DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. This office action is responsive to the amendment filed on February 25, 2026 and Request for Continued Examination (RCE) filed 3/13/26. As directed by the amendment: claims 1 and 7 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1 and 3-13 are presently pending in this application.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/26 has been entered.
Claim Rejections - 35 USC § 102
3. 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.
4. 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.
5. Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mon et al. (US 5,193,532).
Regarding claim 1, Mon discloses a device for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment (fig. 4) comprising a body (fig. 4, plastic body 19A), said body comprising:
a singular fresh gas flow inlet (fig. 4, connection tube 21) arranged to receive a fresh gas flow (col. 3 lines 26-31 states that channel 20 receives fresh-gas supply from a hose via connection tube 21, see col. 3, lines 28-29) from a fresh gas flow tube connectable thereto (fig. 4, connection tube 21 allows attachment to a hose that supplies a fresh gas supply, see col. 3 lines 26-31);
a patient interface end (fig. 4, channels 11) which is connectable with a patient interface (fig. 6, attachment 23 for contacting a patient’s nose can be attached, see col. 3, lines 29-34);
an outlet (fig. 3, second branch-channel 12 opens to the atmosphere, see col. 2, lines 44-47) having an open end (fig. 4, breathing-channel 10 is shown with an opening on the plastic body 19A); and
several variable flow CPAP generators (fig. 4, shows two parallel channels 11, 12, and 13, see col. 3, lines 26-28), wherein each of the several variable flow CPAP generators is connected with the singular fresh gas flow inlet (col. 4, lines 33-35 state that the supply channel 20 is connected to each channel system), the patient interface end (fig. 4, channels 11) and the outlet of the device (fig. 3, channel 12 exits out of the device), wherein the device is configured such that a CPAP level generated by the variable flow CPAP generators is adjustable by varying the fresh gas flow to the fresh gas flow inlet and thereby to the variable flow CPAP generators (col. 4, lines 9-13 states that the flow provided via the inlet channel may be adjusted to obtain an adjustable positive pressure within the breathing channel),
wherein each of the several variable flow CPAP generators (fig. 3, breathing-channel 10) comprises first (fig. 3, channel 13), second (fig. 3, channel 11), and third connection portions (fig. 3, channel 12), and wherein the first connection portion is connected with the singular fresh gas flow inlet (fig. 3, shows inlet 20 feeding into breathing-channel 10), the second connection portion is connected with the patient interface end (fig. 4, channels 11 are attachable with a patient interface via connection tubes 22), and the third connection portion is connected with the outlet of the device (fig. 3, channel 12 goes out into the atmosphere, see col. 2, lines 43-47).
Regarding claim 3, Mon discloses the device of claim 1 and further discloses an inlet chamber (fig. 3, supply channel 20 contains fresh-gas which is conveyed to breathing-channel 10 via inlet channel 13) arranged at the fresh gas flow inlet (fig. 4, supply channel 20 is within connection tube 21), a patient interface chamber arranged at the patient interface end (fig. 3, the tubing that makes up channel 11 can be considered a chamber which extends into fig. 4, connection tubes 22), and an outlet chamber arranged at the outlet of the device (fig. 3, the tubing that makes up channel 12 can be considered a chamber which has a section within plastic body 19a, see annotated fig. 4 below), wherein each of the several variable flow CPAP generators is connected with the fresh gas flow inlet (fig. 3, connection tube 21 has supply channel 20 which feeds into each breathing-channel 10 via channel 13, see col. 4, lines 33-35), the patient interface end (fig. 3, each channel 10 is connected to the interface end via channel 11), and the outlet through the inlet chamber (fig. 3, channel 13 is connected via supply channel 20), the patient interface chamber (fig. 4, channel 11 is connected to the patient interface via connection tubes 22) and the outlet chamber (see annotated fig. 4 below, breathing-channel 10 includes channel 12 which is connected to the atmosphere via a section of 19A), respectively.
PNG
media_image1.png
419
550
media_image1.png
Greyscale
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mon.
