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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/28/2026 has been entered.
Claim Objections
Claim 21 is objected to because of the following informalities:
Regarding claim 21, the claim must end with a period punctuation mark.
Appropriate correction is required.
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 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US 20220258161) (newly cited) in view of Ward (US 20090029870) (previously cited) and Schwartz (US 20160298187) (newly cited).
Regarding claim 17, Zhou discloses:
a system, comprising:
an acoustophoresis device comprising a first microfluidic channel (paragraph [0056]; Fig. 4, element 102 “main channel”) and a second microfluidic channel (paragraph [0056]; Fig. 4, element 102` second “main channel”), the first microfluidic channel having a first outlet (paragraph [0056]; Fig. 4, element 110 “center outlet port”) and a second outlet (paragraph [0057]; Fig. 4, element 112 “side outlet port”), the second microfluidic channel having a third outlet (paragraph [0059]; Fig. 4, element 110` “center outlet port”) and a fourth outlet (paragraph [0059]; Fig. 4, element 112` “side outlet port”), the acoustophoresis device configured to:
receive, via the first microfluidic channel (paragraph [0056]; Fig. 4, element 102 “main channel”), a first solution including a first target particle (paragraph [0006] “first group of biological entities”), a second target particle (paragraph [0006] “second group of biological entities”), a third target particle (paragraph [0006] “third group of biological entities”), a first selection particle (paragraph [0092] “EpCAM PE antibody”), and a second selection particle (paragraph [0092] “CD45 AF488 antibody”),
perform acoustophoresis in the first microfluidic channel (paragraph [0056] “acoustic separation”);
provide, via the first outlet (paragraph [0056]; Fig. 4, element 110 “center outlet port”) and to the second microfluidic channel (paragraph [0056]; Fig. 4, element 102` second “main channel”), a first output stream (paragraph [0057]; Fig. 4, “1st Output Fluid”) comprising the first target particle … and the third target particle … (paragraph [0056] “Alternatively, the first, second, and third types of particles or biological entities may differ in acoustic contrast, which depends on compressibility and density, thereby allowing them to be separated into two groups by the microfluidic device 100.”);
provide, via the second outlet (paragraph [0057]; Fig. 4, element 112 “side outlet port”), a second output stream (Fig. 4, “2nd Output Fluid”) comprising the second target particle … ;
receive, via the second microfluidic channel (paragraph [0056]; Fig. 4, element 102` second “main channel”), the first output stream (paragraph [0057]; Fig. 4, “1st Output Fluid”) and a second solution (paragraph [0058]; Fig. 4, element 104` “center inlet port” introduces a buffer fluid or a fluid not containing particles or biological entities) to modify a density (paragraph [0060]) and a viscosity (paragraph [0060], it would be expected that an inherent compressibility of a fluid would have been expected as well to be able to be modified) of the first output stream (paragraph [0057]; Fig. 4, “1st Output Fluid”) within the second microfluidic channel (paragraph [0056]; Fig. 4, element 102` second “main channel”); and
perform acoustophoresis in the second microfluidic channel (paragraphs [0056] and [0059]; Fig. 4, element 102` second “main channel”).
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Zhou, Fig. 4
If it is deemed that Zhou does not disclose feature 1, below, Ward discloses a similar limitation:
a second solution to modify compressibility.
Ward discloses: a second solution to modify compressibility (paragraphs [0067], [0100], and [0390]).
In the analogous art of particle analyzing systems and methods using acoustic radiation pressure, it would have been obvious to one skilled in the art before the effective filing date to modify Zhou’s second solution with Ward’s second solution with a modified compressibility in order to have a difference in compressibility and acoustic contrast from a liquid medium to a background water medium so that driving with modulated acoustic radiation pressure can be effective for manipulating particles (Ward, paragraph [0101]).
Zhou does not disclose features 2 or 3:
the first target particle is bound to the first selection particle and the second selection particle in the first solution such that a net acoustic contrast of a complex of the first target particle, the first selection particle, and the second selection particle differs from an acoustic contrast of the second target particle.
the first solution having been incubated such that: …
the second target particle is bound to the first selection particle and not the second selection particle; and
the third target particle is bound to the second selection particle and not the first selection particle.
