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 .
DETAILED ACTION
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.
Drawings
The drawings are objected to because Fig. 11 contains to Ref. Nos. 80, the lower left one of which appears to be erroneous. 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.
Claim Objections
Claim 1 is objected to because of the following informalities:
“configured engage” in line 7 should be --configured to engage--;
“the unlatched position” in lines 22-23 should be --the unlatched condition--.
Claim 4 is objected to because of the following informalities:
“includes clamp bearing surfaces” in lines 3-4 should be --includes respective clamp bearing surfaces--;
“includes clamping surfaces” in line 6 should be --includes respective clamping surfaces--;
“the clamping surfaces” in line 8 should be --the respective clamping surfaces--.
Appropriate correction is required.
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 1-3, 6-9, 11-12, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Menz et al. (U.S. 2022/0273876).
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Re claim 1:
Menz discloses a fluid processing system (1, syringe system - Para 48) comprising:
at least one syringe (3, syringe - Para 46) having a barrel (4, cylindrical syringe barrel - Para 46) and a plunger (5, plunger - Para 46) configured for reciprocal movement within the barrel (4)(see Fig. 2 and Para 46), wherein the syringe (3) includes a top face (Modified Fig. 2 above - A (person having ordinary skill in the art would recognize element A as a type of top face of element 3)) and a top flange (7, flange - Para 46) at a proximal end (Modified Fig. 2 above - B (person having ordinary skill in the art would recognize a type of proximal end of element 3 is shown at element B)) and a tip (6, nozzle - Para 46) at a distal end (Modified Fig. 2 above - C (person having ordinary skill in the art would recognize a type of distal end of element 3 is shown at element C))(see Modified Fig. 2 above);
a pump housing (2, syringe holder - Para 45; 8, drive housing - Para 45 (elements 2 and 8 are collectively a type of pump housing as shown in Figs. 1-6));
at least one syringe support (Modified Fig. 2 above - D (person having ordinary skill in the art would recognize element D as a type of syringe support)) arranged on the pump housing (2, 8) having a support surface (Modified Fig. 2 above - E (person having ordinary skill in the art would recognize element E as a type of support surface of element D)) configured engage the top flange (7) to support the syringe (3) in a fluid processing procedure (Para 47)(see Modified Fig. 2 above and Figs. 1-6); and
at least one syringe clamp (Modified Fig. 2 above - F (person having ordinary skill in the art would recognize element F as a type of syringe clamp)) connected to the housing (2, 8)(see Modified Fig. 2 above), the syringe clamp (Modified Fig. 2 above - F) comprising a sealing section (Modified Fig. 2 above - G (person having ordinary skill in the art would recognize element G as a type of sealing section of element F)) connected to the housing (2, 8) with a first hinge (24, joint - Para 45) and a holding section (20, locking lever - Para 45) connected to the sealing section (Modified Fig. 2 above - G) with a second hinge (27, locking lever joint - Para 92)(see Modified Fig. 2 above), the syringe clamp (Modified Fig. 2 above - F) moveable between an unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”) and a clamped condition (Figs. 3-6 and Para 45 - “…closed position…”),
wherein the sealing section (Modified Fig. 2 above - G) includes a sealing element (25, sealing element - Para 46) on a sealing surface (Modified Fig. 2 above - H (person having ordinary skill in the art would recognize element H as a type of sealing surface)) and is pivotable on the first hinge (24) between a raised condition (see Modified Fig. 2 above and Figs. 1-2) and a lowered condition (Figs. 3-6) in which the sealing section (Modified Fig. 2 above - G) is configured to apply a clamping force to the top face (Modified Fig. 2 above - A) of the syringe (3) to form a seal against the top face (Modified Fig. 2 above - A) with the sealing element (25)(see Modified Fig. 2 above, Fig. 3, and Para 46),
wherein the holding section (20) is pivotable on the second hinge (27) between an unlatched condition (see Fig. 8 and Para 45 - “…unlocked by operating the locking lever 20…”) and a latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) engaged with the syringe support (Modified Fig. 2 above - D)(see Modified Fig. 2 above, Figs. 3-4, Fig. 8, and Para 45), and
