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 Amendment
This Office Action is in response to the amendment filed on 06/12/2026. Claims 1 and 5-7 are as currently amended. Claim 4 is canceled. Claims 2-3 are as previously presented. As such, claims 1-3 and 5-7 are pending in the instant application.
All claim objections and rejections pursuant of 35 U.S.C. 112(b) are withdrawn in light of the amendments.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1, line 8 and line 11: “the port” should read “the male threaded port” for consistency and clarity.
Claim 1, line 15: “a first drug solution” should read “the first drug solution” for consistency and clarity.
Claim 1, line 20: “by tube” should read “by the tube” for clarity.
Claim 1, line 20: “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: “an additional drug” should read “the additional drug” for consistency and clarity.
Claim 7, lines 2-4: “an elastic element arranged between each sub-part and the insertion members, so that the insertion members are telescopically arranged on both sides of each sub-part” is not underlined to indicate the amendment of claim 7 (see MPEP 714.II.B; see 37 C.F.R. 1.121.c).
Claim 7, line 3: “the insertion members” should read “insertion members” to establish antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites the limitation “an elastic element arranged between each sub-part and the insertion members, so that the insertion members are telescopically arranged on both sides of each sub-part” in lines 2-4. The specification filed on 06/20/2023 does not explicitly disclose sub-parts of a cap assembly, insertion members of a cap assembly, insertion members telescopically arranged on both sides of each sub-part, an elastic element of a cap assembly, nor an elastic element arranged between each sub-part and insertion members of a cap assembly, as amended claim 7 discloses. Applicant’s specification (filed 06/20/2026) does disclose a cap assembly (161) with a tethered plug (tether 166; plug 164) that can be inserted into an opening of the cap assembly (opening 162) to seal said opening and prevent air leakage, where the tether (166) secures the plug (164) to the cap assembly ([0048]). Applicant’s specification further discloses a second tether (172) can be provided to keep the cap (160) attached to the nebulizer (10, see Fig. 9) when the cap is detached from a branch (150) and is not in use ([0049]). In light of the specification filed on 06/20/2026, one of ordinary skill in the art would be unable to reasonably convey that Applicant had possession of the claimed invention, specifically an elastic element arranged between sub-parts and insertion members and said insertion members being telescopically arranged in each side of the sub-parts, at the time the application was filed.
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 7 is 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 7 recites the limitation “an elastic element arranged between each sub-part and the insertion members, so that the insertion members are telescopically arranged on both sides of each sub-part” in lines 2-4. The scope of an elastic element, sub-parts, and insertion members in unclear and indefinite as Applicant fails to disclose or define such structures in the drawings and specification. For the purpose of examination, the above limitation will be interpreted as – a second tether to connect the plug to the cap assembly – based on paragraphs [0048]-[0049] of Applicant’s specification.
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)(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.
Claim 6 is 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 an addition of a first 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, thereby permitting the addition of an additional drug solution (270 has an opening for 248 to be placed; Fig. 4; col. 11, lines 46-48) 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 the additional drug solution (col. 11, lines 51-53).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts (US 5388571 A).
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 with a tether (278 is connected to 270 via 280, where 270 is part of the nebulizer component 200, see Fig. 4). Roberts fails to explicitly disclose a second tether to connect the plug to the cap assembly, as best understood by the Examiner (see rejection of claim 7 under 35 U.S.C. 112(b) above).
However, an alternative embodiment taught by Roberts (see Fig. 6) teaches a path to introduce a dose of liquid medicine (350; Fig. 6) into a chamber (see Fig. 6) having a line to connect a connector (352; Fig. 6) to a nebulizer (line connects 352 to chamber formed by 304 & 306 via 354, see Fig. 6) and an elongated holder (356; Fig. 6) to connect a cap (354; Fig. 6) to the connector (352), where the connector (352) can be connected to a liquid medicine source when the cap (354) is not engaged (col. 13, lines 26-35).
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 cap assembly (270, 278, and 280) with the cap assembly depicted in Roberts Figure 6 (350), such that the cap assembly (350; Fig. 6) is connected to the nebulizer with a tether (line connecting 352 to 354 at 304, see Fig. 6), and a second tether (356; Fig. 6) to connect the plug (354; Fig. 6) to the cap assembly (356 connects 354 to 352, see Fig. 6) to facilitate the periodic introduction of a drug to a chamber of a nebulizer (col. 13, lines 26-28), minimize the risk of drug leakage, and prevent contaminants from entering the chamber of the nebulizer (col. 13, lines 33-38).
