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 .
Response to Preliminary Amendment
This office action is in response to the preliminary amendment filed on 04/15/2024. Per the amendment claims 1-3 and 5-7 are as previously presented, and claim 4 is canceled. As such, claims 1-3 and 5-7 are pending in the instant application.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1, line 1: “the addition” should read “an addition” to establish antecedent basis.
Claim 1, line 7: “the body of nebulizer” should read “a body of the nebulizer” for clarity.
Claim 1, lines 10-11: “a drug solution reservoir” should read “the drug solution reservoir” for clarity and consistency.
Claim 1, line 18: “the distal end of an axis” should read “a distal end of an axis” for clarity and to establish antecedent basis.
Claim 1, line 27: “a first drug solution and an additional drug solution” should read “the first drug solution and the additional drug solution” for clarity and consistency.
Claim 5, line 1: “the addition” should read “an addition” to establish antecedent basis.
Claim 5, lines 4 and 6: “a drug solution” should read “the drug solution” for clarity and consistency.
Claim 5, lines 6-7: “a nebulizer” should read “the nebulizer” for clarity and consistency.
Claim 5, line 8: “a drug solution reservoir” should read “the drug solution reservoir” for clarity and consistency.
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.
Claims 1-3 and 5-7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the port” in lines 7 and 10. It is unclear if the limitation is a recitation of the male threaded port disclosed in lines 6-7 or if Applicant is attempting to recite a new limitation. For the purpose of examination, the above limitation with be interpreted as a recitation of the male threaded port disclosed in lines 6-7.
Claim 1 recites the limitation “a liquid” in line 10. It is unclear if the limitation is a reference to the drug solution disclosed in line 8 or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the drug solution.
Claim 1 recites the limitation “the seal from the distal end” in line 13. It is unclear if the limitation is referencing the seal of the sealed distal end, disclosed in line 12, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the sealed distal end.
Claim 5 recites the limitation “the seal from the distal end” in lines 3-4. It is unclear if the limitation is referencing the seal of the sealed distal end, disclosed in line 3, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the sealed distal end.
Claim 5 recites the limitation “a liquid” in line 7. It is unclear if the limitation is a reference to the drug solution disclosed in line 1 or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the drug solution.
Claim 6 recites the limitation “an additional drug solution” in lines 3-4 and line 6. It is unclear if the limitation is a recitation of the drug solution in line 1 or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the drug solution – as recited in line 1.
Claim 7 recites the limitation “the nebulizer body” in line 2. It is unclear if the limitation is a recitation of the nebulizer as disclosed in line 1 of claim 6, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as – the nebulizer – as recited in line 1 of claim 6.
Claims 2-3 are rejected due to their dependency on a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 6-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Roberts & Burwell (US 5388571 A), hereinafter Roberts.
Regarding claim 6, Roberts discloses a cap assembly (270, 278, and 280; Fig. 4) for the addition of a drug solution to a nebulizer (where cap assembly 270, 278, 280 is part of nebulizer component 200; Figs. 2 and 4; coll. 3, lines 44-47) having a drug reservoir (205; Fig. 2) and a vertical orientation (nebulizer component 200 has a vertical orientation, where medicine input into the nebulizer component flows downward from connector 270 into a cup-like section 205 of the nebulizer for storage; Fig. 2), comprising a cap (270; Fig. 4) with an opening therein permitting the addition of an additional drug solution (270 has an opening for 248 to be placed; Fig. 4; col. 11, lines 46-48) added by syringe or respule to the nebulizer (248 is a tapered tip, and it is well-known to one of ordinary skill in the art that a syringe has a tapered tip, hence medicine source 250 with tapered tip 248 which delivers liquid medicine via opening of 270 can be interpreted as a syringe; Fig. 4; col. 10, lines 35-37; col. 11, lines 46-50), wherein a plug (278; Fig. 4) is provided to prevent air leakage from the opening when the opening is not in use to add an additional drug solution (col. 11, lines 51-53).
Regarding claim 7, Roberts discloses the invention as set forth in claim 6, wherein the cap assembly (270, 278, and 280; Fig. 4) is connected to the nebulizer body with a tether (278 is connected to 270 via 280, where 270 is part of the nebulizer component 200, see Fig. 4).
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Amaral & Steele (US 20190076612 A1), hereinafter Amaral, in view of Roberts & Burwell (US 5388571 A), hereinafter Roberts.