wherein movement of the holding section (20) to the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) causes movement of the syringe clamp (Modified Fig. 2 above - F) to the clamped condition (Figs. 3-6 and Para 45 - “…closed position…”) by applying a closing force to the sealing section (Modified Fig. 2 above - G) through the second hinge (27) such that the sealing section (Modified Fig. 2 above - G) applies the clamping force to the top face (Modified Fig. 2 above - A), and movement of the holding section (20) to the unlatched position (see Fig. 8 and Para 45 - “…unlocked by operating the locking lever 20…”) causes movement of the syringe clamp (Modified Fig. 2 above - F) to the unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”) by releasing the closing force and the clamping force (see Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 2:
Menz discloses the fluid processing system (1) according to claim 1 (as described above), wherein the holding section (20) includes a clamping surface (Modified Fig. 2 above - I (person having ordinary skill in the art would recognize element I as a type of clamping surface)) and the syringe support (Modified Fig. 2 above - D) includes a clamp bearing surface (Modified Fig. 2 above - J (person having ordinary skill in the art would recognize element J as a type of clamp bearing surface)),
wherein the clamping surface (Modified Fig. 2 above - I) is configured to engage the clamp bearing surface (Modified Fig. 2 above - J) such that movement of the holding section (20) to the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) increases the clamping force applied by the sealing section (Modified Fig. 2 above - G)(See Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 3:
Menz discloses the fluid processing system (1) according to claim 2 (as described above), wherein the holding section (20) further includes a clamping arm (Modified Fig. 2 above - K (person having ordinary skill in the art would recognize element K as a type of clamping arm of element 20)) and the clamping surface (Modified Fig. 2 above - I) is formed on the clamping arm (Modified Fig. 2 above - K) and is configured to engage the clamp bearing surface (Modified Fig. 2 above - J) at an underside (Modified Fig. 2 above - L (person having ordinary skill in the art would recognize element L as a type of underside of element D)) of the syringe support (Modified Fig. 2 above - D) in the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”)(See Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 6:
Menz discloses the fluid processing system (1) according to claim 1 (as described above), wherein the sealing element (25) is a sealing o-ring (see Figs. 1-3 and Para 46 - “…a sealing element 25…in particular a sealing ring…”), and
wherein the sealing o-ring (25) is configured to be pressed against the top face (Modified Fig. 2 above - A) under the clamping force in the clamped condition (Figs. 3-6 and Para 45 - “…closed position…”) to form the seal (See Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 7:
Menz discloses the fluid processing system (1) according to claim 1 (as described above), wherein the sealing section (Modified Fig. 2 above - G) includes a pneumatic fitting (14, connection piece - Para 52), a first channel (13, drive channel - Para 51) fluidically connected to the pneumatic fitting (14 see Fig. 2 and Para 52) and a first channel opening (30, second input - Para 52) arranged on the sealing surface (Modified Fig. 2 above - H) and surrounded by the sealing element (25)(see Modified Fig. 2 above).
Re claim 8:
Menz discloses the fluid processing system (1) according to claim 7 (as described above), wherein the top face (Modified Fig. 2 above - A) includes a second channel (Modified Fig. 2 above - N (person having ordinary skill in the art would recognize element N as a type of second channel)) having a second channel opening (Modified Fig. 2 above - O (person having ordinary skill in the art would recognize element O as a type of second channel opening)), and wherein the first channel (13) and the second channel (Modified Fig. 2 above - N) are fluidically connected in the clamped condition (Figs. 3-6 and Para 45 - “…closed position…”)(see Modified Fig. 2 above and Fig. 3).
Re claim 9:
Menz discloses the fluid processing system (1) according to claim 8 (as described above), wherein air is provided to the syringe (3) via the first channel (13) and the second channel (Modified Fig. 2 above - N) to pressurize the syringe (3) between about -10 PSI and about 100 PSI (see Modified Fig. 2 above and Paras 51-52 (“…with pressure or negative pressure…”)).
Re claim 11:
Menz discloses the fluid processing system (1) according to claim 1 (as described above), wherein the tip (6) includes a tip opening (Modified Fig. 2 above - P (person having ordinary skill in the art would recognize a type of tip opening at element P)) for fluid flow into or out of the barrel (4) in response to pressurization of the syringe (3)(see Modified Fig. 2 above and Para 47).
Re claim 12:
Menz discloses the fluid processing system (1) according to claim 1 (as described above), wherein the syringe (3) is a disposable syringe (see Figs. 1-2 and Para 19 - “…inserting or removing a syringe…”).
