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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Response to Amendment
Examiner acknowledges the reply filed on 03/02/2026 in which claims 70, 76, and 77 have been amended, claim 86 is added, and claim 85 is canceled. Currently, claims 70-72, 74-84, and 86 are pending for examination in this application.
Response to Arguments
Applicant’s arguments, see Remarks pg. 5-6, filed 03/02/2026, with respect to the rejection(s) of claim(s) amended claim 70 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shikani et al. (US 20120152239 A1).
The double patenting rejection(s) has been updated below.
Claim Rejections - 35 USC § 103
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) 70-72, 74, 76-77, 79-81, 83-84, and 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enzinger (US 6516803 B1) and Shikani et al. (US 20120152239 A1).
Regarding claim 70, Enzinger discloses a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1) comprising:
a first end (open end at first opening 1; fig. 1) and a second closed end (closed end formed by cylindrical tube 14 and closing plate 10; fig. 1) with a body therebetween (cylindrical housing 4; fig. 1), the first end being configured to couple to the patient interface (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Enzinger is silent as to the body comprising one or more ribs to provide one or more internal stops or to provide one or more support structures.
However, Shikani teaches a tracheostomy guard (12; figure 1-2) wherein the body ([0055] body 14; figure 2-5) comprising one or more ribs to provide one or more internal stops ([0055] The diameter of the first end 16 of the body is larger than the diameter of the second end 18 of the body forming a chamber having an internal step 20 within the body 14; figure 3) and to provide one or more support structures (The outer surface of the body may have threads 32 or ribs formed thereon to provide a better grip to rotate the body; figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the housing of Enzinger to implement one or more ribs in the form of an internal step within the housing and threads or ribs on the outer surface of the housing, as taught by Shikani in order to limit a tube from fully extending into the housing (see figure 2 and 5) and to provide a better grip to move the housing (see [0056]), respectively.
Regarding claim 71, modified Enzinger teaches the tracheostomy guard according to claim 70, Enzinger teaches wherein the body is symmetrical along an axial plane (a housing 4 in the shape of a cylinder, having a symmetry axis; fig. 1; col. 2 line 66-67. Housing 4 is symmetrical along a vertical axial plane).
Regarding claim 72, modified Enzinger teaches the tracheostomy guard according to claim 70, Enzinger teaches wherein the body comprises a substantially hollow structure (see fig. 1, housing 4 is substantially hollow to allow passage of air).
Regarding claim 74, modified Enzinger teaches the tracheostomy guard according to claim 70, Enzinger teaches wherein the second closed end comprises a non-standard medical shape or size (Applicant’s specifications [00142] gives an example of a non-standard medical shape or size as a frustoconical end or members that project beyond the body in order to prevent incorrect coupling of components thereto) (see figure 1, closing plate 10 projects beyond the housing 4).
Regarding claim 76, modified Enzinger teaches the tracheostomy guard according to claim 70, Enzinger teaches wherein the body comprises a first opening (third opening 3; fig. 1) and a second opening (second opening 2; fig. 1).
Regarding claim 77, modified Enzinger teaches the tracheostomy guard according to claim 76, Enzinger teaches wherein at least one of the first opening are configured to allow patient secretions to drain form the tracheostomy guard in use (The connecting piece 13 in the third opening 3, which preferably points downward in the position of use, has a conical outside wall onto which a bag for catching the sputum or a hose for draining the sputum to such a catch bag can be fitted; col. 3 line 13-17; figure 1).
Regarding claim 79, modified Enzinger teaches an assembly comprising the tracheostomy guard according to claim 70 (see claim 70 above), coupled to the patient interface (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Regarding claim 80, modified Enzinger teaches the assembly according to claim 79, Enzinger teaches wherein the patient interface is a tracheal interface (tracheal catheter).
