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 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) 1-20 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 1 recites the limitation “the user port is configured to collect physiological information of the user” in Ln. 16 which deems the claim indefinite. The term “port” in ordinary language is merely an opening or extension. A “port” itself does not appear suitable to perform the claimed function of collecting physiological information of the user. Rather, it appears that some form of physiological sensor must be located at the user port in order to allow the user port to sufficiently perform the claimed function of collecting physiological information of the user. Note how such a physiological sensor is discussed in ¶0060 of the instant specification. The limitation thus appears to be overly broad by attempting to improperly recite a function without reciting sufficient structure to perform the claimed function (see MPEP 2173.05(g)). For the purposes of examination the limitation will be interpreted as reading “the user port includes a physiological sensor configured to collect physiological information of the user”.
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) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-17 of U.S. Patent No. 12,053,584. Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 1 are found within the overall scope of patent claim 1, the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 2 vs. patent claim 1
Instant claim 3 vs. patent claim 1
Instant claim 4 vs. patent claim 2
Instant claim 5 vs. patent claim 3
Instant claim 6 vs. patent claim 4
Instant claim 7 vs. patent claim 7
Instant claim 8 vs. patent claim 8
Instant claim 9 vs. patent claim 9
Instant claim 10 vs. patent claim 10
Instant claim 11 vs. patent claim 11
Instant claim 12 vs. patent claim 12
Instant claim 13 vs. patent claim 13
Instant claim 14 vs. patent claim 14
Instant claim 15 vs. patent claim 15
Instant claim 16 vs. patent claim 16
Instant claim 17 vs. patent claim 1
Instant claim 18 vs. patent claim 1
Instant claim 19 vs. patent claim 17
Instant claim 20 vs. patent claim 5
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) 1, 13 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haveri (U.S. Pub. 2013/0253336).
Regarding claim 1, Haveri discloses a respiratory system (Fig. 1; ¶¶0017), comprising: a gas-providing circuit (¶0017 – ventilator circuit connected to Fig. 1 #10); a coupler (Fig. 1 #1 including #2, 3; ¶0014); and a gas-delivering circuit (¶0017 – endotracheal tube or mask connected to Fig. 1 #8); wherein the coupler comprises: a first connecting portion (Fig. 1 #9; ¶0017); an accommodating portion (Fig. 1 between #7 and #9); and a second connecting portion (Fig. 1 #7; ¶0017); wherein the first connecting portion is connected to the gas-providing circuit (¶0017); the second connecting portion is connected to the gas-delivering circuit (¶0017); the gas-providing circuit, the coupler, and the gas-delivering circuit form a pathway for providing the gas to a user at a patient side of the coupler (Fig. 1; ¶0017); the accommodating portion is provided with at least one sensor (Fig. 1 any of #18, 27, 28; ¶¶0020-0021), wherein the at least one sensor comprises a sensor configured to measure a first parameter of the gas passing through the coupler (¶¶0020-0021 – flow, pressure or oxygen concentration); and wherein the system further comprises a user port (Fig. 1 #12, 16; ¶0018) provided in the accommodating portion, wherein the user port includes a physiological sensor (Fig. 1 #14; ¶¶0018, 0027 – measures exhaled carbon dioxide) configured to collect physiological information of the user (¶¶0018, 0025, 0027 – measures patient end tidal carbon dioxide). It is noted that the instant application uses the term "circuit" in a broader sense than is standard in the art as the term "circuit" is used in the instant application to refer to any connected element of the system and not merely the tubing of the system. Applicant may wish to consider specifying the user port as collecting physiological information of the user when the user contacts a finger to the user port, as appears to be the intent of the instant application’s user port (e.g. ¶0060).
Regarding claim 13, Haveri discloses a battery (Fig. 1 #22; ¶0014) for providing power for the coupler.
Regarding claim 16, Haveri discloses the at least one sensor comprises at least one of an FiO2 sensor (Fig. 1 #18; ¶0016)
Regarding claim 17, Haveri discloses the gas-delivering circuit is one of .
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, 10-11, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haveri (U.S. Pub. 2013/0253336) in view of Choncholas (U.S. Pub. 2007/0062532).
