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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pillar recited in claim 23 and the actuation assembly recited in claim 29 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character "110" has been used to designate the cylindrical structure in Fig. 1 and the piston chamber in Fig. 2A. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 2010, 356, 357 and 400. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 14 is objected to because of the following informalities: in claim 14, line 1 “magnetically responsive material” should be changed to –the magnetically responsive material—recited in claim 13. 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 1-3, 11-14, 21-30, 32, 35 and 37 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, lines 1-2 recite the “intended use” of the system for transporting a liquid from a chamber into one or more collection containers; however, the chamber from which the liquid is transported and one or more collection containers are not recited as structural elements of the system. Therefore, the recitation of the chamber and the one or more collection containers recited in the body of claim 1 and the dependent claims lack antecedent basis.
Claim 12 recites “the arm” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 2, 21, 23, 24 and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by International Patent Application Publication No. WO2021/138210 to Derfus et al. (cited by applicant)
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Derfus et al. discloses a sample preparation device and methods for using the same (Title).
The sample preparation device of Derfus et al. includes a cartridge for transporting a liquid from a chamber into collection containers, the cartridge comprising a plunger assembly having a plunger (250), a spring (260), a pivotally locking arm together with a trigger (270) forming a single piece (Fig. 8), a sealing plate (240), all of them located within a cylindrical structure (210), a cap (220), and two PCR containers (211). The plunger comprises a gasket seal (820) and a rigid structure (the shaft (830)). The application of pressure to the trigger releases the trigger, such that the spring moves the plunger for transporting the liquid from the liquid chamber where it is contained towards a per container by a channel (Fig. 1C). (page 16, lines 9-12)
I.) Regarding applicant’s claim 1, Derfus et al. teaches all the elements of claim 1.
Therefore, Derfus et al. anticipates claim 1.
II.) Regarding applicant’s claim 2, as noted above Derfus et al. anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the system comprises two collection containers and wherein the channel bifurcates into two sub-channels fluidically connected to the two collection containers.
Derfus et al. teaches that the opening at the bottom of the third chamber may be fluidically connected to two channels that split from the opening to fill the two collection containers with substantially equal volume of liquid drained from the third chamber. (page 24, lines 12-16)
Therefore, Derfus et al. anticipates claim 2.
III.) Regarding applicant’s claim 21, as noted above Derfus et al. anticipates claim 1 from which claim 21 depends.
Claim 21 recites that the system of claim 1 comprises cylindrical cartridge comprising a top end and a bottom end and an annular wall extending between the top and bottom ends, wherein the cylindrical cartridge comprises the chamber, plunger chamber, pivotable locking arm, trigger, a sealing plate assembly and a cap, and wherein the sealing plate assembly is fixedly positioned over the top end of the cylindrical cartridge and wherein upon application of downward force on the cap, the cap is fixedly positioned over the sealing plate assembly.
Derfus et al. teaches all the elements of claim 21 as shown in Fig. 2. (page 16, line 33 through page 17, line 15) In reference to Fig. 2 Derfus notes that the cylindrical structure, the buffer pack, the sealing plate and the protective cover are broken out for illustration. (page 2)
Therefore, Derfus et al anticipates claim 21.
IV.) Regarding applicant’s claim 23, as noted above Derfus et al. anticipates claim 21 from which claim 23 depends.
Claim 23 recites that the trigger comprises a non-magnetic material, the system further comprising a pillar shaped structure positioned adjacent the outer surface of the annular wall, wherein the cylindrical cartridge is rotatable to a position that places the trigger adjacent the pillar shaped structure, wherein the trigger comprises a protruding region extending from inside the cylindrical structure to outside of the annular wall and wherein the pillar shaped structure provides the physical interference that engages the trigger causing the locking arm to disengage from the plunger assembly upon rotation of the cylindrical cartridge.
Derfus et al. teaches that in certain embodiments, the cylindrical structure is rotated to a fourth position to allow a mechanical arm to apply pressure to the trigger. (page 24, lines 21-25)
Therefore, Derfus et al. anticipates claim 23.
V.) Regarding applicant’s claim 24, as noted above Derfus et al. anticipates claim 1 from which claim 24 depends.
Claim 24 recites that the spring is positioned in an interior region of the plunger chamber.
