feNotice 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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IT102020000001213, filed on 01/22/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
The Applicant’s arguments, filed 02/20/2026, with respect to Claim(s) 1-13 under the nonstatutory (obviousness-type) double patenting rejection over the U.S. Patent No. 12,208,388 and/or the Publication No. US20220032296A1 and the provisional statutory double patenting rejection under 35 U.S.C. §101 over copending U.S. Application No. 17/793,713 of 11/19/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the “filler medium itself emits light and whose emission intensity is modulated by marker concentration” (See in pg. 3 of Remarks) of US17/793,713, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that US12208388B2 and US20220032296A1 “relies on spatial confinement of particles to produce a signal, whereas the present claims rely on emission from freely movable particles. The operating principles are different”, and that “the optical signal is produced by marker emission rather than chamber-dependent confinement” (See in pg. 4 of Remarks), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Thus, upon further consideration, a new ground(s) of rejection is made in view of De Angelis et al. (US20220032296A1) herein referred to as De Angelis '296 and De Angelis et al. (US20230051647A1) herein referred to as De Angelis '647.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-13 of U.S. Patent No. 12,208,388 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the microfluidic device of ‘388 discloses similar structural limitations (i.e. “portions” and “compartments”) in comparison to the instant application.
Claim(s) 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-13 of copending Application No. 17/793713 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the microfluidic device of the ‘713 reference application discloses similar structural limitations (i.e. “layers” and “compartments”) in comparison to the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 line 10 has the typo "characterised". Appropriate correction is required.
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) 1-7 and 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Angelis et al. (US20220032296A1) referred to as De Angelis ‘296.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, De Angelis ‘296 teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3) in comprising:
- a lower layer that is electrically conductive and transparent with respect to an incident optical beam (See how the lower layer 2 is electrically conductive and are partly or totally transparent to an incident optical beam generated by an optical source 10 in [0030] in Fig. 1),
- an upper layer (See the upper layer 3 in [0036] in Fig. 1), comprising
- first portions that are electrically conductive and configured to receive an electrical signal (See how the first upper portions 3 are electrically conductive and are configured to receive an electrical signal in [0034] in Fig. 1), and
- second portions that are electrically insulating, the first and second portions being adjacent and alternated between them, characterized in that it comprises (See how the second upper portions 3′ are electrically insulating, and how the microfluidic device 1 comprises second upper portions 3′ disposed between contiguous first upper portions 3 in [0040] in Fig. 1):
- a compartment interposed between the lower layer and the upper layer throughout the extension of the lower layer and of the upper layer and seamlessly extending between the lower layer and the upper layer (See how compartment 6 is interposed between upper layer 3 and lower layer 2 in [0045] in Fig.1), the compartment containing a filler medium that is transparent with respect to the incident optical beam and markers dispersed in the filler medium (See how the device 1 comprises one or more compartments 6 containing a filler means 7 and markers M homogeneously dispersed in the filler means 7 in [0045] in Fig. 1), wherein
- the markers are electrically charged and are adapted to move inside the compartment in all directions in variable amounts according to the intensity of the electrical signal applied to one or more of the first portions (See how the markers M are electrically charged and are configured to move between an upper chamber 9 and one or more lower chambers 8 in variable amounts according to the intensity of the electric signal applied to the first upper portions 3 and to emit an optical emission beam at an emission wavelength when illuminated in the lower chamber 8 by the incident optical beam produced by a light source 10 in [0051] in Fig. 3) and
to emit an optical emission beam when they are lit by an incident optical beam (See how in the presence of a liquid {such as a filler medium}, the markers M can move in all directions in variable amounts, according to the intensity and the sign of the electric potential applied to the first upper portions 3 and the amount and the sign of the electric charge, the molecular weight and the concentration of the markers M in [0060]-[0063] in Fig. 1-3 in Claim 1).
Regarding Claim 2, De Angelis ‘296 teaches the microfluidic device limitations of claim 1.
De Angelis ‘296 further teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3), wherein the first portions are at least partially reflective with respect to the incident optical beam (See how the shielding portions 4 are made of a metal material, e.g. gold. In other words, the shielding portions 4 are opaque to the incident optical beam and are arranged between the first 3 and second 3′ upper portions and the lower portions 2 in [0041] in Fig. 1).
Regarding Claim(s) 3-4, De Angelis ‘296 teaches the microfluidic device limitations of claim 1.
De Angelis ‘296 further teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3), wherein the second portions are transparent with respect to the optical emission beam (See how the second upper portions 3′ are transparent and the first upper portions 3 include electrodes that carry the electrical signal of the cells C on the top face 3b to the bottom face 3a of the first upper portions 3 in [0040] in Fig. 1 and in Claim 3); and
wherein the second portions are at least partially reflective with respect to the incident optical beam (See how the lower portions 2 are electrically conductive and are partly or totally transparent to an incident optical beam generated by an optical source 10 in [0029]-[000033] in Fig. 1-3).
