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 19, 2026. 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, 3, 5, 7, and 9-14 are presently pending in this application.
3. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/2026 has been entered.
Claim Rejections - 35 USC § 112
4. Claim 7 is 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.
Regarding claim 7, the limitation “wherein the internal leakage channel partially extends through the pressure release connection portion to the patient interface end of the device” in lines 1-3 is indefinite because it is unclear if the “pressure release connection portion” is part of the device. In independent claim 1, the “pressure release connection portion” is not positively claimed (only an alternative), but seems to be positively claimed in claim 7. It is recommended to replace “The device according to claim 1,” with –The device according to claim 1, comprising the pressure release connection portion—to clarify that the “pressure release connection portion” is definitively part of the device.
Claim Rejections - 35 USC § 103
5. 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.
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) 1, 3, 5, 7, and 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moa et al. (US 5,193,532) in view of Nilsson et al. (US 2013/0327332).
Regarding claim 1, Moa discloses a device for positive pressure ventilation (PPV) and continuous positive airway pressure (CPAP) treatment (fig. 6) comprising:
a body (fig. 6, 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) 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);
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);
a variable flow CPAP generator (fig. 3, breathing-channel 10) comprising first, second, and third connection portions, wherein the first connection portion is connected with the singular fresh gas flow inlet (fig. 3, shows inlet 20 feeding into breathing-channel 10 via channel 13), 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 (fig. 3, channel 12 goes out into the atmosphere, see col. 2, lines 43-47), wherein the device is configured such that a CPAP level generated by the variable flow CPAP generator is adjustable by varying the fresh gas flow to the singular fresh gas flow inlet and thereby to the variable flow CPAP generator (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); and further discloses multiple breathing channels (fig. 3, 10), but does not expressly disclose:
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 the second connection portion.
However, Nilsson teaches of a device for resuscitating neonatal infants that allows switching between a CPAP and PPV mode ([0003]-[0007]) that uses a second fresh gas flow tube or bypass line to increase pressure and generate an inspiration in a PPV mode ([0016]).
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 Moa with the bypass line as taught by Nilsson to allow quick switching between PPV and CPAP modes which allows higher quality resuscitation and respiratory support (Nilsson [0016]).
The modified device of Moa reads on a leakage channel (Nilsson fig. 8, bypass flow tube 2) extending internally within the body between the singular fresh gas flow inlet and at least one of the patient interface end and the outlet (see annotated Moa fig. 3 below, where bypass line extends between channel 20 which is attached to inlet 21 and channels 11 and 12), such to create an internal fresh gas leakage flow there between (Nilsson [0014]-[0015] states the second fresh gas flow tube, which is synonymous to bypass line according to [0019], provides a second fresh gas flow), the leakage channel bypassing the first connection portion of the variable flow CPAP generator (see annotated Moa fig. 3 below, where the bypass channel bypasses channel 13), which internal fresh gas leakage flow is added to the fresh gas flow provided by the variable flow CPAP generator in the PPV mode (see annotated Moa fig. 3 below, where when channel 12 is occluded, the gas from the bypass line and channel 13 will both flow towards channel 11), wherein the internal leakage channel extends between the singular fresh gas flow inlet and the second connection portion or the third connection portion (see annotated Moa fig. 3 below, the bypass line provides another channel that feeds into channels 11 and 12 which are considered the second and third connection portions).
PNG
media_image1.png
555
586
media_image1.png
Greyscale
Regarding claim 3, the modified device of Moa reads on the limitations of claim 1 and further reads on the internal leakage channel (see annotated Moa fig. 3 above) partially extends through the second connection portion of the variable flow CPAP generator to the patient interface end of the device (see annotated Moa fig. 3 above, where the bypass line provides another gas flow path that extends from channel 20 through channel 11 to the patient interface, see Moa figs. 4 and 6).
Regarding claim 5, the modified device of Moa reads on the limitations of claim 1 and further reads on the internal leakage channel (see annotated Moa fig. 3 above) partially extends through the third connection portion of the variable flow CPAP generator to the outlet of the device (see annotated Moa fig. 3 above, where the bypass line provides another gas flow path that extends from channel 20 through channel 12 to the outlet of the device, see Moa col. 2, lines 43-49 which states channel 12 opens to the atmosphere).
Regarding claim 7, the modified device of Moa reads on the limitations of claim 1, but does not expressly state that the internal leakage channel partially extends through the pressure release connection portion to the patient interface end of the device.
However, Nilsson (fig. 4) teaches of a pressure release connection portion (fig. 4, connection portion 9) which connects to a pressure release valve (fig. 4, 6) and pressure measuring device (fig. 4, 7). The bypass channel 2 of Nilsson feeds into the connection portion 9.
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 Moa with the pressure release valve as taught by Nilsson to maintain a max pressure (Nilsson [0054]) and prevent excessive positive pressure in a PPV mode (Nilsson [0013]).
The modified device of Moa reads on the internal leakage channel partially extends through the pressure release connection portion to the patient interface end of the device (see annotated Moa fig. 3 below, where the bypass line feeds into channels 11 and 12 which are connected to pressure valve 6 and therefore constitute a pressure release connection portion).
PNG
media_image2.png
555
586
media_image2.png
Greyscale
Regarding claim 9, the modified device of Moa reads on the limitations of claim 1, but does not expressly state that the fresh gas flow provided to the variable flow CPAP generator is 5-15 liters per minute.
