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 .
Election/Restrictions
Applicant’s election of species (A) corresponding to claims 1-11 and 14-16 in the reply filed on 06/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 09/06/2023, 08/07/2024, 10/31/2024, 03/10/2025, and 03/17/2026 has/have been considered by the Examiner.
Status of the Claims
Claims 1-16 are currently pending. Claims 12-13 are withdrawn as directed to a non-elected species. Claims 1-11 and 14-16 are rejected.
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 “ball valve or a butterfly valve having a flow path formed in the valve” (claim 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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
Claim 11 is objected to because of the following informalities:
Claim 11 line 2 “the first transfer tube comprise” should read “the first transfer tube comprises”.
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 1-16 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 “a pharmaceutical powder container” on lines 5-6. This limitation was already introduced in claim 1 line 2. It is unclear whether the second instance of this limitation is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 lines 8-9 recites the limitation “the second transfer tube having both ends communication with a conduit mounting part and an air inlet, respectively”. It is unclear whether both ends of the second transfer tube are communicating both with the conduit mounting part and with the air inlet, or whether a first end of the second transfer tube is communicating with the conduit mounting part and a second end of the second transfer tube is communicating with the air inlet (if this is the case, then the first and second ends should be separately recited where “both ends” is currently recited, thus establishing a first end and a second end which can engage, respectively, with the conduit mounting part and the air inlet). Examiner notes that the current use of “respectively” is unclear. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 line 11 recites the limitation “the middle of the first transfer tube”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “a middle of the first transfer tube”.
Claim 1 line 12 recites the limitation “the flow”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “a flow”.
Claim 2 recites the limitation “the valve” in line 2. However, claim 1 introduced “a control valve”, and claim 2 line 1 recites “the control valve”. It is unclear whether the instance of “the valve” in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures), refer back to the same structure earlier introduced (in which case “the valve” on line 2 of claim 2 should be altered to “the control valve”), or specifically refer to the ball valve and/or butterfly valve. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 3 line 3 recites the limitation “the direction in which the pharmaceutical powder passes”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “a direction in which the pharmaceutical powder passes”.
Claim 4 lines 1-2 recite the limitation “wherein in order to open and close the valve, a fine protrusion is formed”. It is unclear whether the fine protrusion is always present and somehow used to cause opening/closing of the valve, whether the fine protrusion is physically formed during the process of opening/closing the valve, or whether the fine protrusion is simply part of the housing the valve sits in and therefore always present during the opening/closing of the valve but not actively used to cause the valve to open/close. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 5 line 3 recites the limitation “based on the housing”. It is unclear what this phrase is meant to convey, that is to say, what limitation is “based on the housing”. The lumen diameter could be based on the housing, or the distal/proximal arrangement could alternatively be interpreted to be based on the housing. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 10 line 4 recites the limitation “the outside of the housing”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “an outside of the housing”.
Claim 11 line 7 recites the limitation “the outside of the housing”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “an outside of the housing”.
Claim 11 line 2 recites “the first transfer tube upper channel”
…line 3 recites “the first transfer tube lower channel”
…line 5 recites “the second transfer tube inlet channel”
…line 6-7 recites “the second transfer tube discharge channel”
There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination, each of these limitations is interpreted to start with “a” instead of “the”.
Claim 14 lines 1-2 recites the limitation “the dispenser device for spraying pharmaceutical powder”, and lines 3-4 recite “the dispenser device for spraying pharmaceutical powder of claim 1”. As written, the first instance of this limitation is not tied back to claim 1 appropriately and thus lacks proper antecedent basis. Please alter the limitation in lines 1-2 of claim 14 to likewise read “the dispenser device for spraying pharmaceutical powder of claim 1” or alter both limitations to read “the dispenser device of claim 1”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 14 line 3 recites the limitation “the air supply device”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “an air supply device”.
Claim 14 line 5 recites the limitation “the tube cap”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “a tube cap”.
