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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Response to Arguments
Applicant’s amendment filed 04/01/2026 is accepted and entered.
Applicant’s arguments with respect to claim(s) 1 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Stowe is now cited instead of Kelly to disclose the claim limitations, as set forth below.
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)(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) 1-4, 8-9, 11, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stowe (US 2021/0353458).
Regarding Claim 1, Stowe discloses a liquid discharge device (100, Fig. 3) comprising:
a liquid storage portion (drug reservoir 122, Fig. 3);
a tube member (membrane 124, Fig. 3; ¶ [0039]);
a striking portion (labeled portion of actuation hammer 118, Fig. 3; see Image 1);
an operation portion (activation button 112, Fig. 3); and
a discharge port (nozzle 128, Fig. 3) capable of discharging liquid (¶ [0040]),
wherein the tube member (124, Fig. 3) has an end portion communicating with an inside of the liquid storage portion (122, Fig. 3), the tube member (124, Fig. 3) delivering the liquid from the liquid storage portion (122, Fig. 3) to a discharge port (128, Fig. 3) side (as seen in Fig. 3; ¶ [0039]),
wherein the tube member (124, Fig. 3) has an elastic region elastically deformable at least partly in a longitudinal direction (¶ [0039]),
wherein the striking portion (see Image 1) is configured to be releasably engaged with the operation portion (112, Fig. 3; ¶ [0039] indicates that when the activation button is pressed, the actuation hammer is cocked and then released, indicating connection between the actuation hammer and the operation button is a releasable engagement); and
wherein when the operation portion (112, Fig. 3) is operated and then released, the striking portion (see Image 1) is released from engagement with the operation portion (112, Fig. 3; ¶ [0039]) and strikes the elastic region of the tube member (124, Fig. 3; ¶ [0039]) by a restoring force and an inertial impact force of the striking portion (see Image 1; ¶ [0039]) to allow the liquid in the tube member (124, Fig. 3) to be pushed out and discharged from the discharge port (128, Fig. 3; ¶ [0039]).
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Image 1: Annotated Fig. 3 of Stowe
Regarding Claim 2, Stowe discloses the tube member (124, Fig. 3) delivers the liquid from the liquid storage portion (122, Fig. 3) to the discharge port (128, Fig. 3) side by capillarity (at least some capillary action will occur within the membrane).
Regarding Claim 3, Stowe discloses an entire region of the tube member (124, Fig. 3) constitutes the elastic region (¶ [0039]).
Regarding Claim 4, Stowe discloses the elastic region (124, Fig. 3) is formed from polypropylene (¶ [0059]).
Regarding Claim 8, Stowe discloses when the operation portion (112, Fig. 3) is operated with the discharge port (128, Fig. 3) facing a horizontal direction, the liquid is discharged from the discharge port (128, Fig. 3) substantially linearly at least in a range of more than 0 cm and 0.5 cm or less (the liquid will release in a linear manner for at least a small distance before beginning to arc downward; additionally, discharge distance can depend on how far the applicator is located from the eye, and the application is configured to be placed such that the nozzle is within 0.5 cm of the eye).
Regarding Claim 9, Stowe discloses a main body portion (110, Fig. 3); and a liquid cartridge (120, Fig. 3), wherein the main body portion (110, Fig. 3) includes the striking portion (see Image 1) and the operation portion (112, Fig. 3), and wherein the liquid cartridge portion (120, Fig. 3) includes the liquid storage portion (122, Fig. 3) and the tube member (124, Fig. 3), the liquid cartridge (120, Fig. 3) being attachable to and detachable from the main body portion (110, Fig. 3; ¶ [0039] indicates the cartridge is replaceable).
