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 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) Measurement unit configured to measure…as in cls. 1&20.
2) Reagent container storage portion configured to store…as in cls. 1&20.
3) Cooling unit configured to cool…as in cls. 1&20.
4) Connection member configured to connect…as in cl. 8.
5) Stopper configured to stop movement…as in cl. 11.
6) Pressing portion configured to press the holder…as in cl. 12.
7) Retaining member configured to retain…as in cls. 14, 15.
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) A photodetector and equivalents thereof as seen through par.[0043] of Applicant’s pre-grant publication US 2024/0329065).
2) A receptacle and equivalents thereof as seen through pars.[0006-0007,0010-0012], figs. 2-5).
3) Those structures and equivalents thereof as seen through pars.[0057,0142].
4) Those structures and equivalents thereof as seen through pars.[0023,0104], fig. 16.
5) Those structures and equivalents thereof as seen through pars.[0064,0065,0096], figs. 7, 10, 11.
6) Those structures and equivalents thereof as seen through pars.[ 0065,0085,0097,0098,0127], figs. 7, 10, 11.
7) Those structures and equivalents thereof as seen through pars.[0066,0084,0085,0099], and likewise called as a “fastening member” therein.
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 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 metes and bounds of the sought operative embodiment of the specimen measurement apparatus are indefinitely defined herein. Claim 7 sets forth “the respective rails,” which lacks proper antecedent basis in the claims.
What is the structural/functional arrangement sought by the added rails and holders with respect to the reagent container? And it appears Applicant intends to establish a one-to-one correspondence when reciting “respective rails” among the plurality and should previously establish this before introducing “the respective rails.”
Claim 15 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 recitation “…are disposed near an outer side” is indefinitely defined as “near” is drawn to a term of degree in which the metes and bounds of the location/spacing are indefinitely set forth. The specification also does not provide a particular definition to “near” in this context.
Claims 18 and 19 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 structure(s) and arrangement to the specimen measurement apparatus are indefinitely defined herein.
Initially, the recitation to “an apparatus housing of the specimen measurement apparatus has a cover…” has been presented in a manner that makes it unclear if an apparatus housing and its cover are positively claimed elements of the specimen measurement apparatus. Further, such recitation is related to the specimen measurement apparatus as a whole in which such prospective apparatus housing and its cover are indefinitely set forth in terms of the structural/functional relationship therewith the constituent elements of the specimen measurement apparatus.
Does Applicant intend to recite something on the order of the specimen measurement apparatus further comprises an apparatus housing for holding/enclosing the measurement unit, the reagent container, the cooling unit, and the holder? [or does the apparatus housing hold/enclose only particular one(s) of the constituent elements?]
Further, the recitation “…are disposed near the cover” is indefinitely defined as “near” is drawn to a term of degree in which the metes and bounds of the location/spacing are indefinitely set forth. The specification also does not provide a particular definition to “near” in this context.
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, 9-12, and 14-19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Onuki et al. (WO 2022049722A1; as seen through in the cited Espacenet English translation), hereafter Onuki.
