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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to a device, classified in CPC B01L 3/502753.
II. Claims 10-20, drawn to a method, classified in CPC G01N 1/40.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed can be practiced by another and materially different apparatus or by hand (e.g. “introducing” can be performed by hand or another materially different apparatus, such as a pipette or pump).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Group I would require a search in at least CPC B01L 3/502753, along with a unique text search. Group II would not be searched as above and would instead require a search in at least CPC G01N 1/40, along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jessica Garcia on a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-20 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.
Drawings
The drawings are objected to because: In Fig. 3, the instances of “Michrochannel” should read “Microchannel”. 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 Rejections - 35 USC § 102
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.
Claims 1, 3-5, and 8-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Toner et al. (US 20090014360 A1).
Regarding claim 1, Toner teaches a fluidic device (abstract; Fig. 4C) for particle separation (abstract; paragraphs [0010]-[0011],[0121]-[0122]) comprising:
at least one inlet (see below annotated Fig. 4C; interpreted as the central inlet);
a curvilinear channel (see below annotated Fig. 4C, spiral shaped channel 50) having multiple sub-outlet divisions arranged along a fluidic path of the fluidic device (see below annotated Fig. 4C, the spiral shaped channel 50 includes first sub-outlets and second sub-outlets that are along a fluidic path of the channel 50), wherein the multiple sub-outlet divisions comprise:
at least two first sub-outlets (see below annotated Fig. 4C, interpreted as the at least two first sub-outlets at the end portion of the channel 50); and
at least four second sub-outlets (see below annotated Fig. 4C, interpreted as the six second sub-outlets), wherein at least two second sub-outlets extend from each of the at least two first sub-outlets (see below annotated Fig. 4C, three sub-outlets extends from each of the first sub-outlets).
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Annotated Fig. 4C of Toner.
Regarding claim 3, Toner further teaches the device of claim 1, wherein the curvilinear channel is a spiral channel (Fig. 4C).
Regarding claim 4, Toner further teaches the device of claim 3, wherein the spiral channel comprises at least 6 spirals prior to the at least two first sub-outlets (Fig. 4C).
Regarding claim 5, Toner further teaches the device of claim 1, wherein the curvilinear channel comprises at least four outlets, each one of the at least four outlets extending from a respective one of the at least four second sub-outlets (see above annotated Fig. 4C; each of the second sub-outlets comprise outlets extending from each second sub-outlet, i.e. six outlets).
Regarding claim 8, Toner further teaches the device of claim 5, wherein a third outlet (Fig. 4C, interpreted as one of the outlets) is configured to collect first zooplankton in a range less than or equal to 350 um (interpreted as a functional limitation, see MPEP 2114; [0010] teaches an outlet for separating particles from other particles; [0133] teaches particles that are ordered and focuses include particles in the range of 0.01-40 microns, i.e. less than 350 um; [0138] teaches the particles of a predetermined size is directed into one or more outlets; [0142] teaches forks to enable stream lines to be separated to different locations for collection of particles of multiple predetermined sizes; therefore, one of the outlets is capable of collecting first zooplankton in a range of less than 350 um since the system and outlet is capable of separating and collecting particles less than 350 um).
Note that “first zooplankton” is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“first zooplankton”) worked upon by a structure (third outlet) being claimed does not impart patentability to the claims (see MPEP 2115).
Regarding claim 9, Toner further teaches the device of claim 5, wherein a fourth outlet (Fig. 4C, interpreted as one of the outlets) is configured to collect third zooplankton in a range of less than or equal to 150 um (interpreted as a functional limitation, see MPEP 2114; [0010] teaches an outlet for separating particles from other particles; [0133] teaches particles that are ordered and focuses include particles in the range of 0.01-40 microns, i.e. less than 150um; [0138] teaches the particles of a predetermined size is directed into one or more outlets; [0142] teaches forks to enable stream lines to be separated to different locations for collection of particles of multiple predetermined sizes; therefore, one of the outlets is capable of collecting third zooplankton in a range of less than 150 um since the system and outlet is capable of separating and collecting particles less than 150 um).
Note that “third zooplankton” is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“third zooplankton”) worked upon by a structure (fourth outlet) being claimed does not impart patentability to the claims (see MPEP 2115).
Claim Rejections - 35 USC § 103
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Toner as applied to claim 1 above, and further in view of Papautsky et al. (US 20110096327 A1).
Regarding claim 2, Toner fails to teach: the device of claim 1, wherein the curvilinear channel comprises a cross section defined by a constant diameter and circumference along the channel.
Toner teaches channel cross-sections can include circular ([0147]).
