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 .
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 1-8 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 recitation “the drive…” in claim 1 lacks proper antecedent basis in the claims. Applicant may intend “a drive.”
Further, in claim 1, “the electrical machinery” is without proper antecedent basis in the claims. Does Applicant intend to refer to the electric motor here?
In claims 2 and 3, the recitation “the position of the objective stage while waiting…” lacks proper antecedent basis.
Additionally, this recitation is indefinitely understood in defining a particular physical position of the stage within the confines of the sought analyzer as it is codified by a conditional state of “while waiting for a user…is set as the starting point” that is indefinitely defined given that the claims are drawn to a device.
This is likewise seen with respect to claim 3 as it also provides indefinite metes and bounds as to the sought position of the objective stage within the analyzer device.
Further to the above, the recitation “the starting point” lacks proper antecedent basis, and wherein this recitation is further indefinitely understood in its intentions to further define the physical structure of the analyzer as the recitation pertains to a conditional state/process recitations within a device claim.
Claim 7 is 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 recitations “the number of moving steps,” “the rear end,” and “the result display area” lack proper antecedent basis in the claims.
Examiner further notes that the metes and bounds of the claim are indefinitely understood as the initial discussion to the number of moving steps is drawn to a narrative discussion relating to process steps not afforded patentable weight, and the remaining recitations provide unclear metes and bounds to the structural arrangement of the analyzer as the analyzer is without positive provision to a “result display area” (nor an actual display) let alone a particular part thereof (herein “the rear end”).
Claims 8-15 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 metes and bounds of the sought methodology are indefinitely defined herein.
The only actively-recited step of the method is drawn to “providing…” wherein such step begets the physical infrastructure of the analyzer.
The claims are drawn to a method of reading a test result of a test apparatus, wherein the only active step amounts to a step of providing the physical infrastructure of an analyzer.
Examiner notes that throughout the claim (and related dependent claims) there is presented general, narrative discussion to various actions, including in conditional senses (i.e. “when…”), wherein the vague narrative discussion to these aspects do not clearly provide for the sought active steps of the method that Applicant may or may not intend in defining the sought method of reading a test result of a test apparatus.
Applicant should clearly delineate the actions taken with respect to elements of the analyzer as actively-provided individual steps that amount to particularly define the sequence of operations sought for their intended purposes in ultimately leading to “reading of a test result.”
This is likewise seen in dependent claims 9-12 and 14, which also utilize vague and indefinite language to various conditional actions correlated with functions of individual structural elements, which is generally narrative and without clear metes and bounds as to the active steps sought to the methodology.
Further, claim 8 recites “the drive” and “the electric motor” that lacks proper antecedent basis in the claims.
Further, claim 8 recites “the starting point” which lacks proper antecedent basis in the claims. Does Applicant intend to provide a particular sample loading unit or input that is structurally/functionally related to the objective stage?
Further, “the number of moving steps” and “the preset number of steps” lack proper antecedent basis in the claims. Does Applicant intend to provide a processor of sorts that sets a number of steps (such as by reading a barcode on the objective stage/test apparatus) and coincident sensor(s) that signal for step(s) being completed such that the processor is able to determine if/when a preset number have been finished?
With regard to claim 11, the recitation “the data processing system” is without proper antecedent basis in the claims.
With regard to claim 12, the metes and bounds of the sought methodology are indefinitely defined as it is unclear what constitutes and correlates with “scanning information” as none of the previously-recited elements pertain to or provide “scanning information.”
With regard to claim 15, the recitations “the number of moving steps,” “the rear end,” and “the result display area” lack proper antecedent basis in the claims. Examiner notes that the claims do not provide a display itself let alone particulars thereto (i.e. rear and result display area).
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.
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.
Claim(s) 1-5 and 8-13, as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Pollack (USPN 9,470,702).
Pollack discloses an automated high volume slide processing system (abstract). Pollack discloses an analyzer comprising a drive system (lines 3-9, col. 15) for transporting a test apparatus and a photoelectric system, wherein the drive system comprises an objective stage (‘carrier or puck’ 250, lines 3-9, col. 15) and an electric motor (‘motor in the carrier body’), under the drive of the electric motor, the objective stage and the electrical machinery work together to make the objective stage to reciprocate in the analyzer, (wherein Examiner notes that such recitation is drawn to both narrative discussion/intended use and process recitations not afforded patentable weight in a device claim; Pollack further discloses driving the carrier/puck forward or backward on the track), and wherein the analyzer is provided with a magnetic sensor chip (lines 52-54, col. 17) and a magnet steel paired therewith (i.e. magnets in the carrier lines 58-61, col. 18) for use is disposed on the objective stage (noting the “for use” amounts to intended use recitation not afforded patentable weight). With regard to claims 2 and 3, as best understood and in as much as recited and required herein, Pollack provides an objective stage physically positioned as commensurately claimed and is thus said to be “at a position while waiting for a user…” as recited therein and noting that the recitations are drawn to intended use recitations not afforded patentable weight and conditional process recitations not afforded patentable weight in a device claim. With regard to claim 4, Pollack discloses that the objective stage (carrier 250) is provided with a test device storage area (i.e. an area defined about item ‘262’ in the vicinity of where sample tube is held and a magnet steel storage area (i.e. defined in the area defined about guide ‘266’ wherein Pollack discloses magnets are provided), and the test device storage area is closer to the insertion port for the test device of the analyzer when the objective stage is entirely located in the analyzer in as much as presently understood and wherein it is noted that such recitation is predicated on a conditional process recitation (“when the objective stage is entirely located…”) that is not attributed patentable weight; as Pollack discloses commensurate “test device storage area” and “magnet steel storage area” it is said the Pollack provides for this “closer” constitution with respect to an undefined “the insertion port…” with respect to such conditional process recitation and wherein the test sample tube is also provided to the analyzer for analysis whereas the opposite end at the magnet steel storage area is away therefrom and for interfacing with guiding components. With regard to claim 5, Pollack discloses that the analyzer comprises a light source angle positioning plate and the magnetic sensor chip is positioned on the light source angle positioning plate as the recitation “light source angle positioning plate” reads on merely any plate (and further noting that a light source itself is not a part of the claimed device), in which Pollack provides that the carrier has such light source/image sensors that indicate relative movement and include a light source and an image sensor to observe the relative motion, and Pollack further discloses that the carriers including mounting surfaces for the different items, in which Pollack discloses that such light source is mounted by way of a bracket that constitutes a plate as in ““light source angle positioning plate” (lines 4-18, col. 5; lines 55-67, col. 17; lines 45-52, col. 32).
