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 .
Status of Claims
Claims 1-11 are currently pending
Claims 12-18 and 20-21 are currently withdrawn from consideration
Claims 19 and 22-66 are currently canceled
Claims 4, 5, 8 and 11 are currently amended
Claims 1-11 are currently rejected
Information Disclosure Statement
The Information Disclosure Statements filed on 05/02/2023, 07/25/2023, 01/16/2024, 07/16/2024, 12/04/2024 and 08/22/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered. An initialed copy of the Form 1449 is enclosed herewith.
Election/Restrictions
Applicant's election with traverse of Group I claims 1-11 in the reply filed on 09/24/2025 is acknowledged. The traversal is on the ground(s) that the restricted inventions are not independent inventions and that examination of both claimed invention together would not present a serious burden on the U.S. Patent and Trademark Office. This is not found persuasive because the issue as to the meaning and intent regarding “independent and distinct” as used in 35 U.S.C 121 and 37 CFR 1.41 has been adequately addressed in MPEP §802.01. Therein, it is stated that the legislative intent was to maintain the substantive law on the subject of restriction practice prior to enactment of 35 USC 121. Such practice permitted restriction between distinct, albeit dependent inventions. If the intent had been otherwise, then only the term “independent” would have been used. Thus, restriction between the distinct inventions set forth in this application is proper even though these inventions are clearly related.
With regard to applicants allegation that joinder of these distinct inventions would not present a serious burden to the U. S. Patent and Trademark Office, such allegations relied on the unsupported assumption that the search and the examination of both the invention would be coextensive. However, the issues raised in the examination of apparatus claims are divergent from those raised in the examination of process claims. Further, while there may be some overlap in the searches of the two inventions, there is no reason to believe that the searches would be identical. Therefore, based on the additional work involved in searching and examining both distinct inventions together, restriction of the distinct inventions is clearly proper.
The requirement is still deemed proper and is therefore made FINAL.
Specification
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract should be on a separate page. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: Lines 3-4 and 8 each state “each microfluidic channel” and instead should each state “each curved microfluidic channel” for further clarity and to maintain consistency. FURTHERMORE, line 25 states “to focus any particles” and instead should state “to focus the any particles” for further clarity. Appropriate corrections are required.
Claim 4 is objected to because of the following informalities: Line 2 states “the inlet and second flow branch,” and instead should state “the inlet and the second flow branch,” for further clarity. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Line 3 states “in the flow” and instead should state “in a flow” to prevent any possible antecedent issues. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Lines 3-4 state “an amount of second fluid in droplet form per unit volume of first fluid based on the droplet rate and droplet size;” and instead should state “an amount of the second fluid in droplet form per unit volume of the first fluid based on the droplet rate and the droplet size;” for further clarity. Appropriate corrections are required.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “an inlet configured to receive” on line 5 of claim 1, “microfluidic channel is configured to direct” on lines 8-9 of claim 1, “a particle sensor positioned along the one or more hydrodynamic separators configured to provide” on lines 12-13 of claim 1, “the controller configured to: control…” on lines 17-18 of claim 1, “a light source configured to direct” on line 2 of claim 2, “the light detector configured to provide” on lines 8-9 of claim 2, “wherein the controller is further configured to determine” on lines 1-2 of claim 6, “wherein the controller is configured to determine” on lines 1-2 of claim 8, “wherein the controller is configured to determine” on lines 1-2 of claim 9, and “wherein the controller is further configured to determine” on lines 1-2 of claim 10.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 9-10 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 9 recites the limitation "a width of a pulse” on line 4. It is unclear and confusing whether Applicant is referring to the same ‘a pulse’ as recited on line 3 of claim 9, or a different pulse? Claim 10 is also rejected since this claim depends on claim 9.
Claim 10 recites the limitation "of a pulse” on lines 5 and 7. It is unclear and confusing whether Applicant is referring to the same ‘a pulse’ as recited on line 3 of claim 9, or different pulses?
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Toner et al. (U.S. 2013/0011210 A1) (hereinafter “Toner”).