In Derfus et al. the spring enters the chamber that the plunger moves in.
Therefore, Derfus et al. anticipates claim 24.
V.) Regarding applicant’s claim 30, as noted above Derfus et al. anticipates claim 1 from which claim 30 depends.
Claim 30 recites that the system is semi-automatic or automatic.
Derfus et al. teaches that methods of using the sample preparation device are also provided. The methods may be semi-automated or completely automated to perform the sample preparation. (page 2, lines 13-14)
Therefore, Derfus et al. anticipates claim 30.
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.
2. Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Derfus et al.
I.) Regarding applicant’s claim 3, as noted above Derfus et al. anticipates claim 1 from which claim 3 depends.
Claim 3 recites that plunger chamber is substantially cylindrical in shape and wherein the plunger assembly comprises a rigid structure and a compressible structure, wherein the rigid structure comprises a narrow-elongated region having substantially curved end and a substantially flat end opposite the curved end, wherein the curved end engages with the locking arm and the flat end is attached to the compressible structure, and wherein the compressible structure forms a seal with the interior surface of the plunger chamber.
As noted above, Derfus et al. teaches that the plunger includes a gasket seal (820) and a rigid shaft (830). In Derfus et al. one end of the rigid shaft of the plunger engages with the locking arm of the trigger as shown in Fig. 2. The opposite end of the rigid shaft having the gasket seal (820) is shown as being substantially flat in Fig. 8.
Derfus et al. does not teach that the distal end of the shaft of the plunger that engages the locking arm of the trigger has a curved end.
It would have been obvious to one of ordinary skill in the art to make the distal end of the end portion of the shaft of the plunger that engages the locking arm curved as a matter of design choice, since the shape of the distal end is not significant as taught by Derfus et al. Note, changes in shape are not patentable absent evidence that the particular configuration of is significant. (MPEP 2144.04(IV)(B)).
Therefore, Derfus et al. renders claim 3 obvious.
II.) Regarding applicant’s claim 11, as noted above Derfus et al. anticipates claim 1 from which claim 11 depends.
Claim 11 recites that the trigger is removably coupled or fixedly coupled to the locking arm.
Derfus et al. does not teach that the trigger is removably coupled or fixedly coupled to the locking arm; however, the trigger that extends out from the cover as shown in Fig. 3 can be removed from the internal locking arm portion, since any portion of a structure and be removed.
Therefore, Derfus et al. renders claim 11 obvious.
3. Claims 13 and 14 stand rejected under 35 USC 103 as being unpatentable over Derfus et al. as applied to claim 1 and further in view of U.S. Patent Application Publication No. 2016/0158716 to Vos et al.
I.) Regarding applicant’s claim 13, as noted above Derfus et al. anticipates claim 1 from which claim 13 depends.
Claim 13 recites that the trigger comprises a magnetically responsive material.
Derfus et al. does not teach that the trigger comprises a magnetically responsive material.
Vos et al. teaches a plug or plunger that may be held in place by frictional forces or may be prevented from moving by a mechanical, electrical or magnetic mechanism which may be released. [0083].
It would have been obvious to one of ordinary skill in the art to modify Derfus et al. to incorporate a magnetic mechanism with a magnetically responsive material into the trigger to control release of the piston in view of Vos et al. teaching the alternate use of mechanical, electrical or magnetic mechanisms to control and release a piston.
Therefore, Derfus et al. in view of Vos et al. renders claim 13 obvious.
II.) Regarding applicant’s claim 14, as noted above Derfus et al. in view of Vos et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that magnetically responsive material comprises iron, nickel, cobalt, oxides thereof, derivatives thereof, and combinations thereof.
Derfus et al. in view of Vos et al. does not teach that magnetically responsive material comprises iron, nickel, cobalt, oxides thereof, derivatives thereof, and combinations thereof.
However, iron, nickel, cobalt, oxides thereof are well known magnetic materials which would have been obvious to use in Derfus et al. in view of Vos et al. as modified above.
Therefore, Derfus et al. in view of Vos et al. renders claim 14 obvious.
4. Claim 22 is rejected under 35 USC 103 as being unpatentable over Derfus et al. as applied to claim 1 above and further in view of Vos.