Papautsky teaches a spiral microchannel particle separator including an inlet and outlets (abstract; Fig. 8), wherein the channel comprises a constant diameter and circumference along the channel (Fig. 8 shows the spiral microchannel 204 having at least portions with constant diameter and circumference from Fig. 8B to Fig. 8C). Papautsky teaches the hydraulic diameter of the spiral microchannel are such that the flow rate of the solution, lift force, and Dean drag force are approximately equal and act in opposite directions for particles of a first size, therefore focusing particles of a first size in a single stream to a first outlet ([0006]). Papautsky teaches principles of inertial migration include circular cross-sectional channel ([0103],[0104]). Papautsky teaches the spiral microchannel particle separator achieves complete separation between different particle sizes using Dean drag ([0057]). Papautsky teaches an embodiment of a spiral microchannel including a plurality of outlets (Fig. 8, 206a-206h) to separate at least three particle sizes ([0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the curvilinear channel of Toner to incorporate Toner’s teachings of circular channel cross-sections ([0147]) and Papautsky’s teachings of spiral microchannels with constant diameters and circumferences for particles of different sizes (abstract; Fig. 8; [0006],[0057],[0082],[ 0103]-[0104]) to provide: the device of claim 1, wherein the curvilinear channel comprises a cross section defined by a constant diameter and circumference along the channel. Doing so would have a reasonable expectation of successfully improving and optimizing control of fluid dynamics of the channel to achieve separation of different sized particles to desired sub-outlets. Additionally, doing so would have been an obvious change in size and shape (MPEP 2144.04(IV)(A)-(B)), wherein the diameter and circumference of the channel is a matter of choice which a person of ordinary skill in the art would have found obvious in view of Toner and Papautsky.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Toner as applied to claim 1 above, and further in view of Le Vot et al. (US 20090286300 A1).
Regarding claim 6, Toner fails to teach: the device of claim 5, wherein a first outlet is configured to collect first particles in a range of about 100 um to 300 um.
Toner teaches particle separation has been applied for numerous technological solutions in industry, medicine, and research; such as industrial applications and biomedical applications ([0002]). Toner teaches focusing particles into multiple localized streams, the channel having a hydraulic diameter and a ratio of a size of the particles focused to the hydraulic diameter, wherein embodiments of the system can increase concentration of particles in solution ([0012]). Toner teaches focusing particles can include cells, beads, viruses, organelles, nanoparticles, and molecular complexes ([0018]). Toner teaches any combination of channel geometries, channel cross-sections, and channel dimensions can be included on a single chip as needed to sort, separate, order, and focus particles of a predetermined size or particles of multiple predetermined sizes ([0142]). Toner teaches particles of a predetermined size flowing within such a channel geometry will be separated, ordered, and focused into four streamlines corresponding to four equilibrium points or potential minimums at a distance from each face of the four channel walls ([0143]). Toner teaches any number of outlets can be provided for receiving and collecting the sample and focused streams of particles within the sample ([0180]). Toner teaches focusing particles to a particular channel branch or outlet based on its size ([0181]).
Le Vot teaches a microfluidic system for separating and sorting cell clusters having sizes ranging from 20-500 um (abstract). Le Vot teaches sorting cell clusters, such as cells, bacteria, organelles, liposomes ([0002]). Le Vot teaches advantageously, the system includes a sorting unit comprising at least one sorting stage for size-sorting of said clusters, which is designed to generate in said sorting microchannels respectively at least two categories of sizes for said sorted clusters ([0039]); where the size-sorting stages makes it possible to obtain many size categories to sort the size of cell clusters ([0040]). Le Vot teaches coupling several successive size-sorting stages so as to optimize the final effectiveness of the sorting unit ([0041]). Le Vot teaches size-sorting into four categories and channels associated with size, such as size less than 100 um, size between 100 and 200 um, size between 200 and 300, and size greater than 300 um ([0152]). Le Vot teaches sorting cell clusters, including cells sorted according to a size of 500 um ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Toner to incorporate Toner’s teachings of sorting particles of different sizes into particular outlets ([0012],[0142],[0143],[0180],[0181]) and the channel having a diameter according to size of particles being focused ([0012]) and Le Vot’s teachings of separating and sorting particles of different sizes ranging from 20-500 um, such as size between 100 and 200 um and 200 and 300 um (abstract; [0039]-[0041], [0152]) to provide: wherein a first outlet is configured to collect first particles in a range of about 100 um to 300 um. Doing so would have a reasonable expectation of successfully improving optimization of effectiveness of separating particles of desired sizes into respective outlets as taught by Le Vot.
Note that “first particle” is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“first particle”) worked upon by a structure (first outlet) being claimed does not impart patentability to the claims (see MPEP 2115).
Regarding claim 7, Toner fails to teach: the device of claim 5, wherein a second outlet is configured to collect first zooplankton in a range of about 350 um to 500 um.
