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 Objections
The claims are objected to because of the following informalities:
The preamble of the dependent claims does not match that of the independent claims. Claims 2-10 and 12-13 recite “The tracheal tube assembly” where claims 1 and 10 recite “A endotracheal tube assemble”.
Appropriate correction is required.
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.
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Claims 1-9, 11-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-11, 14, 17 and 18 of U.S. Patent No. 9,833,588 B2 in view of Shapiro (EP 0072230 A1)
Claim 1 is rejected in view of claim 1 of the ‘588 Patent in further view of Shapiro (EP 0072230 A1). The claims differ in that the instant claims are drawn to an endotracheal tube whereas the ‘588 patent is drawn to a tracheal tube. Shapiro teaches it is known for endotracheal tubes with an inserting cannula (1) to also connect to ventilators via a connector (7) (Page 6, lines 4-8).
Claim 2 is rejected in view of claim 2 of the ‘588 Patent
Claim 3 is rejected in view of claim 4 of the ‘588 Patent
Claim 4 is rejected in view of claim 5 of the ‘588 Patent
Claim 5 is rejected in view of claim 6 of the ‘588 Patent
Claim 6 is rejected in view of claim 7 of the ‘588 Patent
Claim 7 is rejected in view of claim 8 of the ‘588 Patent
Claim 8 is rejected in view of claim 9 of the ‘588 Patent
Claim 9 is rejected in view of claim 11 of the ‘588 Patent
Claim 11 is rejected in view of claim 14 of the ‘588 Patent in further view of Shapiro (EP 0072230 A1). The claims differ in that the instant claims are drawn to an endotracheal tube whereas the ‘588 patent is drawn to a tracheal tube. Shapiro teaches it is known for endotracheal tubes with an inserting cannula (1) to also connect to ventilators via a connector (7) (Page 6, lines 4-8).
Claim 12 is rejected in view of claim 17 of the ‘588 Patent
Claim 13 is rejected in view of claim 18 of the ‘588 Patent
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 9,833,588 B2 in view of Shapiro (EP 0072230 A1) in further view of Elam (US 4,091,816 A).
Regarding claim 10, the ‘588 patents claim 14 in view of Shapiro does not disclose the pair of cuffs as claimed. Elam teaches it is known for an endotracheal tube (10) to comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea (as shown in figure 2).
It would have been obvious to have modified Shapiro’s one cuff to instead comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea as taught by Elam for the benefit of keeping upper airway secretions from entering the laryngeal area (col. 1, lines 56-62).
Claims 1-9, 11-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8, 10 and 11 of U.S. Patent No. 10,328,227 B2 in view of Shapiro (EP 0072230 A1)
Claim 1 and 11 are rejected in view of claim 1 of the ‘588 Patent in further view of Shapiro (EP 0072230 A1). The claims differ in that the instant claims are drawn to an endotracheal tube whereas the ‘588 patent is drawn to a tracheal tube. Shapiro teaches it is known for endotracheal tubes with an inserting cannula (1) to also connect to ventilators via a connector (7) (Page 6, lines 4-8).
Claim 2 is rejected in view of claim 2 of the ‘227 Patent
Claim 3 is rejected in view of claim 4 of the ‘227 Patent
Claim 4 is rejected in view of claim 5 of the ‘227 Patent
Claim 5 is rejected in view of claim 6 of the ‘227 Patent
Claim 6 is rejected in view of claim 6 of the ‘227 Patent
Claim 7 is rejected in view of claim 7 of the ‘227 Patent
Claim 8 is rejected in view of claim 8 of the ‘227 Patent
Claim 9 is rejected in view of claim 10 of the ‘227 Patent
Claim 11 is rejected in view of claim 1 of the ‘227 Patent in further view of Shapiro (EP 0072230 A1). The claims differ in that the instant claims are drawn to an endotracheal tube whereas the ‘227 patent is drawn to a tracheal tube. Shapiro teaches it is known for endotracheal tubes with an inserting cannula (1) to also connect to ventilators via a connector (7) (Page 6, lines 4-8).
Claim 12 is rejected in view of claim 10 of the ‘227 Patent
Claim 13 is rejected in view of claim 11 of the ‘227 Patent
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 10,328,227 B2 in view of Shapiro (EP 0072230 A1) in further view of Elam (US 4,091,816 A).
