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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 62/523998 filed on 06/23/2017.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/625541, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to provide support to claim 14, requiring a “leash or other projection”. Deletion of this language from claim 14 is considered to have adequate support.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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.
Claim(s) 1 – 5, 8, 11 – 13, 21 – 25, and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morejon (US 6318368) in view of Wright (US 5720282).
1. Morejon discloses a connector for a respiratory assistance system (160 and 170, see Fig. 6, c. 3: 14 - 15) comprising: an inspiratory conduit portion (see Fig. 6, one portion of the bifurcated Y-connector inlet 171 on the unlabeled left side of the Y-connector, where the Y-connector is implemented in the conventional normal fashion for permitting the continuance of air flow to and from the patient, c. 9: 49 – 53); an expiratory conduit portion (see Fig. 6, other portion of the bifurcated Y-connector inlet 171 on the unlabeled left side of the Y-connector, where the Y-connector is implemented in the conventional normal fashion for permitting the continuance of air flow to and from the patient, c. 9: 49 – 53); a first interface port extending in a first direction (164, see c. 9: 58 – 61); a second interface port extending in a second direction (163, whereby the port may be used to provide access for other purposes and to other implements per c. 10: 2 – 6, and thus would be fully capable of connecting to a second patient interface), and a body or body portion formed between the inspiratory conduit port, the expiratory conduit port and the first interface port and the second interface port (see Fig. 6, unlabeled side of body 160 inclusive of 165 and additionally formed between 165, 164, 163, and 162) the body or body portion defining an interior cavity that fluidly couples, at least in part, the inspiratory conduit port and the expiratory conduit port to the first interface port and the second interface port (see c. 9: 59 - 64; see also the interior cavity with passage therethrough in Fig. 1, as well as Fig. 6 illustrating the cavity inner diameters to all ports in dashed lines) wherein the first interface port and the second interface port are each fluidly couplable to patient interfaces (see c. 9: 58 – 61 and c. 10: 2 – 6; the second interface port is fully capable of connecting to a second patient interface as explained above).
However, while Morejon discloses a Y-connector with bifurcated portions for connection to a ventilator assembly, Morejon does not explicitly disclose an inspiratory conduit port, and an expiratory conduit port. Nonetheless, Wright discloses a similar Y-connector patient interface assembly, wherein the Y-connector includes an inspiratory conduit port, and an expiratory conduit port (c. 3: 3 – 16, Fig. 2a, ports connected to inspiratory and expiratory limbs 22 and 24, respectively). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the Y-connector inspiratory/expiratory portions of Morejon with ports as taught in Wright for the benefit of facilitating patient ventilation in a conventional manner for inhalation and exhalation therethrough, the ports additionally allowing for disconnection of respective inhalation/exhalation limbs for easy replacement or sterilization.
2. Morejon discloses the connector of claim 1, wherein the second direction is angularly offset relative to the first direction by between 45° and 135° (Morejon clearly illustrates the first and second direction having an angle around 90 degrees, see the dashed lines extending through 164 and 163 in Fig. 6).
3. Morejon discloses the connector of claim 1, wherein the second direction is angularly offset relative to the first direction by between 60° and 120° ((Morejon clearly illustrates the first and second direction having an angle around 90 degrees, see the dashed lines extending through 164 and 163 in Fig. 6).
4. Morejon discloses the connector of claim 1, wherein the inspiratory conduit port and the expiratory conduit port are rotatably coupled to the body or body portion about a first axis that extends in the first direction (see axis extending through 165, where the axis extending through 164 would alternatively be considered as the second axis and second interface port; see c. 9: 64 – 65, and note that a press fit engagement would allow manual rotation of the ports when the Y-connector 170 is not fully pressed against portion 160).
In an alternative interpretation, examiner notes that Wright discloses wherein the inspiratory conduit port and the expiratory conduit port are rotatably coupled to the body or body portion about a first axis that extends in the first direction (c. 3: 16 – 30, see Fig. 2a, 37). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Morejon to rotatably removably receive the Y-connector 170, as taught in Wright, for the benefit of enabling convenient repositioning of the ventilator limbs/interfaces, see c. 4: 7 – 13.
5. Morejon discloses the connector of claim 1, wherein the second direction is angularly offset relative to the first direction by about 90° (Morejon clearly illustrates the first and second direction having an angle around 90 degrees, see the dashed lines extending through 164 and 163 in Fig. 6).
8. Morejon discloses the connector of claim 1, further comprising: a first interface branch including the first interface port, the first interface branch extending from or formed by the body or body portion; and a second interface branch including the second interface port, the second interface branch extending from or formed by the body or body portion (see Fig. 6 illustrating the cavity inner diameters of the interface branches extending from the body portion in dashed lines; the body portion has been described in claim 1 above; the ports correspond to the distal most openings).
11. Morejon discloses the connector of claim 1, wherein at least one of the first interface port or the second interface port is selectively closable (c. 10: 3 – 7).