I.) Regarding applicant’s claim 22, as noted above Derfus et al. in view of Vos et al. renders claim 13 obvious from which claim 14 depends.
Claim 22 recites that the trigger comprises a magnetic material, the system further comprising a magnet positioned adjacent the outer surface of the annular wall, wherein the cylindrical cartridge is rotatable to a position that places the trigger adjacent the magnet, wherein magnetic force from the magnet holds the locking arm in place while the cylindrical cartridge rotates causing the locking arm to disengage from the plunger assembly.
Derfus et al. does not teach that the trigger comprises a magnetic material, the system further comprising a magnet positioned adjacent the outer surface of the annular wall, wherein the cylindrical cartridge is rotatable to a position that places the trigger adjacent the magnet, wherein magnetic force from the magnet holds the locking arm in place while the cylindrical cartridge rotates causing the locking arm to disengage from the plunger assembly.
As noted above, Vos et al. teaches plug or plunger that may be held in place by frictional forces or may be prevented from moving by a mechanical, electrical or magnetic mechanism which may be released. [0083].
It would have been obvious to one of ordinary skill in the art to modify Derfus et al. to incorporate a magnetic mechanism with a magnetically responsive material into the trigger to control release of the piston in view of Vos et al. teaching the alternate use of mechanical, electrical or magnetic mechanisms to control and release a piston.
As for rotating the cylindrical cartridge to a position that places the trigger adjacent the magnet, wherein magnetic force from the magnet holds the locking arm in place while the cylindrical cartridge rotates causing the locking arm to disengage from the plunger assembly, it is noted that Derfus et al. provides for rotating the cylinder housing with respect to an external magnet. (Fig. 9; page 2).
It would have been obvious to one of ordinary skill in the art to modify Derfus et al. to incorporate a magnetic mechanism to control the trigger to release of the piston in view of Vos et al. teaching the alternate use of mechanical, electrical or magnetic mechanisms to control and release a piston. Providing a magnetically responsive material in conjunction with the trigger or Derfus et al. that cooperates with the exterior magnetic of Derfus et al. would have been obvious based on Derfus et al. teaching an external magnet that provides a magnet field that interacts with elements in the cylindrical cartridge.
Therefore. Derfus et al. in view of Vos et al. renders claim 22 obvious.
5. Claim 25 is rejected under 35 USC 103 as being unpatentable over Derfus et al. as applied to claim 1 above and further in view of Korean Patent No. KR102005382 to Lee.
I.) Regarding applicant’s claim 25, as noted above Derfus et al, anticipates claim 1 from which claim 25 depends.
Claim 25 recites that the spring is positioned in an interior region of the plunger chamber.
Derfus et al. does not teach that the spring is positioned in an interior region of the plunger chamber.
Lee teaches a spuit (syringe) which as shown in Fig. 10 includes a pushing plate 232 that is a top portion of a piston 24. As shown in Fig. 10 the pushing plate and extends beyond the cylinder 212 in which the piston moves and a spring is provided outside of the 212.
It would have been obvious to one of ordinary skill in the art to modify Derfus et al. to provide the spring of the plunger assembly on the outer portion of the chamber in which the plunger is moved in view of Lee teaching such an alternative configuration is known and useful. Note, Derfus et al. teaches that the gasket seal (“compressible structure”) can have a shape corresponding to the chamber in which the plunger is integrated. (sentence bridging pages 15-16). Making the chamber cylindrical would have been obvious design choice absent persuasive evidence that the particular configuration is significant. (MPEP 2144.04(IV)B))
Therefore, Derfus et al. in view of Lee renders claim 25 obvious.
Allowable Subject Matter
Claims 12, 26-29, 32, 35 and 37 are 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.
The prior art of record does not teach or suggest a trigger that is coupled to a portion of the arm that extends downwards from the locking arm as recited in claim 12 incorporated in a system as recited in claim 1.
The prior art of record does not teach or suggest an engagement on an outer region of a rigid structure of a plunger that is sized to slidably fit inside a cut-out in a pivotal locking arm as recited in claims 26-29.
The prior art of record does not teach or suggest a trigger that can be engaged to disengage a locking art as recited in claims 32, 35 and 37 incorporated in a system as recited in claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798