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 .
Drawings
The drawings were received on 5/6/2022. These drawings are accepted.
Election/Restrictions
Claims 10 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Pressing assembly in claim 1; and
Frequency conversion module in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
Para. 0045 describes that the pressing assembly 20 includes a base 21, a moving mechanism 22, and a driving mechanism 23. The moving mechanism 22 is sleeved on a driving shaft 231 of the driving mechanism 23. The driving shaft 231 of the driving mechanism 23 rotates to drive the moving mechanism 22 to move along the driving shaft 231, and further to drive the two ultrasonic generators 30 to move towards the isolation chip 10 to make in contact with the outer surface of the first chamber 12 and the outer surface of the second chamber 13, respectively. The pressing assembly 20 in the present disclosure may realize a linkage of the two ultrasonic generators 30, which can reduce unnecessary positioning mechanisms and simplify a structure of the isolation device 100; and
Para. 0054 describes that the frequency conversion module 40 includes a frequency converter 41 and a valve 42 connected to the frequency converter 41.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1, 5, 6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 211784638) (provided by applicant in IDS dated in view of 1/17/2023; English translation provided) in view of Wu et al (CN 204690737).
With respect to claim 1 Chen discloses an isolation device for isolation of target particles from a liquid sample (see abstract), whereby the isolation device comprises:
an isolation chip (separation chip assembly 1, See Pg. 3 of translation) comprising:
a sample reservoir (sample pool 13, See Pg. 5);
at least one first chamber (first chamber 15) disposed on a side of the sample reservoir (See Fig, 1); and at least one second chamber (second chamber 17) (See Pg. 6),
wherein one of the at least one first chamber (15) closest to the sample reservoir is connected to the sample reservoir through a first filtration membrane (first filter film 14) (See Fig. 1 and Pgs. 5-6), one of the at least one second chamber (17) closest to the sample reservoir (13) is connected to the sample reservoir through another second filtration membrane (second filter film 16, See Fig. 1 and Pgs. 5-6), each of an average pore size of the first filtration membrane and an average pore size of each second filtration membrane is smaller than a size of the target particles (See Pgs. 5-6 for discussion of the pore size of the first and second filter films, wherein the size is selected for the type of liquid sample and the target particle to be captured);
an oscillation system (see component below) comprising:
two ultrasonic generators (vibrating members 20, See Pg. 6)
a differential pressure driving system (vacuum system 50, See Fig. 5 and Pgs. 6 and pgs. 7-8);
a frequency conversion module (frequency conversion module 40, See Fig. 6 and Pg. 8) connected to the outermost one of the at least one first chamber and the outermost one of the at least one second chamber through the differential pressure driving system, the frequency conversion module is configured to control the differential pressure driving system to generate differential pressure in the at least one first chamber and the at least one second chamber alternately (See Pg. 8 for discussion of how the frequency conversion module 40 is electrically connected with the vacuum system 50, the frequency conversion module 40 can control the power supply voltage supplied to the vacuum system 50, so that the first chamber 15 and the second chamber 17 alternately generate negative pressure); and
a controller (program module, See Pg. 7) configured to control the two ultrasonic generators to vibrate to generate two ultrasonic waves when the differential pressure driving system stops to generate differential pressure in the at least one first chamber of the at least one second chamber (See Pg. 8 for discussion of how the frequency conversion module 40 is electrically connected with the vacuum system 50, the frequency conversion module 40 can control the power supply voltage supplied to the vacuum system 50, so that the first chamber 15 and the second chamber 17 alternately generate negative pressure).
Chen fails to disclose a pressing assembly carrying the two ultrasonic generators (20), wherein the pressing assembly is configured to drive the two ultrasonic generators to move towards the isolation chip to make in contact with an outer surface of an outermost one of the at least one first chamber and an outer surface of an outermost one of the at least one second chamber.
Wu teaches an ultrasonic standing wave suspending clamping conveying mechanical arm (See abstract), wherein the ultrasound standing wave suspending clamping conveying manipulator using ultrasonic sound to clamp workpiece, ultrasonic standing wave suspending transducer comprising a bracket, on the bracket platform, which is located between the left and right side of the guide rail of the guide rail platform, a guide rail slide block guide way, on the guide rail slider, amplitude, driving a transducer horn along the guide rail direction of the driving component. the driving subassembly drives the transducer and amplitude along the amplitude axis direction close to or away from the rectilinear motion of clamping workpiece, performing the clamping and releasing action, and according to the weight of the work piece clamp to adjust the distance between a pair of horn, adjusting the proper distance of the horn through the numerical control system to control the drive motor to realize the synchronous movement of the two amplitude transformer so as to realize the automatic clamping and releasing work of the work piece (See Para. 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ultrasonic generators of Chen onto the taught clamping conveying mechanism taught by Wu such that one can effectively control the position of the standing wave generated by the ultrasonic generators (See abstract and Para. 0018 of Chen).