Regarding claim 81, modified Enzinger teaches the assembly according to claim 79, Enzinger teaches wherein the patient interface comprises a port (tracheal catheter end that projects from the trachea; col. 3 line 8-9) configured for coupling with a tube (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Regarding claim 83, modified Enzinger teaches the assembly according to claim 79, Enzinger teaches wherein a first end of the patient interface is configured to fluidly connect with an airway of a patient (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9. Given the known definition of a tracheal catheter, the tracheal catheter end opposite to the end that projects from the trachea is the first end of the tracheal catheter and fluidically connects to the trachea of the patient).
Regarding claim 84, modified Enzinger teaches the assembly according to claim 79, Enzinger teaches wherein a second end of the patient interface is configured to couple with the tracheostomy guard (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Regarding claim 86, modified Enzinger teaches the tracheostomy guard according to claim 70, Shikani teaches wherein the one or more ribs extend axially along an internal surface of the body ([0055] a chamber having an internal step 20 within the body 14; see figure 3).
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enzinger (US 6516803 B1) and Shikani et al. (US 20120152239 A1) as applied to claim 70 above, and further in view of Beevers (US 4802474 A).
Regarding claim 75, modified Enzinger teaches the tracheostomy guard according to claim 70, but does not disclose wherein the second closed end is integrally formed with the body.
Enzinger teaches the closed end formed by cylindrical tube 14 and closing plate 10 (fig. 1) as separate components connected to the cylindrical housing 4.
However, Beevers teaches a protective cover for a tracheostomy tube (10; fig. 1-4) wherein the second end is integrally formed with the body (protective cover 10, a collar 11 is adapted in size and shape to frictionally engage the outside end of a tracheal tube 15, as is shown in FIGS. 1 and 2. Collar 11 is fabricated integrally with vent flange 12. Foreign objects of a selected size are kept out of the airway created by tracheal tube 15, by means of a cage which is integral with the rest of the device. Circular end plate 19 is mounted in spaced relationship with the vent flange 12, and interconnected therewith by a plurality of cage bars 14; col. 3 line 6-15. Being an integral construction of resilient material, protective covers 10 and 20 are particularly well adapted to mass production and inexpensive fabrication techniques; col. 4 line 17-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Enzinger to implement the teachings of Beevers by constructing the second end formed by the cylindrical tube and dome shaped closed end integrally with the cylindrical housing forming a one piece design to improve mass production and have inexpensive fabrication techniques as taught by Beevers (abstract and col. 4 line 17-20).
Claim(s) 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enzinger (US 6516803 B1) and Shikani et al. (US 20120152239 A1) as applied to claim 70 above, and further in view of Fukunaga et al. (US 20050188990 A1).
Regarding claim 78, modified Enzinger teaches the tracheostomy guard according to claim 70, but is silent as to wherein the tracheostomy guard comprises a colour that indicates that it is a disposable component (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).).
However, Fukunaga teaches color coding disposable and reusable components. Specifically, Fukunaga discloses [0067] For easy handling in the operating room, a set-up kit can be provided with one set of reusable components and multiple disposable F-tube.TM. devices (preferably about 5). A benefit to having a multilumen fitting between the disposable components and the reusable components is that it is easy to segregate the medical waste portion from the reusable portion, which may be recycled, and only one component needs to be connected and disconnected to connect the multiple lumens. The components may be color coded to facilitate distinguishing between the disposable components and the reusable ones.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Enzinger to implement color coding to easily identify the tracheostomy guard as a disposable component as taught by Fukunaga [0067]. Further, the device of Enzinger is configured as disposable since it would be disposed of after use to ensure a sterilized environment for the next user.
Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enzinger (US 6516803 B1) and Shikani et al. (US 20120152239 A1)as applied to claim 79 above, and further in view of Allum et al. (US 20100071693 A1).
Regarding claim 82, modified Enzinger teaches the assembly according to claim 79, but is silent as to further comprising a tube configured for delivery of gases to the patient interface.
However, Allum teaches a tracheostomy assembly (see [0062] and fig. 3) comprising a tube configured for delivery of gases to the patient interface ([0062] A patient ventilation interface may be a tracheostomy tube, or transtracheal catheter, which is typically connected to a ventilator 20 with a single limb gas delivery circuit 21. The single limb gas delivery circuit 21 may couple to an airway tube 60; see figure 3-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Enzinger to implement a gas delivery circuit and ventilator connected to the tracheal catheter in order to provide ventilation assistance to the patient as taught by Allum [0062].
