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.
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 it exceeds the word limit and includes legal phraseology. 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 elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the claims are directed to apparatuses that are defined by the positively claimed elements listed on separate indented lines after the transitional phrase “comprising”.
Although claim 1 and further claims mention an automatic sample analysis system, an automatic purification and dispensing apparatus, a target nucleic acid, a target nucleic acid solution, a multi-well plate, a plurality of reaction tubes, However, none of such are positively claimed as structural elements the invention, “a nucleic acid amplification test apparatus”. All of such are materials or articles intended to be, can be used with, worked upon by the claimed invention, . However, there is no requirement for the apparatus to be used in any method at all including with any unclaimed articles and materials as may be intended by applicant. I
It is noted that the various “configured to…” clauses recited throughout the claims do not provide for any structural elements but are directed to intended possible use. See also the various “so as to” clauses.
It is noted that that the various “units”, “modules”, “blocks”, “part”, etc. recited throughout the claims are not defined in each of the claims by specific, definitive structures.
It is presumed that the phrase “provided with” recited throughout the claims structurally means comprises, includes, etc. See also the phrase “provided to…” recited throughout the claims that also does not provide for any definitive structural nexus (connections) between any positively claimed structures.
It is noted that such phrases as “disposed above”, “disposed below”, “disposed in”, etc. do not provide for any structural connections nor definitive relative locations, but are directed to general relative locations.
As to claim 11, it is noted that a dispensing position (P) of the automatic purification and dispensing apparatus (10) and an amplification position in the housing are defined as being any specific structures. The positions are not structural elements.
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 1-26 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. The language employed throughout the claims is awkward, ambiguous, vague, and confusing.
As to claim 1, it is noted that the automatic analysis stem and automatic purification and dispensing apparatus are not positively claimed as elements of the test apparatus. However, it is noted that neither of such are defined by any specific structural elements including any elements that can provide for any automation.
It is unclear if the “a nucleic acid amplification test apparatus” recited in line 1 is the same or different from “a nucleic acid amplification test apparatus” recited in line 5. As presently drafted such are not required to be the same. Therefore, it is unclear which/what is nucleic acid amplification test apparatus is being referenced by the phrase “the nucleic acid amplification test apparatus” recited throughout the claims.
Furthermore, it is unclear what is structurally required of a nucleic acid amplification test apparatus to be configured to amplify and measure anything. It is unclear what is intended to be amplified and measured, and acquired form the automatic purification and dispensing apparatus because the claim does not recite such.
Claim 1 recites the limitation "the outside" in second paragraph. There is insufficient antecedent basis for this limitation in the claim. It is unclear what outside of what is being referenced because the claim does not recite such.
As to claim 1, in the 3rd paragraph, it is unclear what the phrase “is inserted through an automatic purification and dispensing apparatus (10)” is intended to be directed to because the claim does not clearly recite such. However, it is noted that there is no requirement for any inserting of anything through the unclaimed, structurally undefined automatic purification and dispensing apparatus (10) required to be performed. If applicant intends to claim that specific positively claimed elements are located in another specific positively claimed structural element, then the claim should clearly recite such.
As to claims 1 and 24, it is unclear what is the structural nexus of the housing and the other positively claimed structural elements because the claims do not recite such.
Claims 2-23 are rejected via dependency upon a rejected claim.
In the 4th paragraph of claim 1, it is unclear if “a sealing plate and a sealing means” are intended to be elements of the invention (including any specific elements of the invention, such as the insertion unit” because the claim does not clearly recite such.
It is unclear what is structurally required by the phrase “into which a sealing plate (50) provided with a sealing means for sealing inlets of the plurality of reaction tubes (1)”.
If applicant intends claim a sealing plate including a sealing means located in the sealing plate insertion unit, then the claim should clearly recite such.
As to claim 1, it is unclear which/what reaction tube(s) is being referenced by the phrases “the reaction tubes” and “the reaction tube” in the last 3 paragraphs because the claim previously recites “a plurality of reaction tubes”. Also applicable to claims 2-3, 13-17, and 19-22.
Furthermore, it is unclear how the last “wherein” paragraph further structurally limits the invention because although no moving is required to be performed, no reaction tube can move itself and there is no structure positively claimed that can move any reaction tube.
The term “adjacent” in claim 1 is a relative term which renders the claim indefinite. The term “adjacent” 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 not moving and sealing of any reaction tube is required be performed, the term “adjacent” does not provide for any definite structural nexus (connection, distance, etc.). What may be considered as “adjacent” to person may not be considered as such to another and vice versa.
It is unclear what is further structurally required by claim 2 because the claim does not provide for any further structural element nor any further structure of any previously claimed element. The claim is directed to what the temperature control block “allows”. There is no structural element claimed that provide for any movement, “ascending” of any reaction tubes. What the block allows, can possibly occur, be performed are intended processes of use.