Regarding claim 1, Amaral discloses a port assembly (16; Fig. 1) for the addition of more than one drug solution to a nebulizer (last sentence of [0038]) having a drug reservoir (20; Fig. 1), wherein the nebulizer is used to administer drugs to a patient by inhalation ([0016]; [0032], lines 7-11), and the nebulizer is part of a breathing circuit connected a mechanical ventilator (see Fig. 1; [0031], lines 1-3; [0039]), comprising
a sleeve (26; Fig. 1) having a branch (68; Fig. 8), wherein the sleeve has a compression nut at a proximal end adapted to mate with a male threaded port integral with the body of nebulizer (threaded coupling 24 couples 26 to cap 22 of nebulizer chamber 18; Fig. 1; [0031], lines 3-8), wherein the port is adapted as a channel for adding a drug solution to a nebulizer (cap 22 retains interior tube 56, where interior tube 56, via its connection to the nebulizer chamber 18 through cap 22, creates a channel for adding medications to the nebulizer chamber 19; [0037], lines 9-15; Fig. 8), wherein the male threaded port is on an upper portion of a nebulizer (cap 22 is on an upper portion of the nebulizer chamber 18; Fig. 1) such that a liquid added to the nebulizer through the port will cascade into a drug solution reservoir in the nebulizer (liquid added through cap 22 via interior tube 56 cascades into medicine cup 20 of nebulizer chamber 18; Fig. 8);
wherein the sleeve (26; Fig. 1) has a sealed distal end (64 of 26 is fluidically sealed with 68; Fig. 8) and a tube (56, where 56 and 68b are connected; Fig. 8) traversing longitudinally through the seal from the distal end to the proximal end (see Figs. 1 and 8, where the distal end is located at 64 and the proximal end is located at 24), wherein a first drug solution can be added into the nebulizer through the tube without disassembling the nebulizer or the compression nut on the sleeve (a first drug can be added to the nebulizer chamber 18 via 56 connected to 68b without disassembling the nebulizer chamber 18 or the threaded connection 24 between 26 and 22, see [0036] and [0038]; Fig. 8);
where the branch (68; Fig. 8) on the sleeve (68 located on 26; Fig. 8) defines a channel (68a; Fig. 8) at an approximately 45° angle with respect to the distal end of an axis defined by tube (the flow passage from 62b through 56 forms a 90° angle with 26, hence 68a forms approximately a 45° angle with the flow passage from 62b through 56, where said flow passage is the axis defined by 56, see Annotated Fig. 8 below), and the channel provides for the addition of an additional drug solution into the nebulizer (last sentence of [0038]); and
wherein a first drug solution and an additional drug solution can be added simultaneously to the nebulizer (last sentence of [0038]).
Amaral further discloses a plug (66) to close injection port (64) when the injection port is not in use (see Fig. 7), but does not explicitly disclose wherein the branch (68; Fig. 8) has a cap having an opening therein permitting the addition of the additional drug solution to the nebulizer, wherein the additional drug solution is added by syringe or respule, wherein a plug is provided to prevent air leakage from the opening when the opening is sealed and not in use to add an additional drug solution.
However, Roberts teaches an analogous port assembly (Abstract) with a flow-path branch (276; Fig. 4) to deliver liquid medicine to a nebulizer component (col. 11, lines 43-50), where the flow-path branch (276; Fig. 4) includes a connector (270; Fig. 4) with an opening for a liquid medicine source with a tapered tip to be inserted, such that the liquid medicine can be received by the flow-path branch (see Fig. 4 and col. 11, lines 43-50), a cap (278; Fig. 4) to cover the opening of the connector (270; Fig. 4) when medicine is not being introduced (col. 11, lines 51-53), and a tether (280; Fig. 4; col. 11, lines 53-56).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the branch taught by Amaral with the cap and tether taught by Roberts such that the branch (68; Fig. 8) has a cap (Roberts 270; Roberts Fig. 4) having an opening therein permitting the addition of the additional drug solution to the nebulizer (Roberts 270 has an opening therein for the addition of liquid medicine, see Roberts col. 11, lines 43-50; liquid medicine added via opening of Roberts 270 flows through Amaral 68 and Amaral 56 to the nebulizer chamber 18 taught by Amaral), wherein the additional drug solution is added by syringe or respule (it is well-known to one of ordinary skill in the art that a syringe has a tapered tip, Roberts teaches a medicine source with a tapered tip delivers liquid medicine via opening of 270, hence the medicine source 250 taught by Roberts can be interpreted as a syringe; Roberts Fig. 4), wherein a plug (Roberts 278; Roberts Fig. 4) is provided to prevent air leakage from the opening when the opening is sealed and not in use to add an additional drug solution (Roberts col. 11, lines 51-53) to minimize leaking of the port assembly as contamination of the treatment being provided to the patient (Roberts col. 11, lines 52-53).
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Annotated Fig. 8
Regarding claim 2, Amaral, as modified, teaches the invention as set forth in claim 1, wherein the plug (Roberts 278; Fig. 4) is on a tether (Roberts 280; Fig. 4) affixed to the nebulizer (Roberts 280 is affixed to the nebulizer via its attachment to Amaral 68; Roberts Fig. 4; Amaral Fig. 8) such that the plug remains attached to the nebulizer when the plug is removed to expose the opening in the cap for the addition of the additional drug solution (Roberts col. 11, lines 53-56).