Re claim 16:
Menz discloses a syringe pump assembly (1, syringe system - Para 48) comprising:
a pump housing (2, syringe holder - Para 45; 8, drive housing - Para 45 (elements 2 and 8 are collectively a type of pump housing as shown in Figs. 1-6));
at least one syringe support (Modified Fig. 2 above - D (person having ordinary skill in the art would recognize element D as a type of syringe support)) arranged on the pump housing (2, 8) having a support surface (Modified Fig. 2 above - E (person having ordinary skill in the art would recognize element E as a type of support surface of element D)) configured to support a syringe (3, syringe - Para 46) in a fluid processing procedure (Para 47)(see Modified Fig. 2 above and Figs. 1-6); and
a corresponding at least one syringe clamp (Modified Fig. 2 above - F (person having ordinary skill in the art would recognize element F as a type of syringe clamp)) connected to the housing (2, 8)(see Modified Fig. 2 above), the syringe clamp (Modified Fig. 2 above - F) comprising a sealing section (Modified Fig. 2 above - G (person having ordinary skill in the art would recognize element G as a type of sealing section of element F)) connected to the housing (2, 8) with a first hinge (24, joint - Para 45) and a holding section (20, locking lever - Para 45) connected to the sealing section (Modified Fig. 2 above - G) with a second hinge (27, locking lever joint - Para 92)(see Modified Fig. 2 above), the syringe clamp (Modified Fig. 2 above - F) moveable between an unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”) and a clamped condition (Figs. 3-6 and Para 45 - “…closed position…”),
wherein the sealing section (Modified Fig. 2 above - G) includes a sealing element (25, sealing element - Para 46) on a sealing surface (Modified Fig. 2 above - H (person having ordinary skill in the art would recognize element H as a type of sealing surface)) and is pivotable on the first hinge (24) between a raised condition (see Modified Fig. 2 above and Figs. 1-2) corresponding to the unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”)(see Modified Fig. 2 above and Figs. 1-2) and a lowered condition (Figs. 3-6),
wherein the holding section (20) is pivotable on the second hinge (27) between an unlatched condition (see Fig. 8 and Para 45 - “…unlocked by operating the locking lever 20…”) corresponding to the unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”)(see Figs. 1-2 and 8) and a latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) engaged with the syringe support (Modified Fig. 2 above - D)(see Modified Fig. 2 above, Figs. 3-4, Fig. 8, and Para 45) and corresponding to the clamped condition (Figs. 3-6 and Para 45 - “…closed position…”)(see Figs. 3 and 4), and
wherein movement of the holding section (20) to the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) causes movement of the syringe clamp (Modified Fig. 2 above - F) to the clamped condition (Figs. 3-6 and Para 45 - “…closed position…”) by applying a closing force to the sealing section (Modified Fig. 2 above - G) through the second hinge (27)(see Figs. 3-4), and movement of the holding section (20) to the unlatched condition (see Fig. 8 and Para 45 - “…unlocked by operating the locking lever 20…”) causes movement of the syringe clamp (Modified Fig. 2 above - F) to the unclamped condition (Figs. 1-2 and Para 45 - “…tilted up position…”) by releasing the closing force (see Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 17:
Menz discloses the syringe pump assembly (1) according to claim 16 (as described above), wherein the holding section (20) includes a clamping surface (Modified Fig. 2 above - I (person having ordinary skill in the art would recognize element I as a type of clamping surface)) and the syringe support (Modified Fig. 2 above - D) includes a clamp bearing surface (Modified Fig. 2 above - J (person having ordinary skill in the art would recognize element J as a type of clamp bearing surface)),
wherein the clamping surface (Modified Fig. 2 above - I) is configured to engage the clamp bearing surface (Modified Fig. 2 above - J) such that movement of the holding section (20) to the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”) increases the clamping force applied by the sealing section (Modified Fig. 2 above - G)(See Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 18:
Menz discloses the syringe pump assembly (1) according to claim 17 (as described above), wherein the holding section (20) further includes a clamping arm (Modified Fig. 2 above - K (person having ordinary skill in the art would recognize element K as a type of clamping arm of element 20)) and the clamping surface (Modified Fig. 2 above - I) is formed on the clamping arm (Modified Fig. 2 above - K) and is configured to engage the clamp bearing surface (Modified Fig. 2 above - J) at an underside (Modified Fig. 2 above - L (person having ordinary skill in the art would recognize element L as a type of underside of element D)) of the syringe support (Modified Fig. 2 above - D) in the latched condition (see Figs. 3 and 4 and Para 45 - “…locked in the closed position…”)(See Modified Fig. 2 above, Figs. 2-8, and Paras 45-46).