Ward discloses the selection particles of feature 3:
the first solution having been incubated (paragraph [0189]) such that:
a first selection particle (paragraph [0279] “high acoustic contrast label … silica, gold …”); or
a second selection particle (paragraphs [0189] and [0279] “negative contrast silicone rubber”) in the first solution (paragraph [0027] “first fluid”).
In the analogous art of particle analyzing systems and methods for using acoustic radiation pressure, it would have been obvious to one skilled in the art before the effective filing date to modify the particles of modified Zhou with the selection particles of Ward in order to probe the targets of interest and separate these targets with acoustic contrast, such as to extract nucleic acids from a sample (Ward, paragraph [0279]).
Regarding the limitations “the second target particle is bound to the first selection particle and not the second selection particle” and “the third target particle is bound to the second selection particle and not the first selection particle”, it would have been obvious to one skilled in the art before the effective filing date to modify the particles of modified Zhou with the selection particles of Ward in order to probe more than one targets of interest and separate these more than one targets with acoustic contrast, such as to extract nucleic acids from a sample (Ward, paragraph [0279]). Regarding these selection particles, a unique selection particle based on acoustic contrast for target particles is known (Schwartz, paragraphs [0004], [0052], and [0055]-[0056]). It would have been obvious to one skilled in the art before the effective filing date to modify modified Zhou with the unique acoustic contrast particles of Schwartz in order to result in unique one-to-one ratio of target particles to selection particles.
Regarding feature 2, the feature is not found in the prior art. Feature 2 results in combinations of acoustic contrast selection particles that would result in a greater than one-to-one ratio of target particles able to be known to first and second selection particles which is not found in Schwartz. The limitation, feature 2 is replicated below:
the first target particle is bound to the first selection particle and the second selection particle in the first solution such that a net acoustic contrast of a complex of the first target particle, the first selection particle, and the second selection particle differs from an acoustic contrast of the second target particle
However, because the structure of the acoustophoresis device is known (instant claim 17, lines 1-5 are disclosed above), and the remainder the claim is “configured to” language, the claim stands rejected due to lack of positive recitation of the limitations. This rejection is because of the nature of intended use and/or manner of operation of the invention. Regarding all limitations after the phrase “configured to” in instant claim 17’s line 5, the material or article worked upon by the apparatus does not limit the apparatus claims. MPEP § 2115. This limitation is a manner of operating or intended use of a claimed apparatus and does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Zhou would be fully capable of operating in this manner given the structures of a first microfluidic channel, a second microfluidic channel, a first outlet, a second outlet, a third outlet, and fourth outlet which are given in Zhou.
Regarding claim 21, Zhou discloses wherein the acoustophoresis device is configured to: provide, via the third outlet (paragraph [0059]; Fig. 4, element 110` “center outlet port”), a third output stream (Fig. 4, “3rd Outlet Fluid”); and provide, via the fourth outlet (paragraph [0059]; Fig. 4, element 112` “side outlet port”), a fourth output stream (Fig. 4, “4th Output Fluid”).
Zhou does not disclose:
comprising the first target particle bound to the first selection particle and the second selection particle; and,
comprising the third target particle bound to the second selection particle and not the first selection particle.
Regarding feature 1, Zhou does not disclose this limitation. However, because the structure of the acoustophoresis device is known (instant parent claim 17, lines 1-5 are disclosed above), and the remainder claim 21 is “configured to” language, the claim stands rejected due to lack of positive recitation of the limitations. This rejection is because of the nature of intended use and/or manner of operation of the invention. Regarding all limitations after the phrase “configured to” in instant claim 21’s line 1, the material or article worked upon by the apparatus does not limit the apparatus claims. MPEP § 2115. This limitation is a manner of operating or intended use of a claimed apparatus and does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Zhou would be fully capable of operating in this manner given the structures of a first microfluidic channel, a second microfluidic channel, a first outlet, a second outlet, a third outlet, and fourth outlet which are given in Zhou.
