DETAILED ACTION
This office action is in response to the preliminary amendment filed 5/16/2024. As directed by the amendment, claims 1-10 have been amended and no claims have been cancelled or newly added. Thus, claims 1-11 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the optical image recorder, image processing device, and screen as recited in claim 7 and the suction tube with suction nozzle as recited in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because the drawings dated 5/16/2024, which appear to be a copy of the drawings from WO2023/095019, has “1/3” on it, and it is unclear whether the drawings are intended to include two more pages.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-11 are objected to because of the following informalities:
Claim 1 recites, “Tracheal administering device for a liquid”; it is suggested to amend the claim to recite --A tracheal administering device for a liquid-- to make the claim more grammatically correct.
Claims 2-11 recite “Device according to claim [X]”; it is suggested to amend the claim to recite --The device according to claim [X]-- to make the claim more grammatically correct.
Claim 2 recites “the distal part of the liquid conduit” in line 2; it is suggested to amend the claim to recite --a distal part of the liquid conduit-- as it is the first time the limitation is being recited.
Claim 3 recites “the spray channel” in line 4; it is suggested to amend the claim to recite --that at least one spray channel-- to maintain claim consistency with the previously recited at least one spray channel. Lines 5-6 recite “the distal outer end of the liquid conduit”; it is suggested to amend the claim to recite --a distal outer end of the liquid conduit-- as it is the first time the limitation is being recited.
Clam 4 recites “the distal outer end of the endotracheal tube” in lines 4-5; it is suggested to amend the claim to recite --a distal outer end of the endotracheal tube-- as it is the first time the limitation is being recited.
Claim 7 recites “wherein the endotracheal tube comprises close to the distal open outer end thereof an optical image recorder” in lines 2-3, which is grammatically incorrect. It is noted that the limitation is rejected under 35 USC § 112, as discussed below.
Claim 9 recites “the proximal outer end” in line 4; it is suggested to amend the claim to recite --a proximal outer end-- as it is the first time the limitation is being recited.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 2-3 and 7-8 is/are 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, the phrase "particularly" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recites the limitation "the spray opening" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, lines 2-3 recite “wherein the endotracheal tube comprises close to the distal open end”. It is unclear how to define the metes and bounds of how to determine when an optical image recorder is “close” to the distal open end of the endotracheal tube. Furthermore, there is insufficient antecedent basis for the limitation “the distal open end” in the claim.
Regarding claim 8, lines 2-3 recite “a suction nozzle which opens close to the spraying device”; it is unclear how to determine the metes and bounds of how to determine when the suction nozzle is “close” to the spraying device.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 11, line 1 recites, “Atomizing catheter as applied in the device of claim 10”. The atomizing catheter of claim 11 does not further limit the tracheal administering device for a liquid, as the atomizing catheter is “applied in the device” and is considered to be a statement of intended use (e.g. the catheter is capable of being applied in the device), and therefore because the atomizing catheter does not require all of the structure of the tracheal administering device of claim 10, claim 11 does not further limit claim 10. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Kruijf et al (2010/0288271).
Regarding claim 1, De Kruijf in figs 1-4 discloses a tracheal administering device for a liquid, comprising an respiratory tube (29) with a ventilation lumen (lumen carrying flow B) which extends axially therein and is able and configured to carry a respiratory gas flow (para [0035]), wherein the respiratory tube may be an endotracheal (intubation) tube (4c) (para [0033]), and comprising a liquid conduit (conduit containing force F) (para [0035]) which connects proximally to a liquid system able and configured to supply a liquid under an increased operating pressure (liquid system shown in fig 2 includes supply containers (19a, b) and pressure-generating elements (not shown) configured exert a force Fa) (para [0034] and from which the liquid is receivable into the respiratory gas flow distally (fig 4q, para [0035]), wherein the liquid conduit is distally coupled to a spraying device comprising a ceramic spray plate (28) (atomizer body) with at least one spray channel (40) (atomizing channels), wherein the at least one spray channel has a cross-section smaller than about five micrometres (internal diameter of 4.5 micrometers), and wherein the at least one spray channel (40) receives the liquid, at least during operation, from the liquid conduit under increased pressure (F) and delivers therefrom at least one mist jet to the respiratory gas flow (para [0035]).
