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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9, 2026 has been entered.
Claims 1-15 remain pending. Applicant amended claims 1 and 12-14.
Response to Arguments
Regarding Applicant’s remarks directed to the finality of the Office action mailed on August 13, 2025 and the outstanding rejections set forth therein, the remarks are moot in light of the filing of the RCE and the withdrawal of the rejections.
Claim Objections
The claims are objected to because of the following informalities:
It is suggested that the claims refer to elements consistently using their full nomenclature. As indicated below, some elements share common nomenclature (e.g. “device”) and references to elements using the common nomenclature (“the device”) render the claims indefinite. In addition, referring to an element using different versions of the nomenclature (e.g. second fluidic connecting element, second connecting element, second element) can render the claims potentially indefinite.
In claim 4, the limitation “by” should be changed to “to”.
In claim 13, there is an extraneous space before a comma in line 9.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 1, the scope of the limitation “device” is rendered indefinite because the device (see line 4) comprises another device (pumping device). It is unclear what constitutes a device.
In claim 1, there is no antecedent basis for “said first connecting element”, “said second connecting element”, “said injection orifice” and “said discharge orifice”. For recitation of “said”, there must be verbatim antecedent basis for the limitation following the “said”.
Likewise, in claims 2, 12 and 13, there is no antecedent basis for the following limitations: “said longitudinal axes”, “said injection orifice”, “said first connecting element”, and “said second connecting element”.
In addition, claims 12 and 13 introduce a second device comprising nominally identical elements as the first device introduced in claim 1. Consequently, subsequent references to the elements (e.g. “said second opening”) render the claims indefinite as it is unclear to which device (first device or the second device) each element belongs.
Any changes made to claim 1 to address antecedent basis may require changes to dependent claims that recite the same limitations. The dependent clams were not rejected because there is antecedent basis for the limitations in claim 1.
Claim 1 recites “generate a depression in the device”. It is unclear to which device the limitation refers. Based on context, it appears that it refers to the pumping device.
Likewise, in claims 9, 11 and 15 it is unclear to which “reservoir” and “device” the limitations “said/the reservoir” and “the device” refer, respectively.
In claims 5 and 7, there is no antecedent basis for the limitation “the cross-sectional width”.
Claim 12 recites “the first device”. There is no antecedent basis for the limitation.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 103
Claims 1-3 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al. (“Okamoto”) (US 2016/0346528 A1) in view of Suzuki et al. (“Suzuki”) (US 2002/0045851 A1).
With respect to claim 1, Okamoto discloses a system for releasing platelets from a fluid comprising megakaryocytic cells comprising cytoplasmic extensions1, said system comprising a device comprising (see Fig. 10a):
a platelet release reservoir α comprising a first opening (left side) and a second opening (right side),
a first fluidic connecting element A attached at the level of said first opening and adapted to inject said fluid into said reservoir, the first connecting element A comprising an orifice (right opening) for injecting the fluid into the platelet release reservoir and a portion Ab narrowing towards the orifice, there being an abrupt widening of cross-section between the injection orifice and the reservoir, and
a second fluidic connecting element B attached at the level of said second opening, the second fluidic connecting element comprising an orifice (left opening) for discharging the fluid.
The system taught by Okamoto differs from the claimed invention in that Okamoto does not disclose the claimed pumping device or the claimed power supply module.
However, Okamoto discloses that the system is intended to be a part of a dialyzer (see [0002], [0044] and Fig. 11). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the system into a dialyzer, such as the one taught by Suzkuki (see title). If the modification is made, then the system would further comprise a pumping device (a diaphragm pump) in fluidic communication with the reservoir by the first fluidic connecting element, and a power supply module for depressing the pumping device so as to generate a continuous flow through the system (see [0104] of Suzuki disclosing a diaphragm pump and a power supply for contracting and expanding the diaphragm pump).
1The limitations are directed to recitation of intended use of the claimed system. In this instance, the limitations merely convey ability, meaning the limitations are anticipated if the prior art system is simply capable of processing a fluid comprising the claimed cells. In this case, because the system taught by Okamoto is intended to be used to process blood (see abstract), it is sufficient to anticipate the limitations. Likewise, the limitations of the last two lines of claim 1 describe a phenomenon within the reservoir caused by generating a continuous flow of fluid. The limitations are deemed to be anticipated by any pump device that produces a continuous fluid flow capable of generating a vortex, which is taught by Okamoto (see Fig. 10a).
With respect to claim 2, the narrowing portion is conical (an oblique cone) (see Fig. 10a; see also abstract disclosing that the narrowing portion has a diameter).
With respect to claim 3, the first fluidic connecting element A comprises a longitudinal axis (lateral axis in Fig. 10a) and the second connecting element B comprises a longitudinal axis (lateral axis in Fig. 10a), the longitudinal axes being parallel and separated by a non-zero distance (see Fig. 10a).
With respect to claim 8, the reservoir has a spherical shape (see Fig. 10a).
With respect to claim 9, the system taught by Okamoto further comprises a source reservoir 2a connected to the first fluidic connecting element for supplying the reservoir, and a reservoir for receiving the fluid (dialyzer connected to c in Fig. 11) connected to the second fluidic connecting element to collect said fluid intended to be sucked from the platelet release reservoir.
With respect to claim 10, as discussed above, the pumping device would be located in the receiving reservoir (i.e. dialyzer).
