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 .
Response to Amendment
The amendment filed on July 13, 2026 is acknowledged. Claims 1 and 3-15 remain pending wherein claims 14 and 15 were indicated as containing allowable subject matter. Applicant amended claims 1, 3-9 and 11-15 to obviate the objections and indefiniteness rejections set forth in the previous Office action. Applicant further amended claim 1 to incorporate the subject matter of previously pending claim 2.
Response to Arguments
Applicant’s arguments with respect to the patentability of the claims have been fully considered but they are not persuasive.
First, Applicant argues that claim 1 is patentable because the narrowing portions taught by Okamoto and Baroud are not “conical”. Remarks 10 and 12. According to Applicant, a “cone” must converge to a point, and neither Okamoto nor Baroud teach a narrowing portion that converges to a point. Id. The argument is not persuasive. Because the limitation “conical” refers to the shape of a channel/conduit narrowing towards an orifice (i.e. an opening) (see claim 1), it is impossible for the limitation “conical” to espouse the narrow, geometric definition of “cone” posited by Applicant. In fact, claim 4 recites that the injection orifice can have an opening diameter up to 1 mm (see claim 4), which is not a point. Consequently, the limitation “conical” is being interpreted to encompass a shape that is “like a cone”, which is the definition of “conical” by “dictionary.cambridge.org”, the same resource Applicant relied on for the definition of “cone” in the Remarks. Based on the context in which “conical” is used in the claims (i.e. referring to the shape of a channel terminating at an orifice) and the broadest reasonable interpretation of “conical”, the examiner maintains that the limitation “conical” does not require a shape converging at a point, meaning the narrowing portions taught by Okamoto and Baroud are “conical” (i.e. “like a cone”).
Alternatively, if an opening of up to 1 mm is considered a “point” (see claim 4), then portion 19 taught by Baroud does converge to a point, as it can comprise dimensions much smaller than 1 mm (see [0062]). Consequently, based on the definition of “point” conveyed by the language of claim 4, the narrowing portion taught by Baroud is “conical”, 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 provided the injection orifice taught by Okamoto with a dimension (up to 1 mm) such that the narrowing portion comprises a “conical” shape.
Second, Applicant argues that claim 1 is further patentable over Baroud because the narrowing portion taught by Baroud is intended to control the size of droplets, not to facilitate the generation of a vortex, let alone a vortex that releases platelets. Remarks 11-12. The argument is not persuasive. As acknowledged by Applicant (see Remarks 10-11), the ability of the claimed invention to release platelets from megakaryocytic cells is due to the shapes of the claimed elements and the operation of the pumping device. Consequently, a prior art device that teaches/renders obvious the claimed structures and teaches/renders obvious a pumping device that can generate sufficient velocity is deemed to anticipate the claimed limitations directed to intended use, regardless of whether the prior art actually teaches the intended use. In this case, not only does Baroud render obvious all of the elements recited in claim 1, it further renders obvious the specific relative dimensions of the claimed elements recited in claim 4 that contribute to platelet release. Consequently, the limitations in claim 1 directed to intended use are deemed to be taught/rendered obvious by the disclosure of Baroud, even if Baroud does not disclose that the device can be used to fragment cytoplasmic extensions from megakaryocytic cells.
For the foregoing reasons, the outstanding rejections are maintained, albeit they have been modified to address the amended language.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5, the limitation “an opening diameter” should be changed back to “the opening diameter”. Claim 4 establishes a proper antecedent basis for the limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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, 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 system 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 injection orifice (right opening) for injecting the fluid into the platelet release reservoir and a conical portion Ab (an oblique cone) (see Fig. 10a; see also abstract disclosing that the narrowing portion has a diameter) narrowing towards the injection orifice, there being an abrupt widening of cross-section between the injection orifice and the platelet release reservoir, and
a second fluidic connecting element B attached at the level of the second opening, the second fluidic connecting element comprising a discharge 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 Suzuki (see title). If the modification is made, then the system would further comprise a pumping device (elements 155, 10, see Fig. 9, [0104]) in fluidic communication with the platelet reservoir by the first fluidic connecting element, and a power supply module (element 156, 157) for depressing a portion of the system device (e.g. a diaphragm) so as to generate a continuous flow through the system (see [0104] and Figs.2 and 9).
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 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 platelet release 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 system devices 1 arranged in a circuit (see Fig. 11). Naturally, another system device of the pair of system devices comprises (see Fig. 10a and rejection of claim 1):
another platelet release reservoir α comprising another first opening (left side) and another second opening (right side),
another first fluidic connecting element A attached at the level of the another first opening and adapted to inject the fluid into the another platelet release reservoir, the another first connecting element comprising another injection orifice (right opening) for injecting the fluid into the another platelet release reservoir, and another first narrowing portion Ab opening onto the another injection orifice, and
another second fluidic connecting element B attached at the level of the another second opening, the another second connecting element comprising another discharge orifice (left opening) for discharging the fluid. Naturally, the another system 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 another system device to the pumping device via one of the fluidic another connecting elements, for example the another second fluidic connecting element.
While Okamoto does not explicitly disclose that the another system device is arranged fluidically parallel to the first device, Okamoto discloses that the position of the system device and the number of system 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 another system device in other locations of the circuit (see Fig. 11), including a portion that is fluidically parallel to the system 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 an additional system device comprising (see Fig. 10a and rejection of claim 1):
an additional platelet release reservoir α comprising an additional first opening (left side) and an additional second opening (right side),
an additional first fluidic connecting element A attached at the level of the additional first opening and adapted to inject the fluid into the additional platelet release reservoir, the additional first fluidic connecting element comprising an additional injection orifice (right opening) for injecting the fluid into the additional platelet release reservoir, and an additional first narrowing portion Ab opening onto the additional injection orifice, and
an additional second fluidic connecting element B attached at the level of the additional second opening, the additional second connecting element comprising an additional discharge orifice (left opening) for discharging the fluid, the additional system device being arranged fluidically serially with the system device (see Fig. 11). Naturally, the additional system device is in fluidic communication with the first fluidic connecting element of the system device.
Claims 1 and 3-7 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 system 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 the first opening and adapted to inject said fluid into said platelet release reservoir 3, the first fluidic connecting element 8 comprising an injection 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 platelet release 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. In addition, Baroud does not disclose the cross-sectional shape of the first fluidic connecting element to enable one to deduce whether portion 19 is conical (a cone requires a round cross-section).
Regarding the provision of the pump device and the power supply module, 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 a portion of a microfluidic channel so as to peristaltically pump fluid through the channel, such as the one taught by Salsman (see abstract and Figs. 3-5). The modification would enable fluid flow through the system of Baroud.
Regarding the cross-sectional shape of portion 19, 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 as independent claims that 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 the 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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