Regarding claim 2, Haveri discloses the gas-providing circuit comprises a main board device (¶0017 – a ventilator circuit will be connected to a ventilator) configured for providing the gas. It is noted that the terminology “main board device” is not a common term of art and is thus interpreted in light of the instant specification as referring to a gas and/or oxygen delivery device (e.g. ¶0039).
Haveri fails to expressly disclose the coupler is communicatively connected to the main board device; and the at least one sensor is configured to send the first parameter of the gas to the main board device.
Choncholas teaches a respiratory system (Fig. 1; ¶0039) including a coupler (Fig. 1 #57; ¶0041) having a sensor (Fig. 1 #62, 66, 70; ¶0041), and wherein the coupler is communicatively connected to a gas delivery device (Fig. 1 #10; ¶0039); and the one sensor is configured to send a sensed parameter to the gas delivery device (Fig. 1 along #72; ¶¶0041, 0045). Choncholas teaches communication between a sensing coupler and a gas delivery device as providing the benefit of using sensed gas delivery parameters as control feedback during respiratory treatment (¶¶0041, 0045).
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 incorporated in Haveri the coupler is communicatively connected to the main board device; and the at least one sensor is configured to send the first parameter of the gas to the main board device in order to provide the benefit of using sensed gas delivery parameters as control feedback during respiratory treatment in view of Choncholas.
Regarding claim 3, Haveri teaches the invention as modified above and further teaches the coupler is powered by the main board device (¶0014 – can be connected through an electrical cable to transmit electrical power).
Regarding claim 4, Haveri teaches the invention as modified above and together with Choncholas further teaches a working mode of the coupler is acquired by the main board device according to attribute information provided by the coupler (Haveri – Fig. 1; ¶0014; Choncholas – Fig. 1; ¶¶0041, 0045). It is noted that the claim does not specify what is to be meant by a working mode. Thus, any information transmitted from the coupler which indicates that the coupler is actively working can be considered as a working mode of the coupler. Additionally, the claim only requires a single working mode which means that the prior art does not need to differentiate between different working modes.
Regarding claim 5, Haveri teaches the invention as modified above and further teaches a resistance (Fig. 1 #29; ¶0019 – barrier) provided in the accommodating portion; wherein the attribute information is a value of the resistance (¶0020 – flow data is communicated), and different values of the resistance correspond to different working modes of the coupler (each discrete flow rate measured by the flow sensor may be read as a different working mode). It is noted that the claim does not recite any change in operation or structure of the coupler in relation to the different working modes. Thus, the different working modes of the claim can be read as merely the normal operation of the coupler at different provided flow rates through the coupler.
Regarding claim 6, Haveri teaches the invention as modified above and further teaches the different working modes of the coupler correspond to different flow rates of the gas (¶¶0019-0020).
Regarding claim 7, Haveri teaches the invention as modified above and further suggests as obvious the working mode of the coupler is used by the main board device to adjust a coupling mode set on the main board device. The active communication of data from the coupler to the main board device in the modified Haveri (see discussion in the rejection of claim 4 above) can be read as causing the main board device to recognize that data is being communicated with that receipt of data, as opposed to an absence of data transmission, being readable as an adjusting of a coupling mode. It is noted that the claim does not specify what is to be meant by a coupling mode.
Regarding claim 10, Haveri teaches the invention as modified above and further teaches the coupler is triggered to operate upon receiving a triggering instruction from the main board device (¶0014 – when the battery is depleted electrical power is required, with an electrical corded connection readable as a triggering).
Regarding claim 11, Haveri teaches the invention as modified above and Choncholas as incorporated therein further suggests as obvious the gas-providing circuit further comprises a gas-heating conduit (Choncholas – ¶0040 – heater on patient limb 36); the gas-heating conduit is operatively connected to the main board device and the first connecting portion of the coupler respectively (Choncholas – Fig. 1); and the gas-heating conduit is configured to heat gas provided by the main board device (Choncholas – Fig. 1; ¶0040).
Regarding claim 15, Haveri fails to expressly disclose the coupler is operatively connected to the gas-providing circuit in a sealed manner.
