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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/29/2024 has been received and considered.
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:
“a cell pop up device” in Claim 1, Line 15 - (The specification teaches the structure of the cell pop up device as a motorized rotator (Page 12, 3rd Paragraph - element 610) or ultrasound vibrator (Page 10, 3rd paragraph);
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Although the specification teaches conductive poles 208 and 302, which allow an EP voltage to be provided in the EP chamber assembly (Page 6 and 7), claim 1 fails to claim the conductive elements to perform electroporation in the device. Thus, it is unclear whether electrodes are intended to be claimed with the device. Furthermore, it is unclear how the electroporation operation would be performed without the presence of electrodes. Claims 2-19 are included in this rejection since they fail to cure the deficiencies of claim 1.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not specifically teach an ultrasonic vibrator with an electroporation chamber assembly (comprising: a nano channel plate, cap, and cell cavity plate). Espinosa et al. (US 20220126292 A1) is the prior art that is closest to the present application. Espinosa et al. teaches an EP chamber assembly comprising a nano channel plate comprising multiple channel holes (layer of microwells 106 – FIG. 3), a cap disposed above and attached to the channel plate (layer of microfluidic channels 104) comprising multiple inlets and outlets (device 102 is structurally capable – See FIG. 7), and a cell cavity plate with multiple cavities to hold multiple cells and disposed below the MEMS cap (membrane 108 – configured to allow culturing of cells 112 adhered to the membrane [para. 0030]). Espinosa et al. specifically does not teach a cell pop up device, wherein the cell pop up device is configured to popup the cells from the cavities after the cell EP operations.
The following claim 1 drafted by the examiner and considered to distinguish patentably over the art of record in this application, is presented to applicant for consideration (please see bold additions):
A microfluidic electroporation (EP) device, comprising:
an EP chamber assembly, comprising:
a MEMS nano channel plate, comprising multiple nano channel holes, an exogenous material passing through the nano channel holes for a cell EP operation;
a MEMS cap, disposed above and attached to the MEMS channel plate, comprising multiple inlets and multiple outlets, a first electrode, and an exogenous material chamber defined between the MEMS cap and the MEMS nano channel plate;
a cell cavity plate, disposed below and attached to the MEMS cap by an adhesive sealing, comprising multiple cavities to hold multiple cells, the cavities vertically aligned with the nano channel holes, a second electrode, and a cell EP chamber defined between the cell cavity plate and the MEMS nano channel plate; and
a cell cavity plate holder, connected with the MEMS cap and the cell cavity plate;
an adaptor, connected with the EP chamber assembly;
a cell pop up device, connected with the adaptor; a syringe pump assembly, connected with the inlets of the MEMS cap through multiple first tubes to input a cell solution, a washing solution, or an exogenous material solution, and connected with the outlets of the MEMS cap through multiple second tubes to output the cell solution, the washing solution, transfected cell solution or the exogenous material solution;
an EP controller, connected to the EP chamber assembly, and configured to generate multiple EP voltage pulses with an ON/OFF period, a pulse number, and a voltage level control; and a system controller, electrically connected to the syringe pump assembly, the EP controller, and the cell pop up device, and configured to control a sequence of multiple cell EP operations,
wherein, the cell pop up device is configured to pop up the cells from the cavities after the cell EP operations, and the cells are outputted and collected from one of the outlets of the MEMS cap.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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