Regarding Claim 5, De Angelis ‘296 teaches the microfluidic device limitations of claim 1.
De Angelis ‘296 further teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3), wherein
- the first portions comprise a plurality of upper electrodes, each upper electrode being configured to receive a respective electrical signal (See how the first upper portions 3 are electrically conductive and are configured to receive an electrical signal in [0034] in Fig. 1 and in Claim 11),
- the lower layer consists of a single lower electrode (See how the lower layer 2 identifies as a lower electrode in [0031] in Fig. 1).
Regarding Claim(s) 6-7, De Angelis ‘296 teaches the microfluidic device limitations of claim 5.
De Angelis ‘296 further teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3), wherein upper electrodes have a conformation selected from plate, polygonal, spheroidal or a combination thereof (Note what is discussed in MPEP § 2144 IV. A. concerning changes in the size or portions of a claimed invention. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The current claims regarding the configuration selected for the upper electrodes, does not change the function of the claimed invention in comparison to the prior art. Thus, De Angelis ‘19 still reads on claim 6); and
wherein the upper electrodes and the lower electrode are electrically connected between them in an electric circuit or are floating (See how the upper layer 3 has a bottom surface 3a and a top surface 3b, opposite to the bottom surface 3a, and how the first upper portions 3 comprise a plurality of upper electrodes, where each upper electrode is configured to receive a respective electric signal in [0036]-[0039] in Fig. 1-3; Also, see how lower layer 2 and upper a layer 3 appear to float in Fig. 1). Regarding
Regarding Claim(s) 11-12, De Angelis ‘296 teaches the microfluidic device limitations of claim 1.
De Angelis ‘296 further teaches a microfluidic device (See the Abstract, Claim 1, and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3), wherein each first portion is configured to house at least a cell and to receive an electrical signal of the action potential generated by the excited cell (See Claim 12); and
wherein the first portions have such dimensions as to house one single cell each (See how the electrically conductive first upper portions 3 are configured to accommodate at least one cell C and to receive an electrical signal of the action potential generated by the cell C in [0038] in Fig. 1-5).
Regarding Claim 13, De Angelis ‘296 teaches an apparatus (See the Abstract, Claim 13, and the apparatus 100, in [0050] in Fig. 1-3) in comprising:
- a microfluidic device according to claim 1 (See Claim 1 and the microfluidic device 1, in [0028]-[0036] in Fig. 1-3),
- an optical source configured to emit an incident optical beam towards the lower layer at least at the first portions of the microfluidic device (See the optical source 10 on lower layer 2 in [0030]-[0033], [0055] in Fig. 1)
- a detection optical device configured to receive an optical emission beam - generated by the markers (See the optical detection device 11, preferably a CCD or CMOS device, or an array of detectors and is filtered on the emission wavelength of the markers M {contained in filler medium 7} to thereby generate an optical signal representative of the electric signal applied to the first upper portions 3 in [0052]).
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) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over De Angelis et al. (US20220032296A1) referred to as De Angelis ’296, as applied to claim 1 above, and further in view of De Angelis et al. (US20230051647A1) herein referred to as De Angelis '647.
Claim(s) 8-10, De Angelis '296 teaches the microfluidic device limitations of claim 5.
De Angelis '296 fails to explicitly teach a microfluidic device, wherein the first portions are spaced between them at a distance between 1 and 100 pm; wherein the markers are nanoparticles of predefined dimensions selected from fluorophores of predefined spectral output and/or shape and/or molecular weight and/or electrical charge and/or hydrodynamic radius; and wherein the filler medium is a substance in liquid or gel form; and wherein the filler medium is a substance in solid form.
However, in the analogous art of microfluidic devices and methods, De Angelis ‘647 teaches a microfluidic device (See the Abstract and the microfluidic device 1 in Fig. 1-3), wherein the first portions are spaced between them at a distance between 1 and 100 pm; wherein the markers are nanoparticles of predefined dimensions selected from fluorophores of predefined spectral output and/or shape and/or molecular weight and/or electrical charge and/or hydrodynamic radius; and wherein the filler medium is a substance in liquid or gel form; and wherein the filler medium is a substance in solid form (See Final Amended Claim(s) 8-10 in US17/793713 aka De Angelis ’647).
Thus, it would be obvious to one with ordinary skills in the arts to modify the device of De Angelis '296 by incorporating first portions that are spaced between them at a distance between 1 and 100 pm, wherein the markers are nanoparticles of predefined dimensions selected from fluorophores of predefined spectral output and/or shape and/or molecular weight and/or electrical charge and/or hydrodynamic radius; and wherein the filler medium is a substance in liquid or gel form; and wherein the filler medium is a substance in solid form (As taught by De Angelis '647) for the benefit of particle monitoring in a microfluidic device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797