Regarding claim 3, Amaral, as modified, teaches the invention as set forth in claim 1, but does not explicitly teach wherein an axis through the center of the branch channel (152) is oriented at a 30° to 80° angle from a longitudinal axis though the center of the nebulizer and with respect to the top of the nebulizer.
However, Amaral does disclose the branch channel (68a; Fig. 8) defines approximately a 45° angle with respect to the distal end of a axis defined by the tube (56; see claim 1 above; see Annotated Fig. 8 above), where the axis defined by the tube (56, see Annotated Fig. 8 above) is a longitudinal axis through the center of the nebulizer chamber (axis defined by 56 is a longitudinal axis through 18, see Fig. 1 and Annotated Fig. 8 above). In addition, the longitudinal axis through the center of the nebulizer chamber (see axis defined by 56 in Annotated Fig. 8 above) forms a 90° angle with the top of the nebulizer chamber. Hence, the angle between the axis through the center of the nebulizer chamber (see axis defined by 56 in Annotated Fig. 8 above) and the top of the nebulizer chamber must be approximately 45°, where said angle is within the claimed range of 30° to 80°.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention that Amaral, as modified, does teaches an axis through the center of the branch channel is oriented at a 30° to 80° angle from a longitudinal axis though the center of the nebulizer and with respect to the top of the nebulizer (see explanation above).
Regarding claim 5, Amaral discloses a port assembly (16; Fig. 1) for the addition of a drug solution to a nebulizer (last sentence of [0038], where one or more drugs may be added to nebulizer chamber 18; Fig. 8) having a drug reservoir (20; Fig. 1) and a vertical orientation (nebulizer chamber 18 is vertically oriented, see Fig. 8), but does not disclose the port assembly (16; Fig. 1) comprising a cap with a sealed distal end and a tube traversing longitudinally through the seal from the distal end to a proximal end, wherein a drug solution can be added into the nebulizer through the tube without disassembling the nebulizer, wherein the cap fits over a port adapted as a channel for adding a drug solution to a nebulizer such that a liquid added to the nebulizer through the port will cascade into a drug solution reservoir in the nebulizer.
However, Roberts teaches an analogous port assembly (Abstract) with a flow-path branch (276; Fig. 4) to deliver liquid medicine to a nebulizer component (col. 11, lines 43-50), where the flow-path branch (276; Fig. 4) includes a connector (270; Fig. 4) with an opening for a liquid medicine source with a tapered tip to be inserted, such that the liquid medicine can be received by the flow-path branch (see Fig. 4 and col. 11, lines 43-50), a cap (278; Fig. 4) to cover the opening of the connector (270; Fig. 4) when medicine is not being introduced (col. 11, lines 51-53), and a tether (280; Fig. 4; col. 11, lines 53-56).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the port assembly taught by Amaral with Roberts such that, the port assembly (16; Fig. 1) comprises a cap (Roberts 278; Roberts Fig. 4) with a sealed distal end (Roberts 278 is closed off at a distal end to create a seal at the opening of Amaral 68 when engaged with Amaral 68; Roberts Fig. 4; Amaral Fig. 8; Roberts col. 11, lines 43-50) and a tube traversing longitudinally through the seal from the distal end to a proximal end (Amaral 56 is connected to Amaral 68 and traverses through the seal of the closed of distal end of Roberts 278 when Roberts 278 is not engaged to a proximal end; Amaral Fig. 8), wherein a drug solution can be added into the nebulizer through the tube without disassembling the nebulizer (a liquid medicine can be input via Amaral 68 and flows through Amaral 56 to the nebulizer chamber 18 without disassembling the nebulizer, when Roberts 278 is not engaged with Amaral 68; Amaral Fig. 8; Amaral [0036] and [0038]), wherein the cap fits over a port adapted as a channel (Roberts 278 fits over the opening of Amaral 68; Roberts Fig. 4) for adding a drug solution to a nebulizer such that a liquid added to the nebulizer through the port will cascade into a drug solution reservoir in the nebulizer (liquid medicine is added via the opening of Amaral 68 and flows through Amaral 68 and Amaral 56 to medicine cup 20; Amaral Fig. 8) to minimize leaking of the port assembly as contamination of the treatment being provided to the patient (Roberts col. 11, lines 52-53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Meech (US 20210138176 A1): Regarding a connector branch with a port for medicament and/or drug dispensing.
Islava (US 20180228993 A1): Regarding a nebulizer apparatus with a port to input a drug solution without interrupting the breathing circuit or the nebulizer component.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785