Choncholas teaches a respiratory system (Fig. 1; ¶0039) including a coupler (Fig. 1 #57; ¶0041) having a sensor (Fig. 1 #62, 66, 70; ¶0041) and teaches that the respiratory system should be sealed (¶0003). One of ordinary skill in the art would have considered it prima facie obvious that respiratory treatment needs to be generally applied in a sealed manner in order to protect the patient’s airways from exterior contamination.
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 incorporated in Haveri the coupler is operatively connected to the gas-providing circuit in a sealed manner in order to provide the benefit of applying the common practice in the respiratory arts of ensuring respiratory treatment is provided in a sealed manner to protect the patient’s airways in view of Choncholas.
Regarding claim 20, Haveri teaches the invention as modified above and further teaches the working modes of the coupler are capable of comprising an adult mode and a pediatric mode. It is again noted that the claim does not recite any change in operation or structure of the coupler in relation to the different working modes. Thus, the adult mode and the pediatric mode of the claim can be read as merely the normal operation of the coupler when used with different patient types. Haveri teaches an intent to use its device with both adult and smaller patients (¶0004).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haveri (U.S. Pub. 2013/0253336) in view of Creusot et al. (U.S. Pub. 2019/0275281).
Regarding claim 14, Haveri discloses at least one of a filter (¶0020)
Haveri fails to explicitly disclose the filter is an HEPA filter.
Creusot teaches a respiratory system (e.g. Fig. 1) and teaches a HEPA filter as a particular species of filter known to be effective in removing dust or other allergens within a gas flow path (¶0059).
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 Haveri the filter is an HEPA filter in order to provide the benefit of selecting a particular species of filter known to be effective in removing dust or other allergens within a gas flow path in view of Creusot.
Allowable Subject Matter
Claim(s) 8-9, 12 and 18-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 8, Haveri fails to teach or suggest an indicator provided in the accommodating portion; wherein the indicator is triggered to generate a notification under a condition that the working mode of the coupler is inconsistent with a coupling mode set on the main board device. The claim requires a particular comparison of mode information between the coupler and the main board device in order to trigger generating of a notification when the recited modes are inconsistent. Haveri has no consideration of that type of mode comparison.
Other prior art of particular note in regard to claim 1 are Tagawa et al. (U.S. Pub. 2011/0265795; Figs. 1-2 with microphone 4 as a physiological sensor) and Karamolegkos et al. (U.S. Pub. 2021/0138170; Figs. 2-3 with camera 104 as a physiological sensor). However, neither Tagawa nor Karamolegkos teach or suggest the type of mode comparison required by the instant claim.
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.
Regarding claim 12, Haveri fails to teach or suggest the coupler is triggered to operate under a condition that the first connecting portion and the second connecting portion are respectively assembled to the gas-providing circuit and the gas-delivering circuit. The claim imposes a limit on the coupler that it is not triggered to operate until both the gas-providing circuit and the gas-delivering circuit have been assembled to the coupler. Haveri has no consideration of making operation of gas analyzer 1 contingent on connection at both ends to other elements.
Other prior art of particular note in regard to claim 1 are Tagawa et al. (U.S. Pub. 2011/0265795; Figs. 1-2 with microphone 4 as a physiological sensor) and Karamolegkos et al. (U.S. Pub. 2021/0138170; Figs. 2-3 with camera 104 as a physiological sensor). However, neither Tagawa nor Karamolegkos teach or suggest the type of constrained triggering of operation upon assembly required by the instant claim.
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.
Regarding claim 18, Haveri fails to teach or suggest the coupler further comprises a heater configured to heat the gas passing through the coupler. Haveri has no consideration of a heater at gas analyzer 1. The closest teaching in Haveri is that the flow detector 27 can operate by using hot wire technology (¶0020). However, one of ordinary skill in the art would recognize that using hot wire technology in a flow detector 27 would not be reasonably understood as heating gas passing through the gas analyzer 1 as the hot wire technology in a flow sensor is highly localized to only the point of flow detection.
Other prior art of particular note in regard to claim 1 are Tagawa et al. (U.S. Pub. 2011/0265795; Figs. 1-2 with microphone 4 as a physiological sensor) and Karamolegkos et al. (U.S. Pub. 2021/0138170; Figs. 2-3 with camera 104 as a physiological sensor). However, neither Tagawa nor Karamolegkos teach or suggest a heater in their coupler.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