Regarding Claim 1:
Toner teaches a system (see FIGS. 1A, 1B, 14 and 15B) (see paragraphs 7, 9, 16, 18, 20, 25-26, 28, 123, 126-128, 130, 133-134 and 138) comprising:
a hydrodynamic separation element (see FIGS. 1A and 1B, a system 10) (see paragraphs 31, 126 and 138) comprising one or more hydrodynamic separators each defining a curved microfluidic channel in fluid communication (see FIGS. 1A and 1B, one or more microfluidic channels 16) (see paragraphs 7, 16, 18, 123, 126-130, 133-134, 138, 144 and 147-148), each microfluidic channel defining:
an inlet configured to receive a first fluid and particles dispersed in the first fluid (see FIGS. 1A and 1B, one or more inlets 12 for introducing a sample 24 having suspended particles 22) (see paragraphs 126-130, 133-134, 138, 144 and 147-148), wherein the particles have a different composition than the first fluid (see paragraphs 7, 16, 18, 123, 126-130, 133-134, 138, 144 and 147-148), and
an outlet comprising a first flow branch and a second flow branch (see FIGS. 1A and 1B, one or more outlets 26) (see paragraphs 10-11, 13, 16 and 22 further describing the outlet can have at least two output branches) (see paragraphs 126-130, 133-134, 138, 144 and 147-148),
wherein at a predetermined flow rate (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, and 184), each microfluidic channel is configured to direct any particles exceeding a corresponding threshold size into the second flow branch and any remaining particles into both the first flow branch and the second flow branch (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, and 184);
a particle sensor configured to provide signal data representing a signal corresponding to the first fluid and the particles in the first fluid (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals); and
a controller operably coupled to the particle sensor to receive the signal data and operably couplable to a fluid pump in fluid communication with the hydrodynamic separation element (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals), the controller configured to:
control the fluid pump to direct the first fluid through the hydrodynamic separation element (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 183-184 and 192),
determine whether a threshold level of particles is present in at least one microfluidic channel based on the signal data from the particle sensor (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 183-184 and 192), and
control a flow rate through the hydrodynamic separation element (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, 179, 183-184 and 192), in response to determining that the threshold level of particles is present in the at least one microfluidic channel (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 183-184 and 192), to direct the first fluid at the predetermined flow rate through the hydrodynamic separation element to focus any particles exceeding the corresponding threshold size to the second flow branch of the at least one microfluidic channel (see FIGS. 1A and 1B, one or more outlets 26) (see paragraphs 10-11, 13, 16 and 22 further describing the outlet can have at least two output branches) (see paragraphs 16, 20, 25, 28, 126-130, 133-134, 138, 144, 147-148, 179, 183-184 and 192).
Although Toner describes a particle detector configured to provide signal data representing a signal corresponding to the first fluid and the particles in the first fluid (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals), one may broadly interpret that Toner does not explicitly teach a particle sensor positioned along the one or more hydrodynamic separators, as recited in independent claim 1.
However, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the hydrodynamic separation system of Toner to reposition the particle sensor/detector along the one or more hydrodynamic separators for optimization purposes and to efficiently and effectively monitor a flow rate and parameters of the particles/fluid accurately (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, 179, 183-184 and 192).
Regarding Claim 2:
Toner teaches the system according to claim 1, wherein the particle sensor comprises:
a light source configured to direct a light beam in a frequency band along a path through at least one hydrodynamic separator, wherein the frequency band is selected to have a different absorbance by the particles than by the first fluid (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals);
an aperture element defining a light aperture positioned in the path of the light beam from the light source (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals); and
a light detector positioned to receive the light beam in a sensing area after passing through the at least one hydrodynamic separator and the light aperture (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals), the light detector configured to provide the signal data representing an amount of light in the frequency band that remains after passing through the at least one hydrodynamic separator (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Although Toner teaches a particle detector, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the particle detector/sensor of Toner to include a light source, an aperture element and a light detector, as recited in dependent claim 2, for optimization purposes (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, 179, 183-184 and 192).