With regard to claim 1, Onuki discloses a specimen measurement apparatus comprising a measurement unit configured to measure a specimen by using a reagent (detection unit 604 of the analysis device 600, pars.[0011,0034] fig. 12, for example), a reagent container storage portion configured to store a reagent container in which the reagent is stored (reagent container holder 302/303; par.[0038], a cooling unit configured to cool the reagent container storage portion (cooler/refrigerator 500[notably the English machine translation shows it as item ‘100’, but appears to be properly as ‘500’], pars.[0028-0030]), and a holder (holder 101 and sliding member holding body 106) slidably mounted to the reagent container storage portion in a state where the holder holds the cooling unit (and noting “in a state where…” is drawn to a prospective intended use/process not necessitated by the claim). With regard to claim 2, Onuki discloses that the holder is movable along the bottom portion of the reagent container storage portion (see figs, 4-5 where the sliding rail member 200 is below the reagent holder, for example). With regard to claim 3, Onuki discloses a rail (sliding member holder 200) disposed along a horizontal direction at the bottom portion wherein the holder is mounted to the rail and is movable along the rail, and as in cl. 4, the rail is disposed in a groove formed in the bottom portion (a groove portion implicitly exists given that is a slidable rail arrangement). With regard to claim 5, the recitation is predicated on a prospective condition given by that of “in a state where…” in which such “state” is not necessitated by the claim and is drawn to a prospective process or use application that is not afforded patentable weight within a device claim; Onuki discloses a commensurately structured and arranged system with respect to the positively claimed elements and is thus said to be fully capable such in as much as claimed and required herein. With regard to claim 9, the holder is detachably mounted to the rail, wherein the holder may be removed by a given applicable force in terms of structure and functional capability, and wherein the act of mounting or in a detachable manner is drawn to a process recitation not afforded patentable weight in a device claim. With regard to claim 10, the recitation is drawn to a process recitation not afforded patentable weight in a device claim. With regard to claim 11, Onuki discloses a door 103 (fig. 3) to seal the cooling box 100 that provides a stopper in as much as claimed herein and wherein it is noted that the stopper’s provision is codified by a prospective, conditional action of “when the cooling unit has been moved…” that is not necessitated by the claimed device. With regard to claim 12, Onuki discloses a pressing portion 202 configured to press the holder against the bottom portion in as much as claimed and required herein, wherein the functionality (herein “configured to”) is dependent upon a prospective, conditional action of “when the cooling unit has been moved…” that is not necessitated by the claimed device. With regard to claims 14 and 15, Onuki discloses a retaining member 104 (slide rails provide functionality to place the holder in such a desired state) configured to retain the holder to the bottom portion in a state where the cooling unit is positioned at a predetermined cooling position, wherein it is noted that the conditional “in a state…” recitation is drawn to a prospective intended use/process not afforded patentable weight in a device claim, and wherein the retaining member is disposed at an end portion near an outer side of the bottom portion in the holder. With regard to claim 16, the holder can be moved as claimed, such as in a state with the holder is adjacent to and separated from the bottom portion as in fig. 3. With regard to claim 17, the holder can be moved as claimed in as much as recited and required herein wherein the potential movement capability is drawn a prospective additional element beyond that of the claimed specimen measurement apparatus. With regard to claim 18, as best understood, Onuki discloses an apparatus housing 101 that has a cover 103 (drawer door) that is detachably attached (see figs. 1-3), and the reagent container storage portion and the holder are disposed near the cover (see fig. 3 and the drawer’s “near” location with respect to the adjacent holder and reagent container). With regard to claim 19, the holder can be dismounted as claimed such as by a given applied force that yields detachment, and noting that the “in a state in which…” is drawn to a prospective, conditional state that is not necessitated by the claim; further, wherein the cover is fully capable of being detached by way of a given applied force.
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) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Behringer (US 2012/0218854), hereafter Behringer, and Uematsu et al. (USPN 6,146,882), hereafter Uematsu.
Onuki has been discussed above.
With regard to claim 6, Onuki does not specifically disclose that the holder holds a plurality of cooling units.
With regard to claims 7 and 8, Onuki does not specifically disclose a plurality of the rails and a plurality of the holders that are moved on the respective rails and a connection member configured to connect the plurality of holders to each other.
Behringer discloses a rotary reagent tray assembly holder holding cooling devices 26 (pars.[0021-0024,0030], figs. 1-3, for example).
Uematsu discloses a combined incubated and analyzer that includes a plurality of rails 20 for holding a plurality of racks that are connected to one another by carriages 19a, 19b, and wherein each of the rails are movably provided and afford the racks to be moved between different incubating blocks and cooling blocks 13 (abstract; lines 46-60, col. 5; figs. 1-3).
