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 .
Drawings
The drawings are objected to because Fig. 12 is blurry. 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.
Specification
The use of the terms “BioOven [24]”, “Supermix [25]”, "BioTherm BioOven III [25]", “VWR [28]”, “Tygon [112]”, “Pyrex [196]”, and “Life Technologies [198]” , which are a trade names or marks used in commerce, have been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
There is a mention of claims in [125] of the specifications. The specification should not reference claims.
There is a period missing at the end of [114].
Appropriate correction is required.
Claim Objections
Claims 154, 165, 166, 167, and 168 objected to because of the following informalities:
Claim 154 recites “flsushing”, however, should recite “flushing".
Claim 165 recite “… wherein, wherein …”, however, it should recite “…., wherein…”.
Claim 166 recite “… wherein, wherein …”, however, it should recite “…., wherein…”.
Claim 167 recite “… wherein, wherein …”, however, it should recite “…., wherein…”.
Claim 168 recite “… wherein, wherein …”, however, it should recite “…., wherein…”.
Appropriate correction is required.
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 148, 153, 154, 156, 159, 160 ,161, and 163 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 148 recites the limitation "filling the microfluidic tube". Claim 143 which claim 148 does not recite that limitation. Claim 143 only recites “filing the lumen” in step b and c. There is insufficient antecedent basis for this limitation in the claim.
Claim 153 recites the limitation "storing the microfluidic tube". It is unclear when this limitation is supposed to occur with regard to claim 143. There is insufficient antecedent basis for this limitation in the claim.
Claim 154 recites the limitation "flushing the hydrophobic fluid liquid". It is unclear when this limitation is supposed to occur with regard to claim 143. There is insufficient antecedent basis for this limitation in the claim. Claim 155 is also rejected under 112b since it dependent upon rejected claim 154.
Claim 156 recites the limitation "performing a reaction". It is unclear when this limitation is supposed to occur with regard to claim 143. There is insufficient antecedent basis for this limitation in the claim. Claims 157-160 are also rejected under 112b since it dependent upon rejected claim 156.
Claim 159 recites the limitation "thermal cycling". It is unclear when this limitation is supposed to occur with regard to claim 156. There is insufficient antecedent basis for this limitation in the claim.
Claim 160 recites the limitation "incubating". It is unclear when this limitation is supposed to occur with regard to claim 156. There is insufficient antecedent basis for this limitation in the claim.
Claim 161 recites the limitation "moving beads through fluid-fluid interfaces". It is unclear when this limitation is supposed to occur with regard to claim 143. There is insufficient antecedent basis for this limitation in the claim. Claims 162-164 are also rejected under 112b since it dependent upon rejected claim 161.
Claim 163 recites the limitation "forming a barcode". It is unclear when and how this limitation is supposed to occur with regard to claim 161. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 143-146 and 148-160 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cox et al. (US 20070062583 A1).
Regarding Claim 143, Cox teaches a process for partitioning biochemical reactions into fluid-fluid interfaces in a microfluidic tube, comprising the following steps in the following order:
(a) providing a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046);
(b) at least partially filling the lumen with a hydrophobic fluid liquid (para 0026); and
(c) filling the lumen with a hydrophilic fluid liquid that partially displaces the hydrophobic fluid liquid (para 0026);
thereby making fluid-fluid interfaces of alternating hydrophobic fluid liquid and hydrophilic fluid liquid in the microfluidic tube (para 0109).
Regarding Claim 144, Cox teaches at step (b) filling at least one-third the volume of the lumen with the hydrophobic fluid liquid (para 0048).
Regarding Claim 145, Cox teaches when displacing the hydrophobic fluid liquid, the hydrophobic fluid liquid being displaced coats the walls of the lumen forming a coating, wherein the coating coalesces periodically along the walls of the lumen (para 0201).
Regarding Claim 146, Cox teaches the lumen is coated with the hydrophobic fluid liquid after step (b) (para 0207).
Regarding Claim 148, Cox teaches filling the microfluidic tube uses positive pressure displacement of the hydrophobic fluid with the hydrophilic solution (para 0272).
Regarding Claim 149, Cox teaches displacing the hydrophobic fluid liquid with the hydrophilic fluid liquid using a vacuum (para 0153).
Regarding Claim 150, Cox teaches using vacuum pumps (para 0023) or pressure sources (para 0177) and control valves to at least partially fill the lumen with a hydrophobic fluid liquid; fill the lumen with a hydrophilic fluid liquid; or both (para 0181).
Regarding Claim 151, Cox teaches filling the lumen using positive pressure at a first end of the microfluidic tube and vacuum pressure at a second end of the microfluidic tube (0272).
Regarding Claim 152, Cox teaches varying a fill rate of the hydrophobic fluid liquid or the hydrophilic fluid liquid into the lumen (para 0046).
Regarding Claim 153, Cox teaches storing the microfluidic tube at a temperature of from 99 °C to -20 °C (para 0257).
Regarding Claim 154, Cox teaches flushing the hydrophobic fluid liquid and the hydrophilic fluid liquid in the microfluidic tube (para 0187).
Regarding Claim 155, Cox teaches wherein flushing the microfluidic tube is with water (para 0133).
Regarding Claim 156, Cox teaches performing a reaction in the microfluidic tube (para 0027).
Regarding Claim 157, Cox teaches the reaction comprises detecting an analyte using fluorescence (para 0125).
Regarding Claim 158, Cox teaches the reaction comprises performing genetic analysis (para 0027).