With respect to claim 5 the combination of Chen and Wu teaches that the two ultrasonic generators are located on a same horizontal plane (See Figs. 1-2 of Chen).
With respect to claim 6 the combination of Chen and Wu teaches each of the two ultrasonic generators comprises a horn (first cover body 110 and second cover body 120, See Pgs. 6-7) close to the isolation chip and a piezoelectric ceramic unit (See Pg. 6 for discussion of how the vibrating member can be a piezoelectric ceramic driver) connected to the horn.
With respect to claim 11, the combination of Chen and Wu does not specifically teach a plurality of first and second chambers and additional first and second filtration membranes. However, the courts have held In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) that even if a reference does not teach a plurality of a feature, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 211784638) (provided by applicant in IDS dated in view of 1/17/2023; English translation provided) and Wu et al (CN 204690737) (provided by applicant in IDS dated 1/17/2023; English translation provided) in view of Lim et al (KR 2012/0139399) (English translation provided).
Refer above for the combined teachings of Chen and Wu.
With respect to claim 2, although the combination does teach that a frequency of each of the two ultrasonic waves is 15KHz to 80 KHz (See Pg. 6 of Chen for discussion of how the vibration frequency of the vibrating members is 1kHz to 10MHz), there is no teaching that within a period of each of the two ultrasonic waves, a duty cycle of each of the two ultrasonic waves is 10% to 90%.
Lim teaches a transonic stimulated perfusion flow culture chamber system for culturing adult stem cells in vitro to be similar to in vivo is provided to use a three-dimensional culture without applied stress and to optimize cell proliferation and differentiation (See abstract), wherein when ultrasonic waves are stimulated at various intensities, the cells do not grow well in the center portion of the plate culture, and the cells grow better in the edge portion. In other words, the cells grow better from the center to the edge. In addition, the cells at the edges of the nucleus are distinct and each cell grows larger and thicker than the control group without ultrasonic stimulation. This is expected to cause the cells to move to the edge due to ultrasonic stimulation in the central portion of the plate culture, which is just above the ultrasonic transducer. Therefore, only ultrasonic stimulation of appropriate intensity may have a positive effect on cell proliferation, and it is not easy to find an ultrasound condition optimized for cell differentiation and proliferation. The ultrasonic stimulation used in the present invention is preferably low intensity and the ultrasonic stimulation of a suitable distance from the ultrasonic sensor is preferable for cell proliferation. Additionally, the ultrasonic stimulation used in the present invention is preferably used within a range having a specific duty cycle. Specifically, the ultrasonic waves used in the present invention may be adjusted to a duty cycle of 5% or more and less than 50%, and preferably to a duty cycle of 5% or more and 30% or less. At 50% or more of the duty cycle, they may adversely affect the proliferation of stem cells (See Pgs. 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the duty cycle taught by Lim into the ultrasonic stimulation taught by combined Chen and Wu, specifically to be between 5-30%, such that the proliferation and viability of target cells is not adversely affected (See Pgs. 6-7 of Lim).
With respect to claim 3 the combination of Chen, Wu, and Lim teaches that a ratio of change between two frequencies of the two ultrasonic waves is less than or equal to 30%, and a ratio of change between two duty cycles of the two ultrasonic waves is less than or equal to 30% (See Pgs. 6-7 of Lim).
Allowable Subject Matter
Claims 4 and 7-9 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: There closest cited prior art of reference fails to disclose or teach that the controller is configured to power on and power off the two ultrasonic generators, within a period of the power on and the power off, a ratio of the power on is 10% to 100$ (claim 4). Additionally, the closest cited prior art of reference fails to disclose or fairly teach that the horn of claim 6 comprises a first horn portion, a second horn portion, a third horn portion, and a connecting portion connected with each other in that order, the connecting portion is connected to the piezoelectric ceramic unit, an end surface of the first horn portion away from the second horn portion is configured to make in contact with the outer surface of the outermost one of the at least one first chamber or the outer surface of the outermost one of the at least one second chamber, wherein along a direction perpendicular to an extension direction of the horn, a size of the second horn portion is respectively smaller than a size of the first horn portion and a size of the third horn portion (claim 7). There is no discussion or teaching that the piezoelectric ceramic unit comprises a plurality of piezoelectric ceramic sheets, a plurality of electrode sheets stacked with the plurality of piezoelectric ceramic sheets, an insulating sleeve, and a connector, the plurality of piezoelectric ceramic sheets are disposed alternately with the plurality of electrode sheets, the plurality of piezoelectric ceramic sheets and the plurality of electrode sheets are sleeved on the insulating sleeve, the connector penetrates through the insulating sleeve to detachably connect to the horn (claim 8). Claim 9 is dependent upon claim 8, and thus, inherits the same status.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 January 24, 2026