Regarding feature 2, regarding the limitation “the third target particle is bound to the second selection particle and not the first selection particle”, it would have been obvious to one skilled in the art before the effective filing date to modify the particles of modified Zhou with the selection particles of Ward in order to probe more than one targets of interest and separate these more than one targets with acoustic contrast, such as to extract nucleic acids from a sample (Ward, paragraph [0279]). Regarding these selection particles, a unique selection particle based on acoustic contrast for target particles is known (Schwartz, paragraphs [0004], [0052], and [0055]-[0056]). It would have been obvious to one skilled in the art before the effective filing date to modify modified Zhou with the unique acoustic contrast particles of Schwartz in order to result in unique one-to-one ratio of target particles to selection particles.
Allowable Subject Matter
Claims 18-19 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding dependent claim 18, Zhou discloses a container (Figs. 7-11 for different kinds of containers available as fluid reservoirs; and, paragraph [0077]), a first target particle, a second target particle, and a third target particle (paragraph [0056] “Alternatively, the first, second, and third types of particles or biological entities may differ in acoustic contrast, which depends on compressibility and density, thereby allowing them to be separated into two groups by the microfluidic device 100.”).
Zhou does not disclose: further comprising a container comprising incubation media including the first selection particle, the second selection particle, the first target particle, the second target particle, and the third target particle, such that the first selection particle and the second selection particle bind to the first target particle in the incubation media, the first selection particle binds to the second target particle and not to the third target particle in the incubation media, and the second selection particle binds to the third target particle and not the second target particle in the incubation media.
Modified Zhou teaches a first selection particle or a second selection particle (see rejection to claim 17), as well as the limitations “the first selection particle binds to the second target particle and not to the third target particle in the incubation media, and the second selection particle binds to the third target particle and not the second target particle in the incubation media” (see rejection to claim 17).
This claim positively recites the contents of the container (i.e. “further comprising a container comprising … not the second target particle in the incubation media”) and the references, either alone or in combination, fail to teach or suggest the subject matter of “further comprising a container comprising … the first selection particle and the second selection particle bind to the first target particle in the incubation media”. This feature is allowable subject matter. No additional prior art was found that teaches this feature.
Regarding the feature of dependent claim 18, positively recited above, the prior art of record, alone or in combination, does not teach or fairly suggest the feature within the claim environment.
Regarding dependent claim 19, this claim is allowed for the same reason as the base claim upon which it depends.
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Ai (US 20180369816) (newly cited) – This invention is a microfluidic particle manipulation device.
Ai (US 20190160463) (newly cited) – This invention is a microfluidic particle manipulation device.
Bruus (US 20200238280) (newly cited) – This invention is a system of an acoustophoretic operation in a polymer chip.
Yanik (US 20200378925) (newly cited) – This invention is a microfluidic acoustic device, but does not introduce a third target particle.
Weitz (US 20180257076) (newly cited) – This invention is an acoustic wave sorting apparatus.
Bohm (US 20040161772) (newly cited) – This invention is a method and apparatus for sorting particles, see Fig. 10 for three different types of particles in a duplicated bifurcating outlet setup similar to the instant invention. However, acoustophoresis is not in the disclosure.
Oswald (US 20230311121) (newly cited) – This invention is a method and system for sorting different objects based on an acoustic wave, see Figs. 21a-c. However, acoustophoresis is not performed twice in sequence.
Warner (US 20150177111) (newly cited) – This invention is a method for processing a biological sample, see Fig. 6 and paragraph [0060] for different acoustic contrast fluids.
Yu (US 20220259555) (newly cited) – This invention is for the separation of immune cells by multiple microfluidic devices, which is similar to Zhou.
Response to Arguments
Applicant’s arguments filed 07/28/2026 with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any primary reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the claims, previous reference Cushing has been dropped in favor of a new primary reference Zhou which discloses the structure of an acoustophoresis device with the claimed microfluidic channels. Secondary references Ward and Schwartz disclose portions of the limitations of the claimed system, but due to “configured to” language, these limitations are considered intended use or a manner of operation of the system of the independent claim 17 and are not positively recited.
For similar reasons, claim 21 has been examined in a similar way.
Regarding the dependent claim 18, allowable subject matter has been found. The references, either alone or in combination, fail to teach or suggest the subject matter of “further comprising a container comprising … the first selection particle and the second selection particle bind to the first target particle in the incubation media” which is a positive recitation of the contents of the container. No additional prior art was found that teaches this feature.
Regarding dependent claim 19, this claim is allowable subject matter for the same reason as the base claim upon which it depends.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
