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
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 includes legal terminology such as “comprises”. 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 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 steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the sample liquid driving apparatus, detection mechanism, detection pool, and reaction pool are not defined by, as being any specific structure(s) such as in claims 1-2.
It is noted that is not specified who/what performs each of the steps recited in the claims. Some of the steps may be performed visually (via one’s eyes) and/or mentally, such as the detecting, judging, determining, and calculating steps.
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 1-14 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
As to claims 1-2, it is unclear what is structurally required by the phrase “provided with” because for example it is unclear if the biochip comprises a sample inlet/a reaction pool or if the phrase that the sample let and reaction are present along with the biochip. It is presumed to mean comprises. If so, the claims should clearly recite such.
As to claims 1-2, it is unclear what is structurally required by the phrases “communicated with”; “being communicated in sequence”; and “sequentially communicated through a micro-channel” because the phrases do not provide for no require any clear structural nexus/connectivity. Furthermore, it is unclear if the biochip is intended to comprise a micro-channel. If it is intended for the biochip to comprise a micro-channel and the further elements to be fluidically connected, in fluidic communication with each other via the micro-channel, then the claims should clearly recite such.
Furthermore, it is noted that a “communication port” and “a sample inlet” are not defined in the claims as being any specific structure(s). Furthermore, it is noted that in the “driving” of claim 1 the sample liquid is not required to flow from any specific location.
Claim 1 recites the limitations " the direction of the sample inlet” and “the detection pool. " in the last paragraph. There is insufficient antecedent basis for these limitations in the claim. Furthermore, it is noted that there no structural basis provided as to where the sample liquid flows from (where the liquid sample is located) in the respective clauses such as to determine what are such directions. See also such phrases as “flow towards” recited in the claims.
Claims 2-14 are rejected via dependency upon a rejected claim.
Claim 3 recites the limitation " the number of the second liquid pushing and drawing operations " in the last paragraph. There is insufficient antecedent basis for this limitation in the claim.
As to claim 4, it is unclear what the term “thereof” references.
Furthermore, it is unclear what is considered as “a preset space margin” because the claim does not define such. It is unclear is space is required to be located between something because the claim does not provide for such and what is required of such space to be considered as “preset” because there is no step that requires any spacing of anything to set prior to anything (further step nor future event/time). See also the term “preset” as employed throughout the claims (3-9 and 12).
Claim 4 recites the limitation " the sample liquid pushed out by the sample liquid driving apparatus”. in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Also applicable to claim 11.
Claim 5 recites the limitation " the quantity of the sample liquid in the reaction pool" in the second paragraph. There is insufficient antecedent basis for this limitation in the claim.
As to claim 6, it is unclear what is “a trigger signal”; what is required to produce, send, etc. such signal and who/what can receive such signal because the claim does not provide for such. See also claim 9.
Claim 7 recites the limitation "the light transmitted through the detection pool" in the next-to-last paragraph. There is insufficient antecedent basis for this limitation in the claim.
The terms “stable” and “unstable” in claim 8 is a relative term which renders the claim indefinite. The term “stable” and “unstable” 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. There is no indication as to what is required
Claim 8 recites the limitation "the number of the first liquid pushing and drawing operations" in the second paragraph and “the detection” in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the detection function" in the first paragraph. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "he temperature of the detection pool " in the second paragraph. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the same first liquid pushing and drawing operation…"; “the same as …”; and “the quantity of the sample liquid sucked”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the same second liquid pushing…" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitations " the sample liquid pushed out by the sample liquid driving apparatus” and “the second liquid pushing action. " in the last paragraph. There is insufficient antecedent basis for these limitations in the claim.
As to claims 13-14, although the claims are dependent upon claim 1, the claims do not further limit the method claim 1 nor are either of the respective inventions (apparatuses) of claims 13 and 14 structurally defined by the method as defined by the steps in claim 1. It is unclear what inventions are intended to be defined in each of the claims. In claim 13, there is no microfluidic detection system defined by any specific structural elements. If applicant intends for the invention to be directed to a microfluidic detection system that comprises specific structural elements then the claim should clearly recite such. The same is applicable to “a refrigerator” of claim 14. There is no structural difference between the microfluidic detection system of claim 1 and the invention of claims 13-14. Renaming, referring to “a microfluidic detection system as “a refrigerators” does not provide for a different/distinct invention than the microfluidic detection system. Therefore, it is unclear what is being claimed in the respective claims as drafted.
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.
Claim(s) 1-8 and 11-14 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Stumbo et al., US 2019/0002956.
Stumbo discloses a system and method of employing the system. In the method, fluid of the emulsion may be aspirated from the well via the open end of the tube. At least a portion of the aspirated fluid may be dispensed back into the well via the open end (sample inlet) of the tube. Droplets of the emulsion may be transported from the well, via the open end of the tube, and to a detection channel, after the steps of aspirating and dispensing. A signal may be detected from droplets passing through the detection channel (detection pool). (paragraphs 0032, 0118-126, 205-211).
Fluid is transported (periodically and repeatedly aspirated/drawn and dispensed/pushed via a driving apparatus) Pumps 78a, 78b, also called pump1 and pump2, respectively, drive fluid flow into and within fluid transporter 60, particularly a channel network 70 thereof. Each pump is configured to be operated selectably as a suction pump that applies negative pressure to draw fluid toward the pump, or as a discharge pump (a positive pressure pump) to push fluid away from the pump. (paragraph 0068; Figures 2-5).
A detection mechanism is employed with the detection channel (detection pool) and comprises a light source and an operatively-associated detector (photosensitive element) of the system's detection module (detection mechanism) depicted schematically to identify a detection zone of the detection channel where droplets are detected. (paragraph 0015).
As to claims 2-6, amplification/reactions are performed prior to detection (in a location that can be referenced as a “reaction pool”). (paragraphs 0061, 108, 113).
As to claim 7-8, the detection mechanism is employed to provide for the calculation of different parameters (including which can be subjectively considered as indicative of “stability”) based upon light intensity detection from the light source.
As to claim 11, the volumes of fluid aspirated and dispensed may be the same as one another. (paragraph 0121).
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) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stumbo et al., US 2019/0002956.
Stumbo does not specify that the detection is performed based upon heating the detection pool to a temperature limit based upon a measured temperature of the detection pool.
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.
It would have been within the common sense, knowledge, skill, and obvious to one of ordinary skill in the art before the effective filing date of the invention to recognize that the temperature of the system is measured and controlled such that the droplets are heated to desired temperatures to provide for anti-clumping and to promote amplification before detection is performed as such would yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stumbo; David P. et al. and Patton; Charles J. disclose dispensing and aspirating devices and methods.
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