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 amendment filed September 11th, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The amendments made in par.[0006] are drawn to new matter in the specification.
The recited “consumables storage unit that stores consumables required for the analysis…” is not supported by the original disclosure, wherein various “storage units” are disclosed but do not clearly or adequately correlate with the disclosed “consumables storage unit that stores…” [the original disclosures at pages 38 and 39 to the “Reference Signs List” provides a waste container 31 (storage unit), waste liquid container 32 (storage unit), system reagent container 33 (storage unit), system water container (storage unit), and assay chip container 35 (storage unit) ].
Further, the original disclosure does not support the amended discussion to “wherein the reagent cover is a structure that is impossible to open when the main cover is not opened…”
Further, the amended disclosure in par.[0119] to “LED 31a, 32a, 33a,34a, 35b, or 36b disposed around…” appears to be drawn to new matter in the disclosure.
LEDs 31a, 32a, 33a,34a, 35b, or 36b are previously discussed as being set around installation parts of the waste container 31, waste liquid container 32, the system reagent container 33, the system water container 34, the assay tip container 35, and the reaction vessel container 36 (see par.[0117]).
Par.[0118] speaks to the control unit flickering LEDs 22b, 23b, 31a, 32a, 33a, 34a, 35b, or 36b.
Further to the above, as the installation parts are not numerically identified in the disclosure and the accompanying drawings, it cannot be confirmed that this amended recitation in par.[0119] is supported by the original disclosure.
Examiner further notes that Applicant has not provided cited support at particular paragraphs within the original disclosure that provide support for the amendments and instead provides a general discussion that no new matter is added, which precludes a more complete assessment of the added disclosure.
Applicant is required to cancel the new matter in the reply to this Office Action.
Priority
Coincident with the above-discussed new matter added to the disclosure, the prior date is herein given as the date of such filed, amended specification of January 11th, 2024.
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:
1) One or more mechanisms…used for analysis of the specimen as in cls. 14, 24.
2) Consumables storage unit that stores consumables…as in cls. 14, 24.
3) Sensing unit that senses…as in cls. 14, 24.
4) Display unit that displays…as in cls. 14, 24.
5) Control unit that controls…as in cls. 14, 24.
6) Memory unit that memorizes as in cl. 14.
7) Residual amount management unit that manages a residual amount…as in cls. 20,22.
8) Waste storage unit that stores a waste…as in cl. 21.
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.
1) Unclear from the disclosure. *Further clarification is required.
2) Unclear form the disclosure. *Further clarification is required.
3) A sensor for the main cover and a sensor for the reagent cover, and equivalents thereof (see par.[0036]).
4) A display and equivalents thereof (see par.[0045]).
5) A computer, processor, and equivalents thereof (see par.[0046]).
6) A hard disk and equivalents thereof (see par.[0046]).
7) Unclear from the disclosure. Examiner notes pars.[0046,0051,0063,0094], however, further clarification is required as to its constituent and equivalent structural elements for the recited functionality.
8) Unclear from the disclosure. Examiner notes par.[0044], however the language is not the same and two different containers are provided, wherein clarification is required.
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 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.
Claims 14-25 are 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.
With regard to independent claims 14 and 24, The recited “consumables storage unit that stores consumables required for the analysis…” is supported by the original disclosure, wherein various “storage units” are disclosed but do not clearly or adequately correlate with the disclosed “consumables storage unit that stores consumables required for analysis…” [the original disclosures at pages 38 and 39 to the “Reference Signs List” provides a waste container 31 (storage unit), waste liquid container 32 (storage unit), system reagent container 33 (storage unit), system water container (storage unit), and assay chip container 35 (storage unit) ].
Further, as in cls. 14 and 24, the original disclosure does not support the recitation to “wherein the reagent cover is a structure that is impossible to open when the main cover is not opened…”
As in claim 21, the original disclosure does not support the recitation “waste storage unit that stores a waste used for the analysis.”
Examiner notes that par.[0044] discusses two different containers in that of a waste container 31, and waste liquid container 32, but does not provide adequate disclosure to the claimed “waste storage unit that stores a waste used for the analysis.”
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 14-25 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 automatic analyzer and its recited reagent cover are indefinitely defined herein.
Claims 14 and 24 recite “the reagent cover is a structure that is impossible to open when the main cover is not opened,” in which such recitation is indefinitely understood.
The qualification of “impossible to open” is indefinitely provided as it is self-contradictory as it proclaims that something cannot happen while at the same time implicitly providing that it is possible.
Further, and practically speaking, it is seen that given an applied force of sufficient amount the main cover will open.
The specification does not remedy this in providing a particular definition/meaning to “impossible to open.”
Does Applicant intend to provide a particular locking mechanism, a particular computer programming that selectively maintains a closed state therewith?