The term “closely contact” and “close contact” in claims 2 and 15 are relative terms which renders the claim indefinite. The terms ““closely contact” and “close contact”” are not defined by the claims, 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. It is presumed that the phrase “closely contact” is intended to be “close contact”. The terms “closely” and “close” do not provide for any definitive structural nexus. What distance may be considered as close to one person may not be considered as such another. However, The phrases appear to be contradictory, redundant because if structures are actually structurally contact with each other, then the term “close” is redundant. It is unclear what is structurally required by each of the phrases. Furthermore, as noted above to process actions, process steps moving, driving, sealing, etc. are required be performed.
As to claim 3, although no heat exchanging is required to be performed, it is unclear what can exchange heat with reaction tubes because the claim does not clearly recite such.
Claim 3 recites the limitation "the heat generated in the thermoelectric module" in 3rd paragraph. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that no multi-well plate has been positively claimed as being located/supported on the heating block nor any other positively claimed structural element.
As to claim 4, it is unclear what the phrase “and a top surface” modifies, what comprises a top surface because the claim does not clearly indicate such. Furthermore, it is unclear what the phrase “into which…” modifies. If applicant intends for a specific element to comprise a plurality of insertion grooves and the plurality of reaction tubes to located in such grooves, then the claim should clearly recite such.
Claim 5 recites the limitation " the reaction block". There is insufficient antecedent basis for this limitation in the claim.
As to claim 6, it is unclear what the term “thereabove” is referencing because the claim does not clearly recite such. Furthermore, it is unclear how the sensor senses an “existence” of the sealing plate. Clearly, the sealing plate exists. It is presumed that it is intended to be whether or not the sealing plate is located at a specific location. Also applicable to claim 23.
As to claim 7, it is unclear if heat dissipation late is actually in surface contact with a lower side of the thermoelectric module be the phrase “provided to be in” implies what is possible, can be rather that what is structurally required.
Claim 7 recites the limitation "the inner space" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim.
As to claim 7, it is unclear what is structurally meant, required by “a separation space (S2) that is separated from the inner surface (S1) to form the separation space (S2) together with the heat dissipation plate (811)” because space is not structure. It is unclear what positively claimed structural elements define such spaces and what is the structural difference/distinction of a separation space and inner space because the claim does not clearly recite such.
Claim 8 recites the limitation "the outside of the housing". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the air circulation part and the separation space (not defined by any structure) are actually structurally connected because the “provided to independently communicate…” phrase does not require any structural connection. Furthermore, although no air is required to be circulated it is noted that any air not in the housing is external air of the housing.
As to claim 9, it is unclear what/which bottom surface part is being referenced by “the bottom surface part” because claim 8 recites “bottom surface parts”.
It is unclear what is further structurally required by claim 10 because the claim does not provide for any further structural element nor any further structure of any previously claimed element. The claim is directed to what can possibly occur, be performed, which are intended processes of use.
As to claim 13, it is unclear if it is intended for the for the apparatus to comprise a sealing cap because the claim does not clearly recite such. It is unclear how the sealing means can comprise a sealing film that the sealing cap comprises without the sealing cap being present.
As to claim 14, it is unclear what inlet of what/which reaction tube is being referenced in the first paragraph because a plurality of reaction tubes are previously recited. See also claim 16 and any other claim reciting such.
As to claim 15, it is unclear what the phrase “each other” references because the claim does not clearly recite such.
As to claim 16, it is unclear what inlet of what/which reaction tube is being referenced in the first paragraph because a plurality of reaction tubes are previously recited. Furthermore, although no rolling is required to be performed, it is unclear what is “horizontal movement rolling” and what such is directed to because the claim does not provide for such.
Claim 16 recites the limitations "the state of…" and “the upper side of the sealing plate insertion unit”. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitations " the sealing plate seated on the sealing plate insertion unit" and “the reaction tube (1) of the multi-well plate” There is insufficient antecedent basis for these limitations in the claim.
The term “high-temperature” in claim 17 is a relative term which renders the claim indefinite. The term “high-temperature” 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 temperatures are considered “high”. What may be considered as “high” to one person may not be considered as such to another and vice versa.
As to claim 21, it is unclear what is meant by the phrase “which the target nucleic acid reacts”. The phrase appears to be grammatically incorrect.
Claim 21 recites the limitation "the reaction of the target nucleic acid". There is insufficient antecedent basis for this limitation in the claim.
As to claim 22, it is unclear if it is intended to for the apparatus to comprise a reaction tube and an identification information code attached to the reaction tube because the claim does not clearly recite such. See also prior remarks/rejections directed to the reactions tubes.