With respect to claim 11, the second fluidic connecting element comprises a portion Bb flared from discharging orifice towards the pumping device (see Fig. 10a).
With respect to claim 12, the system comprises a pair of devices 1 arranged in a circuit (see Fig. 11). Naturally, a second device of the pair of devices comprises (see Fig. 10a and rejection of claim 1):
a platelet release reservoir α comprising a first opening (left side) and a second opening (right side),
a first fluidic connecting element A attached at the level of said first opening and adapted to inject said fluid into said reservoir, said first connecting element comprising an orifice (right opening) for injecting the fluid into the platelet release reservoir, and a first narrowing portion Ab opening onto the injection orifice, and
a second fluidic connecting element B attached at the level of said second opening, the second connecting element comprising an orifice (left opening) for discharging the fluid. Naturally, the second device would also be connected to the pumping device, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fluidly connected the second device to the pumping device via one of the fluidic connecting elements, for example the second fluidic connecting element.
While Okamoto does not explicitly disclose that the second device is arranged fluidically parallel to the first device, Okamoto discloses that the position of the device and the number of devices in the circuit is not limited (see [0047]), Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second device in other locations of the circuit (see Fig. 11), including a portion that is fluidically parallel to the first device (e.g. one of the side paths connected to the needle or the syringe).
With respect to claim 13, as discussed above (see rejection of claim 12), the system comprises a second device comprising (see Fig. 10a and rejection of claim 1):
a platelet release reservoir α comprising a first opening (left side) and a second opening (right side),
a first fluidic connecting element A attached at the level of said first opening and adapted to inject said fluid into said reservoir, the first connecting element comprising an orifice (right opening) for injecting the fluid into the platelet release reservoir, and a first narrowing portion Ab opening onto the injection orifice, and
a second fluidic connecting element B attached at the level of said second opening, the second connecting element comprising an orifice (left opening) for discharging the fluid, the second device being arranged fluidically serially with a first device of the pair of devices (see Fig. 11). Naturally, the second device is in fluidic communication with the first fluidic connecting element of the first device.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Baroud et al. (“Baroud”) (US 2013/0078164 A1) in view of Salsman (US 2012/0275929 A1).
With respect to claim 1, Baroud discloses a system comprising a device comprising (see Figs. 7 and 8):
a platelet release reservoir 3 comprising a first opening (left side) and a second opening (right side in Fig. 7),
a first fluidic connecting element 8 attached at the level of said first opening and adapted to inject said fluid into said reservoir 3, the first connecting element 8 comprising an orifice (right opening) for injecting the fluid into the platelet release reservoir and a portion 19 narrowing towards the orifice, there being an abrupt widening of cross-section between the injection orifice and the reservoir 3 (see Fig. 8), and
a second fluidic connecting element (vertical channel on the right of Fig. 7 illustrating fluid exit) attached at the level of said second opening, the second fluidic connecting element comprising an orifice (top opening) for discharging the fluid.
The system taught by Baroud differs from the claimed invention in that Baroud does not disclose the claimed pumping device or the claimed power supply module.
However, Baroud discloses that the system is intended to be a part of a microfluidic circuit (see [0001]). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the system into a microfluidic circuit comprising conventional features, such as a peristaltic pump powered by a power supply that is configured to compress and expand the peristaltic pump, such as the one taught by Salsman (see abstract and Figs. 3-5). The modification would enable fluid flow through the system of Baroud.
With respect to claim 2, while Baroud does not disclose the shape of the first fluidic connecting element, 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 a channel having a conventional shape, for example a channel having a circular cross-section. In such case, the narrowing portion 19 would be conical (see Fig. 8).
With respect to claim 3, the first fluidic connecting element 8 comprises a longitudinal axis (lateral axis in Fig. 8) and the second connecting element comprises a longitudinal axis (vertical axis in Fig. 7), the longitudinal axes being perpendicular and separated by a non-zero distance.
With respect to claims 4 and 5, the injection orifice has an opening diameter ranging from 10 microns to 100 microns (see [0062]), and a sectional width of the reservoir ranges from 20 microns to 1000 microns (see [0062]), meaning a ratio of the opening diameter to the sectional width can have a value that falls within the claimed range, including 0.05, thus making the subject matter of the claims obvious.
With respect to claims 6 and 7, Baroud does not disclose the dimensions of the discharge orifice. However, the discharge orifice appears to have an opening diameter that is similar or equal to the opening diameter of the injection orifice (see Fig. 7). Based on the available information regarding the dimensions of the discharge orifice, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the discharge orifice with dimensions that are identical to the injection orifice, meaning a ratio of the opening diameter of the discharge orifice to the sectional width can have a value that falls within the claimed range, including 0.05, thus making the subject matter of the claims obvious.
Allowable Subject Matter
Claims 14 and 15 would be allowable if they are rewritten to overcome the applicable objections and 35 U.S.C. 112(b) rejections set forth in this Office action and to include 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:
As discussed above, Okamoto discloses a system of claim 1. However, Okamoto does not disclose or suggest using the system to release platelets from megakaryocytic cells. Rather, the system of Okamoto is used to perform dialysis. While the system of Okamoto does process fluids containing platelets (blood comprises platelets), there is no motivation to use the system to process a fluid containing megakaryocytic cells as recited in claims 14 and 15.
Likewise, Baroud does not disclose a method of using its system to process fluids containing megakaryocytic cells, and it would not have been obvious to use the system to process fluids containing megakaryocytic cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796