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 70, 76-77, 79, 81, and 84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 10,828,445 (hereinafter ‘445). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 70, ‘445 discloses a tracheostomy guard for a patient interface comprising (claim 15):
a first end and a second closed end with a body therebetween, the first end being configured to couple to the patient interface (claim 15: a body with a first end with an opening for coupling to or communicating with a patient interface, a second closed end, and a longitudinal axis extending through the first end and the second closed end); and
the body comprising one or more ribs to provide one or more internal stops or to provide one or more support structures (claim 22).
Regarding claim 76, ‘445 discloses the tracheostomy guard according to claim 70, wherein the body comprises a first opening and a second opening (claim 15: the body further comprising a first opening and a second opening positioned between the first end and the second closed end).
Regarding claim 77, ‘445 discloses the tracheostomy guard according to claim 76, wherein at least one of the first opening are configured to allow patient secretions to drain from the tracheostomy guard in use (claim 15: the first opening and the second opening configured to drain waste from the tracheostomy guard).
Regarding claim 79, ‘445 discloses an assembly comprising the tracheostomy guard according to claim 70, coupled to the patient interface (claim 15: the first end opening is shaped to facilitate coupling a port of a patient interface).
Regarding claim 81, ‘445 discloses the assembly according to claim 79, wherein the patient interface comprises a port configured for coupling with a tube (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim 15: the first end opening is shaped to facilitate coupling a port of a patient interface).
Regarding claim 84, ‘445 discloses the assembly according to claim 79, wherein a second end of the patient interface is configured to couple with the tracheostomy guard (claim 15: the first end opening is shaped to facilitate coupling a port of a patient interface).
Claims 71-72, 74, 80, and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. ‘445, as applied to claim 70 above, and further in view of Enzinger (US 6516803 B1).
Regarding claim 71, ‘445 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the body is symmetrical along an axial plane.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the body is symmetrical along an axial plane (a housing 4 in the shape of a cylinder, having a symmetry axis; fig. 1; col. 2 line 66-67. Housing 4 is symmetrical along a vertical axial plane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement the body being symmetrical along an axial plane as doing so would be an obvious design choice taught by Enzinger.
Regarding claim 72, ‘445 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the body comprises a substantially hollow structure.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the body comprises a substantially hollow structure (see fig. 1, housing 4 is substantially hollow to allow passage of air).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement the body comprising a substantially hollow structure to allow passage of air as taught by Enzinger.
Regarding claim 74, ‘445 discloses the tracheostomy guard according to claim 70, wherein the second closed end comprises a non-standard medical shape or size (Applicant’s specifications [00142] gives an example of a non-standard medical shape or size as a frustoconical end or members that project beyond the body in order to prevent incorrect coupling of components thereto).
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the second closed end comprises a non-standard medical shape or size (see figure 1, closing plate 10 projects beyond the housing 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement the second closed end comprising a non-standard medical shape or size as doing so would be an obvious design choice taught by Enzinger.
Regarding claim 80, ‘445 discloses the assembly according to claim 79, but is silent as to wherein the patient interface is a tracheal interface.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the patient interface is a tracheal interface (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement the patient interface as a tracheal interface, such that the sputum is automatically kept away from the air filter and can be removed without problems to avoid painful and agonizing asphyxia attacks by patients, as taught by Enzinger col. 1 line 62-65.
Regarding claim 83, ‘445 discloses the assembly according to claim 79, but is silent as to wherein a first end of the patient interface is configured to fluidly connect with an airway of a patient.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein a first end of the patient interface is configured to fluidly connect with an airway of a patient (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9. Given the known definition of a tracheal catheter, the tracheal catheter end opposite to the end that projects from the trachea is the first end of the tracheal catheter and fluidically connects to the trachea of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement a first end of the patient interface is configured to fluidly connect with an airway of a patient, in order to perform a tracheostomy as taught by Enzinger.
