DETAILED ACTION
Primary Examiner acknowledges Claims 1-15 are pending in this application, with Claims 1-13 having been currently amended, and Claims 14 and 15 having been newly added by preliminary amendment on May 22, 2023.
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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specifically, the abstract, filed on May 22, 2023, includes implied phrases. Appropriate correction is required.
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 1-4 and 8-13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Brown (2,642,063).
As to Claims 1 and 12, Brown discloses a nozzle (25, best seen Figures 1-3; and Figures 10-12, and 14, “In one end of the body 20 there is frictionally fitted a nosepiece 24 and in the opposite end of the body there is frictionally fitted a mouthpiece 25. The nosepiece 24 is provided with an axially disposed cylindrical air passage 26 of relatively small diameter, and the mouthpiece 25 is provided with a corresponding axially disposed air passage 27. The inner ends of the nosepiece 24 and mouthpiece 25 are reduced in external diameter to provide shoulders 28 which engage against the ends of the body 20.” Column 3, Lines 35-55) for a dispensing device (best seen Figures 1-3, 6 and 7; and Figures 10-15) for dispensing a product (P, best seen Figures 2, 3, and 7; and Figure 10, “Slidably mounted within the cylindrical bore 22 of the body 20 is a medicament cartridge 35 which is formed from a cylindrical shell 36 of small diameter adapted to contain powdered medicament P and positioned axially of the device by means of flanges 38 disposed at its opposite ends” Column 3, Lines 60-75) in powder form, comprising: a dispensing duct (20, best seen Figures 1-3, 6, and 7; and Figures 10-15, “Having reference to the structures shown in the drawings, the inhaler in each form comprises a tubular body 20 of cylindrical form and provided throughout its length with a cylindrical bore 22.” Column 3, Lines 35-55) having a minimum flow section (defined by the change in area/diameter from 20 leading to 27) and a dispensing opening (defined by the region 20 abuts 27, “The nosepiece 24 is provided with an axially disposed cylindrical air passage 26 of relatively small diameter, and the mouthpiece 25 is provided with a corresponding axially disposed air passage 27.” Column 3, Lines 35-55) configured to open freely into an airway of a user (“mouth” of “mouthpiece 25”), a grid (42, best seen Figure 6; and Figure 13, “The mesh of the screens 42 is too fine to permit appreciable air passage through the powder-laden shell 36, and as a consequence the air stream passes the cartridge 35 through the notches 40 and the annular space around the shell 36.” Column 4, Lines 40-75) arranged transversely across the dispensing duct (20), a solid wall (38, best seen Figures 6 and 7; and Figure 13, “Slidably mounted within the cylindrical bore 22 of the body 20 is a medicament cartridge 35 which is formed from a cylindrical shell 36 of small diameter adapted to contain powdered medicament P and positioned axially of the device by means of flanges 38 disposed at its opposite ends. … For the purpose of by-passing sufficient air around the cartridge 35 to provide the required air stream for carrying the charge of powder, each of the flanges 38 is peripherally provided with a plurality of notches 40 so that air may pass along the adjacent wall portions of the cylindrical bore 22.” Column 3, Line 60 thru Column 4, Line 10; and “In the form of Figs. 11, 12, and 13, instead of employing notches 40 in the flanges 38 of the cartridge 35, two series of grooves 50 are formed in the inner wall of the cylindrical bore 22, so that air being drawn through the device may by-pass the cartridge 35 by way of these grooves 50.” Column 5, Lines 15-30) arranged in the dispensing duct (20) around the grid (42) forming a dispensing restriction (defined by the change in area/diameter of 40 of Figures 6 and 7; and defined by the change in area/diameter of 50 of Figure 13), the dispensing restriction (defined by the change in area/diameter of 40 of Figures 6 and 7; and defined by the change in area/diameter of 50 of Figure 13) having a flow section smaller than the minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20).
Regarding the concepts of the minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20) as compared to a dispensing restriction (defined by the change in area/diameter of 40 of Figures 6 and 7; and defined by the change in area/diameter of 50 of Figure 13), as best seen in Figure 3; and Figure 12, the area/diameter of flow of the dispensing duct (20) is a function of the dimensions of 44 and 27, wherein 44 is “a frusto-concial seat 44, and each seat 44 preferably adapted to serve as an abutment for peripheral flange portions of the cartridge 35, when the latter is drawn into an elevated position as shown in Fig. 3…” (Column 4, Lines 10-40) and wherein 27 is “a corresponding axially disposed air passage 27.” (Column 3, Lines 35-55); while, in contrast the concept of the a dispensing restriction (defined by the change in area/diameter of 40 of Figures 6 and 7; and defined by the change in area/diameter of 50 of Figure 13) of the solid wall (38) is a function of the dimensions of each of 40 and 50 respectively, wherein are described by Brown to form a “by-pass” between the maximum diameter of the dispensing duct (20) and the solid wall (38) as retained on the cartridge (35). Consequently, as the dispensing restriction (defined by the change in area/diameter of 40 of Figures 6 and 7; and defined by the change in area/diameter of 50 of Figure 13) of the solid wall (38) as a “by-pass” is of significantly less area than that of the minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20), the area/diameter of the dispensing restriction is smaller than the minimum flow section as claimed. Thus, Brown meets the limitations of the claims.
As to Claim 2, Brown discloses the nozzle (25, best seen Figures 1-3; and Figures 10-12, and 14, “In one end of the body 20 there is frictionally fitted a nosepiece 24 and in the opposite end of the body there is frictionally fitted a mouthpiece 25. The nosepiece 24 is provided with an axially disposed cylindrical air passage 26 of relatively small diameter, and the mouthpiece 25 is provided with a corresponding axially disposed air passage 27. The inner ends of the nosepiece 24 and mouthpiece 25 are reduced in external diameter to provide shoulders 28 which engage against the ends of the body 20.” Column 3, Lines 35-55) is a mouthpiece.
As to Claim 3, Brown discloses the grid (42) is arranged at one end of the dispensing duct (20) opposite the dispensing opening (defined by the region 20 abuts 27). As best seen in Figure 2, and Figure 14, the grid (42) is located on the cartridge 35, which operates as a shuttlecock that moves in response to pressure differential to permit the excitement of the powder to the nozzle (25). Consequently, not only does the grid (42) undergo movement towards the dispensing opening (defined by the region 20 abuts 27) along the dispensing duct (20) but additionally at its final disposition, as shown in Figure 3, and Figures 11 and 12, remains opposite to the dispensing opening (defined by the region 20 abuts 27). Furthermore, it is noted that the cartridge 35 includes a plurality of grids (42) each on the upstream and the downstream side to retain the powder within. Thus, Brown meets the limitations of the claims.
As to Claim 4, Brown discloses the dispensing duct (20) comprises a flow section that is increasing from the grid (42) up to the dispensing opening (defined by the region 20 abuts 27).
As to Claim 8, Brown discloses a surface of the solid wall (38) oriented towards the dispensing opening (defined by the region 20 abuts 27) is coplanar with a surface of the grid (42) oriented towards the dispensing opening (defined by the region 20 abuts 27).
As to Claim 9, Brown discloses the grid (42) is centered in a flow section of the dispensing duct (20).
As to Claim 10, Brown discloses the solid wall (38) is made in one piece with the grid (42). Explicitly, Brown states “To retain the powder P in the shell 36 and at the same time permit escape of an adequate charge of the powder, the ends of the shell 36 are closed with small screens 42 which may be frictionally held or cemented in place…” Column 4, Lines 1-10). The resultant effect of the frictional affixing or cemented affixing is a one piece construction.
As to Claim 11, Brown discloses the nozzle (25) is made of one piece. As seen in the Figures, the nozzle (25) in the form of a mouthpiece is a unitary structure designed of a singular material composition – and thus, has a unitary or singular one piece design.
As to Claim 13, Brown discloses a dosing chamber (35, “Slidably mounted within the cylindrical bore 22 of the body 20 is a medicament cartridge 35 which is formed from a cylindrical shell 36 of small diameter adapted to contain powdered medicament P and positioned axially of the device by means of flanges 38 disposed at its opposite ends” Column 3, Lines 60-75) configured to contain the product (P) in powder form, the dosing chamber (35) comprising an air inlet (via the passage of air from 24 within 40) and an outlet (via the passage of air from 40 to the dispensing opening (defined by the region 20 abuts 27)), the nozzle (25) being directly connected to the outlet (via the passage of air from 40 to the dispensing opening (defined by the region 20 abuts 27)) of the dosing chamber (35).
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 6, 7, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (2,642,063).
As to Claim 6, Brown discloses the area minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20) and an area of the grid (42), as best seen in Figures 6 and 7; and Figure 13.
Yet, does not expressly disclose the specific dimensions of the ratio of the aforementioned areas to be between 2 and 7.
Pursuant to MPEP 2125 (I): DRAWINGS CAN BE USED AS PRIOR ART, “Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972).”
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In this particular case, Primary Examiner provides a marked up view of Figures 6 and 7, whereby the dimensions of the minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20) is approximately 16 mm in diameter and the dimensions of the grid is approximately 7 mm in diameter. The resultant areas of each component are 201.06 mm2 and 38.485 mm2, respectfully, which yields a ratio of 5.22.
This ratio of the areas of at 5.22 meets the claimed limitations of “between 2 and 7” and furthermore would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to entrain the powder to be dispensed into the mouth of the patient from the dispensing device.
It has been held that discovering the optimum or workable ranges involves only routine skill in the art, thus considering the drawings of Brown as prior art, it appears the construction of Brown as shown in the drawings would be able to direct the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
In this particular case, Primary Examiner provides a marked up view of Figure 13,
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whereby the dimensions of the minimum flow section (defined by the change in area/diameter from 20 leading to 27) of the dispensing duct (20) is approximately 17 mm in diameter and the dimensions of the grid is approximately 6 mm in diameter. The resultant areas of each component are 227 mm2 and 28.274 mm2, respectfully, which yields a ratio of 8.0286.
Although this ratio as shown in Figure 13 does not meet the claimed limitations of “between 2 and 7”, the modification of the dimensions to yield the claimed ratio would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to entrain the powder to be dispensed into the mouth of the patient from the dispensing device.
It has been held that discovering the optimum or workable ranges involves only routine skill in the art, thus considering the drawings of Brown as prior art, it appears the construction of Brown as shown in the drawings would be able to direct the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
Applicant has not asserted the specific construction of the areas of each components provides a particular advantage, solves a particular problem or serves a purpose different from providing a structure which permits the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient; thus, the use of the specifically claimed ratio appears to lack criticality in its design. In light of the disclosure of Brown’s prior art drawings, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the device of Brown as the specific ratio of areas would yield the predictable results of directing the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the ratio of areas of each component, a known result effective variable, in order to provide for the directing the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
As to Claims 7 and 15, Brown discloses the dispensing opening (defined by the region 20 abuts 27) has a diameter and the grid (42) has a diameter, as best seen in Figures 6 and 7; and Figure 13.
Yet, does not expressly disclose the specific dimensions of the ratio of the aforementioned diameters to be “between 1.1 and 5” (Claim 7) and “between 1.5 and 2.5” (Claim 15).
Pursuant to MPEP 2125 (I): DRAWINGS CAN BE USED AS PRIOR ART, “Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972).”
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In this particular case, Primary Examiner provides a marked up view of Figures 6 and 7, whereby the dimensions of the dispensing opening (defined by the region 20 abuts 27) is approximately 16 mm in diameter and the dimensions of the grid is approximately 7 mm in diameter. The resultant ratio of diameters is 2.28.
This ratio of the diameters of at 2.28 meets the claimed limitations of “between 1.1 and 5” (Claim 7), “between 1.5 and 2.5” (Claim 15), and furthermore would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to entrain the powder to be dispensed into the mouth of the patient from the dispensing device.
It has been held that discovering the optimum or workable ranges involves only routine skill in the art, thus considering the drawings of Brown as prior art, it appears the construction of Brown as shown in the drawings would be able to direct the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
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In this particular case, Primary Examiner provides a marked up view of Figure 13, whereby the dimensions of the dispensing opening (defined by the region 20 abuts 27) is approximately 17 mm in diameter and the dimensions of the grid is approximately 6mm in diameter. The resultant ratio of diameters is 2.83.
This ratio of the diameters of at 2.83 meets the claimed limitations of “between 1.1 and 5” (Claim 7), “between 1.5 and 2.5” (Claim 15), and furthermore would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to entrain the powder to be dispensed into the mouth of the patient from the dispensing device.
It has been held that discovering the optimum or workable ranges involves only routine skill in the art, thus considering the drawings of Brown as prior art, it appears the construction of Brown as shown in the drawings would be able to direct the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
Applicant has not asserted the specific construction of the areas of each components provides a particular advantage, solves a particular problem or serves a purpose different from providing a structure which permits the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient; thus, the use of the specifically claimed ratio appears to lack criticality in its design. In light of the disclosure of Brown’s prior art drawings, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the device of Brown as the specific ratio of areas would yield the predictable results of directing the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the ratio of diameters of each component, a known result effective variable, in order to provide for the directing the entrainment of powder to be dispensed from the dispensing device into the mouth of the patient.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (2,642,063) in view of Finlay et al. (2004/0107963).