Regarding Claim 11, Stowe discloses a case member (110, Fig. 3); and a striking member (118, Fig. 3) having the striking portion (see Image 1), wherein the striking member (118, Fig. 3) has a connection portion (see Image 1) supported in a cantilever manner by the case member (110, Fig. 3; ¶ [0039]), wherein the elastic region of the tube member (124, Fig. 3) is at a position higher than the connection portion (see Image 1), and wherein when the operation portion (112, Fig. 3) is operated, the striking member (118, Fig. 3) is elastically deformed to allow the striking portion (see Image 1) to strike at least a part of the elastic region (124, Fig. 3) by the restoring force (¶ [0039]).
Regarding Claim 13, Stowe discloses the liquid is a liquid medicine (¶ [0006, 0039]).
Regarding Claim 15, Stowe discloses an energizing member (sliding actuation mechanism 114, Fig. 3) configured to energize the striking portion (see Image 1) toward the liquid storage portion (124, Fig. 3; ¶ [0039]).
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.
Claim(s) 5, 12, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 2021/0353458) in view of Newell (US 2020/0197218).
Regarding Claim 5, Stowe is silent whether a maximum inner diameter of the elastic region in the tube member is 0.1 mm or more and 2 mm or less.
Newell teaches a device for delivering fluid to the eye, thus being in the same field of endeavor, with a fluid delivery tube (56, Fig. 7) with an inner diameter of 0.054 inches, or 1.3716 mm (¶ [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Stowe to have a maximum inner diameter of the tube, and therefore of the elastic region of the tube, be 1.3716 mm, as taught by Newell (¶ [0083]). This allows the dosage of the applicator to be varied based on the difference in size.
Regarding Claim 12, Stowe discloses a liquid discharge device (100, Fig. 3) comprising:
a liquid storage portion (drug reservoir 122, Fig. 3);
a tube member (membrane 124, Fig. 3; ¶ [0039]);
a striking portion (labeled portion of actuation hammer 118, Fig. 3; see Image 1);
an operation portion (activation button 112, Fig. 3); and
a discharge port (nozzle 128, Fig. 3),
wherein the tube member (124, Fig. 3) has a first end portion immersed in liquid inside the liquid storage portion (122, Fig. 3), and a second end communicating with an outside via the discharge port (128, Fig. 3),
wherein the tube member (124, Fig. 3) has an elastic region at an intermediate portion in a longitudinal direction, the elastic region being elastically deformable (¶ [0039]),
wherein the striking portion (see Image 1) is configured to be releasably engaged with the operation portion (112, Fig. 3; ¶ [0039] indicates that when the activation button is pressed, the actuation hammer is cocked and then released, indicating connection between the actuation hammer and the operation button is a releasable engagement); and
wherein when the operation portion (112, Fig. 3) is operated and then released, the striking portion (see Image 1) is released from engagement with the operation portion (112, Fig. 3; ¶ [0039]) and strikes the elastic region of the tube member (124, Fig. 3; ¶ [0039]) by a restoring force and an inertial impact force of the striking portion (see Image 1; ¶ [0039]) to allow the liquid in the tube member (124, Fig. 3) to be pushed out and discharged from the discharge port (128, Fig. 3; ¶ [0039]).
Stowe is silent whether a maximum inner diameter of the elastic region in the tube member is 0.1 mm or more and 2 mm or less.
Newell teaches a device for delivering fluid to the eye, thus being in the same field of endeavor, with a fluid delivery tube (56, Fig. 7) with an inner diameter of 0.054 inches, or 1.3716 mm (¶ [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tube of Stowe to have a maximum inner diameter of the tube, and therefore of the elastic region of the tube, be 1.3716 mm, as taught by Newell (¶ [0083]). This allows the dosage of the applicator to be varied based on the difference in size.
Regarding Claim 14, Stowe further discloses the liquid is a liquid medicine (¶ [0006, 0039]).
Regarding Claim 16, Stowe further discloses an energizing member (sliding actuation mechanism 114, Fig. 3) configured to energize the striking portion (see Image 1) toward the liquid storage portion (124, Fig. 3; ¶ [0039]).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 2021/0353458) in view of Kelly (US 2014/0213989).