Claim 14 line 5 recites the limitation “a conduit” which is coupled to the conduit mounting part. Given that claim 14 incorporates all limitations of claim 1, it is unclear whether “a conduit” coupled to the conduit mounting part in claim 14 is meant to refer back to the second transfer tube which communicates with the conduit mounting part in claim 1, or introduce a new, different tube/conduit which is also connected to the conduit mounting part. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 14 line 6 recites the limitation “a container containing pharmaceutical powder”. Given that claim 14 incorporates all limitations of claim 1, it is unclear whether “a container containing pharmaceutical powder” in claim 14 is meant to refer back “a pharmaceutical powder container” as introduced in claim 1 (in which case the limitation in claim 14 should instead read “the pharmaceutical powder container”), or introduce a new, different container (in which case the naming conventions should be altered to better indicate two separate containers). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 14 line 8 reads “(vi) turning on the powder of the air supply device”. It is unclear whether this is a typo, and meant to read “(vi) turning on the pow[[d]]er of the air supply device”, or whether this is meant to introduce power associated with the air supply device instead of with the container. Examiner further notes that, in either case, there is insufficient antecedent basis for the limitation of “the powder” associated with the air supply device or “the power” of the air supply device. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 14 line 9 recites the limitation “the opening/closing state”. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted as “an opening/closing state”.
Claim 16 lines 2-3 recites the limitation “based on the housing”. It is unclear what this phrase is meant to convey, that is to say, what limitation is “based on the housing”. The lumen diameter could be based on the housing, or the distal/proximal arrangement could alternatively be interpreted to be based on the housing. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-13 and 15-16 are rejected at least for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Pic et al (US 20190232030 A1; hereafter Pic).
Regarding claim 1, Pic discloses a dispenser device (apparatus 10, fig. 1, [0020] apparatus 10 for delivering powdered agents) for spraying pharmaceutical powder, comprising:
(a) a drug container adapter (inlet/port 34, fig. 1, [0026]) enabling a pharmaceutical powder container (see 112b interpretation above) (powder chamber 16, fig. 1, [0024]) to be mounted thereto ([0024] Powder chamber 16 may be removably attached to chassis 12 by screw-type engagement, snap-fit engagement, friction fit engagement, and/or any other suitable form of attachment.) ([0026] Chassis 12 may include…an inlet or port 34 to which powder chamber 16 may be coupled);
(b) a housing (chassis 12, fig. 1, [0024]) comprising a first transfer tube (second portion 62 of passage 52, fig. 8) communicating with the drug container adapter to allow pharmaceutical powder delivered from a pharmaceutical powder container (see 112b interpretation above) to pass therethrough ([0029] describes passage of powder from container 16 through passage 52 to junction 55; see fig. 8 which shows that powder must pass through portion 62), and a second transfer tube (passages 48 and 56, fig. 8, [0029]) communicating with the first transfer tube (portion 62 of passage 52, fig. 8) so as to discharge the pharmaceutical powder together with air ([0029] Passage 48 and passage 52 may meet at a junction 55, where the pressurized gas may be introduced into powdered agent 54, thereby fluidizing powdered agent 54), the second transfer tube (48/56) having both ends communicating with a conduit mounting part (outlet/port 36, fig. 1, [0026]) and an air inlet (inlet/port 32, fig. 1, [0026]) ([0026] Chassis 12 may include an inlet or port 32 to which gas line 22 may be coupled, an inlet or port 34 to which powder chamber 16 may be coupled, and an outlet or port 36 to which catheter 18 may be coupled.), respectively (see 112b interpretation above); and
(c) a control valve (mechanism 91, fig. 8, [0044]) located in the middle (see 112b interpretation above) of the first transfer tube (second portion 62 of passage 52, fig. 8) ([0044] mechanism 91 may be located in any portion of passage 52) of the housing to control the flow (see 112b interpretation above) of the pharmaceutical powder ([0046] mechanism 91 may be configured to be in the open and/or closed states for a predetermined amount of time to allow a predetermined amount of powdered agent 54 to pass by mechanism 91).
Regarding claim 8, Pic discloses the dispenser device of claim 1, as described above. Pic further discloses comprising an air supply device (gas supply 14, fig. 1, [0022]) coupled to the air inlet (inlet 32, fig. 1, [0026] chassis 12 may include an inlet or port 32 to which gas line 22 may be coupled) of the housing (chassis 12, fig. 1) ([0022] Gas supply 14 may include, for example, a gas line 22…A proximal end of gas line 22 may be coupled to a pressurized gas source (not shown), and a distal end of gas line 22 may be coupled to chassis 12).
