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 .
Election/Restrictions
Applicant’s election without traverse of Group I (vs. Group III) in the reply filed on 05/13/2026 is acknowledged.
Applicant's election with traverse of Group I, and species A1, B2, C2, D2, E2, F2, G2, H2, I2, J2 in the reply filed on 05/13/2026 is acknowledged. The traversal is on the ground(s) that: Groups: The difference in language of the first element of claim 1 refers to applying a sample liquid to a carrier substrate, just like claim 7. The second element of claim 1 refers to using an electrode to generate an electric field configure to trap the cell, just like claim 7. The differences in the language between claims 1 and 7 do not require different searches or significantly different analysis relative to the prior art. Species. consideration of all of the alleged species will not alter the search or examination burden.
This is not found persuasive because: Groups: the first element of claim 1 refers to outputting an application signal, whereas the first element of claim 7 refers to applying a sample liquid comprising the at least one nucleated cell to a carrier substrate of the microfluidic device; and the second element of claim 1 refers to providing a current signal to an interface with the at least one electrode, whereas the second element of claim 7 refers to generating an electric field at or in a microcavity of the carrier substrate having the at least one electrode. The differences in the language between claims 1 and 7 would require different searches and/or analysis relative to the prior art (for example, searching different classes/subclasses or electronic resources, or employing different search queries; the prior art applicable to one invention may not be applicable). Species: the "or" option would not require additional search and examination when one element is found in the search.
The requirement is still deemed proper and is therefore made FINAL.
The Applicant is thanked for noting an inadvertent error regarding claim 16. Claim 16 should have been included with Group III.
Claims 1-6 are being examined.
Drawings
The drawings are objected to because the drawings are unclear and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: an electric field configured to trap the at least one nucleated cell as a target cell in the microcavity 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.
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.
Claims 1-6 are 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.
Claims 1-6 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. It would appear the claim attempts to define the result to be achieved without specifying method steps. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 1 is unclear reciting “providing a current signal [...] in order to generate [...] an electric field configured to trap the at least one nucleated cell as a target cell in the microcavity” because it is unclear how generating an electric field would trap a cell. In addition, it is unclear how a nucleated cell differs from a target cell. Dependent claims relating to these elements are similarly unclear.
Claim 3 is unclear reciting “wherein during the step of providing, the current signal is output to interface [...]” because it is unclear what method step is being claimed.
Claim 2 recites the limitation "the electrode" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the electrode" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the electrode" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the cell" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation ‘configured to’ has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; the term “step” is modified by a word, which is ambiguous regarding whether it conveys an act or a function; the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function; and/or the claim limitation uses the word “step” coupled with functional language, but it is modified by some act that is ambiguous regarding whether that act is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kurz et al. (US 2018/0298318 A1).
Regarding claim 1, Kurz et al. teach:
1. A method for trapping at least one nucleated cell (¶ 0043) using at least one electrode (see ¶ 0061+ for example; see also e.g., electrodes 204, 210) for a microfluidic device (e.g., 100), comprising:
outputting an application signal to a sample liquid (i.e., sample material comprising biological micro-objects (e.g., cells) ¶ 0057) comprising the at least one nucleated cell (¶ 0043) to a carrier substrate of the microfluidic device (see Fig. 1A & ¶ 0058+); and
providing a current signal to an interface with the at least one electrode (e.g., sequestration pens 124, 126, 128, 130; see also micro-object traps 132) of the carrier substrate, an electric field capable of trapping the at least one nucleated cell as a target cell in the microcavity (see i.e., the power source 212 can provide a frequency range and an average or peak power (e.g., voltage or current) range sufficient to generate net DEP forces (or electrowetting forces) strong enough to trap and move individual micro-objects (not shown) in the region/chamber 202, ¶ 0109; see also ¶ 0075, 0186+).
With regard to limitations in claims 1-6 (e.g., [...] that causes a sample liquid comprising the at least one nucleated cell to be applied to a carrier substrate of the microfluidic device; and [...] in order to generate, at or in a microcavity of the carrier substrate, [...] to trap the at least one nucleated cell as a target cell in the microcavity, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Further, reciting “configured to” without identifying any structural differences between the structure in the claims and the structure disclosed by the prior art does not further limit the claims.
