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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the droplet evaluation device including at least one of a visible light and a fluorescent light of claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention droplets, a stream of a first aqueous fluid, a stream of a first non-aqueous fluid, one or more droplets of the first aqueous fluid, second aqueous fluid, second non-aqueous fluid, and one or more droplets of the second aqueous fluid; however, none of the prior are positively claimed as structural elements of the invention all of such are materials/articles can be, intended to be worked upon and used with the claim apparatus. No fluids are claimed and do not further structurally define the claimed apparatus.
The claimed apparatus is defined by the positively claimed structural elements. There is no requirement for the claimed apparatus to be used with any fluid nor to perform any process steps. However, it is noted that none of the channels are claimed as comprising any structure which would allow such to be structurally capable of performing any actions including producing any force to provide for any fluid flow, forming any droplets as recited in the “adapted to” and “configured to” clauses recited throughout the claims.
It is noted that the phrase “at least one” only requires one.
It is noted that the phrase “one or more” only requires one.
It is noted that the term “arrange” is broad and is not specifically defined in the claim. Although no droplets are positively claimed and no “arranging” of any droplets is required to be performed, if one droplet is capable of being located within droplets can be located in a reservoir, such one droplet can be considered as being “arranged” in a portion of the reservoir.
It is noted that although no droplets movements are required to performed, a first direction, second direction, third direction are not directed to any specific directions nor defined relative to any positively claimed structure so as to provide a basis to determine what is considered such directions.
It is noted that claims 3, 5, 10, 13, and 16-19 do not provide for any additional structural elements, but are directed to application of voltage and buoyant forces to move droplets, activation and selective activation of electrodes. All of such are directed to intended possible uses, process steps relative to the unclaimed fluids. As noted above, there is no requirement for any process steps to be performed by the apparatus including any applying of any voltage and buoyant forces (which is dependent upon fluid being present), activating/selectively any electrodes such that any attraction of and droplets of any unclaimed fluid to any electrode portion nor anything else. Furthermore, it is noted that there is no structural element claimed that can activate and selectively activate the electrodes nor apply voltage to the electrodes.
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 1-20 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.
As to claim 1, it is unclear what is structurally required to be considered as reservoir queen portion in the first microfluidic reservoir because such portion is not defined as being any specific structure nor as by any definitive structural boundaries so as to determine what is structurally required to define such portion. See also claim interpretation above.
Claims 2-20 are rejected via dependency upon a rejected claim.
As to claims 3, 5, 10, 13, and 16-19, it is unclear what is further structurally required by the claims because the claims do not provide for any further structure nor structurally limit any prior positively claimed structure. See also claim interpretations.
The term “excess amount” in claim 6 is a relative term which renders the claim indefinite. The term “excess amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although no fluid is positively claimed, there is no indication as to what is considered as an “excess amount” of fluid provided for in the claim. What may be considered as an excess amount to one person may not be considered as such to another and vice versa. It is noted that in the phrase “waste port” that the term “waste” does not provide for any further structure of the port. The term “waste” is directed to intended use. The name and intended use of the port does not further structurally define the port. The “waste ports” are not defined as being any specific structure.
The term “sharp” in claims 8-9 is a relative term which renders the claim indefinite. The term “sharp” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What may be considered as a sharp electrode portion to one person may not be considered as such to another and vice versa.
Claim 17 recites the limitations "the first attached electrode portion” and “the fifth microfluidic channel." There is insufficient antecedent basis for these limitations in the claim.
Claim 17 recites the limitation "the one or more droplets of the first and second aqueous solution". There is insufficient antecedent basis for this limitation in the claim. No such droplets of any first and second aqueous solution has been previously mentioned. Furthermore, although no activating of any electrodes is required to occur, it is unclear what is considered as “selective activation” because there is no structure claimed that can “selectively” (based upon anything) perform any activating of any electrodes. See also claims 19-20.
Claim 19 recites the limitations "the one or more droplets of the first aqueous solution", “the second attached electrode portion”, and “the sixth microfluidic channel”. There is insufficient antecedent basis for these limitations in the claim. No such droplets of any first aqueous solution has been previously mentioned.
Claim 20 recites the limitations "the one or more droplets of the first aqueous solution" and “the one or more droplets of the second aqueous solution”. There is insufficient antecedent basis for these limitations in the claim. No such droplets nor solutions have been previously mentioned.
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(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kawano et al, US 2005/0103690 and further in view of Hiddessen et al., US 2017/0152550.
Kawano discloses a microfluidic apparatus for processing droplets in a microfluidic environment, the apparatus comprising:
a first microfluidic channel (50) adapted to flow a stream of a first aqueous fluid through the first microfluidic channel;
a second microfluidic channel (1) fluidically connected to the first microfluidic channel, wherein the second microfluidic channel is adapted to flow a stream of a first nonaqueous fluid through the second microfluidic channel and into the first microfluidic channel;
a main channel (10) fluidically connected to the first microfluidic channel and configured to receive one or more droplets of the first aqueous fluid formed by the first microfluidic channel and suspended in the first non-aqueous fluid;
a first queen portion defined in main channel ( 10) and configured to arrange the one or more droplets of the first aqueous fluid;
a first electrode (41) positioned such that application of a voltage to the first electrode will move tile one or more droplets of the first aqueous fluid in the first reservoir queue portion in a first direction; and
a second electrode (42} positioned such that application of a voltage to the second electrode will move the one m more droplets of the first aqueous fluid in the fast reservoir queue portion in a second direction. (Figures 1-17 and descriptions of such).
Kawano does not disclose a "first fluidic reservoir" to collect and sort tile droplets, but instead the device has a main channel 10 (can be referred to as a reservoir).
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).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Hiddessen discloses microfluidic device for producing droplets of one immiscible fluid in another, whereby downstream of a droplet generating junction, reservoirs (110, 120), collect droplets before further processing.
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to modify the device of Kawano to include reservoirs to transport, store, and collect fluid droplets as taught by Hiddessen as such would yield predictable results.
As to claim 2, the device of Kawano comprise four channels. (Figure 1).
As noted above, claims 3, 5, 10, 13, and 16-19 do not provide for any additional structure to that of claim 2.
As to claim 4, the device of Kawano can include fifth and sixth channels. (Figure 17).
As to claim 6, the device of Kawano includes ports (15, 55, and others unlabeled). (Figure 1).
As to claim 7-9, the electrodes 31, 32 and 41, 42 each include a ground portion and a sharp attached portion. (Figure 2).
As to claims 11-12 and 14-15, the electrodes 31,32 included circular, curved portions having different radius of curvature. (Figure 2).
As to claim 20, the device of Kawano includes a droplet evaluation device (6, 7) including visible light and fluorescent light. (paragraphs 0040-41, 92, 106, 121).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Naisby; Andrew et al.; Tandon; Vishal et al.; Esmail; Adnan et al.; Wen; Weijia et al.; Kuiper; Stein et al.; Wen; Weijia et al.; ROS; Alexandra et al.; Stephenson; William; Li; Zhi et al.; SUNAGA; Nobuya; Vyawahare; Saurabh et al.; Griffiths; Andrew David et al.; Beer; Neil R. et al.; Bailey; Ryan C. et al.; Link; Darren R. et al.; Link; Darren R. et al.; Akiyama; Yuji et al.; Flory; Curt A. et al.; Pollack; Michael G. et al.; HENRY; Isaac Thomas; and AKHREMICHEV; Ivan et al. devices comprising channels and electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/ Primary Examiner, Art Unit 1798