DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 18 is objected to because of the following informalities: -wherein the providing a visual cue for a target rotational speed-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 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.
Regarding claim 1:
The claim recites the limitation "the syringe" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-16 are rejected due to their dependence on claim 1.
Regarding claim 2:
The claim limitation “a syringe” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “the syringe” in line 8 of claim 1 (on which this claim depends) which raises a question of if two of syringes are required by the claim 2 or only one. For the sake of examination, the office has assumed that only one syringe is required by the claim.
Regarding claim 5:
The claim limitation “rotating timing element” in line 1 is unclear. The limitation is unclear because of the earlier recitation of the limitation “rotating timing element” in line 1 of claim 3 (on which this claim depends) which raises a question of if two rotating timing element are required by the claim 5 or only one. For the sake of examination, the office has assumed that only one rotating timing element is required by the claim.
Regarding claim 6:
The claim limitation “rotating timing element” in line 1 is unclear. The limitation is unclear because of the earlier recitation of the limitation “rotating timing element” in line 1 of claim 6 (on which this claim depends) which raises a question of if two rotating timing element are required by the claim 5 or only one. For the sake of examination, the office has assumed that only one rotating timing element is required by the claim.
Regarding claim 10:
The claim limitation “a plunger” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a plunger” in line 8 of claim 1 (on which this claim depends) which raises a question of if two plungers are required by the claim 10 or only one. For the sake of examination, the office has assumed that only one plunger is required by the claim.
Regarding claim 11:
The claim limitation “a plunger” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a plunger” in line 8 of claim 1 (on which this claim depends) which raises a question of if two plungers are required by the claim 11 or only one. For the sake of examination, the office has assumed that only one plunger is required by the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 7-9, 11-13, 15-17 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130245492 A1 to Klenk et al. (Klenk).
Klenk discloses:
Regarding claim 1:
A fluid flow control device (figure 1) for a cancer therapy system (interpreted as intended use of which the structure in figure 1 would be capable of) comprising:
a receiver housing (16), wherein the receiver housing (16) is configured to interface (as shown in figure 1) with a fluid delivery device (14); and
a rotational plunger (18), the rotational plunger (18) comprising indicia (196), wherein the indicia (196) are disposed on an end (disposed on the knob 20 as the end of the plunger 18) of the rotational plunger (18);
wherein the rotational plunger (18) is configured to engage with the receiver housing (16) (as shown in figure 6a); and
wherein rotation of the rotational plunger (18) causes a plunger (34) of the syringe (14) to be depressed (¶0028).
Regarding claim 2:
The fluid flow control device of claim 1, the fluid delivery device (14) comprising a syringe (14; As shown in figure 2B).
Regarding claim 7:
The fluid flow control device of claim 1, the rotational plunger (18) further comprising a knob (20), wherein the knob (20) is disposed on an end (as shown in figure 2A) of the rotational plunger (18).
Regarding claim 8:
The fluid flow control device of claim 1, wherein the receiver housing (16) includes a cutaway portion (see the cut out portion A and Figure 1 below) and/or a transparent portion to allow viewing of markings (interpreted as intended use even though the markings are not shown on the syringe in the figure below) on the fluid delivery device (14) while the receiver housing (16) interfaces with the fluid delivery device (14).
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Figure 1 - Figure 1 of Klenk, annotated by the examiner
Regarding claim 9:
The fluid flow control device of claim 1, wherein the rotational plunger (18) is configured to only turn in one direction (when in the fully extended position as shown in figure 2 E the plunger 18 can only turn in the direction that compresses the plunger since portion 92 cannot engage with the threads within 104).
Regarding claim 11:
The fluid flow control device of claim 1, wherein a maximum travel distance of the rotational plunger (18) is less than a maximum depressed travel distance of a plunger (34) of the fluid delivery device (14) so that the rotational plunger (18) does not cause the plunger (34) of the fluid delivery device (14) to become fully depressed (structure in Klenk is capable of this function since the reference teaches that the plunger shaft of the syringe can be cut to attached to the rotational plunger 18 and this maximum travel distance of the rotational plunger less than a maximum depressed travel distance of the plunger of the syringe is a factor of the cut length; ¶0032).