Re claim 19:
Menz discloses the syringe pump assembly (1) according to claim 16 (as described above), wherein the sealing element (25) is a sealing o-ring (see Figs. 1-3 and Para 46 - “…a sealing element 25…in particular a sealing ring…”).
Re claim 20:
Menz discloses the syringe pump assembly (1) according to claim 19 (as described above), wherein the sealing section (Modified Fig. 2 above - G) includes a pneumatic fitting (14, connection piece - Para 52), a channel (13, drive channel - Para 51) fluidically connected to the pneumatic fitting (14 see Fig. 2 and Para 52) and a channel opening (30, second input - Para 52) arranged on the sealing surface (Modified Fig. 2 above - H) and surrounded by the sealing element (25)(see Modified Fig. 2 above).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Menz et al. (U.S. 2022/0273876), as applied to claim 9 above, and further in view of Lopez et al. (U.S. 2018/0055735).
Re claim 10:
Menz discloses the fluid processing system (1) according to claim 9 (as described above).
Menz fails to disclose a plurality of syringes arranged on the pump housing.
Lopez teaches a fluid processing system (600, system for transferring fluid - Para 216) plurality of syringes (606, syringe - Para 216 (see Fig. 15)) arranged on a pump housing (602, base housing - Para 216)(see Fig. 15 and Para 216).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modeled the fluid processing system of Menz after that of Lopez, thereby including a plurality of syringes of Menz on the pump housing of Menz in the way taught by Lopez, for the advantage of being able to combine fluid from multiple vials into a single IV bag (Lopez; Para 216).
Claims 13-15 is rejected under 35 U.S.C. 103 as being unpatentable over Menz et al. (U.S. 2022/0273876), as applied to claim 1 above, and further in view of Modlin et al. (U.S. 2005/0266582).
Re claim 13:
Menz discloses the fluid processing system (1) according to claim 1 (as described above).
Menz fails to disclose a microfluidic chip fluidically connected to the syringe.
Modlin teaches a fluid processing system (740, system - Para 192) comprising a microfluidic chip (746, microfluidic chip - Para 192) fluidically connected to a syringe (Para 196 - “…a precisely controlled syringe pump…”)(see Fig. 43 and Paras 192 and 196).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modeled the fluid processing system of Menz after that of Modlin, thereby fluidically connecting a microfluidic chip to the syringe pump of Menz in the way taught by Modlin, for the advantage of being able to perform a cellular assay, a biochemical assay, and a chemical assay (Modlin; Para 197).
Re claim 14:
Menz/Modlin teaches the fluid processing system (Menz; 1) according to claim 13 (as described above), wherein the syringe (Menz; 3) is configured to be positively pressurized to drive fluid through the microfluidic chip (Menz; see Figs. 2-3, Para 51 - “…operation of the plunger 5 of a syringe…with pressure…” and Para 5 - “…targeted injection of a substance…”).
Re claim 15:
Menz/Modlin teaches the fluid processing system (Menz; 1) according to claim 13 (as described above), wherein the syringe (Menz; 3) is configured to be negatively pressurized for priming the microfluidic chip (Menz; see Figs. 2-3, Para 51 - “…operation of the plunger 5 of a syringe…with… negative pressure…” and Para 5 - “…targeted… removal of a substance…”).
Allowable Subject Matter
Claims 4 and 5 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 following is a statement of reasons for the indication of allowable subject matter:
Claims 4 and 5 would be allowed primarily because the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by the combination of more than one reference.
Additionally, the prior art of record does not teach “the syringe support further includes spaced apart support flanges configured to receive the barrel therebetween, wherein the clamp bearing surface includes clamp bearing surfaces formed on the respective support flanges, and the holding section further includes spaced apart clamping arms and the clamping surface includes clamping surfaces formed on the respective clamping arms” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 4.
Additionally, the prior art of record does not teach “wherein the clamping surface includes a detent and the clamp bearing surface includes a bearing element, wherein the bearing element is positioned in the detent when the holding section is in the latched condition” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 5.
Therefore, the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by one or more references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Loren C Edwards whose telephone number is (571)272-7133. The examiner can normally be reached M-R 6AM-430PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Laurenzi can be reached at (571) 270-7878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOREN C EDWARDS/Primary Examiner, Art Unit 3746 12/5/25
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