Regarding Claim 159, Cox teaches thermal cycling the microfluidic tube (para 0126).
Regarding Claim 160, Cox teaches incubating the microfluidic tube (para 0160).
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.
Claims 147, 165, 166, 167, and 168 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (US 20070062583 A1) which is cited in the IDS submitted on 10/18/2024.
Regarding claim 147, Cox teaches a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046).
Cox does not specify that the number of fluid-fluid interfaces is 3 to 500,000.
The Applicant is advised that the Supreme Court recently clarified that a claim can be
proved obvious merely by showing that the combination of known elements was obvious to try.
In this regard, the Supreme Court explained that, "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a
person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp." An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where
others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int'l V. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
It would have been obvious to one of ordinary skill in the art before the effective filing date to recognize that the number of fluid-fluid interfaces may be controlled by length of the microfluidic tube. Cox teaches that aqueous immiscible-fluid-discrete-volumes (“hydrophilic fluid liquid”) in oil (“hydrophobic fluid liquid”) can fill the tube and exhibit a banded appearance (“fluid-fluid interfaces”) (para 0109). Cox further teaches that elongated liquid volume (“length of the microfluidic tube”) with additional oil (“hydrophobic fluid liquid”) added alternately can make a sequence (“fluid-fluid interfaces”) of a desired length (para 0336). Therefore, it would be obvious to choose a length of the microfluidic tube that allows for the number of fluid-fluid interfaces to be whatever values one desires including the number of interfaces being 3 to 500,000 to allow for desired number of biochemical procedures to be performed (para 0115).
Regarding claim 165, Cox teaches a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046). Cox teaches that the tubes have a length (para 0018).
Cox does not teach the microfluidic tube has a length of 1 cm to 1000 m.
Although Cox reference does not include the length range of the microfluidic tube, it is not inventive to discover the optimum length range of the microfluidic tube. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to determine a suitable length for the microfluidic for the benefit of controlling the number of fluid-fluid interactions (para 0336).
Regarding claim 166, Cox teaches a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046). Cox teaches that the tubes have a length (para 0018).
Cox does not teach the microfluidic tube has a length of 0.5mm to 10mm.
Although Cox reference does not include the length range of the microfluidic tube, it is not inventive to discover the optimum length range of the microfluidic tube. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to determine a suitable length for the microfluidic for the benefit of controlling the number of fluid-fluid interactions (para 0336).
Regarding claim 167, Cox teaches a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046). Cox teaches that the tubes have a length (para 0018).
Cox does not teach the microfluidic tube has a length of 5 cm to 10 cm.
Although Cox reference does not include the length range of the microfluidic tube, it is not inventive to discover the optimum length range of the microfluidic tube. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to determine a suitable length for the microfluidic for the benefit of controlling the number of fluid-fluid interactions (para 0336).
Regarding claim 168, Cox teaches a microfluidic tube comprising a lumen (“a tube”, para 0006) having a diameter from 35 microns to 500 microns (para 0046). Cox teaches that the tubes have a length (para 0018).
Cox does not teach the microfluidic tube has a length of 0.25 cm to 10 m.
Although Cox reference does not include the length range of the microfluidic tube, it is not inventive to discover the optimum length range of the microfluidic tube. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to determine a suitable length for the microfluidic for the benefit of controlling the number of fluid-fluid interactions (para 0336).
Claims 161-164 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (US 20070062583 A1), as applied to claim 143 above, and further in view of Cayer et al. (US 20210106998 A1).
Regarding claim 161, Cox teaches a process for partitioning biochemical reactions into fluid-fluid interfaces in a microfluidic tube.
Cox does not teach moving beads through fluid-fluid interfaces.
However, Cayer teaches systems and methods for performing high-throughput assays using microfluidic systems to provide detailed information about the effect of various effector molecules on biological systems (para 0003). Cayer teaches moving beads through fluid-fluid interfaces in a microfluidic system (para 0077) for the benefit of attaching both cleavable and non-cleavable ligands (para 0101). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Cox with beads moving through the fluid-fluid interface as taught by Cayer for the benefit of attaching both cleavable and non-cleavable ligands (para 0101).
Regarding claim 162, Cox in view of Cayer teaches the instant invention claimed above.
Cox does not teach the beads are magnetic.
However, Cayer teaches the beads are magnetic (para 0097) to target specific biomolecules (para 0096). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Cox with magnetic beads as taught by Cayer for the benefit of targeting specific biomolecules (para 0096).
Regarding claim 163, Cox in view of Cayer teaches the instant invention claimed above.
Cox does not teach forming a barcode.
However, Cayer teaches forming a barcode (para 0202) for conducting fragment-based screens to identify lead molecules of interest (para 0202). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Cox with the beads forming barcodes for the benefit of conducting fragment-based screens to identify lead molecules of interest (para 0202).
Regarding claim 164, Cox in view of Cayer teaches the instant invention claimed above.
Cox does not teach the beads further comprise reagents, reactant molecules, nucleic acids, proteins, or combinations thereof, attached or encapsulated in the beads.
However, Cayer teaches that the beads may be made with any material as well as surface modification on the surface of the bead such as polyethylene glycol (para 0098-0101) to protect reactive sites. Polyethylene glycol is interpreted to be a reactant molecule containing reactive groups (para 0407). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Cox with beads with surface modifications as taught by Cayer for the benefit of protecting reactive sites (para 0098-0101).
Conclusion
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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