Regarding claim 10, Pic discloses the dispenser device of claim 1, as described above, including wherein the second transfer tube (passages 48 and 56, fig. 2, [0029]) comprises a second transfer tube inlet channel (passage 48, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to introduce air into the housing (see fig. 2, note [0029] describes inflow of pressurized gas through passage 48), and a second transfer tube discharge channel (passage 56, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to discharge air to the outside (see 112b interpretation above) of the housing ([0029] describes fluidized powder from the combined powder and air flowing out through passage 56 toward the housing exit/delivery location).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pic et al (US 20210162122 A1; hereafter Pic122).
Regarding claim 2, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to wherein the control valve is a ball valve or a butterfly valve having a flow path formed in the valve (see 112b interpretation above).
Pic122, directed to pressurized fluid and agent delivery, teaches wherein the control valve (ball valve 711, figs. 7a and 7b, [0047]) is a ball valve (see [0047]) or a butterfly valve (Examiner notes the butterfly valve embodiment in figs. 6a-b, [0045] for the record) having a flow path (lumen 713, fig. 7a and fig. 7b, [0047]) formed in the valve ([0047] Ball valve 711 may be spherical and may include a lumen 713 extending through ball valve 711.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the control valve of Pic to be a ball valve as taught by Pic122, since both Pic and Pic122 deal with delivery of a pressurized fluid along with a solid agent. One would have been motivated to make the modification because the ball valve may be less likely to get trapped open, resulting in improperly high degrees of powder delivery, than the rotatable ball valve which need not push directly against the flow of powder in order to close. Additionally, the substitution of one valve type for another is a simple substitution of one known, equivalent (valves used to close/open a passage) for another to obtain predictable results. Given that both references use the noted control valve to close/open a passage in a fluid/solid delivery system, the substitution of one valve for another would have produced predictable results according to a PHOSITA.
Regarding claim 3, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to an inner diameter of a flow path in the control valve.
Pic112, directed to directed to pressurized fluid and agent delivery, teaches wherein when the control valve (ball valve 711, figs. 7a and 7b, [0047]) is open (see fig. 7b), an inner diameter of a flow path (lumen 713, fig. 7a and fig. 7b, [0047]) in the control valve ([0047] Ball valve 711 may be spherical and may include a lumen 713 extending through ball valve 711.) i) is constant (see fig. 7a and 7b which show that the flow path/lumen 713 through ball valve 711 is constant), ii) narrows in the direction (see 112b interpretation above) in which the pharmaceutical powder passes and then widens again, or iii) becomes narrower in the direction in which the pharmaceutical powder passes and then remains constant.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the control valve of Pic to be a ball valve with a fluid path as taught by Pic122, since both Pic and Pic122 deal with delivery of a pressurized fluid along with a solid agent. One would have been motivated to make the modification because the ball valve may be less likely to get trapped open, resulting in improperly high degrees of powder delivery, than the rotatable ball valve which need not push directly against the flow of powder in order to close. Additionally, the substitution of one valve type for another is a simple substitution of one known, equivalent (valves used to close/open a passage) for another to obtain predictable results. Given that both references use the noted control valve to close/open a passage in a fluid/solid delivery system, the substitution of one valve for another would have produced predictable results according to a PHOSITA.
Regarding claim 4, Pic modified by Pic122 discloses the dispenser device of claim 2, as described above, including wherein in order to open and close the valve (see 112b interpretation above), a fine protrusion (pivot rod noted in [0047] ball valve 711 may include a pivot rod (not shown), and ball valve 711 may pivot about pivot rod; see pivot rod 602 in similar embodiment in fig. 6a/b and [0045]) is formed on a valve accommodating part (see valve accommodating part noted in annotated fig. 7a/b below) where the valve is rotated in the housing (see rotation of valve below between fig. 7a and fig. 7b, note [0047] user may rotate ball valve 711 to transition valve assembly 700 from a closed configuration to an open configuration, and vice versa.).
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Claim(s) 5 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pic in view of Row et al (US 20180142690 A1; hereafter Row).
Regarding claim 5, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to a tube cap, in addition to the conduit, coupled to the conduit mounting part.