Regarding claim 10, the ‘227 patents claim 1 in view of Shapiro does not disclose the pair of cuffs as claimed. Elam teaches it is known for an endotracheal tube (10) to comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea (as shown in figure 2).
It would have been obvious to have modified Shapiro’s one cuff to instead comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea as taught by Elam for the benefit of keeping upper airway secretions from entering the laryngeal area (col. 1, lines 56-62).
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,376,389 B2.
Claims 1-9, 11-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,998,699 B2 in view of Shapiro (EP 0072230 A1)
Claim 1 and 11 are rejected in view of claim 1 of the ‘588 Patent in further view of Shapiro (EP 0072230 A1). The claims differ in that the instant claims are drawn to an endotracheal tube whereas the ‘588 patent is drawn to a tracheal tube. Shapiro teaches it is known for endotracheal tubes with an inserting cannula (1) to also connect to ventilators via a connector (7) (Page 6, lines 4-8).
Claims 2-9, 11-13 are rejected in view of claims 2-12, 14-19 of ‘699 Patent.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,998,699 B2 in view of Shapiro (EP 0072230 A1) in further view of Elam (US 4,091,816 A).
Regarding claim 10, the ‘227 patents claim 1 in view of Shapiro does not disclose the pair of cuffs as claimed. Elam teaches it is known for an endotracheal tube (10) to comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea (as shown in figure 2).
It would have been obvious to have modified Shapiro’s one cuff to instead comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea as taught by Elam for the benefit of keeping upper airway secretions from entering the laryngeal area (col. 1, lines 56-62).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 1-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro (EP 0072230 A1) in view of Fuller et al. (US 2016/0325066 A1).
Regarding claim 1, Shapiro discloses: An endotracheal tube assembly (figure 1; page 6, lines 8-13) comprising:
an inserting cannula (1) adapted to be inserted into a subject’s mouth (abstract), the inserting cannula having a proximal end (5) and a distal end (at 7), the distal end having a connector (7) which connects to a ventilation device (Page 6, lines 4-8).
Shapiro is not explicit in that the connector (7) on the distal end having two or more pins extending laterally from a sidewall of the distal end; and
an elbow adapter configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient;
a pressure release valve on the elbow adapter configured to mitigate high airway pressures that may cause disconnections or lung damage; and
a Bayonet Neill-Concelman (BNC) connector configured to secure the elbow adapter to the inserting cannula, wherein a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula.
In summary, Shapiro does disclose the tube can be a tracheal tube or an endotracheal tube (page 6, lines 8-13), but is not explicit in how it is connected to a ventilator.
Fuller teaches a tracheal tube and thus is analogous art (abstract). Fuller teaches how to connect the tube to a ventilator [0051]. This is accomplished by providing two or more pins (114) extending laterally from a sidewall of the distal end of the tracheal tube (see figure 11; [0091]); and
an elbow adapter (120) configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient [0051] [0091];
a pressure release valve (130) on the elbow adapter configured to mitigate high airway pressures that may cause disconnections or lung damage [0092]; and
a Bayonet Neill-Concelman (BNC) connector (122) configured to secure the elbow adapter to the inserting cannula [0091].
It would have been obvious to have modified Shapiro to connect to the ventilator with the distal end having two or more pins extending laterally from a sidewall of the distal end; and
an elbow adapter configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient;
a pressure release valve on the elbow adapter configured to mitigate high airway pressures that may cause disconnections or lung damage; and
a Bayonet Neill-Concelman (BNC) connector configured to secure the elbow adapter to the inserting cannula as taught by Fuller to prevent unintended disconnections [0054].
In a further embodiment, Fuller teaches wherein a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula [0153].
It would have further been obvious to have modified Shapiro such that a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula as taught by Fuller for the benefit of allowing the user to visually see the pin is fully engaged with the BNC connector [0153].
Regarding claim 2, Fuller further discloses: wherein the BNC connection comprises two or more channels (122) on the elbow adapter configured to mate with the two or more pins (114) on the inserting cannula [0091].
Regarding claim 3, Fuller further discloses: wherein the two or more channels are each arcs that are curved 90 degrees or more (claim 4).
