 40 recites “and conduit” in line 5, suggested to be changed to --and a conduit-- for grammatical reasons.
Claims 39 and 40 recite “of drying mode” in the last line, suggested to be changed to --of the drying mode-- in order to refer back to the drying mode recited earlier. 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 41 and 46 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.
Claim 41 recites “a conduit” however it is unclear if applicant is referring back to the conduit recited in claim 40 or introducing a new and different conduit. Clarification is required.
Claim 46 contains the trademark/trade name USB. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an export device and, accordingly, the identification/description is indefinite.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 31-36, 38-45, 47-48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Payton et al. (2008/0190427) in view of Choncholas et al. (2008/0091117) and Makinson et al. (2004/0016430).
Regarding claim 31, in fig. 1 Payton discloses a system for providing a self-drying (abstract) high-flow (compared to lower flow) breathing apparatus, the system comprising: a controller 9 comprising a microprocessor [0069] configured to execute software commands stored in associated memory [0069], the controller configured to determine characteristics of flows [0071] and operation of the apparatus [0071]; one or more sensors configured to provide feedback to the controller regarding gas flow [0071][0094]; a blower 15, a humidifier 8 having a heatable water chamber (5 is heatable by heater plate 7), and a conduit 3 arranged serially and thereby configured to provide humidity-controlled [0071], high flow air [0073] through the conduit as controlled by the controller; the controller configured to cause the system to enter a drying mode [0082-0088], but is silent regarding a display comprising menus, graphics, and text, and display a mode indication on the display. However, in fig. 3 Choncholas teaches a display 102 comprising menus 108, graphics [0056], and text (see text on display in fig. 3), and display a mode indication on the display [0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Payton’s system with the addition of a display, as taught by Payton, for the purpose of providing visual information to the user or clinician. The modified Payton is silent regarding that the display configured to use information from the controller or one or more sensors to show usage time for compliance reporting. However, in fig. 6 Makinson teaches a display 50 configured to use information from the controller [0048] or one or more sensors to show usage time for compliance reporting (see usage time for compliance reporting to clinician in fig. 6). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified Payton’s display with the addition of showing usage time for compliance reporting, as taught by Makinson, for the purpose of providing visual information regarding compliance to the user or clinician.
Regarding claim 32, the modified Payton discloses enabling exporting of compliance data using a wired ([0049] Makinson) or wireless protocol.
Regarding claim 33, the modified Payton discloses at least one circuit (within microprocessor of controller [0069] Payton, or breathing circuit seen in fig. 1 of Payton) configured to measure gas properties ([0086] Payton).
Regarding claim 34, the modified Payton discloses at least one of the one or more sensors is positioned on or about the conduit ([0071][0094] one of the flow sensors is positioned about the conduit, or near the conduit, due to its location on the patient interface or blower, Payton).
Regarding claim 35, the modified Payton discloses the usage time for compliance reporting is configured to facilitate interaction with a health professional (Fig. 6, [0049] Makinson).
Regarding claim 36, the modified Payton discloses at least one of the one or more sensors is positioned on or about the blower or humidifier in a main body of the system that is upstream from the conduit ([0071][0094] one of the flow sensors is positioned about the blower, due to its location in the blower, Payton).
Regarding claim 38, the modified Payton discloses a heater plate (7, Payton) configured to contact and heat the water chamber ([0069][0071] Payton) to provide humidity control as directed by the controller ([0071] Payton).
Regarding claim 39, the modified Payton discloses that the display is further configured to display the usage time ([0048], fig. 6, Makinson) and enter drying mode after therapeutic use of the system ([0050] Choncholas teaches displaying the mode, Payton discloses entering the drying mode after therapeutic use [0085]).
