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 .
Claim Interpretation
Regarding limitations recited in claims 12, 14, 17-21, 23, 25-28, and 30 which are directed to a manner of operating the disclosed mixer, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim. See Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969) that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.”
Regarding limitations recited in claims 12, 14, 17-21, 23, 25-28, and 30 which are directed to materials worked upon by the instantly recited resonant acoustic mixer, the Applicants are advised that a material or article worked upon does not limit apparatus claims. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). See: MPEP 2115.
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.
Claim(s) 12, 14, 17-21, 23, 25-28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Southard et al. (US 2017/0035937 A1, provisional application No. 62/218,289 filed 09/14/2015), in view of Pashovkin et al. (Cell Exfoliation, Separation, and Concentration in the Field of a Standing Ultrasonic Wave), Guia et al. (WO 2016/112349 A1, provisional application No. 62/101,938 fild 01/09/2015), and Warner et al. (US 20150177111 A1, cited in IDS filed 12/15/2020).
Regarding claims 12 and 20, Southard discloses a resonant acoustic mixer (Fig. 4) comprising:
a mixing container (Fig. 4, see: Processing vessel 420) configured to hold a volume of a sample medium comprising a solid tissue sample in a liquid medium (Fig. 4, see: Tissue 430 in Processing Solution 440); and
a resonant acoustic energy source configured to apply resonant acoustic energy at a frequency ranging from 10 Hz to 100 Hz to the mixing container sufficient to produce a cellular suspension from the sample medium (Fig. 4, see: Resonant Vibratory Mechanism 410; [0054], see: frequency may be between 15 Hertz and 60 Hz).
Southard does not explicitly disclose the mixing container is configured such that application of the resonant acoustic energy provides a standing acoustic wave within the solid tissue sample.
Pashovkin teaches the use of standing ultrasonic waves in cell exfoliation, separation, and concentration applications was well known to one having ordinary skill in the art, before the effective filing date of the claimed invention (ABSTRACT).
Guia teaches an analogous method and device for breaking cell aggregation comprising applying either a standing-wave acoustic field or a traveling-wave acoustic field [0147].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to configure the device disclosed by Southard to apply a standing acoustic wave within the solid tissue sample, as taught by Pashovkin and Guia, in order to provide for simpler device operation by eliminating the need for parallelism adjustment (Pashovkin: pg. 586/Ultrasound Velocity Measurement).
Modified Southard does not explicitly disclose the resonant acoustic mixer being operatively coupled to a flow cytometer/cell sorter configured to process the cellular suspension.
Warner teaches an analogous device and method for processing biological samples, wherein a biological sample comprising a disrupted cell suspension from a tissue sample ([0023]-[0041]) is further separated and homogenized using a cell sorter ([0064], see: cell sorter; Fig. 8, see: FACS system 806). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate a cell sorter into the device disclosed by modified Southard, as taught by Warner, in order to provide for improved cell homogenization, thereby improving the quality of the resulting tissue grafts.
Regarding claim 14, Southard further discloses the mixing container further comprises an enzymatic dissolution agent (Fig. 4, see: Processing solution 440; [0126], see: processing solution may include a tissue digestive enzyme).
Regarding claim 17, Southard further discloses the mixing container is a sealed container (Fig. 4, see: Processing vessel 420; [0171], see: seal).
Regarding claim 18, Southard further discloses the mixing container has a volume ranging from 10 to 500 ml ([0171], see: the processing vessel 420 may hold a volume of up to 500 ml).
Regarding claim 19, Southard further discloses the sample medium is present in the mixing container (Fig. 4, see: Tissue 430 in Processing Solution 440).
Regarding claim 30, Southard further discloses the solid tissue sample consists of gastrointestinal tract, lung, liver, spleen, thymus, endocrine, brain, meningeal, prostate, urogenital system, and/or breast tissue ([0134]-[0150], see: plurality of different tissue types, including nerve tissue which is found in the brain, vascular tissue which is found in every organ, adipose tissue which is found in breast tissue and around most internal organ, etc.).