Claims 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. ‘445, as applied to claim 70 above, and further in view of Beevers (US 4802474 A).
Regarding claim 75, ‘445 discloses the tracheostomy guard according to claim 70, but does not disclose wherein the second closed end is integrally formed with the body.
However, Beevers teaches a protective cover for a tracheostomy tube (10; fig. 1-4) wherein the second end is integrally formed with the body (protective cover 10, a collar 11 is adapted in size and shape to frictionally engage the outside end of a tracheal tube 15, as is shown in FIGS. 1 and 2. Collar 11 is fabricated integrally with vent flange 12. Foreign objects of a selected size are kept out of the airway created by tracheal tube 15, by means of a cage which is integral with the rest of the device. Circular end plate 19 is mounted in spaced relationship with the vent flange 12, and interconnected therewith by a plurality of cage bars 14; col. 3 line 6-15. Being an integral construction of resilient material, protective covers 10 and 20 are particularly well adapted to mass production and inexpensive fabrication techniques; col. 4 line 17-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of ‘445 to implement the second closed end integrally formed with the body forming a one piece design to improve mass production and have inexpensive fabrication techniques as taught by Beevers (abstract and col. 4 line 17-20).
Claim 78 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. ‘445, as applied to claim 70 above, and further in view of Fukunaga et al. (US 20050188990 A1).
Regarding claim 78, ‘445 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the tracheostomy guard comprises a colour that indicates that it is a disposable component (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
However, Fukunaga teaches color coding disposable and reusable components. Specifically, Fukunaga discloses [0067] For easy handling in the operating room, a set-up kit can be provided with one set of reusable components and multiple disposable F-tube.TM. devices (preferably about 5). A benefit to having a multilumen fitting between the disposable components and the reusable components is that it is easy to segregate the medical waste portion from the reusable portion, which may be recycled, and only one component needs to be connected and disconnected to connect the multiple lumens. The components may be color coded to facilitate distinguishing between the disposable components and the reusable ones.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement color coding to easily identify the tracheostomy guard as a disposable component as taught by Fukunaga [0067]. Further, the device of ‘445 is configured as disposable since it would be disposed of after use to ensure a sterilized environment for the next user.
Claim 82 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. ‘445, as applied to claim 70 above, and further in view of Allum et al. (US 20100071693 A1).
Regarding claim 82, ‘445 discloses the assembly according to claim 79, but is silent as to further comprising a tube configured for delivery of gases to the patient interface.
However, Allum teaches a tracheostomy assembly (see [0062] and fig. 3) comprising a tube configured for delivery of gases to the patient interface ([0062] A patient ventilation interface may be a tracheostomy tube, or transtracheal catheter, which is typically connected to a ventilator 20 with a single limb gas delivery circuit 21. The single limb gas delivery circuit 21 may couple to an airway tube 60; see figure 3-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘445 to implement a gas delivery circuit and ventilator connected to the tracheal catheter in order to provide ventilation assistance to the patient as taught by Allum [0062].
Claim 86 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. ‘445, as applied to claim 70 above, and further in view of Shikani et al. (US 20120152239 A1)
Regarding claim 86, ‘445 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the one or more ribs extend axially along an internal surface of the body.
However, Shikani teaches a tracheostomy guard (12; figure 1-2) wherein the body ([0055] body 14; figure 2-5) comprising one or more ribs extend axially along an internal surface of the body ([0055] a chamber having an internal step 20 within the body 14; see figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the body of ‘445 to implement one or more ribs in the form of an internal step within the body, as taught by Shikani in order to limit a tube from fully extending into the housing (see figure 2 and 5).
Claims 70, 79, 81, and 84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,029,855 (hereinafter ‘855). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 70, ‘855 discloses a tracheostomy guard for a patient interface comprising (claim 1):
a first end and a second closed end with a body therebetween, the first end being configured to couple to the patient interface (claim 1: a body with a first end with an opening and a second closed end… the first end opening is shaped to facilitate coupling a port of a patient interface); and
the body comprising one or more ribs to provide one or more internal stops or to provide one or more support structures (claim 8).