Row, in the art of medical tubing connections, teaches further comprising a tube cap (cuff 30, fig. 10, [0062]) coupled to the conduit mounting part (tube 25, fig. 10, [0061] The first end portion 32 of cuff 30 is provided (e.g., fixed, co-molded, etc.) to the tube 25 and the second end portion 34 of cuff 30 (e.g., with a larger diameter than the first end portion) is removably connectable to a tubular connector 100.; [0065] the curved entry surface 35 of cuff 30 leads or guides the connector 100 to the sealing and retention bead 37 of the cuff as described below.) and having a lumen diameter (see d1 in Row fig. 10) at a distal portion (second end portion 34, fig. 10, [0061] second end portion 34 of cuff 30 (e.g., with a larger diameter than the first end portion) is removably connectable to a tubular connector 100) greater than a lumen diameter (see lumen diameter of proximal portion 32 below) at a proximal portion (first end portion 32, fig. 10, [0061] The first end portion 32 of cuff 30 is provided (e.g., fixed, co-molded, etc.) to the tube 25), based on the housing (see 112b interpretation above) (note that the tube 25 is interpreted to be at the housing end of the tube cap).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the conduit mounting part of Pic to be coupled both to a tube cap and a conduit, as taught by Row, since both references deal with medical tubing. One would have been motivated to make the modification because, as noted by row, the curved entry surface of the tube cap/cuff 30 helps to guide the connector/conduit 100 into sealing connection with the conduit mounting part/tube 25. Thus, the modification to include the tube cap would make connection of the conduit and conduit mounting part easier for a user, and help to ensure a strong seal.
Regarding claim 14, Pic discloses a method of using the dispenser device (apparatus 10, fig. 1, [0020] apparatus 10 for delivering powdered agents) for spraying pharmaceutical powder (see 112b interpretation above), the method comprising:
(i) coupling the air supply device (gas supply 14, fig. 1, [0022]) (see 112b interpretation above) to the air inlet (inlet 32, fig. 1, [0026] chassis 12 may include an inlet or port 32 to which gas line 22 may be coupled) of the dispenser device for spraying pharmaceutical powder of claim 1 (see 102 rejection of claim 1);
(ii) coupling a conduit (catheter 18, fig. 1, [0020]) (see 112b interpretation above) to the conduit mounting part (outlet/port 36, fig. 1, [0026]);
(iii) coupling a container (powder chamber 16, fig. 1, [0024]) (see 112b interpretation above) containing pharmaceutical powder to the drug container adapter (inlet/port 34, fig. 1, [0026]) ([0024] Powder chamber 16 may be removably attached to chassis 12 by screw-type engagement, snap-fit engagement, friction fit engagement, and/or any other suitable form of attachment.);
(iv) turning on the powder (see 112b interpretation above) of the air supply device ([0027] trigger 42 may be operatively coupled…to control the flow of one or more of the pressurized gas, powdered agent 54, and the fluidized powdered agent 54.); and
(v) controlling the opening/closing state (mechanism 91, fig. 8, [0044]) (see 112b interpretation above) of the control valve ([0046] mechanism 91 may be configured to be in the open and/or closed states for a predetermined amount of time to allow a predetermined amount of powdered agent 54 to pass by mechanism 91) and spraying the pharmaceutical powder ([0027] trigger 42 may be operatively coupled to one or more valves (not shown) in one or more of inlet 32, inlet 34, mixing chamber 38, and outlet 36, to control the flow of one or more of the pressurized gas, powdered agent 54, and the fluidized powdered agent 54. Additionally or alternatively, trigger 42 may activate one or more actuators in apparatus 10 for facilitating fluidization of powdered agent 54).
Pic is silent to coupling a tube cap, in addition to the conduit, to the conduit mounting part.
Row, in the art of medical tubing connections, teaches (ii) coupling the tube cap (cuff 30, fig. 10, [0062]) (see 112b interpretation above) and a conduit (tubular connector 100, fig. 11-1, [0061]) (see 112b interpretation above) to the conduit mounting part (tube 25, fig. 10, [0061] The first end portion 32 of cuff 30 is provided (e.g., fixed, co-molded, etc.) to the tube 25 and the second end portion 34 of cuff 30 (e.g., with a larger diameter than the first end portion) is removably connectable to a tubular connector 100.; [0065] the curved entry surface 35 of cuff 30 leads or guides the connector 100 to the sealing and retention bead 37 of the cuff as described below.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the conduit mounting part of Pic to be coupled both to a tube cap and a conduit, as taught by Row, since both references deal with medical tubing. One would have been motivated to make the modification because, as noted by row, the curved entry surface of the tube cap/cuff 30 helps to guide the connector/conduit 100 into sealing connection with the conduit mounting part/tube 25. Thus, the modification to include the tube cap would make connection of the conduit and conduit mounting part easier for a user, and help to ensure a strong seal.