12. Morejon discloses the connector of claim 1, further comprising a closure to selectively close off at least one port of the connector (c. 10: 3 – 7).
13. Morejon discloses the connector of claim 12, wherein the closure comprises a stopper, the stopper being configured to be removably received in and/or about the at least one port to selectively close the at least one port (c. 10: 3 – 7, the closure stops flow of fluid and is removably received “about”/around the at least one port).
21. Morejon discloses the connector of claim 1, wherein the first interface port is adapted to be coupled to a first type of interface configured for adult, near-adult, or larger/older pediatric use and the second interface port is adapted to be coupled to a second type of interface configured for smaller/younger pediatric or neonatal use (the port 163 may be used to provide access for other purposes and to other implements per c. 10: 2 – 6, and would be fully capable of connecting to a patient interface; similarly, port 164 is fully capable of connecting to differently sized patient interfaces, e.g. upon connection of different adaptors; examiner notes that the port 163 may be considered the first interface port and port 164 considered the second interface port as described above).
22. Morejon discloses the connector of claim 12, wherein the connector is configurable in at least two configurations, wherein in a first configuration the first interface port is coupled to a first interface or a second interface and the closure is applied to the second interface port (see configuration of Fig. 6, first interface port 164 is coupled to first interface 80 and closure 167 is applied to second interface port 163), wherein in a second configuration the second interface port is coupled to the first interface or the second interface (the second interface 163 is fully capable of adopting a configuration in which it is connected to a second appropriately sized interface and/or first interface, such as by connection via an adaptor, see c. 10: 2 – 6 and discussion above).
However, Morejon does not disclose that a closure is configured to be applied to the first interface port 164. Nonetheless, in a separate aspect of the invention Morejon discloses a closure that is configured to be applied to an interface port of similar size to first interface port 164, and in addition to second interface port 163, see for example closure(s) 166, 168, and 132, c. 14: 10 - 24. Therefore, based on the teachings of additional closure(s) applied to various other ports in the connector of Morejon, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the first interface port 164 with a closure configured to be applied to the port for the benefit of maintaining sterility of the connector and the ventilator assembly prior to connection of the endotracheal tube.
23. Morejon discloses the connector of claim 1, wherein the connector is configurable in at least two configurations, wherein in a first configuration the first interface port is coupled to a first interface or a second interface and the second interface port is coupled to a first gases treatment device and/or a first gases monitoring device (see configuration of Fig. 6, first interface port 164 is coupled to first interface 8; the second port 163 may be used to provide access for other purposes and to other implements per c. 10: 2 – 6, and therefore would be fully capable of adopting a configuration in which the port 163 is coupled to a gases treatment device and/or gases monitoring device), wherein in a second configuration, the second interface port is coupled to the first interface or the second interface (the second interface 163 is fully capable of adopting a configuration in which it is connected to a second appropriately sized interface and/or first interface, such as by connection via an adaptor, see c. 10: 2 – 6 and discussion above), and the first interface port is coupled to the first gases treatment device and/or the first gases monitoring device or a second gases treatment device and/or a second gases monitoring device (the first interface port 164 is fully capable of adopting a configuration in which it is connected to a first and/or second gases monitoring and/or gases treatment device upon appropriate connection, e.g. adaptor; examiner notes that the connector of Morejon is fully capable of adopting the second configuration while additionally allowing for suctioning of patient interface connected to second port 163, since the elongate tubular member 20 may extend through the Y-connector, see c. 9: 48 – 54; regardless, said suctioning is optional given that port 162 may be closed, see c. 13: 53 – c. 14: 32).
24. Morejon discloses the connector of claim 23, wherein the first gases treatment device and the second gases treatment device each comprise a metered-dose inhaler, a nebulizer, and/or a source of aerosolized medication (as discussed in claim 23 above the first and second interface ports are fully capable of connecting to a first and/or second gases monitoring and/or gases treatment device upon appropriate connection such as adaptor connection with the interface ports, said gases monitoring and/or gases treatment grouping inclusive of a metered-dose inhaler, a nebulizer, and/or a source of aerosolized medication for the configurable connection).
25. Morejon discloses the connector of claim 23, wherein the first gases monitoring device and the second gases monitoring device each comprise a sensor configured to sense at least one of humidity, temperature, flow, or pressure (as discussed in claim 23 above the first and second interface ports are fully capable of connecting to a first and/or second gases monitoring and/or gases treatment device upon appropriate connection such as adaptor connection with the interface ports, said gases monitoring and/or gases treatment grouping inclusive of at least one of humidity, temperature, flow, or pressure sensor for the configurable connection).
59. Morejon discloses the connector of claim 1, wherein at least one of the first interface port and the second interface port is adapted to be coupled to a gases treatment device and/or a gases monitoring device (second interface port 163 may be used to provide access for other purposes and to other implements per c. 10: 2 – 6, and would be fully capable of connecting to a gases treatment device and/or a gases monitoring device).