Regarding claim 79, ‘885 discloses an assembly comprising the tracheostomy guard according to claim 70, coupled to the patient interface (claim 1: the first end opening biases into or at least towards the first configuration which is shaped to retain the tracheostomy guard on the patient interface, wherein in the first configuration, the first end opening is elongated).
Regarding claim 81, ‘885 discloses the assembly according to claim 79, wherein the patient interface comprises a port configured for coupling with a tube (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim 1: the first end opening is shaped to facilitate coupling a port of a patient interface).
Regarding claim 84, ‘885 discloses the assembly according to claim 79, wherein a second end of the patient interface is configured to couple with the tracheostomy guard (claim 1: the first end opening is shaped to facilitate coupling a port of a patient interface).
Claims 71-72, 74, 76-77, 80, and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. ‘885, as applied to claim 70 above, and further in view of Enzinger (US 6516803 B1).
Regarding claim 71, ‘885 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the body is symmetrical along an axial plane.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the body is symmetrical along an axial plane (a housing 4 in the shape of a cylinder, having a symmetry axis; fig. 1; col. 2 line 66-67. Housing 4 is symmetrical along a vertical axial plane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement the body being symmetrical along an axial plane as doing so would be an obvious design choice taught by Enzinger.
Regarding claim 72, ‘885 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the body comprises a substantially hollow structure.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the body comprises a substantially hollow structure (see fig. 1, housing 4 is substantially hollow to allow passage of air).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement the body comprising a substantially hollow structure to allow passage of air as taught by Enzinger.
Regarding claim 74, ‘885 discloses the tracheostomy guard according to claim 70, wherein the second closed end comprises a non-standard medical shape or size (Applicant’s specifications [00142] gives an example of a non-standard medical shape or size as a frustoconical end or members that project beyond the body in order to prevent incorrect coupling of components thereto).
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the second closed end comprises a non-standard medical shape or size (see figure 1, closing plate 10 projects beyond the housing 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement the second closed end comprising a non-standard medical shape or size as doing so would be an obvious design choice taught by Enzinger.
Regarding claim 76, ‘885 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the body comprises a first opening and a second opening.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the body (housing 4; fig. 1) comprises a first opening (third opening 3; fig. 1) and a second opening (second opening 2; fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement a first opening and a second opening, in order to connect to a bag for catching the sputum or a hose for draining the sputum, as taught by Enzinger col. 3 line 6-17.
Regarding claim 77, ‘885-Enzinger discloses the tracheostomy guard according to claim 76, but is silent as to wherein at least one of the first opening are configured to allow patient secretions to drain from the tracheostomy guard in use (The connecting piece 13 in the third opening 3, which preferably points downward in the position of use, has a conical outside wall onto which a bag for catching the sputum or a hose for draining the sputum to such a catch bag can be fitted; col. 3 line 13-17; figure 1).
Regarding claim 80, ‘885 discloses the assembly according to claim 79, but is silent as to wherein the patient interface is a tracheal interface.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein the patient interface is a tracheal interface (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement the patient interface as a tracheal interface, such that the sputum is automatically kept away from the air filter and can be removed without problems to avoid painful and agonizing asphyxia attacks by patients, as taught by Enzinger col. 1 line 62-65.
Regarding claim 83, ‘885 discloses the assembly according to claim 79, but is silent as to wherein a first end of the patient interface is configured to fluidly connect with an airway of a patient.
However, Enzinger teaches a tracheostomy guard for a patient interface (Device for Removing Sputum from a Tracheal Catheter; title; fig. 1), wherein a first end of the patient interface is configured to fluidly connect with an airway of a patient (The inside wall of the connecting piece 11 of the first opening 1 has a conical shape, so that this connecting piece 11 can be fitted onto the tracheal catheter end that projects from the trachea; col. 3 line 6-9. Given the known definition of a tracheal catheter, the tracheal catheter end opposite to the end that projects from the trachea is the first end of the tracheal catheter and fluidically connects to the trachea of the patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement a first end of the patient interface is configured to fluidly connect with an airway of a patient, in order to perform a tracheostomy as taught by Enzinger.
