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 .
Preliminary Remarks
The amendment filed on 03/06/2026 has been entered. Claim 1 has been amended, claim 16 remains canceled, and claims 11, 14, and 17-21 remain withdrawn from consideration. Therefore, claims 1-15, and 17-21 remain pending in the application.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 5-10, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over EP0968760A1-Jalenques (hereinafter “Jalenques”, all citations are made to the machine English translation, and further in view of US 7,425,192 B2-Sacco et al. (hereinafter “Sacco”).
Regarding claim 1, Jalenques discloses a device for the disaggregation of tissue samples into individual cells or cell clumps (para. [0001]) in a closed flexible bag (bag 16, para. [0005], line 2, Fig. 1), the device including a mechanical disaggregation mechanism (para. [0003], line 1; para. [0005], lines 1-3) and a tissue sample bag receiving area (door 8, para. [0025], line 4, Fig. 1),
Jalenques discloses said device further including a heat transfer plate for transferring heat energy to or from the tissue sample bag area (para. [0019]); further, Jalenques discloses the heating and/or cooling means are integrated into said door 8 (para. [0022], where door 8 as shown in Fig. 1, where the heating/cooling means are in the tissue sample bag area (homogenizing bag 6),
Jalenques discloses and each foot being further movable away from the first plate under influence of a treading bar (shaft 37, 38 parallel to the longitudinal axis, para. [0040], Fig. 3) which is arranged also to compress said respective spring during said movement away from the first plate (para. [0033], elastic link 22, 23, Fig. 1).
Jalenques discloses wherein the device is configured to disaggregate tissue samples into individual cells or cell clumps (the device of Jalenques is capable of disaggregating tissue samples into individual cells or cell clumps; this is apparent via homogenizing animal tissue or biological samples in homogenizer bag 6, shown in Fig. 1).
Regarding claim 1, Jalenques teaches the invention discussed above. Further, Jalenques teaches the surfaces of jaws 12, 13, para. [0045]; and para. [0045]) which faces away from the tissue sample receiving area, the disaggregation mechanism including plural treading feet (ends of jaws 12 and 13, para. [0005], lines 1-4, shown in Fig. 1) each urged toward the first plate surface (para. [0030], lines 1-2, Fig. 1) with generally linear motion only by force from a respective spring (spring—elastic link 22, 23, para. [0033], Fig. 1; and para. [0012], actuating mechanism by means of a resilient connection, further the linear motion is shown in Figs. 1 and 2, via jaws 12 and 13). Also, Jalenques teaches a heating/cooling means of the device. However, Jalenques does not teach an external heat source.
For claim 1, Sacco teaches an invention relating to biological fluid and/or cell processing apparatus and, more particularly, to an apparatus for separating fluid materials (col. 1, lines 56-58) and Sacco teaches a heater and/or cooler element 506 such that the temperature of the external source 425 (col. 12, lines 47-48), which reads on the instant claim limitation of an external heat source.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an external heat source of the device as taught by Sacco, because Sacco teaches controlling the temperature of the external source, the temperature of the entire processing system, including the interior chamber may be controlled, where the flexible wall of the bag/enclosure 604 makes contact within the chamber 421 (col. 12, lines 34-36).
Regarding claim 2, Jalenques discloses wherein the mechanism includes two or more feet arranged to tread sequentially the tissue sample bag receiving area (mechanism enabled by jaws 12 and 13, para. [0005], lines 1-5, Figs. 1 and 2).
Regarding claim 3, Jalenques discloses wherein said linear motion is motion toward and away from the bag receiving area in a direction generally perpendicular to the first plate surface (this is illustrated in Figs. 1 and 2, where jaws 12 and 13 shown in a linear motion toward and away from the bag 15, shown in Fig. 1).
Regarding claim 5, Jalenques discloses wherein the feet (feet of jaws 12 and 13, Fig. 1) have a collective treading area (shown at the ends of jaws 12 and 13, as teeth 15 of said jaws, shown in Fig. 1) equal (up to plus or minus 30%) to the area of the bag (bag 16, Fig. 1) intended to be trodden (shown in Fig. 1), when such a bag is laid flat (bag 16, is shown as flat in Fig. 1).
Regarding claim 6, Jalenques discloses wherein said feet (ends of jaws 12 and 13) when moving (movement, para. [0005], lines 2-3) moving toward the area (shown in Fig. 1), act to push a sample bag (bag 16, para. [0030], line 3, Fig. 1) directly to onto the adjacent first surface (jaws 12, 13 equipped with heating means, para. [0045]) of the heat transfer plate (plate of heating means).