As to claim 24, it is unclear what is structurally required to define an automatic purification and dispensing apparatus (10) because such is not defined in the claim as comprising any definitive structures, including any structure that can perform any purification, dispensing, and provide for any automation of anything.
Furthermore, it is noted that a plurality of reaction tubes, a dispensing position (not structurally defined by any structure), and multi-well plate are not positively claimed as elements of the invention. However, it is unclear what is the nexus of “a plurality of reaction tubes” recited in the last paragraph to the “a plurality of reaction tubes” recited in the first paragraph and “the plurality of reaction tubes” recited in the 2nd paragraph because it is unclear if such are the same or different.
The nucleic acid amplification test apparatus is only structurally defined by housing having an inner space and a multi-well plate insertion unit (not defined by any specific structures). It is noted that there is no structural element claimed such that the apparatus can be capable of performing nucleic acid amplification. Therefore, it is unclear how the housing and multi-well plate are considered as defining “a nucleic acid amplification test apparatus”.
Claims 25-26 are rejected via dependency upon a rejected claim.
As to claim 25, it is noted that positions are not structures. What is intended to be, can be done as such structurally undefined positions are not structural elements. See prior remarks/rejections above. However, it is unclear if the “a dispensing position” is the same or different from that recited in claim 24. It is noted that “())” appears to be a typo.
As to claim 26, although no carrying of anything in and out of the multi-well plate insertion unit is required to be performed, it is unclear what the shutter can carry because the claim does not recite such.
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) 1-2, 11-15, and 20-26 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Maltezos et al., US 2012/0171678.
Maltezos discloses a thermal cycler for monitoring the progress of the amplification reaction in real time (see Fig. 1 A-4, [0005], [0041], [0075],[0085]) comprising
a housing (101) with an inner space,
a multiwell plate insertion unit (the receptacle barrier (307) for receiving the multiwell plate (305)),
a sealing plate insertion unit (the sealing caps (303)),
a fluorescent detection unit located above the sealing plate insertion unit (see [0005], [0075], [0085]), and
a temperature control block (Peltier element (315), a heat sink (107)), and guiding rails (113)).
It is noted that the last “wherein” paragraph is directed to a process step that is not a structural element of the apparatus.
As to claim 2, the temperature control block is structurally capable of allowing reactions tubes to ascend to be in closely contact the sealing unit through elevation driving.
As to claims 11-12 and 25-26, a removable heat block assembly, or swap block (105; 155) (FIG. 1) (support part/shutter). The swap block (105; 155) is inserted into and removed from the thermal cycler body (103; 153) by optionally sliding the swap heat block on sliding rails (113;163) (driving part).
As to claims 13-15, a lid can be fastened to the block by various means (e.g., clip, spring, screws, etc.). In one embodiment the lid contains a closing and pressing device for securing the sealed sample vessels positioned in the receptacle of the liquid metal or thermally conductive fluid heat block. In an alternative embodiment the lid may seal the sample vessels as it closes. A lid may have a spring held pressure plate (pressing part), which presses each sample vessel with a defined force into the wells of the receptacle of the liquid metal or thermally conductive fluid heat block. (paragraph 0113).
As to claim 20-23, the optical assembly for detecting fluorescence comprises a light source 603 that provides lights passing through an excitation filter 605 which is directed into a sample vessel by a dichroic reflector/mirror 611 through an objective lens 609 which focuses the light beam into the sample vessel. (paragraph 0124). The reader (scanner) is a LED reader which detects a fluorescence signal. (paragraph 0127, 131, 157).
Allowable Subject Matter
Claims 3-10 and 16-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Maltezos does not teach nor fairly suggests the temperature control block (500) comprises: a heating block (510) comprising a thermoelectric module (520) and disposed below the multi-well plate insertion unit (100) to control the temperature of the reaction tube (1) by exchanging heat with the reaction tube (1); a heat dissipation unit (800) provided below the heating block (510) to discharge the heat generated in the thermoelectric module (520) to the outside; an elevation driving unit (600) configured to drive the heat dissipation unit (800) vertically to allow the heating block (510) configured support the multi-well plate (40) to move vertically so as to drive a position of the multi-well plate (40) vertically.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Postrel; Richard; YOON; Su Mi et al.; PARK; Han Oh et al.; Cheung; Tiffany et al.; Postrel; Richard; Williams; Jeff et al.; Wilson; Brian D. et al.; Froehlich; Thomas et al.; Merz; Hartmut et al.; Modlin; Douglas N. et al.; Amirkhanian, Varouj et al.; DeWalch, Binz; Lebl, Michal et al.; and Moring; Stephen E. et al. disclose amplification and/or analysis systems/apparatuses.
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
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