Regarding claim 4, Fuller further discloses: wherein the pressure release valve (130) comprising a casing (131) with an aperture (134), a spring (132), and a pressure release valve spring disc (ridge as per [0094]).
Regarding claim 5, Fuller further discloses: further comprising a seal (133) mated with the pressure release valve spring disc [0094], wherein the seal is configured to push back at high air pressures, compress the spring, and allow air to escape through the aperture [0094].
Regarding claim 6, Fuller further discloses: wherein the pressure release valve comprises a variety of selectable pressure release settings [0093].
Regarding claim 7, Fuller further discloses: wherein the pressure release valve (130) is coupled to the elbow adapter through a pressure release valve-elbow adapter threaded connection [0095].
Regarding claim 8, Fuller further discloses: further comprising a ventilator-elbow adaptor connection that is adapted to swivel [0010].
Regarding claim 9, Fuller further discloses: wherein the BNC connector of the elbow adapter is configured to connect to the inserting cannula with a connection strength of greater or equal to 45 N [0011].
Regarding claim 11, Shapiro discloses: An endotracheal tube assembly (figure 1; page 6, lines 8-13) comprising:
an inserting cannula (1) adapted to be inserted into a subject’s mouth or nose (abstract), the inserting cannula having a proximal end (5) and a distal end (at 7), the distal end having a connector (7) which connects to a ventilation device (Page 6, lines 4-8).
Shapiro is not explicit in that the connector (7) on the distal end having two or more pins extending laterally from a sidewall of the distal end;
an elbow adapter configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient; a
Bayonet Neill-Concelman (BNC) connector on the elbow adapter configured to secure the elbow adapter to the inserting cannula wherein a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula; and
a pressure release valve on the elbow adapter configured to release excess pressure to mitigate high airway pressures that may cause disconnections or lung damage.
In summary, Shapiro does disclose the tube can be a tracheal tube or an endotracheal tube (page 6, lines 8-13), but is not explicit in how it is connected to a ventilator.
Fuller teaches a tracheal tube and thus is analogous art (abstract). Fuller teaches how to connect the tube to a ventilator [0051]. This is accomplished by providing two or more pins (114) extending laterally from a sidewall of the distal end of the tracheal tube (see figure 11; [0091]); and
an elbow adapter (120) configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient [0051] [0091];
a Bayonet Neill-Concelman (BNC) connector (122) on the elbow adapter (120) configured to secure the elbow adapter to the inserting cannula [0091]; and
a pressure release valve (130) on the elbow adapter configured to mitigate high airway pressures that may cause disconnections or lung damage [0092].
It would have been obvious to have modified Shapiro to connect to the ventilator with the distal end having two or more pins extending laterally from a sidewall of the distal end; and
an elbow adapter configured to couple the inserting cannula with a mechanical ventilator for providing air to a patient;
a Bayonet Neill-Concelman (BNC) connector configured to secure the elbow adapter to the inserting cannula; and
a pressure release valve on the elbow adapter configured to mitigate high airway pressures that may cause disconnections or lung damage as taught by Fuller to prevent unintended disconnections [0054].
In a further embodiment, Fuller teaches wherein a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula [0153].
It would have further been obvious to have modified Shapiro such that a locking region of the BNC is transparent or translucent and is configured to change color when the BNC is engaged with the inserting cannula as taught by Fuller for the benefit of allowing the user to visually see the pin is fully engaged with the BNC connector [0153].
Regarding claim 12, Fuller further discloses: wherein connection between inserting cannula and the elbow adapter has a connection strength of greater or equal to 45 N [0011].
Regarding claim 13, Fuller further discloses: wherein the pressure release valve is configured to release pressure above 65 cm H20 [0014].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro (EP 0072230 A1) in view of Fuller et al. (US 2016/0325066 A1) in further view of Elam (US 4,091,816 A).
Regarding claim 10, Shapiro as modified does not explicitly disclose the endotracheal tube further comprising a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea.
However, Elam teaches it is known for an endotracheal tube (10) to comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea (as shown in figure 2).
It would have been obvious to have modified Shapiro’s one cuff to instead comprise a pair of laterally offset cuffs on the inserting cannula configured to seal and secure the inserting cannula within the patient's trachea as taught by Elam for the benefit of keeping upper airway secretions from entering the laryngeal area (col. 1, lines 56-62).
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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