Regarding claim 40, in fig. 1 Payton discloses high-flow (compared to lower flow) breathing assistance apparatus comprising: a flow generator 15; a humidifier chamber 5; and the flow generator connected to and configured to generate a flow of gases through the humidifier chamber and conduit 3 [0069]; a heater 7 configured to heat water in the humidifier chamber [0071], thereby humidifying the flow of gases in the humidifier chamber [0071]; the apparatus configured to: use the flow generator to cause gases to flow through the humidifier chamber and conduit toward a user [0069], and enter a drying mode wherein gases flow during a drying period [0082-0088], but is silent regarding a display screen configured to provide visual information to a user and displaying an indication of a mode on the display screen. However, in fig. 3 Choncholas teaches a display screen 102 configured to provide visual information to a user (Fig. 3) and displaying an indication of a mode on the display screen [0050] and Payton discloses a drying mode [0082-0088]. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Payton’s system with the addition of a display screen and displaying the drying mode during drying the mode, as taught by Choncholas and Payton, for the purpose of providing visual information to the user or clinician. The modified Payton is silent regarding that the display is configured to include an indication of usage time; while displaying on the display screen therapy information comprising one or more of humidity, temperature, and flow rate information. However, in fig. 6 Makinson teaches a display 50 configured to include an indication of usage time ([0048] see usage time for compliance reporting to clinician in fig. 6); while displaying on the display screen therapy information comprising one or more of humidity [0048], temperature, and flow rate information. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified Payton’s display with the addition of showing usage time for compliance reporting as well as humidity, as taught by Makinson, for the purpose of providing visual information regarding compliance and humidity to the user or clinician.
Regarding claim 41, the modified Payton discloses a conduit (3, Payton) comprising a heater wire (11 [0069] Payton), wherein the drying mode causes gases to flow through and dry the conduit during the drying period ([0082-0088] Payton).
Regarding claim 42, the modified Payton discloses a power button ([0085] Payton), the apparatus configured to enter the drying mode after the power button is pressed ([0085] Payton).
Regarding claim 43, the modified Payton discloses the indication of usage time comprises usage hours compliance data ([0048] Makinson).
Regarding claim 44, the modified Payton discloses the indication of usage time comprises an indication of the average number of hours of usage per day ([0053] Makinson).
Regarding claim 45, the modified Payton discloses the apparatus is configured to facilitate export of the indication of usage time from the apparatus by any suitable technique ([0049] Makinson).
Regarding claim 47, the modified Payton discloses that the apparatus is configured to operate in a reduced power mode ([0085] in the drying mode the heater plate is off, which reduces the power of the apparatus, or [0077] in the warm up mode when low flow is provided, which reduces the power of the apparatus Payton).
Regarding claim 48, the modified Payton discloses that the apparatus is configured to reduce the power used by the heater when the apparatus enters the reduced power mode ([0085] in the drying mode the heater plate is off, which reduces the power of the apparatus, Payton).
Regarding claim 50, the modified Payton discloses the apparatus is configured to use the heater to perform a warm-up procedure to heat the water ([0078] Payton).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Payton, Choncholas and Makinson, as applied to claim 31 above, in further view of Taylor et al. (2013/0263854).
Regarding claim 37, the modified Payton discloses that the one or more sensors are configured to provide real time readings of flow rate (time is real, and therefore the readings of the flow rate are real time readings [0094] Payton), but is silent regarding real time readings of oxygen level. However, Taylor teaches an oxygen sensor that detect the oxygen level of the air pumped to the patient [0064]. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified Payton’s one or more sensors with the addition of an oxygen sensor, as taught by Taylor, for the purpose of preventing incorrect levels of oxygen to a user ([0064] Taylor).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Payton, Choncholas and Makinson, as applied to claim 40 above, in further view of Barlow et al. (2014/0137870).
Regarding claim 46, the modified Payton is silent regarding that the apparatus is configured to facilitate export of the indication of usage time by USB. However, Makinson teaches the export of the indication of usage time [0049] and Barlow teaches the transfer of data by USB [0191]. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified Payton’s apparatus with the addition of export of the indication of usage time by USB, as taught by Makinson and Barlow, for the purpose of transferring data as needed.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Payton, Choncholas and Makinson, as applied to claim 47 above, in further view of Taylor et al. (2013/0263854).