Claim(s) 13, 14, 57, and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morejon (US 6318368) in view of Wright (US 5720282) in view of Lorenzen (US 5735271).
13 and 14. Morejon discloses the connector of claim 12, but fails to disclose wherein the closure comprises a stopper, the stopper being configured to be removably received in and/or about the at least one port to selectively close the at least one port, wherein the closure comprises a hook, loop, leash, or other projection extending therefrom configured to be gripped by a user for removal of the closure from the at least one port. Nonetheless, Lorenzen discloses a closure for an accessory port on a connector connected to a patient interface, wherein the closure comprises a stopper, the stopper being configured to be removably received in and/or about the at least one port to selectively close the at least one port (closure, which includes 292, 294, and unlabeled tether, comprises stopper 292, which is removably received about/around the accessory port, as illustrated in Fig. 8, c. 16: 42 – 49) wherein the closure comprises a hook, loop, leash, or other projection extending therefrom configured to be gripped by a user for removal of the closure from the at least one port (294 creates a loop/projection extending therefrom, which is fully capable of being gripped by the user for removal of the closure, see Fig. 8; additionally, the tether/leash described in c. 16: 27 – 42 is fully capable of being gripped by the user and is intended for removal from the port upon exceeding the compressive force). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the cap 167 of Morejon according to the cap features of Lorenzen for the benefit of allowing the entry of multiple different types of accessory devices within the connector as appropriate, as well as allowing for tethering of the cap to prevent its loss.
57. Morejon discloses the connector of claim 12, but does not disclose wherein the closure comprises an extension to enable the closure to be applied to and removed from one or both of the first interface port and the second interface port while keeping the closure attached to the connector. Nonetheless, Lorenzen discloses wherein the closure comprises an extension to enable the closure to be applied to and removed from one or both of the first interface port and the second interface port while keeping the closure attached to the connector (see c. 16: 27 – 42). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the cap 167 of Morejon according to the cap features of Lorenzen for the benefit of allowing the entry of multiple different types of accessory devices within the connector as appropriate, as well as allowing for tethering of the cap to prevent its loss.
58. Morejon discloses the connector of claim 12, but does not disclose wherein the closure comprises a port for coupling to a gases treatment device and/or a gases monitoring device. Nonetheless, Lorenzon discloses a closure comprising a port for coupling to a gases treatment device and/or a gases monitoring device (see c. 16: 27 – 42, the closure port fitting 294 is intended for accessory devices and is fully capable of connecting a gases treatment device and/or a gases monitoring device). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the cap 167 of Morejon according to the cap features of Lorenzen for the benefit of allowing the entry of multiple different types of accessory devices within the connector as appropriate, as well as allowing for tethering of the cap to prevent its loss.
Claim(s) 55 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morejon (US 6318368) in view of Wright (US 5720282) in view of Beran (US 4723543).
55. Morejon discloses the connector of claim 12, but does not disclose wherein the closure is configured to extend into a branch associated with the at least one port. Nonetheless, Beran discloses a closure configured to extend into a branch associated with the at least one port (see Fig. 5, closure 30 extending past port or distal opening of the connector and into the branch as illustrated; see c. 4: 48 – 50; device 30 is considered a closure based on the description in c. 4: 57 - 58). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the closure 167 of Morejon to extend into the branch as taught in Beran for the benefit reducing dead space, as well as creating improved sensing for connected accessory sensors such as gas monitoring devices, see c. 4: 23 – 48.
56. Morejon as modified discloses the connector of claim 55, wherein the closure is configured to reduce dead space of the branch associated with the at least one port when applied to the at least one port (see Beran, c. 4: 48 – 50).
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 1 – 5, 8, 11 – 14, 21 – 25, and 55 – 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 12005192 (hereinafter ‘192). Although the claims at issue are not identical, they are not patentably distinct from each other because USPN ‘192 discloses all the features of the instant claims.
Regarding claim 1, ‘192 discloses a connector for a respiratory assistance system comprising: an inspiratory conduit port; an expiratory conduit port; a first interface port extending in a first direction; a second interface port extending in a second direction (c. 15: 31 – 36); and a body or body portion formed between the inspiratory conduit port, the expiratory conduit port and the first interface port and the second interface port, the body or body portion defining an interior cavity that fluidly couples, at least in part, the inspiratory conduit port and the expiratory conduit port to the first interface port and the second interface port (c. 55 – 60), wherein the first interface port and the second interface port are each fluidly couplable to patient interfaces (c. 15: 36 – 38).
Dependent claims 2– 5, 8, 11 – 14, 21 – 25, and 55 – 59 are additionally rejected based on USPN ‘192.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CA 2288465 – dual interface connector
US 5433195 – connector
US 20100163022 – connector
US 5482031 – connector
US 5099833 – connector
US 5474058 – closure
US 20040168690 – closure
US 5057093 – closure
US 5139018 – closure
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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