Regarding claim 4, Mon discloses the device according to claim 1. Mon discloses two breathing-channels (fig, 4, 10 which includes channels 11, 12, and 13) that can be considered variable flow CPAP generators but is silent on the device comprising three variable flow CPAP generators.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to duplicate the breathing-channel of Mon to create three variable flow CPAP generators since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 5, Mon discloses the device according to claim 1. Mon discloses two breathing-channels (fig, 4, 10 which includes channels 11, 12, and 13) that can be considered variable flow CPAP generators but is silent on the device comprising four variable flow CPAP generators.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to duplicate the breathing-channel of Mon to create four variable flow CPAP generators since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
8. Claim(s) 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mon in view of Nilsson et al. (US 2013/0327332).
Regarding claim 6, Mon discloses the device of claim 1, and further discloses an effort is made to maintain pressure within the device (see col. 1, lines 29-35 state that for breathing, a constant pressure is ideal, col. 1, lines 62-68 through col. 2, lines 1-12 state that the fresh gas flow inlet size and angle helps maintain pressure at constant gas flows) but is silent on a pressure release connection portion having a first end connected with the patient interface end of the device and a second end connectable with a pressure release tube.
However, Nilsson teaches of a device for positive pressure ventilation (fig. 8) that uses a pressure release valve (fig. 8, 6) attached near the patient interface portion (fig. 8, infant interface 5) for preventing an excessive positive pressure in a positive pressure ventilation mode ([0013]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Mon with the pressure release valve as taught by Nilsson in order to prevent excessive pressure buildup (Nilsson [0013]) thereby maintaining an optimal pressure for breathing (Mon col. 1, lines 29-35).
The modified device of Mon reads on the limitations of claim 1 and further reads on a pressure release connection portion (see annotated Nilsson fig. 8 below) having a first end (see annotated Nilsson fig. 8 below) connected with the patient interface end (fig. 8, the end where 5 is located) of the device and a second end connectable with a pressure release tube (see annotated Nilsson fig. 8 below).
PNG
media_image2.png
531
1055
media_image2.png
Greyscale
Regarding claim 7, Mon discloses a system for PPV and CPAP treatment comprising a device according to claim 1 (fig. 4), a fresh gas flow tube (fig. 4, connection tube 21 allows attachment of a hose for fresh gas supply, see col. 3, lines 28-29), and further discloses the associated fresh gas channel allows the adjustment of pressure within the breathing-channel by adjusting the flow of fresh gas (col. 1, lines 13-18), but does not expressly disclose a fresh gas source.
However, Nilsson teaches of a device for positive pressure ventilation (fig. 8) that includes a fresh gas source ([0029] states that a fresh gas source connects with connection unit 11, fig. 8) and a pressure release valve (fig. 8, 6) attached near the patient interface portion (fig. 8, infant interface 5) for preventing an excessive positive pressure in a positive pressure ventilation mode ([0013]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Mon with the fresh gas source and pressure release valve as taught by Nilsson in order to provide the adjustable fresh gas flow (Mon col. 3, lines 28-29 states a hose conveys a variable fresh gas flow provided by the fresh gas source of Nilsson [0029]) and prevent excessive pressure buildup (Nilsson [0013]) thereby maintaining an optimal pressure for breathing (Mon col. 1, lines 29-35), respectively.
The modified device of Mon reads on the limitations of claim 1 and further reads on a fresh gas source (Nilsson [0029] states that a fresh gas source connects with connection unit 11, which is the hose of Mon, see col. 3, lines 28-29) connected with the singular fresh gas flow inlet (Mon fig. 4, connection tube 21) by means of the fresh gas flow tube (Mon col. 3, lines 28-29 states the hose connects to connection tube 21), and a pressure release valve (Nilsson fig. 8, pressure release valve 6) arranged to prevent an excessive positive pressure in a PPV mode ([0013]).
Regarding claim 8, the modified device of Mon reads on the system according to claim 7 and further reads on that when the open end of the outlet of the device is occluded (Mon fig. 4, breathing-channels 10 are blocked), the pressure will increase from the variable flow CPAP generators (Mon fig. 4, connection tube 21 will continue receiving fresh gas) until an opening pressure of the pressure release valve is reached (Nilsson fig. 8, pressure release valve 6 opens at a set pressure, see [0030]), which increase in pressure results in an inspiratory flow, whereby the pressure in the system will remain at the set PPV pressure until the occlusion is removed from the outlet (Mon fig. 4, breathing-channels 10 communicate with the atmosphere), and when the occluded outlet is opened, the pressure will return to the set CPAP level (Mon abstract states that the device provides a CPAP), whereby the reduction in pressure leads to an expiratory flow (Nilsson [0030] states ).
