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 .
Claim Rejections - 35 USC § 103
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 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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wirth (US 20240157058 A1) in view of Dirksing et al. (US 5006004 A, hereafter “Dirksing”).
Regarding claim 1, Wirth discloses a graduated dose dispenser (100, fig. 14A, 15) and applicator (syringe tip 6) comprising of:
a) cap (Luer Lock cap, para. [0062]);
b) body (1);
c) plunger (5);
d) screw rod (threaded plunger 2);
e) pins (16, para. [0095], fig. 16);
f) knob (4);
g) channel (66, para. [0085]);
h) plunger lip (side edge of plunger tip 5, see A in annotated fig. 24C);
i) detents (13, fig. 16);
j) alignment ribs (29, para. [0110]);
k) plastic bottle thread (para. [0080], see threaded tip 6 of fig. 14C).
However, Wirth fails to disclose a round tip.
Dirksing teaches a topical applicator with a round tip (fig. 2J, column 6 line 51 – column 7 line 5).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wirth and incorporate the rounded tip of Dirksing because the rounded surface area allowed for an even film when dispensing the contents of the dispenser (column 6 line 51 – column 7 line 5).
However, the combination of Wirth and Dirksing fails to disclose a 22-400 plastic bottle thread.
Firstly, Wirth teaches a plastic thread (para. [0080], see threaded tip 6 of fig. 14C), but does not disclose a specific size for the body or tip. Wirth actually discloses a wide range of 10 to 750 microliters that the body can carry and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wirth to have a 22-400 plastic thread 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 Wirth would not operate differently with the claimed 22-400 thread, and a contained medication would still dispense at a desired amount.
Regarding claim 2, the combination of Wirth and Dirksing discloses the device of claim 1. Wirth further discloses wherein the graduated dose dispenser (100) and applicator (6) is designed to dispense an exact amount of product per one-half turn of knob (para. [0117], fig. 23).
Regarding claim 3, the combination of Wirth and Dirksing discloses the device of claim 1. Wirth further discloses wherein two detents (13) are located 180 degrees apart so as to catch pin (16) when twisting the knob (fig. 16, para. [0095, 0106-0109]).
Regarding claim 4, the combination of Wirth and Dirksing discloses the device of claim 1. Wirth further discloses wherein the body (1) slides vertically over the plunger (5), screw rod (2), and affixed to the knob (4, fig. 15).
Regarding claim 5, the combination of Wirth and Dirksing discloses the device of claim 1. Wirth further discloses wherein the plunger lip (A) presses against the interior surface of the body (annotated fig. 24C, para. [0082]) to accurately dispense a medication.
However, Wirth fails to disclose a topical medication.
Dirksing teaches a topical medication (column 6 line 41 – column 7 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the device of Wirth for dispensing a topical medication as shown in Dirksing with reasonable and predictable results namely, dispensing of a medication. Further, it has been established that Wirth teaches a wide range of 10 to 750 microliters that the body can carry and Wirth is not limited to any diameter of the device or certain types of medications, so using the applicator and dispenser for a topical medication is an obvious variant for use of the device.
Regarding claim 6, the combination of Wirth and Dirksing discloses the device of claim 1. Wirth further discloses wherein alignment ribs (29) rotate to accurately dispense a medication (para. [0110]).
However, Wirth fails to disclose a topical medication.
Dirksing teaches a topical medication (column 6 line 41 – column 7 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the device of Wirth for dispensing a topical medication as shown in Dirksing with reasonable and predictable results namely, dispensing of a medication. Further, it has been established that Wirth teaches a wide range of 10 to 750 microliters that the body can carry and Wirth is not limited to any diameter of the device or certain types of medications, so using the applicator and dispenser for a topical medication is an obvious variant for use of the device.
Regarding claim 7, Wirth discloses a method of constructing a graduated dose dispenser (100, fig. 14A, 15) and applicator (syringe tip 6) comprising of:
a) cap (Luer Lock cap, para. [0062]);
b) body (1);
c) plunger (5);
d) screw rod (threaded plunger 2);
e) pins (16, para. [0095], fig. 16);
f) knob (4);
g) channel (66, para. [0085]);
h) plunger lip (side edge of plunger tip 5, see A in annotated fig. 24C);
i) detents (13, fig. 16);
j) alignment ribs (29, para. [0110]);
k) plastic bottle thread (para. [0080], see threaded tip 6 of fig. 14C).
However, Wirth fails to disclose a round tip.
Dirksing teaches a topical applicator with a round tip (fig. 2J, column 6 line 51 – column 7 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wirth and incorporate the rounded tip of Dirksing because the rounded surface area allowed for an even film when dispensing the contents of the dispenser (column 6 line 51 – column 7 line 5).
However, the combination of Wirth and Dirksing fails to disclose a 22-400 plastic bottle thread.
Firstly, Wirth teaches a plastic thread (para. [0080], see threaded tip 6 of fig. 14C), but does not disclose a specific size for the body or tip. Wirth actually discloses a wide range of 10 to 750 microliters that the body can carry and it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dispenser of Wirth to have a 22-400 plastic thread 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 Wirth would not operate differently with the claimed 22-400 thread, and a contained medication would still dispense at a desired amount.
Regarding claim 8, the combination of Wirth and Dirksing discloses the method of claim 7. Wirth further discloses wherein the graduated dose dispenser (100) and applicator (6) is designed to dispense an exact amount of product per one-half turn of knob (para. [0117], fig. 23).
Regarding claim 9, the combination of Wirth and Dirksing discloses the method of claim 7. Wirth further discloses wherein two detents (13) are located 180 degrees apart so as to catch pin (16) when twisting the knob (fig. 16, para. [0095, 0106-0109]).
Regarding claim 10, the combination of Wirth and Dirksing discloses the method of claim 7. Wirth further discloses wherein the body (1) slides vertically over the plunger (5), screw rod (2), and affixed to the knob (4, fig. 15).
Regarding claim 11, the combination of Wirth and Dirksing discloses the method of claim 7. Wirth further discloses wherein the plunger lip (A) presses against the interior surface of the body (annotated fig. 24C, para. [0082]) to accurately dispense a medication.
However, Wirth fails to disclose a topical medication.
Dirksing teaches a topical medication (column 6 line 41 – column 7 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the device of Wirth for dispensing a topical medication as shown in Dirksing with reasonable and predictable results namely, dispensing of a medication. Further, it has been established that Wirth teaches a wide range of 10 to 750 microliters that the body can carry and Wirth is not limited to any diameter of the device or certain types of medications, so using the applicator and dispenser for a topical medication is an obvious variant for use of the device.
Regarding claim 12, the combination of Wirth and Dirksing discloses the method of claim 7. Wirth further discloses wherein alignment ribs (29) rotate to accurately dispense a medication (para. [0110]).
However, Wirth fails to disclose a topical medication.
Dirksing teaches a topical medication (column 6 line 41 – column 7 line 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the device of Wirth for dispensing a topical medication as shown in Dirksing with reasonable and predictable results namely, dispensing of a medication. Further, it has been established that Wirth teaches a wide range of 10 to 750 microliters that the body can carry and Wirth is not limited to any diameter of the device or certain types of medications, so using the applicator and dispenser for a topical medication is an obvious variant for use of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 17 January 2026