Toner teaches particle separation has been applied for numerous technological solutions in industry, medicine, and research; such as industrial applications and biomedical applications ([0002]). Toner teaches focusing particles into multiple localized streams, the channel having a hydraulic diameter and a ratio of a size of the particles focused to the hydraulic diameter, wherein embodiments of the system can increase concentration of particles in solution ([0012]). Toner teaches focusing particles can include cells, beads, viruses, organelles, nanoparticles, and molecular complexes ([0018]). Toner teaches any combination of channel geometries, channel cross-sections, and channel dimensions can be included on a single chip as needed to sort, separate, order, and focus particles of a predetermined size or particles of multiple predetermined sizes ([0142]). Toner teaches particles of a predetermined size flowing within such a channel geometry will be separated, ordered, and focused into four streamlines corresponding to four equilibrium points or potential minimums at a distance from each face of the four channel walls ([0143]). Toner teaches any number of outlets can be provided for receiving and collecting the sample and focused streams of particles within the sample ([0180]). Toner teaches focusing particles to a particular channel branch or outlet based on its size ([0181]).
Le Vot teaches a microfluidic system for separating and sorting cell clusters having sizes ranging from 20-500 um (abstract). Le Vot teaches sorting cell clusters, such as cells, bacteria, organelles, liposomes ([0002]). Le Vot teaches advantageously, the system includes a sorting unit comprising at least one sorting stage for size-sorting of said clusters, which is designed to generate in said sorting microchannels respectively at least two categories of sizes for said sorted clusters ([0039]); where the size-sorting stages makes it possible to obtain many size categories to sort the size of cell clusters ([0040]). Le Vot teaches coupling several successive size-sorting stages so as to optimize the final effectiveness of the sorting unit ([0041]). Le Vot teaches size-sorting into four categories and channels associated with size, such as size less than 100 um, size between 100 and 200 um, size between 200 and 300, and size greater than 300 um ([0152]). Le Vot teaches sorting cell clusters, including cells sorted according to a size of 500 um ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Toner to incorporate Toner’s teachings of sorting particles of different sizes into particular outlets ([0012],[0142],[0143],[0180],[0181]) and the channel having a diameter according to size of particles being focused ([0012]) and Le Vot’s teachings of separating and sorting particles of different sizes ranging from 20-500 um, such as size greater than 300 um, for example 500 um (abstract; [0039]-[0041], [0076], [0152]) to provide: wherein a second outlet is configured to collect first zooplankton in a range of about 350 um to 500 um. Doing so would have a reasonable expectation of successfully improving optimization of effectiveness of separating particles of desired sizes into respective outlets as taught by Le Vot.
Note that “first zooplankton” is not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“first zooplankton”) worked upon by a structure (second outlet) being claimed does not impart patentability to the claims (see MPEP 2115).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leland et al. (US 20150218548 A1; cited in the IDS filed 06/13/2024) teaches devices for separation of plankton (abstract). Leland teaches zooplankton can be separated into size classes ([0058]).
Girault et al. (GIRAULT, M. et al., "Microfluidic technology for plankton research", Current Opinion in Biotechnoloqv, Volume 55, October 13, 2018, pp. 134-150; cited in the IDS filed 06/13/2024) teaches a fluidic device for separation of plankton (abstract; Figs. 2-3). Girault teaches inertial focusing with a series of spiral channels with different diameters to progressively cut-off and sort particles (Fig. 2a; page 137, right column, first paragraph).
Jaeggi et al. (US 20080290048 A1) teaches a fluidic device for particle separation (abstract; Fig. 9) comprising at least one inlet (2); a spiral channel (3) having multiple sub-outlet divisions (Fig. 9 shows multiple divisions), the sub-outlet divisions comprising at least two sub-outlets (Fig. 9) and at least four second sub-outlets, wherein at least two second sub-outlets extend from each of the at least two first sub-outlets (Fig. 9).
Madmoni (US 20180280837 A1) teaches a fluidic device for particle separation (abstract; Figs. 1 and 6) including duct 100, i.e. a spiral channel (Fig. 1). Madmoni teaches a plurality of particles separation systems having ducts formed with portions as described about can be used in combination; the ducts can each enable the separation of an incoming fluid into three channels ([0061]).
Chun et al. (KR 20160064768 A) teaches a fluidic device for particle separation including spiral channels (Fig. 7c) including at least one inlet (110), at least two first sub-outlets (outlets at the split from channel 10 to channels 40,50), and at least four second sub-outlets that extend from each of the first two sub-outlets (outlets that split from channels 40,50 into channels towards outlets 431,432,531,532).
Kumar et al. (Kumar et al., “High throughput viscoelastic particle focusing and separation in spiral microchannels”, Scientific Reports volume 11, Article number: 8467 (2021)) teaches a fluidic device for particle separation including a spiral channel (title; abstract; Fig. 8) including at least one inlet and at least three outlets (Fig. 8).
Bhagat et al. (US 20190344273 A1) teaches a fluidic device for particle sorting based on inertial separation (abstract; [0001]; Fig. 2a-2b) including spiral channels (Figs. 2a-2b) and at least two inlets and at least four outlets (Figs. 2a-2b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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