DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendment filed 11/13/2025 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejection and the previous 112 rejection has been withdrawn.
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant alleges that the amended claim language including “inertial impact force” would be understood by one of ordinary skill in the art as the striking portion’s collision force generated from its own momentum after being accelerated, rather than from continuous actuator pressure, and that the term “inertial impact force” would require momentum-based striking following free acceleration of the striking portion, such that the striking portion collides with the tube due to its own inertia rather than via continuous external driving force. However, this is not found persuasive. Prior to the button of Kelly being pressed, the anvil of Kelly is at rest, and the anvil will remain at rest until a force acts upon it to overcome it’s inertia. The force of a user pressing upon the button is transferred to the anvil, causing the anvil to accelerate from at rest to a movement velocity, and then the anvil comes in contact with the tube of Kelly. The collision force is generated from the anvil’s momentum and therefore is an inertial impact force. If a user continues to depress the push button after use, this would not cause the anvil to repeatedly strike the tube as there would be no further force working on the anvil to overcome its inertia. As such, the impact force of the anvil of Kelly can be interpreted as an inertial impact force rather than a force from continuous actuator pressure.
Applicant did not specifically argue the dependent claims.
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.
Claim(s) 1-4, 6, 8, 10, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US 2014/0213989).
Regarding Claim 1, Kelly discloses a liquid discharge device (Fig. 2a) comprising:
a liquid storage portion (holding tank 20/reservoir 125, Figs. 2a and 10; ¶ [0076, 0117]);
a tube member (11, Figs. 2a and 10; ¶ [0080]);
a striking portion (anvil 31, Fig. 2a; ¶ [0084]);
an operation portion (push button 21, Fig. 2a; ¶ [0083]), and
a discharge port (67, Fig. 2a; ¶ [0076, 0080]) capable of discharging liquid,
wherein the tube member (11, Figs. 2a and 10) has an end portion (19, Figs. 2a and 10) communicating with an inside of the liquid storage portion (20/125, Figs. 2a and 10) to a discharge port side (63, Fig. 2a; ¶ [0080]),
wherein the tube member (11, Figs. 2a and 10) has an elastic region (squeezing section 64, Fig. 2a) elastically deformable at least partly in a longitudinal direction (¶ [0080, 0084, 0096]), and
wherein when the operation portion (21, Fig. 2a) is operated, at least a part of the elastic region (64, Fig. 2a) of the tube member (11, Fig. 2a) is struck with an inertial impact force by the striking portion (31, Fig. 2a; since the anvil is at rest prior to the button being pressed, and the force of the button press overcomes the inertia of the anvil to cause the anvil to move, the anvil can be considered to strike the tube with an inertial impact force) to allow the liquid in the tube member (11, Fig. 2a) to be pushed out and discharged from the discharge port (67, Fig. 2a; ¶ [0080, 0084, 0096]).
Regarding Claim 2, Kelly discloses the tube member (11, Figs. 2a and 10) delivers the liquid from the liquid storage portion (20/125, Figs. 2a and 10) to the discharge port side (63, Fig. 2a) by capillarity (¶ [0105]).
Regarding Claim 3, Kelly discloses an entire region of the tube (11, Fig. 2a) constitutes the elastic region (¶ [0076-0077]; the entire tube is compliant and therefore the entire tube can be considered the elastic region).
Regarding Claim 4, Kelly discloses the elastic region is formed of at least one elastic material selected from the group consisting of polyethylene, polypropylene, silicone, fluororubber, polytetrafluoroethylene, nylon, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, natural rubber, and synthetic rubber (¶ [0074, 0077]).
Regarding Claim 6, Kelly discloses a discharge amount of the liquid from the discharge port (67, Fig. 2a) when the operation portion (21, Fig. 2a) is operated once is 0.01 microliters or more and 100 microliters or less (¶ [0081]).
Regarding Claim 8, Kelly discloses the operation portion (21, Fig. 2a) is operated with the discharge port (67, Fig. 2a) facing a horizontal direction, the liquid is discharged from the discharge port substantially linearly at least in a range of more than 0 cm and 0.5 cm or less (¶ [0012], Fig. 4).
Regarding Claim 10, Kelly discloses a case portion (10, Fig. 2a) accommodating at least a part of the tube member (11, Fig. 2a) so as to incorporate the discharge port (67, Fig. 2a) therein; and
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),
the case portion (10, Fig. 2a) having a liquid passage hole (18, Fig. 2a) at a position facing the discharge port (67, Fig. 2a; ¶ [0076, 0080]),
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).
Regarding Claim 11, Kelly discloses a case member (10, Fig. 2a); and
a striking member (hinge pieces 26 and 27, Fig. 2a) having the striking portion (31, Fig. 2a; ¶ [0084]),
wherein the striking member (26 and 27, Fig. 2a) has a connection portion (pivot 16, Fig. 2a) supported in a cantilever manner (¶ [0087]) by the case member (10, Fig. 2a),
wherein the elastic region (64, Fig. 2a) of the tube member (11, Fig. 2a) is at a position higher than the connection portion (16, Fig. 2a), and
wherein when the operation portion (21, Fig. 2a) is operated, the striking member (26 and 27, Fig. 2a) is elastically deformed to allow the striking portion (31, Fig. 2a) to strike at least a part of the elastic region (64, Fig. 2a) by a restoring force (¶ [0080, 0084, 0096]).