Regarding Claim 6, Stowe is silent whether the discharge amount of the liquid from the discharge port when the operation portion is operated once is 0.01 microliters or more and 100 microliters or less.
Kelly teaches an ophthalmic fluid dispenser, thus being in the same field of endeavor, with a discharge amount of liquid when the operation portion is operated once is 0.01 microliters to more and 100 microliters or less (¶ [0012]). Kelly indicates that it is common practice to prescribe small dosages of ophthalmic fluid such as 5 to 50 microliters (¶ [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the discharge amount of liquid when the operation portion is operated once to be within 0.01 microliters and 100 microliters, as taught by Kelly, who indicates that small dosages in the range of 5 to 50 microliters are commonly prescribed for ophthalmic conditions (as motivated by Kelly ¶ [0004, 0012]).
Regarding Claim 10, Stowe further discloses a case portion (110, Fig. 3) accommodating at least a part of the tube member (124, Fig. 3) so as to incorporate the discharge port (128, Fig. 3) therein; and
the case portion (110, Fig. 3) having a liquid passage hole at a position facing the discharge port (128, Fig. 3; since the nozzle is inside the device body, there will necessarily be a liquid passage hole in the body at a position facing the discharge port to allow the device to function).
Stowe is silent regarding a closing portion configured to move or change a posture relative to the case portion, following a movement of the operation portion, wherein the liquid discharge device includes: a closed state where the closing portion closes the liquid passage hole, and an open state where the closing portion opens the liquid passage hole, the closed state and the open state being changeable when the operation portion is operated to move or to change a posture of the closing portion.
Kelly teaches an ophthalmic fluid dispenser, thus being in the same field of endeavor, with a closing portion (flip closure 79, Fig. 5a) configured to move or change a posture relative to the case portion (10, Fig. 2a; ¶ [0102]), following a movement of the operation portion (21, Fig. 2a; the flip closure is fully capable of being moved following the movement of the push button; the claim does not require that the movement of the operation portion causes the movement of the closing portion), wherein the liquid discharge device (Fig. 2a) includes:
a closed state where the closing portion (79, Fig. 5a) closes the liquid passage hole (18, Figs. 2a and 5a; ¶ [0102]); and
an open state where the closing portion (79, Fig. 5a) opens the liquid passage hole (18, Figs. 2a and 5a; ¶ [0102]),
the closed state and the open state being changeable when the operation portion (21, Fig. 2a) is operated to move or to change a posture of the closing portion (79, Fig. 2a; the flip closure is fully capable of being moved following the movement of the push button; the claim does not require that the movement of the operation portion causes the change in the position of the closing portion). This structure allows the liquid passage hole to be covered and uncovered as needed, helping to contain fluid within the dispenser in the case of an accidental actuation (as motivated by Kelly ¶ [0102]).
Therefore, it would have been obvious to modify the applicator of Stowe to include a closing portion configured to move or change a posture relative to the case portion, where the closing portion closes the liquid passage hole in a closed state of the liquid discharge device and opens the liquid passage hole in an open state of the liquid discharge device, as taught by Kelly. This allows the liquid passage hole to be covered and uncovered as needed, helping to contain fluid within the dispenser in case of an accidental actuation (as motivated by Kelly ¶ [0102]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 2021/0353458).
Regarding Claim 7, Stowe is silent whether a portion of the tube member struck by the striking portion is a range of 1 mm or more and 30 mm or less in a longitudinal direction.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Stowe to have a portion of the tube member struck by the striking portion be in a range of 1 mm to 30 mm in the longitudinal direction since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Stowe would not operate differently with a striking portion extension in the range of 1 mm to 30 mm and since changing the size of the struck portion would merely change the amount of fluid dispensed, the device would function appropriately with the claimed striking portion range. Further, applicant places no criticality on the range claimed, indicating simply that the length of the striking portion “can” be within the claimed ranges (¶ [0054] of instant specification).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