Regarding claim 15, Pic modified by Row discloses the method of claim 14, as described above, including wherein the order of operations (i) to (iii) is changeable (Examiner notes that neither claim 14 nor the cited prior art establishes any temporal relationship for the order of connections between pieces, and the order of operations is thus changeable.).
Regarding claim 16, Pic modified by Row discloses the method of claim 14, as described above, including wherein the tube cap (cuff 30, fig. 10) has a lumen diameter (see d1 in Row fig. 10) at a distal portion (second end portion 34, fig. 10, [0061] second end portion 34 of cuff 30 (e.g., with a larger diameter than the first end portion) is removably connectable to a tubular connector 100) greater than a lumen diameter (see lumen diameter of proximal portion 32 below) at a proximal portion (first end portion 32, fig. 10, [0061] The first end portion 32 of cuff 30 is provided (e.g., fixed, co-molded, etc.) to the tube 25), based on the housing (see 112b interpretation above).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pic in view of Hoang et al (US 6308866 B1; hereafter Hoang).
Regarding claim 6, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to wherein a bottom cap is coupled to a portion where the first transfer tube and the second transfer tube communicate with each other. Examiner notes that the portion where the first transfer tube and the second transfer tube communicate with each other is located toward the bottom of the device (see figs. 1 and 8).
Hoang, directed to a foam dispenser with a mixing container, teaches wherein a bottom cap (cap 50, fig. 1, col. 7 ln. 50-col. 8 ln. 58 “Apparatus 10 also includes a cap 50 that incorporates mixing chamber 22 and delivery tube 32 that forms a substantially gas tight seal with reservoir 12”) is coupled to a portion (wall bracket 44, fig. 1, col. 7 ln. 50-col. 8 ln. 58 “Cap 50 preferably is sized and shaped to releasably engage wall bracket 44”) where the first transfer tube and the second transfer tube communicate with each other (see fig. 3 below, note also fig. 6).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Pic to include a cap at the bottom portion of Pic where the first transfer tube and the second transfer tube communicate with each other, since both references deal with dispensing a fluid mixture. One would have been motivated to make the modification because having the cap located at the juncture of the transfer tubes ensures a tight sealing connection between the parts, which is necessary because the device must be air tight. Additionally, the bottom cap is useful since during assembly the bottom cap provides access to the tubing connections to ensure that no obstruction is present in the path prior to assembly.
Claim(s) 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pic in view of Jang et al (KR 20190121553 A; hereafter Jang). Text reference is made to the Espacenet English Translation of Jang included with this Office Action.
Regarding claim 7, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to wherein an inner diameter of the first transfer tube widens toward the second transfer tube.
Jang, in the art of powder spray devices, teaches wherein an inner diameter of the first transfer tube widens toward the second transfer tube (see Modified Fig. 3 below, note that the lower channel of the first transfer tube has a wider diameter than the first transfer tube upper channel, and that the fluidized powder flows out through the first transfer tube lower channel into the second transfer tube).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Pic to include the first transfer tube upper channel and first transfer tube lower channel taught by Jang to respectively transfer air upward into and downward out of the drug container, along with the wider diameter of the first transfer tube towards the second transfer tube, as taught by Jang, since both references deal with fluidized powder. One would have been motivated to make the modification because, as noted by Jang this arrangement helps to prevent backflow of powder from the drug container through the air inlet (see Jang [0069], for example). Additionally, one would have been motivated to make this modification because the upper channel allows air in, but the lower channel is meant to facilitate passage of both air and powder, and thus it would have been obvious to have a wider diameter since more material is meant to exit the drug container than enter.
Note that it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first transfer tube widen toward the second transfer tube, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05 (II-A). Since the diameter of the tube is a result effective variable, limiting the possible flow rate through the tube, it would be a matter of routine skill in the art to arrive at the claimed limitation of the tube widening toward the exit through which both powder and fluid must flow.
Regarding claim 9, Pic discloses the dispenser device of claim 1, as described above.