Regarding Claim 13, Kelly discloses the liquid is a liquid medicine (¶ [0016]).
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) 5, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2014/0213989) in view of Newell (US 2020/0197218).
Regarding Claim 5, Kelly 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 Kelly 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 is further motivated by Kelly, who indicates that the size of the dose can be changed by changing various factors, such as the dimension of the bore of the tube (¶ [0081]), and therefore one of ordinary skill in the art would find it obvious to modify the maximum diameter of the tube to be the maximum diameter of Newell to arrive at a more desired dosage amount.
Regarding Claim 12, Kelly discloses a liquid discharge device (Fig. 2a) comprising:
a liquid storage portion (holding tank 20/reservoir 125, Figs. 2a and 10; ¶ [0076, 0117]);
a tube member (11, Figs. 2a and 10; ¶ [0080]);
a striking portion (anvil 31, Fig. 2a; ¶ [0084]);
an operation portion (push button 21, Fig. 2a; ¶ [0083]), and
a discharge port (18, Fig. 2a; ¶ [0076]) capable of discharging liquid,
wherein the tube member (11, Figs. 2a and 10) has a first end portion (19, Figs. 2a and 10) immersed in liquid (127, Fig. 10) inside the liquid storage portion (20/125, Figs. 2a and 10), and a second end (67, Fig. 2a) communicating with an outside via the discharge port (18, Fig. 2a; ¶ [0076]),
wherein the tube member (11, Figs. 2a and 10) has an elastic region (squeezing section 64, Fig. 2a) at an intermediate portion in a longitudinal direction, the elastic region (64, Fig. 2a) being elastically deformable (¶ [0080, 0084, 0096]), and
wherein when the operation portion (21, Fig. 2a) is operated, at least a part of the elastic region (64, Fig. 2a) of the tube member (11, Fig. 2a) is struck with an inertial impact force by the striking portion (31, Fig. 2a; since the anvil is at rest prior to the button being pressed, and the force of the button press overcomes the inertia of the anvil to cause the anvil to move, the anvil can be considered to strike the tube with an inertial impact force) to allow the liquid in the liquid storage portion (20/125, Figs. 2a and 10) to be pushed out and discharged from the discharge port (18, Fig. 2a; ¶ [0080, 0084, 0096]).
Kelly 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 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 Kelly 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 is further motivated by Kelly, who indicates that the size of the dose can be changed by changing various factors, such as the dimension of the bore of the tube (¶ [0081]), and therefore one of ordinary skill in the art would find it obvious to modify the maximum diameter of the tube to be the maximum diameter of Newell to arrive at a more desired dosage amount.
Regarding Claim 14, Kelly further discloses the liquid is a liquid medicine (¶ [0016]).
Claim(s) 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2014/0213989).
Regarding Claim 7, Kelly 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 Kelly 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 Kelly 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).
Regarding Claim 9, Kelly discloses a main body portion (portion of 10 above the line separating the top from the storage portion 20/125, Figs. 2a and 10); and
a liquid cartridge (portion of 10 below the line separating the top from the storage portion 20/125, Figs. 2a and 10),
wherein the main body portion (portion of 10 above the line separating the top from the storage portion 20/125, Figs. 2a and 10) includes the striking portion (31, Fig. 2a) and the operation portion (21, Fig. 2a), and
wherein the liquid cartridge (portion of 10 below the line separating the top from the storage portion 20/125, Figs. 2a and 10) includes the liquid storage portion (20/125, Figs. 2a and 10) and the tube member (11, Figs. 2a and 10).
Kelly does not specifically disclose that the liquid cartridge is attachable to and detachable from the main body portion.
However, Kelly indicates in ¶ [0079] that the fluid dispenser may include an integral reservoir as in Fig. 10 or a dropper bottle can serve as the direct source of fluid to be dispensed. Additionally, ¶ [0079] states “the structure of the reservoir – the source of the fluid to be dispensed, may vary significantly.” Since Kelly provides motivation for both a detachable reservoir in the form of a dropper bottle placed into the main body portion, an integral reservoir as in Fig. 10, and indicates that any structure of reservoir can be utilized as long as the general purpose of providing fluid for the fluid dispenser is satisfied (¶ [0079]), one of ordinary skill in the art would have found it obvious that the liquid cartridge of Kelly (portion of 10 below the line separating the top from the storage portion 20/125, Figs. 2a and 10) could be modified to be attachable to and detachable from the main body portion. This would allow the structure of Fig. 10 to be refillable by disconnecting the liquid reservoir portion 125 from the rest of the device and refilling it with medication before reattaching the reservoir portion.
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781