Regarding claim 49, the modified Payton discloses a blower (Payton 15) that is used at reduced power mode upon warming up ([0077] Payton), but is silent regarding that that the apparatus comprises a motor. However, Taylor teaches an apparatus that comprises a blower and a motor ([0060] blower motor). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified Payton’s blower with a blower having a motor, as taught by Taylor, for the purpose of providing an alternate blower having the predictable results of providing flow to an apparatus. The modified Payton discloses that the apparatus is configured to reduce the power used by the motor when the apparatus enters the reduced power mode ([0077] during the warm up period when the blower motor power is reduced, Payton).
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 40-41, 43 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,596,752. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are broader than the patented claim (i.e. the instant claims do not include “a warm-up procedure” found in patented claim 10). Therefore, any infringement over the patented claim would result in infringement over current claims.
Claims 42 and 47-48 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,596,752 in view of Payton et al. (2008/0190427).
Patented claim 10 fails to teach a power button, the apparatus configured to enter the drying mode after the power button is pressed, with respect to claim 42. However, Payton teaches a power button ([0085] Payton), the apparatus configured to enter the drying mode after the power button is pressed ([0085] Payton). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s apparatus with a power button, as taught by Payton, for the purpose of providing a button to allow for the drying mode.
Patented claim 10 fails to teach the apparatus is configured to operate in a reduced power mode, with respect to claim 47. However, Payton teaches an apparatus is configured to operate in a reduced power mode ([0085] in the drying mode the heater plate is off, which reduces the power of the apparatus, or [0077] in the warm up mode when low flow is provided, which reduces the power of the apparatus). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s apparatus with a reduced power mode, as taught by Payton, for the purpose of drying the conduit.
Patented claim 10 fails to teach the apparatus is configured to reduce the power used by the heater when the apparatus enters the reduced power mode, with respect to claim 48. However, Payton teaches the apparatus is configured to reduce the power used by the heater when the apparatus enters the reduced power mode ([0085] in the drying mode the heater plate is off, which reduces the power of the apparatus, Payton). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s apparatus with an apparatus configured to reduce the power used by the heater when the apparatus enters the reduced power mode, as taught by Payton, for the purpose of allowing for the drying mode.
Claims 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,596,752 in view of Makinson et al. (2004/0016430).
Patented claim 10 fails to teach the indication of usage time comprises an indication of the average number of hours of usage per day, with respect to claim 44. However, Makinson teaches the indication of usage time comprises an indication of the average number of hours of usage per day ([0053] Makinson). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s usage with an average number of hours of usage per day, as taught by Makinson, for the purpose of providing compliance data to a user or clinician.
Patented claim 10 fails to teach the apparatus is configured to facilitate export of the indication of usage time from the apparatus by any suitable technique, with respect to claim 45. However, Makinson teaches the apparatus is configured to facilitate export of the indication of usage time from the apparatus by any suitable technique ([0049] Makinson). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s apparatus with indication of usage time, as taught by Makinson, for the purpose of providing compliance data to a user or clinician.
Claim 46 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,596,752 in view of Makinson et al. (2004/0016430) and Barlow et al. (2014/0137870).
Patented claim 10 fails to teach the indication of usage time comprises an indication of the average number of hours of usage per day, with respect to claim 46. However, Makinson teaches the export of the indication of usage time [0049] and Barlow teaches the transfer of data by USB [0191]. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify claim 10’s apparatus with the addition of export of the indication of usage time by USB, as taught by Makinson and Barlow, for the purpose of transferring data as needed.
Claim 49 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11,596,752 in view of Payton, as applied to claim 47 above, in further view of Taylor et al. (2013/0263854).
Patented claim 10 is silent regarding a motor and wherein the apparatus is configured to reduce the power used by the motor when the apparatus enters the reduced power mode, with respect to claim 49. However, Taylor teaches an apparatus that comprises a blower and a motor ([0060] blower motor) and Payton teaches that the blower is used at reduced power mode upon warming up ([0077] Payton). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified claim 10’s apparatus with a blower having a motor used at reduced power upon warming up, as taught by Taylor and Payton, for the purpose of providing an alternate flow generator having the predictable results of providing flow to an apparatus.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bonassa et al. (2013/0125883) directed towards a lung ventilation device having a display and O’Donnell et al. (2008/0310994) directed towards a breathing assistance apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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