Regarding claims 2-4, 6, Kurz et al. teach:
2. The method according to claim 1, further comprising: varying an amperage, so as to strengthen or weaken the field after the step of outputting or before or after the step of providing (i.e., Regardless of the configuration of the microfluidic device 200, a power source 212 can be used to provide a potential (e.g., an AC voltage potential) that powers the electrical circuits of the microfluidic device 200. The power source 212 can be the same as, or a component of, the power source 192 referenced in FIG. 1. Power source 212 can be configured to provide an AC voltage and/or current to the top electrode 210 and the bottom electrode 204. [...] the power source 212 can provide a frequency range and an average or peak power (e.g., voltage or current) range sufficient to generate net DEP forces (or electrowetting forces) strong enough to trap and move individual micro-objects (not shown) in the region/chamber 202, as discussed above, and/or to change the wetting properties of the inner surface 208 of the support structure 104 (i.e., the dielectric layer and/or the hydrophobic coating on the dielectric layer) in the region/chamber 202, as also discussed above. Such frequency ranges and average or peak power ranges are known in the art. See, e.g., U.S. Pat. No. 6,958,132 (Chiou et al.), U.S. Pat. No. RE44,711 (Wu et al.) (originally issued as U.S. Pat. No. 7,612,355), and US Patent Application Publication Nos. US2014/0124370 (Short et al.), US2015/0306598 (Khandros et al.), and US2015/0306599 (Khandros et al.) ¶ 0109; The nest 300 can include a socket 302 capable of interfacing with the microfluidic device 320 (e.g., an optically-actuated electrokinetic device 100) and providing electrical connections from power source 192 to microfluidic device 320. The nest 300 can further include an integrated electrical signal generation subsystem 304. The electrical signal generation subsystem 304 can be configured to supply a biasing voltage to socket 302 such that the biasing voltage is applied across a pair of electrodes in the microfluidic device 320 when it is being held by socket 302. Thus, the electrical signal generation subsystem 304 can be part of power source 192. The ability to apply a biasing voltage to microfluidic device 320 does not mean that a biasing voltage will be applied at all times when the microfluidic device 320 is held by the socket 302. Rather, in most cases, the biasing voltage will be applied intermittently, e.g., only as needed to facilitate the generation of electrokinetic forces, such as dielectrophoresis or electro-wetting, in the microfluidic device 320. ¶ 0186; Typically, the electrical signal generation subsystem 304 will include a waveform generator (not shown). The electrical signal generation subsystem 304 can further include an oscilloscope (not shown) and/or a waveform amplification circuit (not shown) configured to amplify a waveform received from the waveform generator. The oscilloscope, if present, can be configured to measure the waveform supplied to the microfluidic device 320 held by the socket 302. In certain embodiments, the oscilloscope measures the waveform at a location proximal to the microfluidic device 320 (and distal to the waveform generator), thus ensuring greater accuracy in measuring the waveform actually applied to the device. Data obtained from the oscilloscope measurement can be, for example, provided as feedback to the waveform generator, and the waveform generator can be configured to adjust its output based on such feedback. ¶ 0188; In order to more effectively move micro-objects from one location (e.g. a specific location where the micro-objects may have been cultured within a microfluidic device) to another location (e.g. another area of the same microfluidic device or a separate device such as a multiwell plate), varying force vectors may be applied to achieve cell translocation. ¶ 0201; see also the incorporated reference Short et al. each power source 226, 926, 946 can be configured to provide a different level of voltage and/or current. ¶ 0072).