Regarding claim 9, the modified device of Mon reads on the system according to claim 7 and further reads on that during spontaneous breathing, the patient flow and the fresh gas flow leaves the system through the variable flow CPAP generators keeping the positive pressure within the airway of the patient stable (Mon col. 1, lines 62-68 through col. 2, lines 1-12 state an ejector action is used to maintain pressure in the device at constant gas flows), by varying the flow that generates the CPAP, whereby the CPAP in the airway can be adjusted as needed (Mon col. 1, lines 13-18 state that the positive pressure is adjustable dependent on the flow of fresh gas).
Regarding claim 10, the modified device of Mon reads on the system according to claim 7 and further reads on the pressure release valve (Nilsson fig. 8, 6) is connected with the patient interface end (Nilsson fig. 8, shows pressure release valve 6 connected to infant interface 5).
Regarding claim 11, the modified device of Mon reads on the system according to claim 7 and further reads on a pressure release connection portion (see annotated Nilsson fig. 8 above) having a first end connected with the patient interface end of the device and a second end connectable with a pressure release tube (see annotated Nilsson fig. 8 above); and wherein the pressure release valve is connected with the pressure release connection portion (see annotated Nilsson fig. 8 above where 6 extends from pressure release tube).
Regarding claim 12, the modified device of Mon reads on the system according to claim 7, but is silent on a pressure measuring device.
However, Nilsson teaches of a device for positive pressure ventilation (fig. 8) with a pressure measuring device (fig. 8, 7) to monitor operation of the device and make desirable adjustments ([0027])
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified device of Mon with the pressure measuring device of Nilsson to help monitor the device and make desirable adjustments (Nilsson [0027]).
Regarding claim 13, the modified device of Mon reads on the system according to claim 12 and further reads on the pressure measuring device is in connection with the pressure release connection portion of the device (see annotated Nilsson fig. 8 above where 7 is connected to the pressure connection portion via a pressure release tube), a pressure release connection portion having a first end connected with the patient interface end of the device and a second end connectable with a pressure release tube (see annotated Nilsson fig. 8 above regarding the first and second end).
Double Patenting
9. 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.
10. Claims 1, 7-10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 10-14 of copending Application No. 17/995,670 hereinafter ‘670. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in at least one aspect and the claimed structures are labelled differently but are effectively the same structure.
Regarding the broadening aspect of the application claims, the following comparison between the ‘670 claims and the application claims highlights (see underlined features in the ‘670 claims) what elements have been excluded in the presentation of the application claims
Instant Application 17/995,672
Copending Application 17/995,670
Claim 1
Claim 1
A device for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment comprising a body, said body comprising:- a singular fresh gas flow inlet arranged to receive a fresh gas flow from a fresh gas flow tube connectable thereto; - a patient interface end which is connectable with a patient interface; - an outlet having an open end ; and - several variable flow CPAP generators, wherein each of the several variable flow CPAP generators is connected with the singular fresh gas flow inlet, the patient interface end and the outlet of the device, wherein the device is configured such that a CPAP level generated by the variable flow CPAP generators is adjustable by varying the fresh gas flow to the fresh gas flow inlet and thereby to the variable flow CPAP generators,- wherein each of the several variable flow CPAP generators comprises first, second and third connection portions, and wherein the first connection portion is connected with the singular fresh gas flow inlet, the second connection portion is connected with the patient interface end, and the third connection portion is connected with the outlet of the device.