Regarding claims 21 and 28, Southard discloses a resonant acoustic mixer (Fig. 4) comprising:
a mixing container (Fig. 4, see: Processing vessel 420) configured to hold a volume of a sample medium comprising a solid tissue sample in a liquid medium (Fig. 4, see: Tissue 430 in Processing Solution 440);
a resonant acoustic energy source configured to apply resonant acoustic energy at a frequency ranging from 10 Hz to 100 Hz to the mixing container sufficient to produce a cellular suspension from the sample medium (Fig. 4, see: Resonant Vibratory Mechanism 410; [0054], see: frequency may be between 15 Hertz and 60 Hz); and
the sample medium present in the mixing container (Fig. 4, see: Tissue 430 in Processing Solution 440), wherein the solid tissue sample comprises at least one of gastrointestinal tract, lung, liver, spleen, thymus, endocrine, brain, meningeal, prostate, urogenital system, or breast tissue ([0134]-[0150], see: plurality of different tissue types, including nerve tissue which is found in the brain, vascular tissue which is found in every organ, adipose tissue which is found in breast tissue and around most internal organ, etc.).
Southard does not explicitly disclose the mixing container is configured such that application of the resonant acoustic energy provides a standing acoustic wave within the solid tissue sample.
Pashovkin teaches the use of standing ultrasonic waves in cell exfoliation, separation, and concentration applications was well known to one having ordinary skill in the art, before the effective filing date of the claimed invention (ABSTRACT).
Guia teaches an analogous method and device for breaking cell aggregation comprising applying either a standing-wave acoustic field or a traveling-wave acoustic field [0147].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to configure the device disclosed by Southard to apply a standing acoustic wave within the solid tissue sample, as taught by Pashovkin and Guia, in order to provide for simpler device operation by eliminating the need for parallelism adjustment (Pashovkin: pg. 586/Ultrasound Velocity Measurement).
Modified Southard does not explicitly disclose the resonant acoustic mixer being operatively coupled to a flow cytometer/cell sorter configured to process the cellular suspension.
Warner teaches an analogous device and method for processing biological samples, wherein a biological sample comprising a disrupted cell suspension from a tissue sample ([0023]-[0041]) is further separated and homogenized using a cell sorter ([0064], see: cell sorter; Fig. 8, see: FACS system 806). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate a cell sorter into the device disclosed by modified Southard, as taught by Warner, in order to provide for improved cell homogenization, thereby improving the quality of the resulting tissue grafts.
Regarding claim 23, Southard further discloses the mixing container further comprises an enzymatic dissolution agent (Fig. 4, see: Processing solution 440; [0126], see: processing solution may include a tissue digestive enzyme).
Regarding claim 25, Southard further discloses the mixing container is a sealed container (Fig. 4, see: Processing vessel 420; [0171], see: seal).
Regarding claim 26, Southard further discloses the mixing container has a volume ranging from 10 to 500 ml ([0171], see: the processing vessel 420 may hold a volume of up to 500 ml).
Regarding claim 27, Southard further discloses the tissue sample is a biopsy sample ([0134]-[0150], see: plurality of different tissue types obtained from a donor subject).
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s Argument A (see: pg. 10-11 of the Arguments): The new rejections in view of Pashovkin and Guia address the new limitations presented in the claim amendments filed 01/27/2026.
Regarding Applicant’s Argument B (see: pg. 11-15 of the Arguments):
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate a cell sorter into the device disclosed by modified Southard, as taught by Warner, in order to provide for improved cell homogenization, thereby improving the quality of the resulting tissue grafts.
The Examiner respectfully disagrees with the Applicant’s argument that any flow cytometrically processed product would be unsuitable for introduction into a patient and thereby rendered Southard’s invention unsatisfactory for its intended purpose. Cytometric processing does not inherently require the conjugation of a substantial number of spectrally distinct fluorophores and the disclosed invention of Warner is not limited to fluorescence based cytometric processing. Additionally, as the Applicant’s acknowledge, Southard teaches the need for “substantial downstream processing” (see: pg. 14 of the Arguments) to isolate an SVF fraction. One having ordinary skill in the art would have recognized flow cytometry as a potential “downsteam processing” technique to isolate a particular cell type.
Regarding Applicant’s Arguments directed towards claims 21, 23, 25-28, and 30 (see: pg. 15-17 of the Arguments): The Examiner respectfully disagrees with the Applicant’s assertion that the recitation of the tissue sample types would further “define a structural relationship between the mixing container of the claimed resonant acoustic mixer and the solid tissue sample contained therein that constrains the container’s design based on the mechanical properties of the specific tissue being process”. The instantly claimed “mixing container” is recited as being limited to containers that can “hold a volume of a sample medium comprising a solid tissue sample in a liquid medium”. It is unclear what additional structural limitations (e.g. container material, minimum volume, etc.) are being invoked by the recitation of the material being worked upon. The Applicants are advised that a material or article worked upon does not limit apparatus claims, see: MPEP 2115.
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 ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J EOM/Primary Examiner, Art Unit 1797
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