With regard to claims 8-11, as best understood, Pollack discloses a method for reading a test result in as much as understood and recited herein, wherein Pollack, as discussed above w/ respect to claim 1, provides the analyzer as recited in claim 8. Further, while the claims are drawn to a method in which process recitations are afforded patentable weight, the recitations herein are indefinitely understood as it is provided by way of general narrative discussion and the sought active steps to the methodology are not particularly provided in which particular active steps to the method are not clearly provided. Further, as seen in fig. 3,6, for example, the movement and processing of the sample tubes held on the carrier and moved throughout the tracks include pathways of a coincident number of steps in order to reach the various modules therein (i.e. immunoassay at 205a, low-volume chemistry module 205, ISE electrolyte testing module at 205b) and include reciprocal path movement as indicated by the bidirectional arrows throughout the transportation paths (lines 10-67, col. 10; line 65, col. 13 – line 21, col. 14; line 55, col. 22 – line 67, col. 23), and wherein Pollack discloses that the carriers can be self-driven and can know where it is and its relative motion to the track such that this information provides a routing list that identifies a specific path of the individual track sections and decision points that a carrier will traverses as it is processed to have its test result read within a module(s) (cols. 17&18).
With regard to claims 11 and 12, as best understood, Pollack discloses a data processing system (including both a central management processor as well as local processor(s) at the assay stations) as claimed, and including utilizing inductive signals (lines 5-14, col. 23; line 45, col. 24 – line 44, col. 25).
With regard to claim 13, as best understood, Pollack discloses that the analyzer comprises a light source angle positioning plate and the magnetic sensor chip is positioned on the light source angle positioning plate as the recitation “light source angle positioning plate” reads on merely any plate (and further noting that a light source itself is not a part of the claimed device), in which Pollack provides that the carrier has such light source/image sensors that indicate relative movement and include a light source and an image sensor to observe the relative motion, and Pollack further discloses that the carriers including mounting surfaces for the different items, in which Pollack discloses that such light source is mounted by way of a bracket that constitutes a plate as in ““light source angle positioning plate” (lines 4-18, col. 5; lines 55-67, col. 17; lines 45-52, col. 32).
Claim Rejections - 35 USC § 103
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 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) 6, 7, 14, and 15, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollack in view of Dailey, JR et al. (US 2009/0027693), hereafter Dailey.
With regards to claims 6 and 14, Pollack does not specifically disclose that the light source angle positioning unit is provided with a light receiving channel and a light irradiation channel.
With regard to claim 7, the recitation is drawn to general narrative discussions and to conditional process recitations not attributed patentable weight. Similarly as to claim 7, with regard to claim 14, while the claims are drawn to a method in which process recitations are afforded patentable weight, the recitation therein is indefinitely understood as it is provided by way of general narrative discussion in which particular active steps to the method are not clearly provided.
Further, as discussed above, Pollack discloses moving the objective stage (i.e. carrier) to have the test apparatus be examined and assayed through various modules in particular guided movement steps as best construed therewith (lines 23-46, col. 4; lines 3-10, col. 7, figs. 2-3, for example).
Dailey discloses an analyzer including an optical interrogation system for detecting and correction positional misalignment of a microplate (abstract). Dailey discloses utilizing vision system including a light source whose interrogation beam passes through an optical fiber (i.e. providing at least a light irradiation channel) in which the irradiated beam is directed at the microplate bottoms and reflected back into to optical fiber 2907 as a received beam at the light receiving channel given by the emission beam being directed by a beam splitter 2914 that is communicated with a CCD imager 2902 to determine the position of the particular wells of the microplate (par.[0048]).
It would have been obvious to one of ordinary skill in the art to modify Pollack so as to include that the light source angle positioning unit is provided with a light receiving channel and a light irradiation channel such as taught by the analogous prior art of Dailey to an analyzer that monitors particular positions of the elements by optical means in which providing a light receiving channel and a light irradiation channel as in the irradiation fiber and reception beam splitter to the CCD image sensor provides optical elements for assuredly and accurately directing the light source for defined and confined particular optical interrogation as well as emission analysis thereof at the CCD as likewise desired in Pollack (lines 55-67, col. 17) in order to afford an optical emission and reception system that yields accurate positional data that would have a reasonable expectation of success therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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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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/NEIL N TURK/Primary Examiner, Art Unit 1798