A device for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment comprising:- a body, said body comprising:- a singular fresh gas flow inlet, arranged to receive a fresh gas flow from a fresh gas flow tube connectable thereto; - a patient interface end, arranged to be connected with a patient interface; - an outlet having an open end; - a variable flow CPAP generator comprising first, second and third connection portions, wherein the first connection portion is connected with the singular fresh gas flow inlet, the second connection portion is connected with the patient interface end, and the third connection portion is connected with the outlet, wherein the generated CPAP level is adjusted by varying the fresh gas flow to the singular fresh gas flow inlet and thereby to the variable flow CPAP generator; and - a leakage channel extending internally within the body between the singular fresh gas flow inlet and at least one of the patient interface end and the outlet, such to create an internal fresh gas leakage flow there between, the leakage channel bypassing the first connection portion of the variable flow CPAP generator, which internal fresh gas leakage flow is added to the fresh gas flow provided by the variable flow CPAP generator in the PPV mode- wherein the internal leakage channel extends between the singular fresh gas flow inlet and one of the second connection portion, the third connection portion, or a pressure release connection portion, the pressure release connection portion is arranged partially in parallel with the second connection portion, and having a first end connection with the patient interface end and a second end connectable with a pressure release tube.
Thus, it is apparent, for the broadening aspect, that ‘672 claim 1 includes features that are not in application claim 1. Following the rational in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by ‘670 claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over ‘670 claim 1 with respect to the broadening aspect.
With respect to claim 1 of the instant application, the limitation “several variable flow CPAP generators” includes more than one variable flow CPAP generators that are not expressly disclosed by claim 1 of the copending application ‘670. However, the “internal leakage channel arranged to extend between the fresh gas flow inlet and at least one of the patient interface end and the outlet” as disclosed by claim 1 of the copending application ‘670 reads on a variable flow CPAP generator due to the connections between the inlet, outlet, and patient interface and therefore claim 1 of the copending application discloses more than one variable flow CPAP generator.
With respect to claim 1 of the instant application, the limitation “each of the several variable flow CPAP generators comprises first, second and third connection portions, and wherein the first connection portion is connected with the fresh gas flow inlet, the second connection portion is connected with the patient interface end, and the third connection portion is connected with the outlet of the device” specifies a portions that are not expressly disclosed by the internal leakage channel. However, the “internal leakage channel arranged to extend between the fresh gas flow inlet and at least one of the patient interface end and the outlet” as disclosed by claim 1 of the copending application ‘670 reads on a variable flow CPAP generator due to the connections between the inlet, outlet, and patient interface and therefore claim 1 of the copending application discloses more than one variable flow CPAP generator.
For independent claims 7 and dependent claims 8-10, and 12, in view of the rationale provided above, the following are obvious over claims 10-16 of ‘670 due to having the same language and recited structures.
Instant Claim 7
Copending Claim 10
A system for PPV and CPAP treatment comprising a device according to claim 1, a fresh gas flow tube, a fresh gas source connected with the singular fresh gas flow inlet by means of the fresh gas flow tube, and a pressure release valve arranged to prevent an excessive positive pressure in a PPV mode.
A system for PPV and CPAP treatment comprising a device according to claim 1, a fresh gas flow tube, a fresh gas source connected with the fresh gas flow inlet by means of the fresh gas flow tube, and a pressure release valve arranged to prevent an excessive positive pressure in a PPV mode.
Instant Claim 8
Copending Claim 11
Instant Claim 9
Copending Claim 12
Instant Claim 10
Copending Claim 13
Instant Claim 12
Copending Claim 14
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
11. Applicant’s arguments with respect to claim(s) 1 and 3-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
12. In response to Applicant’s arguments under “Remarks” on page 7 paragraph 4 and page 8 paragraph 1, Applicant states that the variable flow CPAP generator is different than a conduit and generating is different from simply conveying. However, the term “variable flow CPAP generator” of the application (fig. 1, variable flow CPAP generator 6) does not distinguish how it is generating as the figures appear to show the variable flow CPAP generator as conveying a fresh gas or exhaled gas from an inlet to an interface and exhaust. It is suggested to amend the claims to clearly how the variable flow CPAP generators are acting as “one that generates” as the current claim (claim 1 lines 7-11) is only detailing how the variable flow CPAP generators are connected to the inlet, interface, and outlet for conveying a variable fresh gas flow.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zollinger et al. (US 2007/0125387) discloses an infant nasal interface prong device for delivering CPAP that has two prongs and a sampling port. Pierro et al. (US 2007/0125379) discloses a nCPAP device that has two prongs and a sampling port.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights