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 .
In light of the amendments to the claims filed 06/26/2026 in which claims 1, 11-12, 14, and 19-21 were amended, claims 10, 13, and 18 were cancelled, claims 1-8, 11-12, 14-17, and 19-21 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims no priority.
Claims 1-8, 11-12, 14-17, and 19-21 receive the filing date of the instant application, filed on 05/12/2023.
Response to Arguments
Rejections of the Claims under 35 U.S.C. 102/103
Applicant's arguments filed 06/26/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended independent claims 1, 14 and 21, the applicant asserts on pg. 10-12 that the prior art to Py fails to disclose the central portions of the first and second contact surfaces angled relative to one another (language from cancelled claim 13).
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully disagrees. The applicant asserts that Fig. 16 shows the valve body (434) and valve portion (442) defining a straight channel and not contact surfaces angled relative to one another. As cited in the previous Office Action filed 04/23/2026, Py (col. 21:59-67 – col. 22:7) discloses that Fig. 16 shows the closed position of the nozzle wherein the valve portion is engaged with the valve body at the nozzle opening (444); therefore, the first and second walls of the valve body (434) and the valve portion (442) explicitly have contact surfaces which are shown in Fig. 16 and noted in Ex. Fig. 1. Further, “angled relative to one another” is a very broad limitation that requires only that both of the first and second contact surfaces are angled compared to each other, such that the contact surfaces can be at the same or different angles. The applicant further asserts that Py’s disclosure that the valve portion (442) defines a thickness that is progressively thinner from the interior toward the exterior of the valve does not bear on whether the contact surfaces are angled relative to one another. Py (col. 1:59-67 – col. 22:1) discloses that making the valve portion (442) progressively thinner allows for the valve portion to move radially away from the valve body (434). Further, the structure of the flange (467) delimits the movement and shape that the valve portion (442) can take when moving radially away from the valve body (434) as the valve cover (438) upstream of the valve portion (442) is fixedly secured against movement relative to the snap ring (466) (col. 21:30-34); therefore, when the valve portion (442) of Py moves radially away from the valve body (434), the angle of the valve portion changes. Py discloses the limitation as claimed.
The amendments to the claims have necessitated new grounds of rejection as explained below.
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.
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Ex. Fig. 1 of Py Fig. 16
Claims 1-2, 5-8, 14-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 7,810,677 B2 to Py in view of U.S. Patent no. 7,806,301 B1 to Ciavarella and U.S. Patent no. 5,099,885 A to Nilsson.
Regarding claims 1 and 12, Py discloses
(Claim 1) a non-gravitational fluid delivery device for delivering fluid (Fig. 16; col. 20:48-67 – col. 22), the device comprising:
a cartridge including a container and a cartridge head coupled to the container (Ex. Fig. 1 comprising container 425 and cartridge head), the container defining an inner container chamber configured to accommodate a fluid (Fig. 16, container 425 defining inner container chamber comprising pouch 422 comprising fluid; col. 21:13-17), the cartridge head including:
opposing first and second walls collectively defining both a nozzle and a nozzle opening extending through the nozzle (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7), the first wall being at least partially formed from a deformable material (col. 21:56-59), the second wall being at least partially formed from a rigid material (col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425);
the nozzle opening through which fluid is selectively delivered from the device to a target site,
the nozzle opening extending in a fluid delivery direction between the first and second walls (Fig. 16, nozzle opening 444; col. 21:59-67 – col. 22:7),
the nozzle opening being selectively transitioned between an opened condition and a closed condition via selective manipulation of the first wall (col. 21:59-67 – col. 22:7),
the nozzle opening being at least partially open to permit flow of the fluid therethrough when in the opened condition (col. 22:35-67),
the nozzle opening being at least partially closed to restrict the flow of the fluid therethrough when in the closed condition (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7); and
a deformable striking wall facing parallel in at least one section in the fluid delivery direction (Ex. Fig. 1, [dome-shaped actuator] deformable striking wall 415 comprising bottom face facing in the fluid delivery direction),
wherein the first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 1), a portion of the first contact surface being connected to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7),
wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Fig. 18 showing valve cover 438 comprising arcuate shape comprising a first end portion separated from a second end portion by a central portion; col. 22:4-12), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (col. 22:4-12), and
wherein the central portions of the first and second contact surfaces are angled relative to one another, wherein the first wall has a decreased thickness from the inner side of the wall to the outer side of the wall such that it is angled relative to the second wall (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; Ex. Fig. 1; col. 21:59-67 – col. 22:7; col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425).
Py differs from the instantly claimed invention in that Py fails to explicitly disclose
(Claim 1) wherein the device is “for delivering fluid to an eye of a user”; however, because Py discloses substantially similar structure to the claimed prior art, it follows naturally that Py could be used for fluid delivery to the eye, as supported in MPEP section 2112.01.
Further, “for delivering fluid to an eye of a user” is considered to be a preamble statement reciting intended use. As recited in MPEP 2111.02, “statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” As explained above, Py discloses substantially similar structure to the claimed prior art. Py further discloses that their invention can be used for the delivery of biological or biopharmaceutical fluids aseptically (see col. 7:37-47; col. 26:59-63). Therefore, Py is structured to be used for delivery of fluid to an eye.
Further, Py differs from the instantly claimed invention in that Py fails to disclose
(Claim 1) wherein the deformable striking wall faces substantially parallel to the fluid delivery direction.
Ciavarella teaches a nozzle assembly comprising a deformable striking wall with a bottom face that is substantially flat with fold lines (Fig. 3, [flexible dome] deformable striking wall 22 shown to be substantially [mostly] flat at tiers 41/42 between ridged fold lines 40) to ensure that the dome collapses in a repeatable consistent fashion (col. 1:31-41; col. 4:44-57).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the deformable striking wall of Py to be substantially flat as taught by Ciavarella, because Ciavarella teaches that hemi-spherical domes do not collapse in a repeatable consistent fashion which creates dead spaces where fluid is trapped behind the collapsed portion of the dome (col. 1:31-41), and that their design ensures that the dome collapses in a repeatable consistent fashion for a more complete evacuation of fluid (col. 4:44-57).
In the modification of Py with Ciavarella, Py would be considered to comprise a deformable striking wall facing substantially parallel to the fluid delivery direction in that the modification would make the hemi-spherical deformable striking wall of Py substantially flat.
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Ex. Fig. 2 of Nilsson Fig. 1A-B
Further still, Py differs from the instantly claimed invention in that Py fails to disclose
(Claim 1) a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces, and
(Claim 12) wherein the first end portions of each of the first and second contact surfaces are fixedly attached to one another, and the second end portions of each of the first and second contact surfaces are fixedly attached to one another.
Nilsson teaches a nozzle assembly
(Claim 1) wherein a first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 2 showing first contact surface facing toward second contact surface), a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34), and
(Claim 12) wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of first contact surface separated from each other by a central portion), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of second contact surface separated from each other by a central portion),
wherein the first end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34), and the second end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34),
wherein when the nozzle opening is in the closed condition, the central portions of the first and second contact surfaces contact another (Ex. Fig. 2 showing central portion of first contact surface in contact with second contact surface in closed condition [Fig. 1A]), and
wherein when the nozzle opening is in the opened condition, the central portions of the first and second contact surfaces are spaced from one another (Ex. Fig. 2 showing central portion of first contact surface spaced from central portion of second contact surface in open condition [Fig. 1B]),
wherein the fixedly attached ends of the first and second walls provide increased sealing of the device (col. 1:53-57; col. 3:20-25)
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nozzle assembly of Py to comprise fixedly attached end portions of the first and second wall as taught by Nilsson, because Nilsson teaches that this provides increased sealing as near to the surrounding atmosphere as possible (col 1:53-57; col. 3:20-25).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Py further discloses: wherein the deformable striking wall is spaced from the nozzle to form an inner head chamber (Fig. 16, deformable striking wall 415 spaced away from nozzle assembly 412 to form chamber 432), the inner head chamber being in fluid communication with the inner container chamber such that the fluid selectively flows from the container chamber to the inner head chamber (col. 20:56-67 – col. 21:1-17).
Regarding claim 5, the cited prior art suggests the invention of claim 2. Py further discloses: wherein the cartridge head includes a rigid head portion and a deformable portion (Ex. Fig. 1, rigid head portion comprising valve body 430 and deformable portion comprised of deformable striking wall 415 and valve cover 438), the rigid head portion including the second wall (Ex. Fig. 1, rigid head portion comprising valve body 430 comprising second wall 434), the deformable portion being connected to the rigid head portion and including the first wall and the deformable striking wall (col. 21:27-34; Ex. Fig. 1, deformable portion comprised of deformable striking wall 415 and valve cover 438 comprising first wall 442).
Regarding claim 6, the cited prior art suggests the invention of claim 5. Py further discloses: wherein the first wall and the deformable striking wall are integrally formed together as a single monolithic piece that is separate from and subsequently connected to the rigid head portion (col. 21:27-34; Ex. Fig. 1, rigid head portion comprising valve body 430 and deformable portion comprised of deformable striking wall 415 and valve cover 438).
Regarding claim 7, the cited prior art suggests the invention of claim 1. Py further discloses: wherein the first and second walls are configured such that both the nozzle and the nozzle opening are arcuate along a lateral length of the nozzle (col. 21:34-36; col. 22:4-12; Fig. 18).
Regarding claim 8, the cited prior art suggests the invention of claim 1. Py further discloses: a nozzle opening comprising first and second walls wherein the first wall is flexible and the second wall is rigid and further wherein the first wall has a decreased thickness from the inner side of the wall to the outer side of the wall (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7; col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425).
The prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the nozzle opening gradually closes from an inner side of the nozzle opening toward an outer side of the nozzle opening as the nozzle opening is selectively transitioned from the opened condition to the closed condition.
Although Py does not explicitly disclose that the nozzle opening gradually closes from an inner side of the nozzle opening toward an outer side of the nozzle opening as the nozzle opening is selectively transitioned from the opened condition to the closed condition, a flexible wall having an increased thickness at the inner side of the nozzle would close first at the inner side of the nozzle as it would come into contact with the second rigid wall before an area of the flexible wall having a decreased thickness. As Py discloses substantially similar nozzle structure to the claimed prior art, it follows naturally that Py’s first and second walls would be configured to act in the manner as claimed, as supported in MPEP section 2112.01.
Regarding claim 11, the cited prior art suggests the invention of claim 10. Py further discloses: wherein the central portion of the first contact surface contacts the second contact surface when the nozzle opening is in the closed condition (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7, surfaces in contact with one another to maintain a closed condition), the central portion of the first contact surface being spaced from the second contact surface when the nozzle opening is in the opened condition (col. 21:59-67 – col. 22:7, surfaces out of contact with one another to provide an opening condition).
Regarding claims 14 and 20, Py discloses
(Claim 14) a nozzle for a fluid delivery device (Ex. Fig. 1, cartridge head; Fig. 16; col. 20:48-67 – col. 22), the nozzle comprising:
opposing first and second walls (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7), the first wall being at least partially formed from a deformable material (col. 21:56-59), the second wall being at least partially formed from a rigid material (col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425);
the nozzle opening through which fluid is selectively delivered from the device to a target site,
the nozzle opening being defined by the first and second walls and extending in a fluid delivery direction between the first and second walls (Fig. 16, nozzle assembly comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7)
the nozzle opening being selectively transitioned between an opened condition and a closed condition via selective manipulation of the first wall (col. 21:59-67 – col. 22:7),
the nozzle opening being at least partially open to permit flow of the fluid therethrough when in the opened condition (col. 22:35-67),
the nozzle opening being at least partially closed to restrict the flow of the fluid therethrough when in the closed condition (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7); and
the nozzle opening being spaced from a deformable striking wall facing parallel in at least one section in the fluid delivery direction (Ex. Fig. 1, [dome-shaped actuator] deformable striking wall 415 comprising bottom face facing in the fluid delivery direction and spaced from the nozzle opening);
wherein the first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 1), a portion of the first contact surface being connected to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7),
wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Fig. 18 showing valve cover 438 comprising arcuate shape comprising a first end portion separated from a second end portion by a central portion; col. 22:4-12), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (col. 22:4-12),
wherein the central portions of the first and second contact surfaces are angled relative to one another (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; Ex. Fig. 1; col. 21:59-67 – col. 22:7; col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425); and
(Claim 20) wherein the first end portions of each of the first and second contact surfaces are connected to one another, and the second end portions of each of the first and second contact surfaces are connected to one another (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7, surfaces in contact with one another to maintain a closed condition),
wherein when the nozzle opening is in the closed condition, the central portions of the first and second contact surfaces contact another (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7, surfaces in contact with one another to maintain a closed condition), and
wherein when the nozzle opening is in the opened condition, the central portions of the first and second contact surfaces are spaced from one another (col. 21:59-67 – col. 22:7, surfaces out of contact with one another to provide an opening condition).
Py differs from the instantly claimed invention in that Py fails to disclose
(Claim 14) wherein the deformable striking wall faces substantially parallel to the fluid delivery direction.
Ciavarella teaches a nozzle assembly comprising a deformable striking wall with a bottom face that is substantially flat with fold lines (Fig. 3, [flexible dome] deformable striking wall 22 shown to be substantially [mostly] flat at tiers 41/42 between ridged fold lines 40) to ensure that the dome collapses in a repeatable consistent fashion (col. 1:31-41; col. 4:44-57).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the deformable striking wall of Py to be substantially flat as taught by Ciavarella, because Ciavarella teaches that hemi-spherical domes do not collapse in a repeatable consistent fashion which creates dead spaces where fluid is trapped behind the collapsed portion of the dome (col. 1:31-41), and that their design ensures that the dome collapses in a repeatable consistent fashion for a more complete evacuation of fluid (col. 4:44-57).
In the modification of Py with Ciavarella, Py would be considered to comprise a deformable striking wall facing substantially parallel to the fluid delivery direction in that the modification would make the hemi-spherical deformable striking wall of Py substantially flat.
Further, Py differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 14) a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces, and
(Claim 20) wherein the first end portions of each of the first and second contact surfaces are fixedly attached to one another, and the second end portions of each of the first and second contact surfaces are fixedly attached to one another.
Nilsson teaches a nozzle assembly
(Claim 14) wherein a first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 2 showing first contact surface facing toward second contact surface), a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34), and
(Claim 20) wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of first contact surface separated from each other by a central portion), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of second contact surface separated from each other by a central portion),
wherein the first end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34), and the second end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34),
wherein when the nozzle opening is in the closed condition, the central portions of the first and second contact surfaces contact another (Ex. Fig. 2 showing central portion of first contact surface in contact with second contact surface in closed condition [Fig. 1A]), and
wherein when the nozzle opening is in the opened condition, the central portions of the first and second contact surfaces are spaced from one another (Ex. Fig. 2 showing central portion of first contact surface spaced from central portion of second contact surface in open condition [Fig. 1B]),
wherein the fixedly attached ends of the first and second walls provide increased sealing of the device (col. 1:53-57; col. 3:20-25)
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nozzle assembly of Py to comprise fixedly attached end portions of the first and second wall as taught by Nilsson, because Nilsson teaches that this provides increased sealing as near to the surrounding atmosphere as possible (col 1:53-57; col. 3:20-25).
Regarding claim 15, the cited prior art suggests the invention of claim 14. Py further discloses: wherein a selective increase in fluid pressure in the fluid delivery device deforms the first wall to at least partially transition the nozzle opening from the closed condition to the opened condition (col. 22:35-67).
Regarding claim 16, the cited prior art suggests the invention of claim 14. Py further discloses: wherein the first and second walls are configured such that both the nozzle and the nozzle opening are arcuate along a lateral length of the nozzle (col. 21:34-36; col. 22:4-12; Fig. 18).
Regarding claim 17, the cited prior art suggests the invention of claim 14. Py further discloses: a nozzle opening comprising first and second walls wherein the first wall is flexible and the second wall is rigid and further wherein the first wall has a decreased thickness from the inner side of the wall to the outer side of the wall (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7; col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425).
The prior art differs from the instantly claimed invention in that the prior art fails to explicitly disclose that the nozzle opening gradually closes from an inner side of the nozzle opening toward an outer side of the nozzle opening as the nozzle opening is selectively transitioned from the opened condition to the closed condition.
Although Py does not explicitly disclose that the nozzle opening gradually closes from an inner side of the nozzle opening toward an outer side of the nozzle opening as the nozzle opening is selectively transitioned from the opened condition to the closed condition, a flexible wall having an increased thickness at the inner side of the nozzle would close first at the inner side of the nozzle as it would come into contact with the second rigid wall before an area of the flexible wall having a decreased thickness. As Py discloses substantially similar nozzle structure to the claimed prior art, it follows naturally that Py’s first and second walls would be configured to act in the manner as claimed, as supported in MPEP section 2112.01.
Regarding claim 19, the cited prior art suggests the invention of claim 14. Py further discloses: wherein the central portion of the first contact surface contacts the second contact surface when the nozzle opening is in the closed condition (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7, surfaces in contact with one another to maintain a closed condition), the central portion of the first contact surface being spaced from the second contact surface when the nozzle opening is in the opened condition (col. 21:59-67 – col. 22:7, surfaces out of contact with one another to provide an opening condition).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Py, Nilsson, Ciavarella as applied above, and further in view of US/2020/0360180 A1 to Stowe.
Regarding claim 3, the cited prior art suggests the invention of claim 2; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose an applicator configured to accommodate the cartridge, the applicator including a trigger movable between a loaded position and a striking position, the trigger being spaced from the deformable striking wall when in the loaded position, the trigger contacting and deflecting the deformable striking wall toward the nozzle when in the striking position, selective deflection of the deformable striking wall urging the fluid from the head chamber through the nozzle opening.
Stowe teaches an applicator configured to accommodate a cartridge (Fig. 21, fluid container 20 and deformable striking wall 55 at back of nozzle as sections of cartridge within applicator 15) , the applicator including a trigger movable between a loaded position and a striking position (Fig. 21, trigger 305 within applicator 15; para. 0081), the trigger being spaced from the striking wall when in the loaded position (Fig. 21 showing trigger 305 spaced from deformable striking wall 55 in a loaded position), the trigger contacting and deflecting the striking wall toward the nozzle when in the striking position, selective deflection of the striking wall urging the fluid from the head chamber through the nozzle opening (para. 0081), wherein the trigger mechanism can provide a specific strike force to ensure fluid output (para. 0081).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the fluid delivery device of the cited prior art to further comprise an applicator as taught by Stowe, because Stowe teaches that the applicator comprising a trigger mechanism of their invention can provide specific strike force to ensure a proper strike impact for release of fluid from the nozzle (para. 0081). Further, it would be considered obvious to one of ordinary skill in the art to automate a manual activity (i.e. pressing the deformable wall) as is shown in Stowe, and as supported in MPEP 2144.04(III).
Regarding claim 4, the cited prior art suggests the invention of claim 3. Py further discloses: wherein a fluid pressure in the head chamber increases as the deformable striking wall is deflected, the increased fluid pressure at least partially deforming the first wall to at least partially transition the nozzle opening from the closed condition to the opened condition (col. 22:35-67).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent no. 7,810,677 B2 to Py in view of U.S. Patent no. 5,099,885 A to Nilsson and US/2020/0360180 A1 to Stowe.
Regarding claim 21, Py discloses a non-gravitational fluid delivery device for delivering fluid (Fig. 16; col. 20:48-67 – col. 22), the device comprising:
a cartridge including a container and a cartridge head coupled to the container (Ex. Fig. 1 comprising container 425 and cartridge head), the container defining an inner container chamber configured to accommodate a fluid (Fig. 16, container 425 defining inner container chamber comprising pouch 422 comprising fluid; col. 21:13-17), the cartridge head including:
opposing first and second walls collectively defining both a nozzle and a nozzle opening extending through the nozzle (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; col. 21:59-67 – col. 22:7), the first wall being at least partially formed from a deformable material (col. 21:56-59), the second wall being at least partially formed from a rigid material (col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425);
the nozzle opening through which fluid is selectively delivered from the device to a target site,
the nozzle opening extending in a fluid delivery direction between the first and second walls (Fig. 16, nozzle opening 444; col. 21:59-67 – col. 22:7),
the nozzle opening being selectively transitioned between an opened condition and a closed condition via selective manipulation of the first wall (col. 21:59-67 – col. 22:7),
the nozzle opening being at least partially open to permit flow of the fluid therethrough when in the opened condition (col. 22:35-67),
the nozzle opening being at least partially closed to restrict the flow of the fluid therethrough when in the closed condition (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7); and
a deformable striking wall spaced from the nozzle opening (Ex. Fig. 1, [dome-shaped actuator] deformable striking wall 415 spaced from the nozzle opening);
the deformable striking wall configured to be deformed in a direction which is substantially the same as the fluid delivery direction (Ex. Fig. 1; col. 21:59-67 – col. 22:7);
wherein the first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 1), a portion of the first contact surface being connected to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Fig. 16 showing closed position; col. 21:59-67 – col. 22:7),
wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Fig. 18 showing valve cover 438 comprising arcuate shape comprising a first end portion separated from a second end portion by a central portion; col. 22:4-12), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (col. 22:4-12), and
wherein the central portions of the first and second contact surfaces are angled relative to each other (Fig. 16, nozzle assembly 412 comprising first wall [valve portion] 442 formed of valve cover 438 extending from dome-shaped actuator 415 and second wall [axially-extending valve seat] 434 formed of valve body 430 cooperating to create nozzle opening 444 therebetween; Ex. Fig. 1; col. 21:59-67 – col. 22:7; col. 20:54-56, second wall 434 formed of valve body 430 which is a part of rigid container 425).
Py differs from the instantly claimed invention in that Py fails to explicitly disclose wherein the device is “for delivering fluid to an eye of a user”; however, because Py discloses substantially similar nozzle structure to the claimed prior art, it follows naturally that Py could be used for fluid delivery to the eye, as supported in MPEP section 2112.01.
“[F]or delivering fluid to an eye of a user” is considered to be a preamble statement reciting intended use. As recited in MPEP 2111.02, “statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” As explained above, Py discloses substantially similar structure to the claimed prior art. Py further discloses that their invention can be used for the delivery of biological or biopharmaceutical fluids aseptically (see col. 7:37-47; col. 26:59-63). Therefore, Py is structured to be used for delivery of fluid to an eye.
Further, Py differs from the instantly claimed invention in that Py fails to disclose wherein a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces.
Nilsson teaches a nozzle assembly wherein a first wall includes a first contact surface facing toward a second contact surface of the second wall (Ex. Fig. 2 showing first contact surface facing toward second contact surface), a portion of the first contact surface being fixedly attached to a portion of the second contact surface in such a manner that a nozzle opening is defined between the first and second contact surfaces (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34),
wherein the first contact surface of the first wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of first contact surface separated from each other by a central portion), and the second contact surface of the second wall includes a first end portion laterally separated from a second end portion by a central portion (Ex. Fig. 2 showing first and second end portions of second contact surface separated from each other by a central portion),
wherein the first end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34), and the second end portions of each of the first and second contact surfaces are fixedly attached to one another (Ex. Fig. 2 showing first and second end portions of first contact surface fixedly attached to first and second end portions of second contact surface such that the nozzle opening is defined between the contact surfaces; col. 3 ln. 20-34),
wherein when the nozzle opening is in the closed condition, the central portions of the first and second contact surfaces contact another (Ex. Fig. 2 showing central portion of first contact surface in contact with second contact surface in closed condition [Fig. 1A]), and
wherein when the nozzle opening is in the opened condition, the central portions of the first and second contact surfaces are spaced from one another (Ex. Fig. 2 showing central portion of first contact surface spaced from central portion of second contact surface in open condition [Fig. 1B]),
wherein the fixedly attached ends of the first and second walls provide increased sealing of the device (col. 1:53-57; col. 3:20-25)
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nozzle assembly of Py to comprise fixedly attached end portions of the first and second wall as taught by Nilsson, because Nilsson teaches that this provides increased sealing as near to the surrounding atmosphere as possible (col 1:53-57; col. 3:20-25).
Further still, Py differs from the instantly claimed invention in that Py fails to disclose an applicator configured to accommodate the cartridge, the applicator including a trigger configured to strike the deformable striking wall in a direction which is substantially the same as the fluid delivery direction.
Stowe teaches an applicator configured to accommodate a cartridge (Fig. 21, fluid container 20 and deformable striking wall 55 at back of nozzle as sections of cartridge within applicator 15) , the applicator including a trigger configured to strike the deformable striking wall in a direction which is substantially the same as the fluid delivery direction (Fig. 21 showing trigger 305 in first position before striking deformable striking wall 55 within applicator 15; Fig. 23 showing deformable striking wall 55 facing the fluid delivery direction; para. 0081), wherein the trigger mechanism can provide a specific strike force to ensure fluid output (para. 0081).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the fluid delivery device of the cited prior art to further comprise an applicator as taught by Stowe, because Stowe teaches that the applicator comprising a trigger mechanism of their invention can provide specific strike force to ensure a proper strike impact for release of fluid from the nozzle (para. 0081). Further, it would be considered obvious to one of ordinary skill in the art to automate a manual activity (i.e. pressing the deformable wall) as is shown in Stowe, and as supported in MPEP 2144.04(III).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
15 September 2026
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