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 .
Election/Restrictions
Applicant's election with traverse of Group I and the chemical disruption species in the reply filed on 03/12/2026 is acknowledged. The traversal is on the ground(s) that the apparatus and the method recite the same technical features in view of the claim amendments dated 03/12/2026. This is not found persuasive because the technical feature common to both independent claims is now a pretreatment unit that sorts out contaminating microorganism from a sample and concentrates the contaminating microorganism by physical disruption, chemical disruption, and/or filtering, and a measurement unit that measures a content of ATP in a concentrate obtained by concentration. However, this feature is not a special technical feature as it does not make a contribution over the prior art. Nakai et al. (WO 2020045053 A1) (machine translation) discloses a pretreatment unit that sorts out contaminating microorganisms from a sample and concentrates the contaminating microorganism by filtering and/or chemical disruption (p. 3 lines 14-39) and a measurement unit that measures a content of ATP in a concentrate obtained by concentration (p. 3 lines 34-39). Furthermore, the Examiner maintains that the species election requirement is proper because the common technical feature, sorting out contaminating microorganism, is not a special technical feature as it does not make a contribution over the prior art, because Nakai et al. discloses sorting out contaminating microorganism as set forth above.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 4, and 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/12/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/08/2024 and 07/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
It is believed claim 9 should read “The microorganism detection apparatus according to .
Appropriate correction is required.
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 pre-treatment unit that sorts out a contaminating microorganism from a sample and concentrates the contaminating microorganism in claim 1
(This limitation has been interpreted to cover a bottle, a cartridge mounted to a lower end opening of the bottle, and a filter included therein as described in the specification, see para. 55, and equivalents thereof);
a measurement unit that measures a content of adenosine triphosphate (ATP) in a concentrate in claim 1
(This limitation has been interpreted to cover an ATP meter as described in the specification, see para. 25, and equivalents thereof); and
a biofilm decomposition unit that decomposes a biofilm in claim 9
(This limitation has been interpreted to cover a filtration apparatus or a biofilm-decomposing enzyme as described in the specification, see para. 82, and equivalents thereof).
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 § 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.
Claims 1, 3, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakai et al. (WO 2020045053 A1) (machine translation).
Regarding claim 1, Nakai et al. discloses a microorganism detection apparatus that detects a contaminating microorganism in a sample (p. 3 lines 14-16, p. 6 lines 45-49), the microorganism detection apparatus comprising:
a pre-treatment unit (called pretreatment device) that sorts out a contaminating microorganism from a sample and concentrates the contaminating microorganism (p. 3 lines 14-39) (specifically, the pretreatment device comprises a bottle, a cartridge mounted to a lower end opening of the bottle, and a filter included therein, see p. 3 lines 14-39 and Fig. 7, and therefore reads on the claimed pre-treatment unit consistent with the 112(f) interpretation discussed above); and
a measurement unit (called analyzer) that measures a content of adenosine triphosphate (ATP) in a concentrate obtained as a result of concentration by the pre-treatment unit (p. 3 lines 14-39) (specifically, the analyzer is a sample analyzer that measures amounts of ATP, see p. 3 lines 34-39, and therefore reads on the claimed measurement unit consistent with the 112(f) interpretation discussed above).
As to the limitation wherein the pre-treatment unit sorts out the contaminating microorganism from the sample by removing a cell other than the contaminating microorganism in the sample by chemical disruption (elected species), this limitation represents an intended use of the pre-treatment unit and has been given appropriate patentable weight. It is well established that "[A]pparatus claims cover what a device is, not what a device does." (MPEP 2114). In this case, the limitation does not add any additional structural component and only further limits the prior art inasmuch as the prior art pre-treatment unit must be fully capable of sorting out the contaminating microorganism from the sample by removing a cell other than the contaminating microorganism in the sample by chemical disruption. Applicant’s own specification indicates that the chemical disruption is performed by adding a disruption chemical such as a predetermined culture medium component, a surfactant, an enzyme, an apoptosis inducer, or a cytolysin to the sample (para. 66). The pre-treatment unit disclosed by Nakai et al. is structurally capable of achieving the claimed intended use, because a user could add one or more of a disruption chemical such as a predetermined culture medium component, a surfactant, an enzyme, an apoptosis inducer, or a cytolysin into the bottle, which holds the sample (see p. 3 lines 18-39), so as to selectively remove a cell other than the microorganism. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Regarding claim 3, the entirety of the claim is directed to an intended use of claimed apparatus rather than a further structural limitation of the apparatus, and has therefore been given appropriate patentable weight (MPEP 2114). As discussed in the rejection of claim 1, above, the pre-treatment unit disclosed by Nakai et al. is fully capable of being used such that a user adds one or more selected from a predetermined culture medium component, a surfactant, an enzyme, an apoptosis inducer, and a cytolysin. Therefore, the claim does not introduce a patentable distinction over the prior art.