As to Claims 5 and 14, Brown discloses a dispensing duct (20) having a transverse minimum inner diameter which engages the nozzle (25); yet, does not expressly disclose the specific minimum inner diameter to be “between 15 and 30 mm” (Claim 5), and “between 20-25 mm” (Claim 14).
Finlay teaches an alternative dispensing device (Figures 1-6) having a nozzle (50, best seen Figures 5 and 6, “Referring to FIGS. 5 and 6, the device 10 may further include a mouthpiece 50 with a first end 51 being connectable to the outlet 22 and a second end 52 being insertable in the mouth of the user.” Para 0034) in the form of a mouthpiece for connection to the dispensing device (10, “device 10” Para 0034) to permit the dispensing of a product (via “a powder source such as a powder capsule (not shown) so that powder and air can enter through channel 42 when the user inhales from the outlet 22.” Para 0036) in the form of powder to the patient, wherein the dispensing device (10) includes a dispensing duct (defined by the interior of 22, “outlet 22” Para 0037) having a minimum flow section and a dispensing opening (defined as the apex of 22 which receives 50) configured to open freely into an airway of a user, a grid (28, “As shown in FIG. 5, the mesh 28 may be permanently located at the base of the outlet 22 while the mouthpiece 50 may be connected separately to the outlet 22.” Para 0034) and a solid wall (12, “The deagglomeration device 10 has a body 12 defining a chamber 40 adapted for fluid circulation therethrough.” Para 0028) arranged in the dispensing duct (defined by the interior of 22) around the grid (28).
Regarding the remaining limitations of the claims, Finaly teaches the nozzle (50) in the form of the mouthpiece has a diameter of between 15-25 mm – “The mouthpiece 50 may have an internal diameter of 15 to 25 mm and a length of 5 to 25 mm.” (Para 0034). Clearly the nozzle (50) dimensions meet the claimed ranges of “between 15 and 30 mm” (Claim 5), and “between 20-25 mm” (Claim 14).
Nevertheless, as the arrangement of the nozzle (50) is designed to fit within the dispensing duct (defined by the interior of 22), the dimensions of the dispensing duct must be larger than the internal diameter of the nozzle. Hence, it would have been obvious to one having ordinary skill in the art to select the diameter of the dispensing duct to be within the claimed ranges of “between 15 and 30 mm” (Claim 5), and “between 20-25 mm” (Claim 14), since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
In this particular case, as the nozzle (50) has a diameter of 15-25 mm, and this diameter is within the claimed ranges of “between 15 and 30 mm” (Claim 5), and “between 20-25 mm” (Claim 14), the specific diameter of the dispending duct would be obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to excise the powder for introduction into the mouth of the patient.
Applicant has not asserted the specific claimed ranges provides a particular advantage, solves a stated problem or serves a particular purpose, thus, the use of the specific diameter of the dispensing duct appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Brown, as the teachings of Finlay, clearly support a known result effective variable in order to achieve the entrainment of powder from the dispensing device into the mouth of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the dimensions of the dispensing duct with respect to the nozzle, a known result effective variable, as considered by the modified Brown to achieve the entrainment of powder from the dispensing device into the mouth of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chawala (5,787,881) discloses an additional nozzle (2) for a dispensing device (Figures 1-6) having a dispensing duct (1), a dispending opening (defined by the region where 1 meets 2), a grid (4), and a solid wall (bordered by 5 and 5a) in the dispensing duct (1) around the grid (4).
Ziegler et al. (2007/0295332) discloses an additional nozzle (60) for a dispensing device (Figures 1 and 2) having a dispensing duct (30), a dispensing opening (defined as the lumen of 30), a grid (70) and a solid wall (65) in the dispensing duct (30) around the grid (70).
Geser et al. (2008/0295832) discloses an additional nozzle (12) for a dispensing device (Figure 1) having a dispending duct (11), a dispensing opening (defined by the apex of 11 as aligned with the lumen of 12), a grid (10) and a solid wall (9) in the dispending duct (11) around the grid (10).
Hannon et al. (2018/0369513) discloses an additional nozzle (308) for a dispensing device (Figures 5) having a dispensing duct (302), a dispending opening (306), a grid (360), and a solid wall (304) in the dispending duct (302) around the grid (360).
The following IS NOT prior art BUT is considered pertinent to applicant's disclosure.
Aydin et al. (2025/0295871) discloses an additional nozzle (100) for a dispensing device (Figures 1A-1B) having a dispensing duct (102), a dispensing opening (113), a grid (124) and a solid wall (101) in the dispensing duct (102) around the grid (124).
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785