It would have been obvious to one of ordinary skill in the art to modify Onuki to provide a holder holds a plurality of cooling units, such as suggested by the analogous art of Behringer to a rotary reagent tray assembly holder, and to provide a plurality of the rails and a plurality of the holders that are moved on the respective rails and a connection member configured to connect the plurality of holders to each other, such as suggested by the analogous art of Uematsu to an incubator and analyzer arrangement, so as to allow for increased throughput by way of added cooling units affording further sample/reagent to be processed and assessed and likewise with respect to a plurality of the rails and a plurality of the holders that are moved along the respective rails in order to process a larger amount of samples in a shorter time frame than with fewer holders, cooling units, and rails.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Mawhirt et al. (USPN 4,944,924), hereafter Mawhirt.
Onuki does not specifically disclose a pressing portion comprising an inclined upper surface and an inclined lower surface as recited therein.
Further, it is noted that the conditional recitation to “the inclined lower surface…fit to each other when the cooling unit has been moved to the cooling position” is drawn to a conditional process step both not necessitated by the claim and also not afforded patentable weight in a device claim.
Mawhirt discloses a test tube holder wherein opposing inclined surfaces are provided as a stop surface 98 (lines 33-41, col. 6).
As discussed above, Onuki disclose a pressing portion as in claim 12, and wherein it would have been obvious to one of ordinary skill in the art through routine engineering and design choices to shape the pressing portion as in claim 13 such as suggested by the analogous art of Mawhirt to reagent holders and holding housings therefor for the likewise purpose of providing a pressing force as guided to a converged stop akin to that of the pressing portion compression spring and is seen as an obvious analog thereof in providing an alternative arrangement, and further maintained as an obvious modification for the reasons discussed above absent a showing of a criticality or unexpected results arising otherwise.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Behringer and Steuerwald et al. (US 2009/0293645), hereafter Steuerwald.
Onuki has been discussed above.
As likewise provided above with respect to claim 1, Onuki discloses the likewise-recited specimen measurement apparatus as recited in claim 20.
Onuki does not particularly disclose dismounting the holder holding the cooling unit from the reagent container storage portion and mounting the holder holding a new cooling unit or a new holder holding a new cooling unit to the reagent container storage portion.
Behringer discloses a rotary reagent tray assembly holder holding cooling devices 26 and reagent packs 20, 35, wherein the cooling devices are releasable (abstract; pars.[0021-0024,0030], figs. 1-3, for example).
Steuerwald discloses a reagent sampler device for automated sampling taking, and discloses it is known to provide a cooling module in the housing of the online analyzer for cooling the reagents and/or sample, as well as a desire to replace a defective cooling unit, and preferably without replacing the complete housing, such as by way of equipping a cooling module that can be easily installed or uninstalled on the housing of the sampler or online analyzer(abstract; pars.[0008,0009,0014], figs., for example).
It would have been obvious to one of ordinary skill in the art to provide a maintenance method in dismounting the holder holding the cooling unit from the reagent container storage portion and mounting the holder having a new cooling unit or a new holder holding a new cooling unit to the reagent container storge section such as suggested by the analogous art of Behringer to rotary reagent tray assembly holder for holding and conveying cooling devices and reagent packs and Steuerwald in a reagent sampler utilizing a cooling module in an online analyzer that can be easily installed/uninstalled, in which one of ordinary skill in the art would appreciate a replacement operation in which the holder having a defective or old cooling unit is uninstalled and replaced with a new cooling unit in order to continue with desired and proper reagent sampling, preparation, and analysis thereof in the analyzer. Further, the provision of the holder being slidably mounted to the reagent container in lieu of the rotary mounting in Behringer is drawn to a matter of routine engineering and design choice in which a choosing of slidable movement as opposed to rotary movement is a matter of design choice for a likewise desired function of affording selective movement to processing stations and particular locations in the analyzer, and is also seen as obvious absent a showing of a criticality or unexpected results arising otherwise.
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
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