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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/25/2026 has been entered.
Preliminary Remarks
The amendment filed on 06/25/2026 has been entered. Claim 1 has been amended and claim 16 was previously canceled. No new claims have been entered, and claims 17-21 are were not elected and therefore, withdrawn from consideration.
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).
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 comprising a mechanical disaggregation mechanism (para. [0003], line 1; para. [0005], lines 1-3) and a tissue sample bag receiving area (inside door 8, para. [0025], line 4, Fig. 1),
Jalenques discloses 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), the plate having a first plate surface (a first surface of door 8, that is, the inner surface of door 8, Fig. 1) and an opposing second plate surface (the second or outer surface of door 8, Fig. 1), where the first plate surface (inner surface of door 8, Fig. 1) is adjacent to the tissue sample bag receiving area (inside door 8, Fig. 1).
Jalenques discloses 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, a different embodiment of Jalenques teaches section of the door is equipped with a heating resistor and a heating means is integrated on door 108, which also can be external to the door 108, and Jalenques teaches the door could be disconnectable, (para. [0059], lines 3-5). Therefore, if the rear articulation of the door can be disconnected (shown in Fig. 9; also shown in Fig. 2, door 8), that allows for the heating means to be external, which reads on the instant claim limitation of an external heat source.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Jalenques and further include an external heat source as taught by a different embodiment of Jalenques, because the other embodiment of Jalenques teaches articulation system of the door on the housing, it is possible to propose interchangeable doors having different properties or functions, heating/cooling, maintaining at ambient temperature, lighting, etc. (para. [0023]).
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 further in view of CN107694447A-Cao (all citations are made to the English machine translation).
Regarding claim 4, Jalenques teaches the invention discussed above in claim 2. Further, Jalenques teaches similar cams (shafts 17 and 18, para. [0032], Fig. 1). However, 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 cams (shafts 17,18) of Jalenques and 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 filed 06/25/2026 have been fully considered but they are not persuasive. Applicant’s remarks begin on page 7, where applicant responds to the Advisory Action mailed on 06/05/2026. Regarding applicant’s arguments on the bottom of page 6 and the top of page 7, the Advisory Action was addressing applicant’s argument that the proposed modification or combination of the prior art would change the principle of the operation of the prior art being modified. In particular applicant is suggesting the modification would render the device inoperable. Moreover, it is unclear how the proposed combination would render Jalenques inoperable, based on applicant’s arguments. Nevertheless, a different embodiment of Jalenques teaches a door 108 having a disconnected feature which would allow for the heat source to be external, as discussed in this section. Regarding applicant’s argument of an external heat source, Jalenques teaches section of the door is equipped with a heating resistor and a heating means is integrated on door 108, which also can be external to the door 108, and Jalenques teaches the door could be disconnectable, the door so as to be able to equip the mixer with a door 108 corresponding to its heating/cooling needs (para. [0059], lines 3-5). Therefore, if the rear articulation of the door can be disconnected (shown in Fig. 9; also shown in Fig. 2, door 8), that allows for the heating means to be external. Additionally, the secondary reference, Sacco, was not relied upon for the current rejection, and therefore, applicant’s arguments regarding Sacco, will not be discussed in this section.
On the bottom of page 7 and the top of page 9, applicant asserts “the Examiner fails to establish that Jalenques is suitable for use with an external heat source simply because the door thereof is capable of removal. Opening or removing the door from the mixing system of Jalenques so that the heat exchanger within the door may be arranged with an external heat source would render the mixing system unsuitable for its intended purpose. MPEP 2143.01(V) ("If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification"); see also In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed.
Cir. 1984). Jalenques is directed to a mixing system, and it is critical for the functioning of said system that the tissue sample bag be enclosed within the housing. That is, the sample bag must be contained within the housing for mixing to occur. Removing door (either partially or fully) to connect the heating or cooling means present within said door to an external heat source would prevent the sample bag from being contained within the housing, making the mixing system unsuitable for or incapable of mixing the contents of the sample bag.” In response, Jalenques teaches section of the door is equipped with a heating resistor and a heating means is integrated on door 108, which also can be external to the door 108, and Jalenques teaches the door could be disconnectable, the door so as to be able to equip the mixer with a door 108 corresponding to its heating/cooling needs (para. [0059], lines 3-5). Therefore, if the rear articulation of the door can be disconnected (shown in Fig. 9; also shown in Fig. 2, door 8), that allows for the heating means to be external. Regarding the middle and bottom of page 8 of applicant’s remarks, applicant’s remarks are drawn to the secondary reference, Sacco, which has not been relied upon for the current rejection, and therefore, will not be discussed in this section. Claims 1-10, 12-13, and 15 stand rejected.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
Prosecution Insights