NON-FINAL 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 October 2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant's arguments filed 15 October 2025 have been fully considered but they are not persuasive.
Regarding claim 1, in response to Applicant’s argument that “Katariya specifically teaches away from the use of enclosed centrifugation units, and as such it is established that references that teach away cannot serve to create a prima facie case of obviousness”, the examiner respectfully disagrees. It has been held that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). In this case, Katariya teaches that a centrifuge can be avoided by using the propellers, but it does not criticize, discredit, or otherwise discourage the use of a separate centrifuge on the drone.
Regarding claim 3, in response to Applicant’s argument that “[i]n contrast to at least claim 3, Nakajima does not describe any centrifuge-linked temperature control, and instead generally describes consistent generic temperature control of some cargo”, the examiner respectfully disagrees. The claim does not require any centrifuge-linked temperature control, only that the sample temperature be maintained within the SPU while centrifugation occurs during flight. Nakajima is deemed fully capable of maintaining a target sample temperature during aerial transport, because that is what it is designed to do (page 5 last paragraph – page 6 first paragraph of machine translation). Applicant remarks that “[a]s will be appreciated by one of skill in the art, centrifugation can generate vibration and heat which can require specific configuration to ensure a sample is properly thermally controlled which is enabled by the claimed SPU-internal cooling while centrifugation is occurring” (page 9, remarks). However, no specific configuration is claimed and thus this feature is an attorney imported limitation not found in the claim.
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.
Claims 1, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ghiraldi et al. (U.S. Patent Application Pub. No. 2018/0364157, hereafter Ghiraldi) in view of Katariya et al. (Mayur Katariya, Dwayne Chung Kim Chung, Tristan Minifie, Harshit Gupta, Alifa Afiah Ahmad Zahidi, Oi Wah Liew, Tuck Wah Ng; Note: Biochemical samples centrifuged in-flight on drones. Rev. Sci. Instrum. 1 October 2018; 89 (10): 106102. https://doi.org/10.1063/1.5031039, hereinafter Katariya), and further in view of Letourneur et al. (U.S. Patent No. 10,052,641).
Regarding claim 1, Ghiraldi discloses a method for transporting and processing biological materials (Abstract, para. [0058]-[0062], drone collects biological sample, transports sample, performs processing in flight), comprising the steps of: providing a sample processing unit (SPU)-equipped drone for transporting and processing biological materials, the SPU-equipped drone comprising: a drone (10; Fig. 1) having a drone body and propellers (para. [0091], see annotated Fig. 1); and a sample processing unit (SPU) (first remote detection device 3, second detection device, sampling device 5, and/or processing unit 6; Fig. 1) connected to the drone body; collecting the biological sample (para. [0058]); placing the biological sample into the SPU-equipped drone (para. [0058]); and activating the SPU of the SPU-equipped drone at a sending destination (para. [0058]-[0062]); and processing the biological sample at the same time of aerial transport (para. [0058], [0061], [0062]), but does not disclose a centrifuge for processing a biological sample, the centrifuge including a mechanism to counter a force produced by a centrifuge action, the mechanism configured to operate independently of the propellers; processing the biological sample by at least the centrifuge.
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Katariya discloses analogous art related to drones for sample processing in-flight, wherein the SPU comprises a centrifuge (Fig. 1) for processing a biological sample (milk and blood samples; page 106102-1 right column lines 35-36); processing the biological sample by at least the centrifuge at the same time of aerial transport (pages 106102-1 to 106102-3). Although Katariya uses the drone’s propellers as the centrifuge rotor, it nevertheless teaches the benefits and feasibility of performing centrifugation of biological samples during aerial transport. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Ghiraldi with the sample processing via centrifugation during aerial transport as taught by Katariya for the purpose of conducting en-route centrifugation of samples, improving quality and timeliness in the pre-analytical phase (Abstract, Katariya).
