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/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Group I, Claims 21-26, drawn to “device”.
Group II, Claims 27-29, drawn to “substrate”.
Group III, Claims 30-34, drawn to “microsieve arrangement”.
Group IV, Claim 35, drawn to “kit-of-parts”.
Group V, Claim 36, drawn to “use of the device”.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack a special technical feature that defines a contribution which each of the claimed inventions, considered as a whole, makes over the prior art for the following reasons:
Groups I-V lack unity of invention because even though the inventions of these groups require the technical feature of the device of Claim 21 and/or the microsieve arrangement of Claim 30, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Stakenborg. As discussed below in the body of the action, Stakenborg anticipates the claimed device and microsieve arrangement under 35 USC 102(a)(1) and thereby cannot be considered a special technical feature.
During a telephone conversation with Applicant’s representative on 03/16/2026, a provisional election was made without traverse to prosecute the invention of Group I, Claims 21-26. Affirmation of this election must be made by applicant in replying to this Office action. Claims 27-36 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04.
Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 21-26 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.
Claim 21 recites the limitation "the assembly" in line 3. There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to recite “the microsieve assembly”.
Further regarding Claim 21, the phrase "such as" in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant should remove the “such as” phrasing from the claim.
Claim 21 further recites, “a substrate comprising an array of 3D electrodes extending from the substrate”. Therein, the substrate itself is provided as being the array of 3D electrodes protruding from themselves, which is not possible and thus the scope of the claim is unclear. Applicant may wish to amend the claim to recite “a substrate and an array of 3D electrodes extending from the substrate”.
Claim 21 recites the limitation "the microsieves" in line 7. There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to recite the miocrosieve array as comprising pores, as it appears applicant intends the microsieves to mean pores given that a microsieve is made of multiple pores, not multiple further microsieves. Or merely amending wherein the overall microsieve arrangement is embedded by the electrodes, omitting the “the microsieves” provision.
Claim 21 recites the limitation "the design" in line 9. There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to recite “a design”.
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.
Claims 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stakenborg et al. (US 2012/0064567 A1), hereinafter “Stakenborg”.
Regarding Claim 21, Stakenborg teaches a device for detecting and/or characterizing one or more cells by the electrical properties of the cells ([0084]), the device comprising at least one electrode integrated microsieve assembly 1 (Fig. 3A and [0078]), wherein the assembly 1 comprises:
(a) a microsieve arrangement, such as a microsieve array ([0087, 0097]), comprising one or more micropores 2 ([0078]: “State of the art techniques for fabrication of micro- and nanoholes may provide holes with almost nanometer precision.” – See also Fig. 27 and [0061].) for retaining the cells (See para. [0010], and further Figs. 6A-C showing the micropores retaining the cells 41/42. See also Fig. 4.); and
(b) a substrate 7 comprising an array of 3D electrodes 3 extending from the substrate 7 ([0024]: “Each region comprises a hole, at least one electrode embedded in or located on the substrate” – [0087]: “at least one electrode 3 electrically associated with the hole 2, which may be embedded in or located on the substrate 7, e.g. deposited on top of the substrate 7” – As Stakenborg discusses the electrode as being deposited on top of the substrate in preferred embodiments, said electrode is interpreted as a 3D electrode extending from the substrate. – See also Fig. 4.), wherein the microsieves of the microsieve arrangement are embedded by the electrodes of the array of 3D electrodes (See Fig. 4 and [0087]: “Each region 10 further comprises at least one electrode 3 electrically associated with the hole 2, which may be embedded in or located on the substrate 7, e.g. deposited on top of the substrate 7, such that, in use, the at least one electrode 3 is electrically accessible by a particle present in or on the hole 2.”),
characterized in that the design of the microsieve arrangement is provided such that the microsieve arrangement is pluggable with the array of 3D electrodes of the substrate (As para. [0087] discusses the electrode being deposited within the pore, the pores are interpreted as being “pluggable” with the array of 3D electrodes of the substrate as “pluggable” is broadly interpreted herein as merely being able to accept a guest into the pore.),
as in Claim 21.
Regarding Claim 22, the prior art meets the limitations of Claim 21 as discussed above. Further, Stakenborg provides the device of Claim 21 wherein the microsieve arrangement is a disposable microsieve arrangement comprising a dielectric material ([0118]) and wherein the substrate comprising an array of 3D electrodes is a re-usable substrate (Given their commensurate structure as in Claim 21, the microsieve arrangement of Stakenborg is fully capable of being disposed of while the dielectric electrode material is fully capable of re-use. The materials may be separated by physical removal of each electrode 3 (Fig. 4), or by other methods such as melting down and separating the materials. Further, re-use/disposal of either the microsieve arrangement or the substrate does not necessitate or preclude re-use/disposal of the respective pieces independent of what is done with another piece. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).), as in Claim 22.
Regarding Claim 23, the prior art meets the limitations of Claim 21 as discussed above. Further, Stakenborg provides the device of Claim 21 wherein the microsieve arrangement is connected to the substrate such that the array of 3D electrodes is configured to form an electric field in at least one micropore of the microsieve arrangement (Paras. [0085, 0098] discuss electric field generation by energizing the electrodes.), as in Claim 23.
Regarding Claim 24, the prior art meets the limitations of Claim 21 as discussed above. Further, Stakenborg provides the device of Claim 21 wherein the electrodes of the array of 3D electrodes are arranged in parallel to each other (Fig. 3A shows the electrodes 3 as arranged in parallel.), as in Claim 24.
Regarding Claim 25, the prior art meets the limitations of Claim 21 as discussed above. Further, Stakenborg provides the device of Claim 21 wherein the microsieve arrangement is detachably connected to the substrate (Given the commensurate arrangement of pluggable pores and embedded electrodes therein in Stakenborg commensurate with that of the instant claims, the microsieve arrangement of Stakenborg is commensurately detachably connected to the substrate. Given an applied force, the electrodes 3 are fully capable of being removed from the substrate 7, as seen through Fig. 4.), as in Claim 25. If Applicant desires to provide a particular structure(s)/mechanism that affords such “detachable” aspect then Applicant is invited to claim the added structure(s)/mechanism therefor.
Regarding Claim 26, the prior art meets the limitations of Claim 21 as discussed above. Further, Stakenborg provides the device of Claim 21 wherein the microsieve arrangement comprises a plurality of slots arranged such that each electrode of the array of 3D electrodes can be received into a respective slot ([0006]: “at least one electrode electrically associated with the hole and embedded in or located on the substrate” – As the electrodes 3 are taught as embedded in the substrate, there must necessarily exist a corresponding slot for receiving the electrode so as to achieve such embedding, and such as further seen through Fig. 4.), as in Claim 26.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798