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 .
Status of Claims
There are three (3) set of claim submitted on 31 AUGUST 2023. The claim set considered is the set where the claims have status identifiers consisting of three (3) pages. In the claim set, Claim 1, 3, 4, 8, 6, 7 is ‘Previously Amended’ or ‘Original’; and Claim 2 is ‘Cancelled’.
Current pending claims are Claims 1 and 3-7 and are considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 31 AUGUST 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 19 OCTOBER 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 11 DECEMBER 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A “sample dispensing mechanism configured to discharge a sample” in Claims 1 and 7.
A “mechanism” does not connotate any particular structure. The specification describes a “dispensing mechanism” to be a plunger, [0016] and in Claim 1.
A “reagent dispensing mechanism configured to discharge a sample” in Claims 1 and 7.
A “mechanism” does not connotate any particular structure. The specification describe a “dispensing mechanism” to be a plunger, [0016] and in Claim 1.
A “plunger drive unit configured to drive the plunger” in Claims 1 and 7. The specification describes the “drive unit” to be a motor, ball screw and a drive plate, [0034].
A “control unit configured to control operations…” in Claims 1 and 7.
A “unit” does not connote any particular structure. The specification describes a “unit” to be electrolyte analysis unit , [0024].
A “display unit…to display…” in Claim 4.
A “unit” does not connote any particular structure. The specification does not describes the “display unit” .
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 4 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.
Claim limitation ““display unit…to display…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of “to display” is performed by displaying. There is no disclosure of any particular structure, either explicitly or inherently, to display. The use of the term “display unit” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which displaying structure or structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 5 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.
Instant Claim 5 lack a proper transitional phrase. In Claim 5, the language recites ‘the automated analysis device includes…’. It is interpreted by the Examiner that ‘includes’ has the same meaning as ‘comprises’ or ‘comprising’.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As described above, the disclosure does not provide adequate structure to perform the claimed function of “to display”. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over KOSAKA , JP 2002-350453 A, submitted on the Information Disclosure Statement on 31 AUGUST 2023.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the KOSAKA reference discloses an automated analysis device, abstract, Figure 1, device, [0010], comprising:
a sample dispensing mechanism having a liquid-level sensing function and configured to discharge a sample into a liquid storage container, Figure 1, dispensing nozzle 50 with electrode 54 into cell 60 [0010-0012];
a reagent dispensing mechanism configured to discharge a reagent into the liquid storage container, Figure 1, [0010], liquid is injected into a cell 60; and
a control unit configured to control operations of the sample dispensing mechanism and the reagent dispensing mechanism and analyze the sample, Figure 1, control unit 130/160, [0015], Claim 4 and 5, wherein the sample dispensing mechanism and the reagent dispensing mechanism each include a nozzle configured to aspirate and discharge liquid and a drive unit configured to drive the unit, [0015], Claim 4 and 5, and
the control unit performs operation control by the drive unit of at least one of the sample dispensing mechanism or the reagent dispensing mechanism such that the unit moves reciprocally a predetermined number of times by a distance of the backlash, [0015-0024], and detects failure of the nozzle by detecting an amount of liquid discharged into the liquid storage container by the liquid-level sensing function, Claims 4-6, [0006, 0010-0012].
The KOSAKA reference discloses the claimed invention, but is silent in regards to specifically a plunger, but the reference does teach liquid are dispensed and sucked by a pump and controlled by control unit and since the nozzle unit pump, it inherently has a plunger.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date modify KOSAKA to nozzle unit include a plunger drive unit to accurately dispense and suction liquid into and out the reaction cell.
Regarding Claim 3-6, the instant claim language is directed at steps of the intended use of the apparatus rather than a structural feature. Applicant’s invention is directed towards an apparatus. Applicant is reminded that an “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Since KOSAKA teaches and/or suggests the structural features of the claimed invention the way Claims 3-6 are presented, the reference teaches and/or suggests Claims 3-6.
See Examiner’s Note below for suggestion of allowable subject matter.
Applicant’s invention is directed towards a method.
Regarding Claim 7, the reference KOSAKA discloses a failure detection method of an automated analysis device, Claim 11, the automated analysis device including:
a sample dispensing mechanism having a liquid-level sensing function and configured to discharge a sample into a liquid storage container, Figure 1, dispensing nozzle 50 with electrode 54 into cell 60 [0010-0012];
a reagent dispensing mechanism configured to discharge a reagent into the liquid storage container, Figure 1, [0010], liquid is injected into a cell 60; and
a control unit configured to control operations of the sample dispensing mechanism and the reagent dispensing mechanism and analyze the sample, Figure 1, control unit 130/160, [0015], the sample dispensing mechanism and the reagent dispensing mechanism each including a nozzle configured to aspirate and discharge liquid and a drive unit configured to drive the unit, [0015],
the failure detection method of the automated analysis device comprising:
performing operation control by the drive unit of at least one of the sample dispensing mechanism or the reagent dispensing mechanism such that the nozzle moves reciprocally a predetermined number of times by a distance of the backlash [0015-0024]; and
detecting failure of the nozzle by detecting an amount of liquid discharged into the liquid storage container by the liquid-level sensing function, Claims 4-6, [0006, 0010-0012].
The KOSAKA reference discloses the claimed invention, but is silent in regards to specifically a plunger, but the reference does teach liquid are dispensed and sucked by a pump and controlled by control unit and since the nozzle unit pump, it inherently has a plunger. Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date modify KOSAKA to nozzle unit include a plunger drive unit to accurately dispense and suction liquid into and out the reaction cell.
Examiner’s Note
Possible Allowable Subject Matter
As mentioned above, Claims 3-6 are not directed towards structural limitations of the device, but rather its intended use and limitations of possibly what the control unit does when it is being used. If Applicant where to change the language in Claims 3-6 to language such as ‘the control unit is configured to determine the failure of the plunger…’ or ‘the control unit is programed to determine the failure of the plunger…’; this would possibly make the Claim 3 define over the art of record. Similarly, in Claim 4, if the language was amended to recite ‘when the control unit is programmed to/configured to detect the failure…’. If Applicant has questions regarding particular language, please reach out the Examiner and set up an interview.
Keep in mind, Claim 1 is rejected under art.
The claim language in Claim 3 directed towards “wherein the automated analysis device according to claim 1, wherein the failure of the plunger is failure in which a plunger fixing nut configured to fix the plunger and the plunger drive unit is not attached to the plunger.” is not found or suggested in the prior art.
While it is known in the art to detect a disorder of a syringe pump, as submitted by Applicant on the IDS, US Publication 2006/0129084 A1, and to clean an aspiration tube, US Publication No. 2020/0306804 A1, these methods fail to teach or suggest the requirement of “wherein the failure of the plunger is failure in which a plunger fixing nut configured to fix the plunger and the plunger drive unit is not attached to the plunger”. As Applicant has explain in the specification in [0011-0014], dispensing abnormality is due to forgetting to attach the plunger fixing nut of the syringe pump unit occurs, the occurrence of the dispensing abnormality can be detected, but it is difficult to detect that the reason is forgetting to attach the plunger fixing nut.
The Examiner has searched the prior art using text searching, inventor/assignee search, forward/backward and more like this searching of prior art and is unable to find a reference that would at least suggest the feature in Claim 3 of detecting an abnormality or failing of the plunger by determining whether or not a plunger fixing nut of the syringe pump unit is attached.
Claims 4-6 depend directly or indirectly from Claim 3 and are also objected to.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797