Regarding claim 7, Jalenques discloses wherein said heat transfer plate has a heat conductance of 100 W/m K or more and preferably above 200 W/m K measured at 20 degrees Celsius (para. [0059], that is, Jalenques discloses in the case where it is desired to raise the temperature of the sample to a value greater than the ambient temperature, it is also possible to provide, inside the door, an electrical heating resistor REC associated with conventional regulation means (not shown). Advantageously, the hinge AR of the door may be disconnectable so as to be able to equip the mixer with a door 108 corresponding to its needs (heating/cooling/maintaining at ambient temperature, etc.).
Regarding claim 8, Jalenques discloses wherein the finally urged position of the feet above the first surface is adjustable (via jaws 12, 13), and the first surface is adjustable as shown in Fig. 1 of Jalenques.
Regarding claim 9, Jalenques discloses wherein the mechanism is within a housing (housing 1, Fig. 1) and the tissue sample bag receiving area (door 8, Fig. 1) is separable or moveable relative to said housing (Fig. 1 shows door 8 is moveable relative to housing 1 via a hinge which allows door 8 to move).
Regarding claim 10, Jalenques discloses wherein the mechanism (shafts 17,18; crank pin 19,20 of crankshaft 21 driven by motor M, para. [0032]) is sealed from said feet (when door 8 is closed, the mechanism, previously mentioned, allows for a sealed state, shown in Fig. 1).
Regarding claim 12, Jalenques discloses a method for disaggregating tissue samples into cells or clumps of cells (para. [0001], where Jalenques discloses preparation (process) of samples, the method comprising the following steps in any suitable order: a) providing a tissue sample sealed in a flexible sample bag (bag 16, para. [0005], line 2, Fig. 1); b) providing a device including a mechanical disaggregator (para. [0003], line 1; para. [0005], lines 1-3), including a sample bag receiving area (door 8, para. [0025], line 4, Fig. 1), and including a heat transfer plate having a first surface adjacent the area and an opposing surface exposed to external thermal influence (the surfaces of jaws 12, 13, para. [0045]; and para. [0045]) which faces away from the area, and including any one or more of the remaining features of the device of claim 1 (claim 1 above comprises any remaining features of the device of claim 1 and therefore, addressed by Jalenques);
c) subjecting said tissue sample to disaggregation in the device (para. [0001]-[0003]),
and d) transferring heat energy into or out of the bag via said plate (para. [0019], by means of disposing the device in a controlled temperature rate change device (para. [0045]; and para. [0059], lines 1-4).
Regarding claim 13, Jalenques discloses wherein step d) includes initially introducing heat energy (para. [0019]; and para. [0022]) into the bag contents (bag 16) via the plate (surfaces of jaws 12, 13) to aid enzymatic disaggregation or to thaw the contents of the bag (the heating of the contents of bag 16 via the heating means would thus allow for aid enzymatic disaggregation or to thaw the contents of the bag).
Regarding claim 15, Jalenques discloses wherein said disaggregation device exerts a cyclic pressure on the bag (the device shown in Fig. 1, and discussed above, applies a cyclic pressure , via jaws 12, 13, and shafts 17,18, and motor, M, Fig. 1, on bag 16, shown in Fig. 1).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over EP0968760A1-Jalenques (all citations are made to the English machine translation), in view of US 7,425,192 B2-Sacco, as applied to claim 2 above, and further in view of CN107694447A-Cao (all citations are made to the English machine translation).
Regarding claim 4, modified Jalenques teaches the invention discussed above in claim 2. Further, modified Jalenques teaches similar cams (shafts 17 and 18, para. [0032], Fig. 1). However, modified Jalenques does not explicitly teach two cams each having lobes arranged at a 180 degree rotational separation.
For claim 4, Cao teaches an invention relating to the field of a homogenizer, in particular to a bidirectional cam tapping homogenizer (pg. 1, line 3), and Cao teaches two cams 15 fixed to the first drive motor (pg. 2, line 10), and Cao teaches rings 21,13 (lobes) is provided with a cam 15 inside the ring, the cam 15 is fixed on the motor shaft 16 (pg. 3, paragraph 1, lines 30-31), which reads on the instant claim limitation of two cams each having lobes arranged at a 180 degree rotational separation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the modified the cams (shafts 17,18) of Jalenques to further include cams each having lobes arranged at a 180 degree rotational separation as taught Cao. Further, Cao teaches the cams with rings 13, 21 (lobes) allow for staggering and hitting the homogenized bag, thus, achieving the effect of beating homogenization (pg. 3, paragraph 2, lines 8-9).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the current rejection above pertains to new reference(s) relied upon to address the newly amended claim limitations; the arguments filed rely on the reference or combination of references not currently being used in the present Office Action.
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 LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799