Pic is silent to wherein the first transfer tube comprises a first transfer tube upper channel configured to transfer air flow upward, and a first transfer tube lower channel configured to transfer air flow downward.
Jang, in the art of powder spray devices, teaches wherein the first transfer tube (first flow path 110 and third flow path 130, fig. 3, [0058]) comprises a first transfer tube upper channel (first flow path 110, fig. 3) configured to transfer air flow upward (see fig. 3, [0062] a first flow path 110 that supplies air supplied from an air supply unit 200 into a storage unit 300), and a first transfer tube lower channel (third flow path 130, fig. 3) configured to transfer air flow downward (see fig. 3, note that [0068] describes passage of air down through third flow path 130).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Pic to include the first transfer tube upper channel and first transfer tube lower channel taught by Jang to respectively transfer air upward into and downward out of the drug container, since both references deal with fluidized powder. One would have been motivated to make the modification because, as noted by Jang this arrangement helps to prevent backflow of powder from the drug container through the air inlet (see Jang [0069], for example).
Regarding claim 11, Pic discloses the dispenser device of claim 1, as described above, including wherein the second transfer tube (passages 48 and 56, fig. 2, [0029]) comprises the second transfer tube inlet channel (see 112b interpretation above) (passage 48, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to introduce air into the housing (see fig. 2, note [0029] describes inflow of pressurized gas through passage 48), and the second transfer tube discharge channel (see 112b interpretation above) (passage 56, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to discharge air to the outside (see 112b interpretation above) of the housing ([0029] describes fluidized powder from the combined powder and air flowing out through passage 56 toward the housing exit/delivery location).
Pic is silent to the first transfer tube comprising upper and lower channels.
Jang, in the art of powder spray devices, teaches wherein: the first transfer tube (first flow path 110 and third flow path 130, fig. 3, [0058]) comprise the first transfer tube upper channel (see 112b interpretation above) (first flow path 110, fig. 3) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to transfer air flow upward (see fig. 3, [0062] a first flow path 110 that supplies air supplied from an air supply unit 200 into a storage unit 300), and the first transfer tube lower channel (see 112b interpretation above) (third flow path 130, fig. 3) configured to transfer air flow downward (see fig. 3, note that [0068] describes passage of air down through third flow path 130);
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the second transfer tube (second flow path 120 and nozzle 121, fig. 3, [0062]) comprises the second transfer tube inlet channel (see 112b interpretation above) (second flow path 120, see fig. 3 above) configured to introduce air into the housing ([0062] a second flow path 120 that receives air from the air supply unit 200), and the second transfer tube discharge channel (see 112b interpretation above) (nozzle 121, see fig. 3 above) configured to discharge air to the outside (see 112b interpretation above) of the housing ([0085] air mixed with powder is discharged through nozzle 121); and
the second transfer tube inlet channel (120) communicates with the first transfer tube upper channel (110) (see fig. 3 above which shows intersection of noted channels), and the second transfer tube discharge channel (121) communicates with the first transfer tube lower channel (130) (see fig. 3 above which shows intersection of noted channels).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Pic to include the first transfer tube upper channel in communication with the second transfer tube inlet channel and first transfer tube lower channel in communication with the second transfer tube discharge channel taught by Jang to respectively transfer air upward into and downward out of the drug container, since both references deal with fluidized powder. One would have been motivated to make the modification because, as noted by Jang this arrangement helps to prevent backflow of powder from the drug container through the air inlet (see Jang [0069], for example).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gittard (US 20150094649 A1) - [0038], fig. 8 shows a container 130 with caps 160 and 165 at the top and bottom of the container, tubes traversing the caps.
Leonard et al (US 20190366016 A1) - [0041], fig. 2 shows an impacting cap 200 in the area where inlet port 120 and aerosol port 130 meet in mixing chamber 100 prior to exiting through outlet port 140
Rivest (US 20180216762 A1) - [0027], fig. 2 shows a tubing adaptor with a wider diameter at the distal end than the proximal end
Hanlon et al (US 20090240178 A1) - figures show a variety of safety connectors, several of which widen toward the distal end (see for example, fig. 7)
Decaria (US 20050033267 A1) - [0008] describes prior art connectors in figs. 3-4 which widen toward a distal end; [0036] describes fig. 5 and 5a which show connectors with wider diameters at one end
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/06/2026
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