Regarding Claim 3:
Toner teaches the system according to claim 1, wherein the particle sensor comprises a capacitance sensor (see paragraphs 9, 16, 21, 22, 126-130, 133-134, 138, 144, 147-148, 179, 183-184 and 192).
Regarding Claim 4:
Toner teaches the system according to claim 1, further comprising a source reservoir in fluid communication with the inlet and second flow branch, wherein the first fluid and the particles are pumpable from the source reservoir to the hydrodynamic separation element and selectively back to the source reservoir through the second flow branch (see FIGS. 1A, 1B, 14 and 15B) (see paragraphs 7, 9, 16, 18, 20, 25-26, 28, 123, 126-128, 130, 133-134 and 138).
Regarding Claim 5:
Toner teaches the system according to claim 1, wherein the particles comprise a second fluid different than the first fluid (see FIGS. 1A and 1B, one or more inlets 12 for introducing a sample 24 having suspended particles 22) (see paragraphs 126-130, 133-134, 138, 144 and 147-148).
Regarding Claim 6:
Toner teaches the system according to claim 5, wherein the controller is further configured to determine an amount of the second fluid in droplet form per unit volume of the first fluid based on the signal data (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Regarding Claim 7:
Toner teaches the system according to claim 6, wherein the amount excludes the second fluid dissolved in the first fluid (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Regarding Claim 8:
Toner teaches the system according to claim 5, wherein the controller is configured to determine a droplet rate or a droplet size of one or more droplets of the second fluid dispersed in the flow of the first fluid based on the signal data (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Regarding Claim 9:
Toner teaches the system according to claim 8, wherein the controller is configured to determine the droplet rate or the droplet size based on at least one of:
a magnitude of a pulse contained within the signal data (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals),
a width of a pulse contained within the signal data (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals),
a first threshold signal level for detecting a minimum size droplet in a sensing area (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals),
a second threshold signal level for detecting a droplet that fills the sensing area (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals), and
a threshold signal level crossing rate (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Regarding Claim 10:
Toner teaches the system according to claim 9, wherein the controller is further configured to determine at least one of:
an amount of second fluid in droplet form per unit volume of first fluid based on the droplet rate and droplet size (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals);
the droplet size based on the magnitude of a pulse contained within the signal data in response to the signal not crossing the second threshold signal level (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals);
the droplet size based on the width of a pulse contained within the signal data in response to the signal crossing the second threshold signal level (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals); and
the droplet size based on the droplet rate (see paragraphs 16, 20, 25, 28, 126-130, 138, 148, 179, 184 and 192 further describing a particle detector in communication with a controller via signals).
Regarding Claim 11:
Toner teaches the system according to claim 5, wherein the first fluid comprises a hydrocarbon fluid and the second fluid comprises water (see FIGS. 1A and 1B, one or more inlets 12 for introducing a sample 24 having suspended particles 22) (see paragraphs 126-130, 133-134, 138, 144 and 147-148).
Other References Considered
REZAI et al. (U.S. 2018/0369817 A1) (hereinafter “Rezai”) teaches a system and method of performing separation in curved fluidic channels.
EBRAHIMI WARKIANI et al. (U.S. 2017/0292104 A1) (hereinafter “Ebrahimi”) teaches a microfluidic system and method.
Wagner et al. (U.S. 2015/0276589 A1) (hereinafter “Wagner”) teaches a motion modulation fluidic analyzer system and method.
Lim et al. (U.S. 2013/0130226 A1) (hereinafter “Lim”) teaches a microfluidic system and method.
Papautsky et al. (U.S. 2011/0096327 A1) (hereinafter “Papautsky”) teaches a spiral microfluidic particle separator system and method.
Volkel et al. (U.S. 2014/0367349 A1) (hereinafter “Volkel”) teaches a separation element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AKASH K. VARMA whose telephone number is (571)272-9627. The examiner can normally be reached Monday-Friday 9-5 pm.
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/AKASH K VARMA/Primary Examiner, Art Unit 1773