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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 10, 2026 has been entered.
Claims 1-5, 7, 8, 11, 15-21, 26-28, 30 and 34 remain pending. Applicant amended claims 1, 2, 5, 7, 15 and 20.
Response to Arguments
While the amendment necessitated the new grounds of rejection set forth below, thus rendering moot most of Applicant’s arguments, some of the issues raised by Applicant remain pertinent. They are hereby addressed.
Applicant argues that the “claims explicitly recite that flow control is ‘based on’ the classification output”. Remarks 8. The argument is not persuasive. Claim 1 does not establish a relationship between flow control and classification, let alone recite the words “based on” as argued by Applicant. Consequently, Applicant’s argument that claim 1 is patentable over prior art that does not teach classification-based flow control (Remarks 8) is not persuasive.
Applicant also argues that Manalis is cited only as evidence that Weinstock’s sample may contain debris. Remarks 9. Applicant’s characterization of Manalis is not correct. Based on the disclosure of Manalis, the purpose of the low pass filter and the high pass filter taught by Weinstock is to disregard SMR signals corresponding to non-cellular material (e.g. debris) in the sample. In other words, the disclosure of Manalis provides evidence that the classifier taught by Weinstock has the ability to distinguish cellular material (cancer cells) from non-cellular material (e.g. debris), and the classifier actually does classify particles as cellular material based on whether a signal falls within the range delimited by the filters.
Claim Objections
Claim 1 is objected to because of the following informalities:
The limitation “channels” at the end of claim 1 should be changed to “channel”.
Appropriate correction is 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 1-5, 7, 8, 11, 20 and 28 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.
Claim 1 recites “the sample”. There is no antecedent basis for the limitation in the claim.
Despite the amendment, claim 20 remains indefinite because it still contradicts claim 15. Claim 15 recites a step of “introducing a mixture…to a measurement device”, meaning the mixture must be formed prior to the introduction. Yet, claim 20 recites that the cellular and non-cellular particles are “separately” introduced into the device. Due to the contradictory nature of claim 20, it will not be examined on the merits.
Claim 28 recites “the bead with a known mass”. There is no antecedent basis for the limitation in the claim.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 5, 7, 8 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weinstock (US 2020/0225239 A1). Alternatively, the claims are rejected under 35 U.S.C. 103 as being unpatentable over Weinstock in view of in view of Manalis et al. (“Manalis”) (WO 2018/236708 A1).
With respect to claim 1, Weinstock discloses a method for optimized cellular measurement, the method comprising the steps of:
introducing a sample comprising cellular material 329 into a measurement device comprising a sample channel 309, a secondary channel 305 comprising at least one suspended microchannel resonator 333, and a sensor 363 operating over a sensing region (see Fig. 3);
classifying particles (measuring mass changes, see [0006]) in the sample in real-time (see [0055]) using a classifier (computer, see [0090]-[0092]) that utilizes data from the sensor; and
controlling flow of the particles from the sample channel into the secondary channel (see [0057]).
While Weinstock does not explicitly disclose that the classifier classifies particles as cellular material or non-cellular material, Weinstock discloses that the SMR uses a low-pass filter and a high pass filter to screen signals (see [0065]). Based on the disclosure of Manalis (see lines 14-30, p. 49), this is done to filter signals produced by non-cellular particles (e.g. debris) detected by the SMR. Based on the disclosure of Manalis, it is apparent that the classifier, using the filters, classifies particles detected by the SMR as cellular material (cells) or non-cellular material (e.g. debris).
Alternatively, based on the disclosure of Manalis, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the classifier, via use of signal filters, to classify particles as cellular material (cells) or non-cellular material (debris). The modification would improve the accuracy of the measurements.
With respect to claim 3, the sensor is a photodetector (see [0058]), which is an imaging sensor.
With respect to claim 5, as discussed above (see rejection of claim 1), based on the use of filters, it appears that the sample comprises cellular material (cells) and non-cellular material (debris). Naturally, the method further comprises loading particles and cellular and non-cellular material at a specified ratio into the secondary channel 305, the specified ratio being the natural ratio of cellular material to non-cellular material in the sample.
With respect to claim 7, the method further comprises obtaining a measurement from the SMR for each particle in the secondary channel 305 (see [0061]), and pairing the measurement of each particle as cellular material or non-cellular material depending on whether the measurement signal passes through the filters.
With respect to claim 8, the cellular material comprises cells (see [0058]).
With respect to claim 11, the subject matter of claim 11 is directed to an alternative method in which cellular AND non-cellular particles are introduced. Absent claim 11 first limiting the scope of the claimed method to the alternative in which both the cellular and non-cellular material are introduced into the device, the subject matter of claim 11 is deemed to be directed to an alternative, and thus optional, subject matter. Nevertheless, the sample is an eluate comprising isolated cells suspended in a fluid (see [0057] and Fig. 3). That said, cellular (cells) and non-cellular (fluid, debris) material are introduced simultaneously in the same sample.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstock in view of Kimmerling et al. (“Kimmerling”) (US 2020/0227168 A1).
With respect to claim 2, while Weinstock discloses that the classifier can use measurement data to determine a stage or progression of cancer (see [0096]), Weinstock does not disclose that the classifier uses a neural network architecture to make this determination. Nevertheless, it would have been obvious to one of ordinary skill in the art to use a neural network to make the determination. The use of a neural network for such purpose is well-known in the art (see abstract of Kimmerling), and the modification would enable the classifier to improve the accuracy of its determination in real-time as it gathers more data (i.e. the neural network learns).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Weinstock in view of Deliwala (US 9,274,202 B2).
With respect to claim 4, the imaging sensor does not appear to comprise a lens (see Fig. 3). However, the disclosure does not explicitly disclose that the sensor is lens-free.
Deliwala discloses an optics system that is lens-free. According to Deliwala, the size and manufacturing costs can be reduced by forgoing the use of a lens (see lines 25-30, col. 7). In light of the disclosure of Deliwala, it would have been obvious to one of ordinary skill in the art to use a lens-free imaging sensor in the device taught by Weinstock.
Allowable Subject Matter
Claims 15-19, 21, 26, 27, 30 and 34 are allowed. In addition, claim 28 would be allowable if it is rewritten or amended to overcome the 35 U.S.C. 112(b) rejection forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As discussed above, Weinstock as evidenced by/in view of Manalis discloses a method of classifying particles in a sample mixture as cellular material (cells) or non-cellular material (debris). However, Weinstock does not disclose or suggest distinguishing cellular particles from non-cellular particles when the size and/or mass distribution of the particles overlap, as recited in claim 15. Based on the disclosure of Weinstock and other prior art directed to SMR-based sensors (e.g. Babcock US 2009/0044608 A1), SMR signals provide information regarding the size and mass of particles, and hence SMR-based sensors would not be able to distinguish cellular particles from non-cellular particles if the size and/or mass distribution of the cellular particles and the non-cellular particles overlap. As discussed above (see rejection of claim 1), the classifier taught by Weinstock has the ability to distinguish cellular particles (cells) from non-cellular particles (e.g. debris), but only if the SMR signals corresponding to the non-cellular particles fall outside a range delimited by lower and upper thresholds.
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