3. The method according to claim 1, wherein during the step of providing, the current signal is output to interface with the at least one electrode and with at least one other electrode arranged in an adjacent microcavity (see electrodes 204, 210, 214, and sequestration pens 124, 126, 128, 130/micro-object traps 132 in Figs. 1B-1C; see also electrodes 212, 224, 232, and opening 234 in Figs. 2B and 2C of the incorporated reference (¶ 0098) U.S. Patent Publication No. 2014/0124370 (Short et al.), wherein the field generated at the electric electrode differs with respect to a direction or intensity from the electric field generated at the other electrode or wherein the other electric field is generated at the other electrode, which is arranged in a microcavity that is arranged in a common column or a common row with respect to the microcavity having the electrode (Regardless of the configuration of the microfluidic device 200, a power source 212 can be used to provide a potential (e.g., an AC voltage potential) that powers the electrical circuits of the microfluidic device 200. The power source 212 can be the same as, or a component of, the power source 192 referenced in FIG. 1. Power source 212 can be configured to provide an AC voltage and/or current to the top electrode 210 and the bottom electrode 204. [...] the power source 212 can provide a frequency range and an average or peak power (e.g., voltage or current) range sufficient to generate net DEP forces (or electrowetting forces) strong enough to trap and move individual micro-objects (not shown) in the region/chamber 202, as discussed above, and/or to change the wetting properties of the inner surface 208 of the support structure 104 (i.e., the dielectric layer and/or the hydrophobic coating on the dielectric layer) in the region/chamber 202, as also discussed above. Such frequency ranges and average or peak power ranges are known in the art. See, e.g., U.S. Pat. No. 6,958,132 (Chiou et al.), U.S. Pat. No. RE44,711 (Wu et al.) (originally issued as U.S. Pat. No. 7,612,355), and US Patent Application Publication Nos. US2014/0124370 (Short et al.), US2015/0306598 (Khandros et al.), and US2015/0306599 (Khandros et al.) ¶ 0109; The nest 300 can include a socket 302 capable of interfacing with the microfluidic device 320 (e.g., an optically-actuated electrokinetic device 100) and providing electrical connections from power source 192 to microfluidic device 320. The nest 300 can further include an integrated electrical signal generation subsystem 304. The electrical signal generation subsystem 304 can be configured to supply a biasing voltage to socket 302 such that the biasing voltage is applied across a pair of electrodes in the microfluidic device 320 when it is being held by socket 302. Thus, the electrical signal generation subsystem 304 can be part of power source 192. The ability to apply a biasing voltage to microfluidic device 320 does not mean that a biasing voltage will be applied at all times when the microfluidic device 320 is held by the socket 302. Rather, in most cases, the biasing voltage will be applied intermittently, e.g., only as needed to facilitate the generation of electrokinetic forces, such as dielectrophoresis or electro-wetting, in the microfluidic device 320. ¶ 0186; Typically, the electrical signal generation subsystem 304 will include a waveform generator (not shown). The electrical signal generation subsystem 304 can further include an oscilloscope (not shown) and/or a waveform amplification circuit (not shown) configured to amplify a waveform received from the waveform generator. The oscilloscope, if present, can be configured to measure the waveform supplied to the microfluidic device 320 held by the socket 302. In certain embodiments, the oscilloscope measures the waveform at a location proximal to the microfluidic device 320 (and distal to the waveform generator), thus ensuring greater accuracy in measuring the waveform actually applied to the device. Data obtained from the oscilloscope measurement can be, for example, provided as feedback to the waveform generator, and the waveform generator can be configured to adjust its output based on such feedback. ¶ 0188; In order to more effectively move micro-objects from one location (e.g. a specific location where the micro-objects may have been cultured within a microfluidic device) to another location (e.g. another area of the same microfluidic device or a separate device such as a multiwell plate), varying force vectors may be applied to achieve cell translocation. ¶ 0201; see also the incorporated reference Short et al. each power source 226, 926, 946 can be configured to provide a different level of voltage and/or current. ¶ 0072).
4. The method according to claim 1, further comprising: washing the sample liquid using a wash buffer after the step of providing, or wherein, during or after the step of providing, a release signal is provided to the electrode (see ¶ 0085 for example).
5. The method according to claim 1,wherein, during the step of outputting, the application signal is output, or wherein a step of identifying the nucleated cells from the sample liquid is provided after the step of providing, wherein, during the step of identifying, the nucleated cells from a cell sediment are optically detected or quantified (see ¶ 0194-0196 for example).
6. The method according to claim 1, wherein, during the step of providing, the nucleated cell or at least one further nucleated cell is trapped in a trapping plane of the microcavity or wherein, a cell or at least one further nucleated cell is released from the sample liquid from the electric field into a transport plane (see Fig. 2C, ¶ 0114; Figs. 5A-5E, ¶ 0267-0268 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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