Does Applicant intend a particular structural, layered arrangement of the disposition of the main cover to the reagent cover (further noting that the general recitation in cls. 14/24 to “the main cover that covers the mechanism and the reagent cover” does not provide for this “impossible to” recitation, and further noting “impossible to” itself is a problematic, indefinite recitation for the additional reasons discussed above)?
Clarification as to the “the structure” of the reagent cover is required.
Further, as discussed above, items 1, 2, 7, and 8 from the “Claim Interpretation” section are unclearly defined in their structure(s) and equivalents thereof that provide for their respective recited functionalities.
With respect to item 1) and the “One or more mechanisms…used for analysis of the specimen as in cls. 14, 24,” Examiner notes that the disclosure speaks of a reagent dispensing mechanism 51, of a sample dispensing mechanism 52 (par.[0015)), in addition to a conveying mechanism (par.[0016]), and grasping mechanism (par.[0022]), but does not clearly set forth “One or more mechanisms…used for analysis of the specimen as in cls. 14, 24.”
Initially, Examiner asserts that it would appear Applicant’s intentions lie in the realm of the two dispensing mechanisms 51, 52.
Examiner notes that the claim recites “one or more mechanisms…” in which a choosing of a single one of the [assumed] reagent or sample dispensing mechanism would not provide for the “are used for analysis of the specimen,” in which it is seen from the preamble that the dispensing of specimen and reagent are necessary for reaction with one another to analyte the reacted liquid.
Does Applicant intend to claim a sample dispensing mechanism and a reagent dispensing mechanism included along with the reagent disk that holds a reagent container?
To this end, it should also be noted that the claims are absent positive provision to a source of specimen itself (i.e. a holder/receptacle that contains specimen that may be accessed by such a dispensing mechanism to withdraw).
Examiner lastly notes that while the recitation to “one or more mechanism that include a reagent disk that holds…” sets forth structure, this recitation remains properly construed under 35 USC 112 F/6th as the structure of a reagent disk alone does not suffice for the claimed functionality of “are used for analysis of the specimen.”
Further, the reagent dispensing mechanism and sample dispensing mechanisms themselves are further defined by additional means-for-type recitations in that of “rotational drive mechanism and vertical drive mechanism” that are not particularly discussed in terms of the constituent structure(s) thereof. Are these drawn to dispensers with a guide rail/arm and rotor that afford X-Y movement and rotational movement?
Further, item 2 of the Consumables storage unit that stores consumables…as in cls. 14, 24 is indefinitely defined in its constituent structure(s) and equivalents thereof that provide for the recited functionality.
Examiner notes that the original disclosures at pages 38 and 39 to the “Reference Signs List” provides a waste container 31 (storage unit), waste liquid container 32 (storage unit), system reagent container 33 (storage unit), system water container (storage unit), and assay chip container 35 (storage unit).
Is the consumable storage unit, as claimed herein, one or a combination of these containers/storage units?
With regards to claims 20 and 22 and item 7) Residual amount management unit that manages a residual amount…, the corresponding structure(s) and equivalents thereof are indefinitely defined.
Examiner notes pars.[0046,0051,0063,0094], however, clarification is required. This appears to be drawn to a non-physical element as in particular software or the like, however, particular and disclosure thereto is not found.
As in item 8 and the Waste storage unit that stores a waste…as in cl. 21, the corresponding structure(s) and equivalents thereof are indefinitely defined.
Examiner notes par.[0044], however the language is not the same and two different containers are provided, wherein clarification is required.
Lastly, as in claims 14 and 24, the recitation “the mechanism” (found within the recitation to the ‘control unit’) lacks proper antecedent basis in the claims in which the claims previously establish one or more mechanism. Applicant may intend to recite “the one or more mechanisms.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kitagawa et al. (US 2008/0014118) discloses an automated analyzer in which an LED indicator light functions to alert the user that the reagent container rack corresponding to a reagent on the reagent table specified by the user on a reagent placement screen has been moved to a pick up position, as well with respect to another LED indicator light with respect to a second reagent container and corresponding reagent to a second reagent table, which is relevant to Applicant’s field of endeavor.
Hamada et al. (US 2011/0244557) discloses an automated analyzer including a computer for reading out a notification message from the hard disk to display a message that there is no reagent and to open the cover and replace the reagent container, and wherein when the opened cover is different from the cover of the holder section corresponding to the reagent replacement target, the computer reads out a notification message and display the message that a cover not corresponding to the replacement target has been opened and to close the cover, which is relevant to Applicant’s field of endeavor.
Ariyoshi et al. (US 2014/0119994) discloses an automated analyzer that has a reagent replace/add button to be pressed while the reagent display region shows the layout of the reagent containers and rotatable reagent tables, and provides that the reagent container which corresponds to the specified reagent display section is moved directly below the particular cover therefor, which is relevant to Applicant’s field of endeavor.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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