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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/12/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 2, 4, 5, 7, and 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 7 recites “the electromagnet being coupled to the device by the bracket”. However, the electromagnet is part of the plunger unit, which is part of the device (introduced in the preamble). The claim therefore requires that the electromagnet is both part of the device and coupled to the device. In other words, the claim requires that the device is coupled to itself. It is not clear if the applicant intends to consider the bracket as part of the device or as a separate entity.
Dependent claims inherit the deficiencies of the claims from which they depend.
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 of this title, 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.
Claim(s) 1, 2, 5, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moran (US 2,726,019) in view of Lee et al. (US 2022/0143313 A1, hereafter “Lee”).
As to claim 1, Moran discloses a device for controlled, repeated dispensing of a predefined quantity of fluid comprising (see Figs. 1-3):
a primary tank (11) configured to store the fluid (see para beginning line 29 col. 2),
a plunger unit (valve body assembly 15 & actuating assembly 16) positioned under the primary tank, the plunger unit including an electromagnet (25), a bracket (support 18 and/or bracket mentioned in paragraph beginning line 68 col. 2), a plunger (21), and a spring (23),
the electromagnet being coupled to the device by the bracket (Fig. 2),
the plunger being reciprocally movable along an x-axis relative to the electromagnet from a first position (position when tube is closed – see Fig. 3) to a second position (position when tube is open, i.e. Fig. 2) and vice versa, and
the spring being configured to position the plunger in the first position in response to the electromagnet not being activated (see para beginning line 41 col. 3);
a tube (12) that passes through a bottom end of the plunger unit that is configured to receive the fluid from the primary tank (Fig. 2); and
a controller (30) configured to repeatedly activate the electromagnet to dispense the predefined quantity of the fluid from the tube (see paragraphs beginning line 50 col. 1, line 55 col. 2, & line 58 col. 3),
wherein flow of the fluid is in the tube is being blocked in the tube when the plunger is in the first position (see Fig. 3 and paragraph beginning line 58 col. 3), and
wherein the flow of the fluid is released from the tube when the plunger is in the second position (see Fig. 2).
Moran does not expressly recite the controller configured to repeatedly activate the electromagnet to dispense the predefined quantity of the fluid from the tube via a needle unit configured to be removable and replaceable from the device and thus wherein the flow of the fluid is released to the needle unit from the tube when the plunger is in the second position.
Lee discloses a needle unit (34) configured to be removable and replaceable from the device (connected via Luer lock 26b) and thus wherein the flow of the fluid is released to the needle unit from the tube (see Fig. 1, para 0049 & 0054).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Moran such that the tube (12) includes a Luer lock, such as that taught by Lee, at a bottom end of the tube. One would have been motivated to do so to allow for removable/replaceable attachment of a needle unit which can be used to deliver the fluid to a patient (see Fig. 1, para 0049 & 0054 of Lee).
As to claim 2, Moran in view of Lee teaches the device as claimed in claim 1, wherein the plunger unit further includes a flange (see annotated Fig. 2 below), a tip (end of plunger closest to tube 12 – see annotated Fig. 2 below), and a plate (annotated wall of the housing 26).
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As to claim 5, Moran in view of Lee teaches the device as claimed in claim 1, wherein a first end of the tube is connected to a bottom portion of the primary tank (see Fig. 2, top end of tube connected to 11), and a second end of the tube being connected to the needle unit (see rejection of claim 1 above which added a Luer connector to a bottom end of tube for connecting needle unit).
As to claim 7, Moran in view of Lee teaches the device as claimed in claim 1 as described above. Moran does not expressly recite wherein the tube is guided by tube guides while entering the plunger unit and also while exiting the plunger unit. However, Lee further discloses wherein its tube (18) is guided by tube guides (20) while entering the plunger unit and also while exiting the plunger unit (see Figs. 1-2; tube guides 20 providing a clear structure for placement of tube 18 when opening and closing hinges 14). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, when modifying Moran, to further do so such that the tube is guided by tube guides while entering the plunger unit and also while exiting the plunger unit (i.e. providing a hinged opening for the support 18 and/or tube guides similar to those shown by Lee). One would have been motivated to do so as a way to place/support the tube as it is placed in the support 18 of Moran (see Figs. 1-3 and para 0046 of Lee).
As to claim 9, Moran in view of Lee teaches the device as claimed in claim 1, wherein the fluid flows through the tube due to gravitational force (see para beginning line 29 col. 2 of Moran).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moran in view of Lee as applied to claim 1 above, and further in view of Jacobson et al. (US 2004/0073175 A1, cited previously and hereafter "Jacobson").
As to claim 4, Moran in view of Lee teaches the device as claimed in claim 1 as described above, but is silent to wherein the primary tank is sealed and pressurised defining a non- free flow fluid flow through the tube.
Jacobson discloses a primary tank (vial 146; see Fig. 9) wherein the primary tank is sealed and pressurised defining a non- free flow fluid flow through the tube (see para 0065).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Moran (as already modified above) further and instead of using a container 11 of Moran, to have used a sealed and pressurized tank such as a vial as seen in Jacobson. One would have been motivated to do so as a way to control how fluid flows through the tube of modified Lee (see para 0065 of Jacobson).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moran in view of Lee as applied to claim 1 above, and further in view of Tversky (US 6,117,103, cited previously).
As to claim 10, Moran in view of Lee teaches the device for controlled dispensing of fluid as claimed in claim 1 as described above, but is silent to wherein the controller is defined as a timer.
Tversky discloses a controller defined as a timer (see paragraphs beginning line 24 col. 4 and line 48 col. 8).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Moran (as already modified above) such that the controller is defined as a timer. One would have been motivated to do so as a way to set desired periods of times for delivery (see paragraphs beginning line 24 col. 4 and line 48 col. 8 of Tversky).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moran in view of Lee as applied to claim 2 above, and further in view of Newell et al. (US 2017/0304605 A1, hereafter “Newell”).
As to claim 11, Moran in view of Lee teaches the device as claimed in claim 2, but is silent to wherein the tip of the plunger unit presses a portion of the tube positioned immediately below the tip.
Lee discloses wherein a tip (134) of the plunger unit (100) presses a portion of the tube (50) positioned immediately below the tip (see Figs. 1-4 and para 0039-0040, 0043).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Moran (as already modified above), which uses a design having two sliding pins, and instead use a design like where a tip of the plunger directly flattens the tube. In other words, the prior art discloses two different designs capable of compressing a tube and it therefore it would have been obvious to one having ordinary skill in the art to select either design (see paragraphs beginning line 20 col. 3 and line 41 col. 3 of Moran and Figs. 1-4 and para 0039-0040, 0043 of Lee).
Response to Arguments
Applicant’s Remarks submitted 1/12/25 have been considered.
With regard to the arguments under the heading “Claim Objections”, the arguments are moot/persuasive as the amendments have canceled previous claims 3 and 6.
With regard to the arguments under the heading “Claim Rejections Under 35 U.S.C. § 103”, the arguments are moot because the amendments to the claims have prompted new rejections which use the Moran reference (see above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783