Regarding claim 12:
The fluid flow control device of claim 1, wherein the fluid flow control device (14) is configured to generate sounds and/or tactile vibrations (see the structure shown in figure 5A and the noise/vibrations generated by this structure as indicated in ¶0040) as the rotational plunger (18) is rotated.
Regarding claim 13:
The fluid flow control device of claim 12, wherein the fluid flow control device (14) is configured to generate timing sounds to guide the device user to achieve a target rotational speed (see the structure shown in figure 5A and the noise/vibrations generated by this structure as indicated in ¶0040) of the rotational plunger (18).
Regarding claim 15:
The fluid flow control device of claim 1, further comprising a rotating cover (20), wherein the rotating cover is configured to rotate (knob/cover 20 rotates with the shaft 18) with respect to the receiver housing (16).
Regarding claim 16:
The fluid flow control device of claim 15, further comprising a stop member (see surface B of the housing as indicated in Figure 2 below), wherein the stop member is configured to prevent rotation of the rotating cover beyond a specific point (prevents the rotating cover/knob 20 from rotating beyond the housing).
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Figure 2 - Figure 6A of Klenk, annotated by the examiner
Regarding claim 17:
A method of controlling a flow rate of a fluid delivery device (14) comprising:
engaging (as shown in Figure 1) a fluid flow control device (14; syringe) with the fluid delivery device (14);
rotating a rotational plunger (18) of the fluid flow control device (As indicated in ¶0027 ); and
providing a visual cue (see structures 196, 112 or the bumps on the edge of the knob that provide a visual clue to the rotation of the knob 20 and by extension the rotation of the plunger 18) for a target rotational speed of the rotational plunger (18).
Regarding claim 19:
The method of claim 17, further comprising generating sounds and/or tactile vibrations (see the structure shown in figure 5A and the noise/vibrations generated by this structure as indicated in ¶0040) as the rotational plunger (18) is rotated.
Regarding claim 20:
The method of claim 17, further comprising generating timing sounds to guide the device user to achieve a target rotational speed (see the structure shown in figure 5A and the noise/vibrations generated by this structure as indicated in ¶0040) of the rotational plunger (18).
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5800405 A to McPhee.
McPhee discloses:
Regarding claim 1:
A fluid flow control device (figures one through 6) for a cancer therapy system (interpreted as intended use) comprising:
a receiver housing (24), wherein the receiver housing (24) is configured to interface with a fluid delivery device (12); and
a rotational plunger (38), the rotational plunger (38) comprising indicia (see the bumps on knob 42), wherein the indicia are disposed on an end of the rotational plunger (38) (the rotation of the speed of the bumps on knob 42 indicate the speed of the plunger);
wherein the rotational plunger (38) is configured to engage with the receiver housing (24) (as shown in Figures 1 and 4 through 6); and
wherein rotation of the rotational plunger (38) causes a plunger (the plunger 20 in figure 5) of the syringe (12) to be depressed (as shown in figure 6; The rotational plunger 38 is threaded Into the housing 24 which pretensions the spring 66 which then actuates the plunger 20).
Regarding claim 10:
The fluid flow control device of claim 1, wherein the rotational plunger (38) is configured so that rotation of the rotational plunger (38) causes a plunger (plunger 20) of the syringe to be depressed without rotating (the spring 66 connecting the rotational plunger 38 to the plunger 20 prevents rotation of the plunger 20 and only allows it to be axially actuated) the plunger (plunger 20) of the syringe (12).
Allowable Subject Matter
Claims 3-6 and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20210128944-A1
Martin
See the rotational plunger 108
US-4973318-A
Holm
See the rotational plunger 21
US-4668220-A
Hawrylenko
see the rotational portion 21
EP-2968732-B1
COWAN
See the rotational plunger 202
WO-2018052055-A1
TAKAHASHI
see the rotational portion 24
WO-2017170629-A1
IIBUCHI
see the rotational portion 30
WO-2018052101-A1
TAKAHASHI
see the rotational portion 24
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