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 of this title, 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of De Kruijf et al as applied to claim 1 above, and further in view of Baran (2004/0084049).
Regarding claim 2, De Kruijf discloses a liquid conduit.
De Kruijf does not disclose that at least the distal part of the liquid conduit extends inside the endotracheal tube and particularly ends at least substantially concentrically therein.
However, Baran in figs 3-5 teaches a nebulizing catheter (20) including a liquid conduit (33) (liquid lumen) (para [0093]), and wherein the distal part of the liquid conduit extends inside an endotracheal tube (52) and particularly ends at least substantially concentrically therein using centering device (50) (para [0103]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the liquid conduit is formed as a nebulizing catheter which extends inside the endotracheal tube and particularly ends at least substantially concentrically therein as taught by Baran in order to allow the device for delivering a nebulized substance to be used in combination with an endotracheal tube and be removable from the endotracheal tube (Baran, abstract).
Regarding claim 10, De Kruijf discloses a liquid conduit.
De Kruijf does not disclose the liquid conduit is provided by an individual atomizing catheter comprising an elongate shaft body in which a liquid lumen extends axially with a distal outer end which connects to the spraying device, wherein the atomizing catheter is received exchangeably in the endotracheal tube.
However, Baran teaches a nebulizing catheter (20) including a liquid conduit (33) (liquid lumen) which is provided by an individual atomizing catheter (20) (nebulizing catheter) (para [0093]) comprising an elongate shaft body (152) (main shaft section) in which a liquid lumen (164) (liquid orifice) extends axially with a distal outer end which connects to a spraying device (160) (tip) (para [0125]), wherein the atomizing catheter (20) is received exchangeably in the endotracheal tube (10) (para [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the liquid conduit is provided by an individual atomizing catheter comprising an elongate shaft body in which a liquid lumen extends axially with a distal outer end which connects to the spraying device, wherein the atomizing catheter is received exchangeably in the endotracheal tube as taught by Baran in order to allow the device for delivering a nebulized substance to be used in combination with an endotracheal tube and be removable from the endotracheal tube (Baran, abstract).
Regarding claim 11, the modified De Kruijf’s reference discloses an atomizing catheter (20 of Baran) applied in an endotracheal tube (52 of Baran) (Baran, para [0113]).
Claim(s) 3, 6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of De Kruijf et al as applied to claim 1 above, and further in view of Van Rijn et al (WO2020/085908A1).
Regarding claim 3, De Kruijf discloses a ceramic spray plate.
De Kruijf does not disclose the ceramic spray plate comprises a silicon nitride layer in which the spray opening extends over a whole layer thickness, wherein the silicon nitride layer extends over a silicon carrier body with a body cavity which opens at the position of the spray channel at a surface thereof, and wherein the body cavity maintains a liquid connection to the distal outer end of the liquid conduit.
However, Van Rijn in fig 3 teaches a spray device including a ceramic spray plate including a silicon nitride layer (14) in which a spray opening (16) (spray orifice) extends over a whole layer thickness, wherein the silicon nitride layer (14) extends over a silicon carrier body (10) (silicon plate body) with a body cavity (15) which opens at the position of the spray channel (16) at a surface thereof (page 7, lines 16-22), and wherein the body cavity (15) maintains a liquid connection to a distal outer end (connects to a pressurized source at an inlet (2) of the cavity (5) (page 7, lines 11-14), and during operation, pressurized fluid that is received by the cavity (5) of said nozzle unit will enter the cavities (15) of said nozzle chip (10) and will pass through these nozzle orifices (16)) (page 7, lines 26-28).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the ceramic spray plate comprises a silicon nitride layer in which the spray opening extends over a whole layer thickness, wherein the silicon nitride layer extends over a silicon carrier body with a body cavity which opens at the position of the spray channel at a surface thereof, and wherein the body cavity maintains a liquid connection to the distal outer end of the liquid conduit as taught by Van Rijn in order to allow the device to be user with materials and manufacturing processes that result in a high precision and reliability combined with a very well controlled reproducibility (Van Rijn, page 5, lines 24-34).