Letourneur discloses analogous art related to a centrifuge equipped with a balancing mechanism, the centrifuge including a mechanism to counter a force produced by a centrifugation action, the mechanism configured to operate independently of the propellers (a mechanism for balancing the parts integral with said vertical shaft, comprising: a plate integral with the vertical shaft, at least one compensating mass freely displacing on said plate, said mass being designed to limit the imbalance of parts integral with the vertical shaft, and a mechanism for blocking said compensating mass, said blocking mechanism being designed to immobilize said compensating mass on said plate when the rotation speed exceeds a determined value, col. 2 lines 40-60; Letourneur’s mechanism operate independently of any propellers). It would have been obvious for one having ordinary skill in the art to adopt a known centrifuge that includes internal balancing/force-countering mechanism taught by Letourneur and mount that centrifuge in the SPU-equipped drone of the combination of Ghiraldi and Katariya for the purpose of obtain the lowest possible level of vibrations throughout the cycle, including during acceleration and braking. The substitution of the sample processing module (sample processing module in the combination of Ghiraldi and Katariya) with the known sample processing module (Letourneur’s centrifuge) represents the simple substitution of one known element for another to obtain predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007); see also MPEP § 2143.
Regarding claim 4, the combination of Ghiraldi, Katariya, and Letourneur discloses wherein the biological sample comprises blood, tissue, plasma, serum, organ, urine, saliva, or other body fluid (milk and blood samples; page 106102-1 right column lines 35-36, Katariya).
Regarding claim 5, the combination of Ghiraldi, Katariya, and Letourneur discloses wherein the processing comprises generating a counter force to a force generated by the centrifuge (compensating mass is designed to limit the imbalance of parts integral with the vertical shaft, col. 2 line 40 – col. 3 line 57, Letourneur; the imbalance is a force generated by the centrifuge, and the centrifugal force produced by the compensating mass is the counter force).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ghiraldi, Katariya and Letourneur, as applied to claim 1, and further in view of Farris et al. (U.S. Patent Application Pub. No. 2016/0033966, hereinafter Farris).
Regarding claim 2, the combination of Ghiraldi, Katariya and Letourneur discloses the steps of: setting a receiving destination and deploying the SPU-equipped drone for aerial transport of the biological sample (para. [0058], Ghiraldi); executing a flight path of the SPU-equipped drone while at the same time processing the biological sample (para. [0059], Ghiraldi; Abstract, Katariya); receiving the SPU-equipped drone carrying the pre-processed biological sample at the receiving destination (para. [0061], Ghiraldi); removing the pre-processed biological sample from the SPU-equipped drone (para. [0061], the operator would need to remove the sample to perform “further analysis”, Ghiraldi); and returning the SPU-equipped drone to sending destination or to another destination (drone can be sent on another “mission”, para. [0058], Ghiraldi), but does not disclose notifying the receiving destination of the incoming biological sample arriving by the SPU-equipped drone and notifying a sender of the received pre-processed biological sample.
Farris discloses analogous art related to drone operation, comprising the steps of notifying the receiving destination of the incoming biological sample (corresponding to parcel of Farris) arriving by the drone and notifying a sender of the received pre-processed biological sample (para. [0118]; “communicating with of at least one of a recipient of the parcel and a sender of the parcel to at least one notify when delivery occurs and confirm that delivery is intended at the landing pad with the homing device”, see also para. [0120]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Ghiraldi, Katariya and Letourneur with the steps of Farris for the purpose of determining whether a designated path to be taken by the drone to land at the landing location is acceptable for the drone to land with a homing device (para. [0118], Farris).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ghiraldi, Katariya and Letourneur, as applied to claim 1, and further in view of WO 2019/059394 (Nakajima, hereinafter Nakajima).
Regarding claim 3, the combination of Ghiraldi, Katariya and Letourneur does not disclose comprising maintaining the temperature of the biological sample during the time of aerial transport.
Nakajima discloses analogous art related to unmanned mobile body for package collection and delivery method, comprising maintaining the temperature of the biological sample within the SPU while the centrifuge is operating during the time of aerial transport (Fig. 3A, a heater 301 and a cooling member 302). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the modified method of the combination of Ghiraldi, Katariya and Letourneur with the temperature control taught by Nakajima for the purpose of maintaining a temperature of -10 degree C to 40 degree C for storing the sample (page 5 last paragraph – page 6 first paragraph of machine translation of Nakajima).
Allowable Subject Matter
Claims 6 and 7 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, because the prior art of record fails to teach or suggest the specific centrifuge counter force mechanisms recited therein. In particular, the prior art does not teach or suggest a centrifuge having two motors coupled to two concentric sleeved shafts rotating in opposite directions, or a motor-driven gear arrangement adapted to rotate two independent shafts in opposite directions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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/Shuyi S. Liu/Examiner, Art Unit 1774