Claims 75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. ‘885, as applied to claim 70 above, and further in view of Beevers (US 4802474 A).
Regarding claim 75, ‘885 discloses the tracheostomy guard according to claim 70, but does not disclose wherein the second closed end is integrally formed with the body.
However, Beevers teaches a protective cover for a tracheostomy tube (10; fig. 1-4) wherein the second end is integrally formed with the body (protective cover 10, a collar 11 is adapted in size and shape to frictionally engage the outside end of a tracheal tube 15, as is shown in FIGS. 1 and 2. Collar 11 is fabricated integrally with vent flange 12. Foreign objects of a selected size are kept out of the airway created by tracheal tube 15, by means of a cage which is integral with the rest of the device. Circular end plate 19 is mounted in spaced relationship with the vent flange 12, and interconnected therewith by a plurality of cage bars 14; col. 3 line 6-15. Being an integral construction of resilient material, protective covers 10 and 20 are particularly well adapted to mass production and inexpensive fabrication techniques; col. 4 line 17-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of ‘885 to implement the second closed end integrally formed with the body forming a one piece design to improve mass production and have inexpensive fabrication techniques as taught by Beevers (abstract and col. 4 line 17-20).
Claim 78 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. ‘885, as applied to claim 70 above, and further in view of Fukunaga et al. (US 20050188990 A1).
Regarding claim 78, ‘885 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the tracheostomy guard comprises a colour that indicates that it is a disposable component (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
However, Fukunaga teaches color coding disposable and reusable components. Specifically, Fukunaga discloses [0067] For easy handling in the operating room, a set-up kit can be provided with one set of reusable components and multiple disposable F-tube.TM. devices (preferably about 5). A benefit to having a multilumen fitting between the disposable components and the reusable components is that it is easy to segregate the medical waste portion from the reusable portion, which may be recycled, and only one component needs to be connected and disconnected to connect the multiple lumens. The components may be color coded to facilitate distinguishing between the disposable components and the reusable ones.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement color coding to easily identify the tracheostomy guard as a disposable component as taught by Fukunaga [0067]. Further, the device of ‘885 is configured as disposable since it would be disposed of after use to ensure a sterilized environment for the next user.
Claim 82 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. ‘885, as applied to claim 70 above, and further in view of Allum et al. (US 20100071693 A1).
Regarding claim 82, ‘885 discloses the assembly according to claim 79, but is silent as to further comprising a tube configured for delivery of gases to the patient interface.
However, Allum teaches a tracheostomy assembly (see [0062] and fig. 3) comprising a tube configured for delivery of gases to the patient interface ([0062] A patient ventilation interface may be a tracheostomy tube, or transtracheal catheter, which is typically connected to a ventilator 20 with a single limb gas delivery circuit 21. The single limb gas delivery circuit 21 may couple to an airway tube 60; see figure 3-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘885 to implement a gas delivery circuit and ventilator connected to the tracheal catheter in order to provide ventilation assistance to the patient as taught by Allum [0062].
Claim 86 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. ‘885, as applied to claim 70 above, and further in view of Shikani et al. (US 20120152239 A1)
Regarding claim 86, ‘885 discloses the tracheostomy guard according to claim 70, but is silent as to wherein the one or more ribs extend axially along an internal surface of the body.
However, Shikani teaches a tracheostomy guard (12; figure 1-2) wherein the body ([0055] body 14; figure 2-5) comprising one or more ribs extend axially along an internal surface of the body ([0055] a chamber having an internal step 20 within the body 14; see figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the body of ‘885 to implement one or more ribs in the form of an internal step within the body, as taught by Shikani in order to limit a tube from fully extending into the housing (see figure 2 and 5).
Conclusion
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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