Regarding claim 5, Nakai et al. discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate (p. 3 lines 9-39).
Regarding claim 6, Nakai et al. discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate after the addition of reagents (p. 3 lines 9-39). As to the limitation after the addition of an ATP scavenger that removes free ATP, this limitation is directed to an intended use of the apparatus rather than a further structural limitation of the apparatus, and has therefore been given appropriate patentable weight (MPEP 2114). Nakai et al. discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate after the addition of reagents, as discussed above, and therefore the measurement unit would be fully capable of measuring after the addition of a reagent such as an ATP scavenger that removes free ATP.
Regarding claim 7, Nakai et al. discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate after the addition of reagents (p. 3 lines 9-39). As to the limitation after the addition of a spore reaction solution that germinates the contaminating microorganism in a form of a spore, this limitation is directed to an intended use of the apparatus rather than a further structural limitation of the apparatus, and has therefore been given appropriate patentable weight (MPEP 2114). Nakai et al. discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate after the addition of reagents, as discussed above, and therefore the measurement unit would be fully capable of measuring after the addition of a reagent such as a spore reaction solution that germinates the contaminating microorganism in a form of a spore.
Regarding claim 8, the entirety of the claim is directed to a further limitation of the sample; however, the sample is not a positively recited structural component of the apparatus. Thus, the claim is directed to an intended use of the apparatus rather than a further structural limitation of the apparatus, and has therefore been given appropriate patentable weight (MPEP 2114). Nakai et al. discloses wherein the apparatus is configured to handle a liquid sample including a microorganism (p. 3 lines 9-39) and therefore the apparatus is fully capable of operating with a sample that contains a cultured cell as a cell other than the contaminating microorganism.
Claim Rejections - 35 USC § 103
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nakai et al. (WO 2020045053 A1) (machine translation) in view of Boyette et al. (US Patent Application Publication 2010/0112682).
Regarding claim 9, Nakai et al. discloses the apparatus that detects a contaminating microorganism in a sample, as set forth above.
Nakai et al. is silent as to the apparatus further comprising a biofilm decomposition unit that decomposes a biofilm, wherein the biofilm decomposition unit is provided in a preceding stage of the pre-treatment unit.
Boyette et al. is directed to detecting contaminating microorganisms in a sample (Abstract, para. 5-10) and discloses that any biofilms present within the sample should be dispersed, e.g. by means of a sonication bath, prior to detection to improve detection (para. 7-8, 60-63).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the apparatus disclosed by Nakai et al. to comprise a sonication bath that decomposes a biofilm (reads on the claimed biofilm decomposition unit consistent with the 112(f) interpretation discussed above), based on the teachings of Boyette et al., in order to improve microorganism detection in the event that the sample includes a biofilm. As to the limitation of the biofilm decomposition unit being provided in a preceding stage of the pre-treatment unit, this is best understood as a recitation of intended use of the claimed biofilm decomposition unit and has therefore been given appropriate patentable weight. The biofilm decomposition unit (sonication bath) taught by the prior art would be fully capable of being used in a preceding stage of the pre-treatment unit, e.g., a sample could be sonicated prior to being treated in the pre-treatment unit. Therefore, this limitation does not introduce a patentable distinction over the prior art.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fleming et al. (US Patent Application Publication 2011/0076706) is directed to sorting out a contaminating microorganism from eukaryotic cells in a sample within a tube via chemical disruption, and subsequently measuring a content of ATP in the concentrate by an luminometer.
Nakagawa et al. (US Patent Application Publication 2020/0110033) is directed to a measurement device for measuring ATP in a sample comprising a photodetector, sample holder, holder driving mechanism, and light shielding mechanism.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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