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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
It is recommended to change “a sample” in line 6 of claim 1 to “the sample” for consistency with the remainder of the claim.
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 configured to chemically disrupt the sample by adding a predetermined component to the sample, sort out a contaminating microorganism from a sample, and concentrate 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, 5-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trudil (US Patent 6,395,504).
Regarding claim 1, Trudil discloses a microorganism detection apparatus that detects a contaminating microorganism in a sample (col. 2 lines 59-62), the microorganism detection apparatus comprising:
a pre-treatment unit (comprising disposable test device) configured to chemically disrupt the sample by adding a predetermined component (called somatic cell lysing agent) to the sample (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 29), sort out a contaminating microorganism from a sample (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 44), and concentrate the contaminating microorganism (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 44) (note: the prior art pre-treatment unit comprises at least a compartment 13 and inlet 8 for receiving the sample, a filter 11 for sorting and concentrating the contaminating microorganism, and a compartment 16 and outlet 9 for removing a liquid phase, see col. 4 line 3-col. 5 line 15 and col. 7 line 33-col. 8 line 44, and thus reads on the claimed pre-treatment unit); and
a measurement unit that measures a content of adenosine triphosphate (ATP) in a concentrate obtained as a result of concentration by the pre-treatment unit (col. 2 lines 59-67, col. 4 line 3-col. 5 line 15, col. 8 line 30-col. 9 line 7) (note: the prior art measurement unit comprises at least a luminometer instrument for measuring ATP content in the concentrate, see col. 8 line 30-col. 9 line 7, and thus reads on the claimed measurement unit),
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 and/or filtering (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 44).
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 apparatus disclosed by Trudil sorts out the contaminating microorganism from the sample by removing a cell other than the contaminating microorganism in the sample by chemical disruption. Specifically, Trudil discloses conducting chemical disruption by adding a somatic cell lysing solution to the sample (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 29). Although Trudil does not expressly teach wherein the somatic cell lysing solution comprises one or more selected from a predetermined culture medium component, a surfactant, an enzyme, an apoptosis inducer, and a cytolysin, the apparatus disclosed by Trudil would nonetheless be fully capable of operating such that a solution comprising one or more of the claimed components is added. E.g., the apparatus is fully capable of operating such that a lysis solution comprising a surfactant, as is notoriously well known in the field of lysing solutions, is added during use of the pre-treatment unit. Therefore, the claim does not introduce a patentable distinction over the prior art.
Regarding claim 5, Trudil discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate (col. 2 lines 59-67, col. 4 line 3-col. 5 line 15, col. 8 line 30-col. 9 line 7).
Regarding claim 6, Trudil discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate (col. 2 lines 59-67, col. 4 line 3-col. 5 line 15, col. 8 line 30-col. 9 line 7). 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). Trudil 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, Trudil discloses wherein the measurement unit measures a content of ATP extracted from the contaminating microorganism in the concentrate (col. 2 lines 59-67, col. 4 line 3-col. 5 line 15, col. 8 line 30-col. 9 line 7). 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). Trudil 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). Trudil discloses wherein the sample comprises somatic cells as well as the contaminating microorganism (col. 4 line 3-col. 5 line 15) and wherein the sample may comprise a body fluid (col. 6 lines 55-56), 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, e.g., a sample comprising a cultured cell-containing body fluid.
Regarding claim 12, Trudil discloses wherein the pre-treatment unit is configured to chemically disrupt cells other than the contaminating microorganism in the sample (col. 4 line 3-col. 5 line 15, col. 7 line 33-col. 8 line 44).
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 Trudil (US Patent 6,395,504) in view of Boyette et al. (US Patent Application Publication 2010/0112682) (already of record).
Regarding claim 9, Trudil discloses wherein the apparatus further comprises a unit (called container) provided in a preceding stage of the pre-treatment unit for handling the sample before the sample is received by the pre-treatment unit (col. 7 lines 33-67).
Trudil is silent as to the unit comprising a biofilm decomposition unit that decomposes a biofilm.
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 unit provided preceding the pre-treatment unit disclosed by Trudil 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