However, Nilsson teaches of providing a fresh gas flow between 10-15 liters per minute ([0052]).
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 Moa with a fresh gas flow rate of between 10-15 liters per minute as taught by Nilsson to prevent rebreathing, achieve adequate inspiration, and allow leakage in the device (Nilsson [0054]).
The modified device of Moa reads on the fresh gas flow provided to the variable flow CPAP generator is 5-15 liters per minute (Nilsson [0053] states that the fresh gas flow of each line can be between 3-12 liters/min while the sum of the flows is typically between 10-15 liters/min which is within the claimed range).
Regarding claim 10, Moa reads on a system for PPV and CPAP treatment comprising a device according to claim 1 (see annotated fig. 3 of the modified device of Moa above), 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), a pressure release valve (Nilsson fig. 4, 6) arranged to prevent an excessive positive pressure in a PPV mode (Nilsson [0054]), 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) that can be split and is adjustable ([0053]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the system of Moa with the gas source and method for adjusting the flow as taught by Nilsson to provide a source for the adjustable fresh gas flow (Moa col. 3, lines 28-29 states a hose provides a gas flow).
Regarding claim 11, the modified system of Moa reads on the limitations of claim 10 and further reads on the system arranged such that when the open end of the outlet of the device is occluded, the pressure will increase from the variable flow CPAP generator until an opening pressure of the pressure release valve is reached, 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, and when the occluded outlet is opened, the pressure will return to the set CPAP level, whereby the reduction in pressure leads to an expiratory flow (see Nilsson [0030] which recites the claim language, and the structure of the modified system of Moa can allow the same function).
Regarding claim 12, the modified system of Moa reads on the limitations of claim 10 and further reads on the system arranged such that during spontaneous breathing, the flow from the patient interface end (Moa fig. 4, channel 11 is located where the patient interface is) and the fresh gas flow leaves the system through the variable flow CPAP generator keeping the positive pressure within the airway stable (Moa fig. 2, shows inlet flow 16 and expired flow 17 being directed out of channel 12, see arrows 18), by varying the flow that generates the CPAP (Nilsson [0053] states that the fresh gas flow is adjustable, and the gas flow is provided from the gas source, see Nilsson [0050]), whereby the CPAP in the airway can be adjusted as needed (Nilsson [0031] recites the same language).
Regarding claim 13, the modified system of Moa reads on the limitations of claim 10 and further reads on the system wherein the pressure release valve (Nilsson fig. 4, 6) is connected with the patient interface end (see annotated Moa fig. 3 above, where valve 6 is connected to channel 11 which is at the patient interface end).
Regarding claim 14, the modified system of Moa reads on the limitations of claim 10, but does not expressly read on the system comprising a pressure measuring device.
However, Nilsson teaches of a pressure measuring device (fig. 8, pressure measuring device 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 system of Moa with the pressure measuring device as taught by Nilsson to allow monitoring of the device (Nilsson [0027]).
Double Patenting
8. 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.
9. Claims 1 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10, and 12 of copending Application No. 17/995,672 hereinafter ‘672 in view of Nilsson. 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 ‘672 claims and the application claims highlights (see underlined features in the ‘672 claims) what elements have been excluded in the presentation of the application claims
Instant Application 17/995,670
Copending Application 17/995,672
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, 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.
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.
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 ‘672 claim 1, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over ‘672 claim 1 with respect to the broadening aspect.
With respect to claim 1 of the instant application, the limitation “a variable flow CPAP generator comprising first, second and third connection portions, 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, wherein the generated CPAP level is adjusted by varying the fresh gas flow to the variable flow CPAP generator” includes a first, second, and third connection portions that are not expressly disclosed by claim 1 of the copending application. However, a first, second, and third connection portions is inherent in the connections between the CPAP generator and the “fresh gas flow inlet, patient interface, and the outlet of the device” as disclosed by claim 1 of the copending application ‘672.
With respect to claim 1 of the instant application, the limitation “an internal leakage channel arranged to extend between the 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, 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” includes a leakage channel which connects to the gas flow inlet, patient interface, and the outlet of the device that is not expressly disclosed by claim 1 of the copending application. However, a second CPAP generator of “several CPAP generators” similarly connects between the gas flow inlet, patient interface, and the outlet of the device as disclosed by claim 1 of the copending application ‘672 and can therefore be defined as a leakage channel.
With respect to claim 1 of the instant application, the limitation “partially in parallel” with respect to the pressure release connection portion and would be obvious in view of Nilsson which teaches of a pressure release connection portion (see the rejection to claim 1 above), and would be a simple substitution of the unknown oriented pressure release connection portion of ‘672 with the partially parallel pressure release connection portion as taught by Nilsson.
For independent claim 10 and dependent claims 11-14, in view of the rationale provided above, the following claims are obvious over claim 11 of ‘672 due to having the same recited structures.
Claim 10
Claim 7
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.
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.
Claim 11
Claim 8
Claim 12
Claim 9
Claim 13
Claim 10
Claim 14
Claim 12
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
10. Applicant’s arguments with respect to claim(s) 1, 3, 5, 7, and 9-14 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.
Conclusion
11. 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. Moa et al. (2011/0000487) discloses a nebulizing device with a separate channel for introducing a drug. Lewis et al. (US 2009/0253995) discloses a device for measuring respiratory parameters of a subject that has a pressure measuring port that can be considered a bypass channel.
12. 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