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 (US 5388571 A).
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 first 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 a first medication 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 the first drug solution and an additional drug solution added to the nebulizer through the port will cascade into the drug solution reservoir in the nebulizer (liquid added through cap 22 via interior tube 56 cascades into medicine cup 20 of nebulizer chamber 18, see Fig. 8; last sentence of [0038]);
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 sealed 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 the additional drug solution into the nebulizer (last sentence of [0038]); and
wherein a first drug solution and the additional drug solution can be added simultaneously to the nebulizer (last sentence of [0038]).
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Annotated Fig. 8
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).
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 an addition of a first 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 solution 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 sealed distal end to a proximal end, wherein the first 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 the first drug solution to a nebulizer such that the first drug solution and/or an additional drug solution added to the nebulizer through the port will cascade into the 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 sealed 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 the first 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 the first drug solution to a nebulizer such that the first drug solution and/or an additional drug solution added to the nebulizer through the port will cascade into the 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).
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
With regard to independent claim 6, Applicant argues Roberts fails to teach or suggest a cap assembly configured to provide the introduction and addition of a first drug solution and an additional drug solution to a nebulizer (see pages 9-10 of the Remarks filed 06/12/2026). Specifically, Applicant argues Roberts teaches two separate ports, one to introduce a drug (176; Fig. 1) and one to drain fluids (182; Fig. 1), and thus does not provide means to administer two drugs, or two drugs simultaneously. Ports 176 and 182 of the Roberts device depicted in Figure 1 were not relied upon in the Office Action (mailed 1/14/2026). In the Office Action (mailed 1/14/2026), the Roberts’ nebulizer device and cap assembly depicted in Figures 2 and 4 is provided, where Roberts discloses a connector (270; Fig. 4) to receive a tip (248) of a liquid medicine source (250) to introduce liquid medicine into the nebulizer via a shared flow path (276, see Fig. 6). It would be well-understood by one of ordinary skill in the art that one or more liquid medicine sources may be present and contain one or more types of liquid medicine; hence, one of ordinary skill in the art would recognize the Roberts device as capable of introducing and adding one or more drug solutions to a nebulizer. Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., means to administer/provide two drugs simultaneously) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With regard to independent claim 1, Applicant argues the Amaral nasal inhaler, whether alone or in combination with Roberts, does not provide a nebulizer system that permits placement of an infusion line as well as a rapid injection port that allows for independent controlled administration of two drugs into the aerosol. Applicant’s specification and claims do not include the language of “infusion line” and “rapid injection port”; however, similar concepts are disclosed (i.e., sleeve 140 with tube 120 for administration of a drug, and branch 150 with channel 152 for the administration of a second drug). Amaral discloses a sleeve (26) with a tube (connected 56 and 68b) for the administration of a drug (see Fig. 8), and a branch (68) with a channel (68a) for the administration of a second drug (see Fig. 8; see last sentence of [0038]). Thus, Amaral teaches the same concept of a nebulizer system with an infusion line and rapid injection port as Applicant’s claimed invention (according to at least claim 1).
On page 11 of the Remarks, Applicant further argues the combination of Amaral and Roberts would be unable to achieve the claimed port assembly that provides for the addition of more than one drug solution without dissembling the nebulizer or otherwise disconnecting from a ventilation circuit. However, at least the arms 68a and 68b are capable of providing more than one drug solution without dissembling the nebulizer or disconnecting from a ventilation circuit (see Fig. 8, see last sentence of [0038]).
On page 12 of the Remarks, Applicant argues Amaral, alone or in combination with Roberts, fails to teach or suggest a steady state infusion of one or more drugs with linear drug delivery. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., steady state infusion of a drug with linear drug delivery) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 13 of the Remarks, Applicant argues Amaral, alone or in combination with Roberts, fails to demonstrate or teach a device in which multiple drugs can be added to the nebulizer while it is in-line in a breathing circuit where breathing circuit rates and nebulization rates are simultaneously provided to the patient. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., one or more drugs are added to the nebulizer while the patient is receiving a flow from the breathing circuit and the nebulizer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Reden & Mikaelsson (US 20070144511 A1): Regarding a nebulizer with a port allowing for the provision of at least one medication without dissembling the nebulizer or disconnecting the device from a ventilator unit.
Enk (WO 2004028607 A1): Regarding a drug nebulizer usable with a therapeutic instrument, where the nebulizer has a branch with two flow paths ending in luer lock connectable to at least two different input sources.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 9:00 AM to 6:00 PM 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
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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