Regarding claim 6, De Kruijf discloses at least one spray channel.
De Kruijf does not disclose the at least one spray channel has a length of less than about five micrometres.
However, Van Rijn teaches a teaches a spray device including a ceramic spray plate including a silicon nitride layer (14) including at least one spray channel (16) (spray orifices), wherein the at least one spray channel (16) has a length of less than about five micrometres (silicon nitride layer (14) has a thickness of one or more micron, and as the spray channel (16) extends through the thickness of the silicon nitride layer (14) would have a thickness of one or more micron, which is less than 5 microns) (page 7, lines 16-22).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that at least one spray channel has a length of less than about five micrometres as taught by Van Rijn in order to allow the device to generate a micro-jet spray of very fine droplets (Van Rijn, page 1, lines 21-31).
Regarding claim 9, De Kruijf discloses the liquid system comprises a medical syringe comprising a container (52a, b) (supply containers) with a volume for the liquid (51a, b) (medications) in which a force (Fa, Fb) can be exerted by a pressure-generating element (not shown), and connected to a proximal end of the liquid conduit (53a, b) (tubes) (para [0039]).
De Kruijf does not disclose the liquid system comprises a medical syringe including a manually energizable piston body that is moveable, and wherein the liquid conduit comprises at the proximal outer end a coupling for a liquid-tight and pressure-resistant connection to an outlet of the medical syringe.
However, Van Rijn in fig 3 teaches a spray device, wherein the spray device comprises spray nozzle unit connected to a medical syringe including a manually energizable piston body that is moveable (spray nozzle unit may be fitted onto a syringe and a syringe is considered to include a manually energizable piston body that is moveable), and wherein the spray nozzle unit comprises at a proximal outer end a coupling (Luer fitting) for a liquid-tight and pressure-resistant connection to an outlet of the medical syringe (page 7, lines 9-14).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the liquid system comprises a medical syringe including a manually energizable piston body that is moveable, and wherein the liquid conduit comprises at the proximal outer end a coupling for a liquid-tight and pressure-resistant connection to an outlet of the medical syringe as taught by Van Rijn, as the use of a liquid system including a medical syringe including a manually energizable piston body that is moveable, and a coupling for a liquid-tight and pressure-resistant connection to an outlet of the medical syringe is known in the art, and it appears that the device of modified De Kruijf would perform equally well to provide a pressurized liquid to the spraying device using a medical syringe and a liquid-tight and pressure-resistant connection such as a Luer fitting. See MPEP 2143(I)(A).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of De Kruijf et al as applied to claim 1 above, and further in view of Wright (6,766,801).
Regarding claim 4, De Kruijf discloses an endotracheal tube (para [0033]).
De Kruijf does not disclose the endotracheal tube comprises an inlet tube with a port through which the liquid conduit is receivable, which inlet tube continues in the ventilation lumen of the endotracheal tube and, within a distance of 10 centimeters upstream of the distal outer end of the endotracheal tube, opens therein.
