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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Claim Interpretation
Regarding limitations recited in claims 12, 14, 17-19, 21, 23, 25-27, 30, and 32-39 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, 17-19, 21, 23, 25-27, 30, and 32-39 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, 17-19, 21, 23, 25-27, 30, 34-35, and 38-39 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 Howe et al. (USP 7,188,993 B1)
Regarding claim 12, 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), wherein the resonant acoustic energy is applied uniformly throughout all volume elements of the container to minimize velocity gradients within the solid tissue sample in the mixing container (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, in this instance, the operator of the prior art device is fully capable of using the prior art device to perform the recited functions), and
wherein the volume of the sample medium is at least half of a total volume of the mixing container (Fig. 4, see: processing vessel is filled greater than half way).
Southard does not explicitly disclose the mixing container is configured such that application of the resonant acoustic energy provides a standing displacement wave within the solid tissue sample.
Howe teaches an analogous method and device for mixing fluids and/or solids in a manner that can be varied from maintaining the integrity of fragile molecular and biological materials in the mixing vessel to homogenizing heavy aggregate material by supplying large amounts of energy, wherein the device employs linear displacement to introduce a standing linear acoustic wave into a medium (Fig. 1-4). 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 provide a standing displacement wave within the solid tissue sample, as taught by Howe, in order to provide the added advantage of producing variable force and frequency (Howe: C14/L22-36).
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 total volume of the mixing container ranges 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).
Claims 30 and 34 are directed towards materials worked upon by the instantly claimed apparatus. The Applicants are advised that a material or article worked upon does not limit apparatus claims. In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). See: MPEP 2115.
Regarding claim 35, Southard further discloses the resonant acoustic energy source is configured to apply resonant acoustic energy at 50 to 150 g of acceleration ([0054], see: 60 G to 100 G).
Regarding claim 21, 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), wherein the resonant acoustic energy is applied uniformly throughout all volume elements of the container to minimize velocity gradients within the solid tissue sample in the mixing container (A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, in this instance, the operator of the prior art device is fully capable of using the prior art device to perform the recited functions), 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.), and
wherein the volume of the sample medium is at least half of a total volume of the mixing container (Fig. 4, see: processing vessel is filled greater than half way).
Southard does not explicitly disclose the mixing container is configured such that application of the resonant acoustic energy provides a standing displacement wave within the solid tissue sample.
Howe teaches an analogous method and device for mixing fluids and/or solids in a manner that can be varied from maintaining the integrity of fragile molecular and biological materials in the mixing vessel to homogenizing heavy aggregate material by supplying large amounts of energy, wherein the device employs linear displacement to introduce a standing linear acoustic wave into a medium (Fig. 1-4). 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 provide a standing displacement wave within the solid tissue sample, as taught by Howe, in order to provide the added advantage of producing variable force and frequency (Howe: C14/L22-36).
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 total volume of the mixing container ranges 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).
Claim 38 is directed towards materials worked upon by the instantly claimed apparatus. The Applicants are advised that a material or article worked upon does not limit apparatus claims. In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). See: MPEP 2115.
Regarding claim 39, Southard further discloses the resonant acoustic energy source is configured to apply resonant acoustic energy at 50 to 150 g of acceleration ([0054], see: 60 G to 100 G).
Claim(s) 32-33 and 36-37 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 Howe et al. (USP 7,188,993 B1), as applied to claims 12 and 21 above, in further view of Warner et al. (US 20150177111 A1, cited in IDS filed 12/15/2020).
Regarding claims 32-33 and 36-37, modified Southard does not explicitly disclose the mixing container comprises an inverted conical tube.
Warner teaches an analogous device and method for processing biological samples (Fig. 5), comprising a cell disruptor (502) comprising an inverted conical tube shape (see: funnel shaped bottom of the device). 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 processing vessel in the device disclosed by Southard into the funnel shaped test tube configuration taught by Warner, as such a modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Response to Arguments
Applicant’s arguments with respect to claim(s) 12, 14, 17-19, 21, 23, 25-27, 30, and 32-39 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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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