However, Wright teaches a tracheal aerosol delivery device including an endotracheal tube (16), wherein the endotracheal tube comprises an inlet tube (26) (sub-port tube) (col 2, ln 41-45) through which a liquid conduit (28) (delivery conduit) is receivable (col 3, ln 16-24) which inlet tube (26) continues in a ventilation lumen of the endotracheal tube (16) and, within a distance of 10 centimeters upstream of the distal outer end of the endotracheal tube (16) (opening of inlet tube (26) is such that the nozzle (24) extends to a distal end of the endotracheal tube (16) such that a distance D form the nozzle (24) to the distal end is 0.0 to 0.2 centimeters) (col 2, ln 49-55).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the endotracheal tube comprises an inlet tube with a port through which the liquid conduit is receivable, which inlet tube continues in the ventilation lumen of the endotracheal tube and, within a distance of 10 centimeters upstream of the distal outer end of the endotracheal tube, opens therein as taught by Wright in order to allow the device to deliver an aerosol to a distal portion of an endotracheal tube and to reduce local mucosal impact and irritation (Wright, col 2, ln 5-10).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of De Kruijf et al and Wright as applied to claim 4 above, and further in view of Baran.
Regarding claim 5, modified De Kruijf discloses an inlet tube.
Modified De Kruijf does not disclose at least an outer end of the inlet tube is received by a centering device, which centering device centers at least the outer end of the inlet tube substantially coaxially in the ventilation lumen.
However, Baran in figs 1 and 5 teaches a nebulizing catheter (20), wherein an outer end of the nebulizing catheter (20) is received by a centering device (50), which centering device (50) centers at least the outer end of the nebulizing catheter (20) substantially coaxially in the ventilation lumen (fig 5, para [0103]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified De Kruijf so that at least an outer end of the inlet tube is received by a centering device, which centering device centers at least the outer end of the inlet tube substantially coaxially in the ventilation lumen as taught by Baran in order to help to center and align the distal end of the nebulizing catheter for improved performance (Baran, para [0103]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of De Kruijf et al as applied to claim 1 above, and further in view of Black et al (2011/0237896).
Regarding claim 7, De Kruijf discloses an endotracheal tube.
De Kruijf does not disclose the endotracheal tube comprises close to the distal open outer end thereof an optical image recorder which is couplable to an image processing device and screen.
However, Black teaches an endotracheal, including an endoscopy port (67) for allowing a channel (2) to pass an optical image recorder (endoscope) close to the distal outer end of an endotracheal tube (endoscope is passed near its tip) (para [0069]), which is couplable to an image processing device and screen (endoscopes include an image processing device and screen at a proximal end to allow a user to view an image produced by the endoscope).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf by providing an endoscopy port to allow an optical image recorder (endoscope) close to the distal open outer end of the endotracheal tube which is couplable to an image processing device and screen as taught by Black in order to permit videolaryngoscopic accurate placement of the endotracheal tube between the vocal cords and properly locate it in the trachea (Black, para [0069]).
Regarding claim 8, De Kruijf discloses an endotracheal tube.
De Kruijf does not disclose the endotracheal tube comprises a suction tube with a suction nozzle which opens close to the spraying device, and wherein the endotracheal tube comprises a port with a tube connection for connecting the suction tube to an external suction device.
However, Black teaches an endotracheal tube (improved endotracheal tube), wherein the endotracheal tube comprises a suction tube (2) (suction channel) with a suction nozzle (opens) which opens close a distal end of the endotracheal tube (para [0057]), and wherein the endotracheal tube comprises a port (9) with a tube connection (5) (suction extension tube) for connecting the suction tube (2) to an external suction device (suction source (SS) (not shown)) (para [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of De Kruijf so that the endotracheal tube comprises a suction tube with a suction nozzle which opens close to the spraying device, and wherein the endotracheal tube comprises a port with a tube connection for connecting the suction tube to an external suction device as taught by Black in order provide a built in suction channel for the removal of excessive secretions from the lumen of the endotracheal tube (Black, abstract). The now-modified De Kruijf’s device is considered that the suction nozzle which opens close to the spraying device, as the both the spraying device and the suction nozzle are disposed proximate a distal end of the endotracheal tube and therefore would be close to one another.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fukumoto (2010/0083956), Truthan (5,605,147), Wolf (4,767,416), Frache (2018/0296775), Melsheimer et al (2014/0018616) discloses devices to deliver an aerosol to a respiratory tract of a user.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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