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 .
Specification
The disclosure is objected to because of the following informalities:
In the specification, para 0006 [1] recites “hemolysys”, however, should recite “hemolysis”.
Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites "(e.g., Lysis buffer)" . A suggestion would be to delete the phrase 'e.g.’. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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. Such claim limitation is: ‘a means for mixing a culture of a blood sample’ in claim 11. A “ means” does not connate any particular structure. The specification describes the “a means for mixing a culture of a blood sample” to be stirring and shaking equipment (Specification, para 0032). Under the 3-prong analysis, the limitation should be interpreted under § 112(f) for the following reasons:
The claim limitation uses the term “means” or a term used as a substitute for “means” that is a generic placeholder.
The term “means” or the generic placeholder is modified by functional language. The term “means” is modified by functional language “for mixing a culture of a blood sample”.
The term “means” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. See MPEP §2181(I). The term “means” is not modified by sufficient structure.
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.
Claims 1, 2, 4, 7, 8, 9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Setoguchi (JP 2003207497 A). The examiner has obtained an archived written translation of the JP document above from Translation Service Center (TSC) Archive database. The rejection below is based off the written translation.
Regarding claim 1, Setoguchi teaches a hemolysis reagent (pg 13, para 0028) for use in a pretreatment for a clinical microbiological test (pg 3, par 0002-0003), comprising a nonionic surfactant (pg 15, section 6), wherein the test comprises a bacterial identification test or a drug susceptibility test.
Regarding claim 2, Setoguchi teaches the hemolysis reagent wherein the nonionic surfactant comprises a polyoxyethylene (POE) alkyl ether (pg 15, section 6).
Regarding claim 4, Setoguchi teaches the hemolysis agent further comprising a dispersing agent (pg 14 , section 1).
Regarding claim 7, Setoguchi teaches a pretreatment kit for a clinical microbiology test, comprising the hemolysis reagent (pg 15, section 6) and a dispersing agent to be mixed with the hemolysis reagent (pg 14 , section 1).
Regarding claim 8, Setoguchi teaches a pretreatment method for a clinical microbiological test, comprising a step of mixing a culture of a blood sample collected from a subject and the hemolysis reagent to obtain a hemolyzed sample (pg 23, para 0048).
Regarding claim 9, Setoguchi teaches the pretreatment method comprising a step of removing impurities from the mixture of the culture and the hemolysis reagent by filtration (pg 29, Section: Measurement result).
Regarding claim 12, Setoguchi teaches a clinical microbiology testing system, comprising the pretreatment system (pg 23, para 0048).
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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Setoguchi (JP 2003207497 A) as applied to claims 1 above.
Regarding claim 11, Setoguchi teaches mixing a culture of a blood sample collected from a subject and the hemolysis reagent to obtain a hemolyzed sample (pg 23, para 0048).
Setoguchi does not mention a stirring and shaking device.
Although, Setoguchi does not explicitly mention a “stirring or shaking device”, there are only a finite number of ways to mix the hemolyzing reagent and the blood sample. These methods of stirring or shaking the two reagents would lead to the predictable solution of the reagents being mixed together. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to use a stirring and shaking device to mix the hemolyzing reagent and the blood sample as taught in Setoguchi. See MPEP 2143(E).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Setoguchi (JP 2003207497 A) as applied to claims 1 and 2 above.
Regarding claim 3, Setoguchi teaches the hemolysis reagent wherein the nonionic surfactant comprises a polyoxyethylene (POE) alkyl ether (pg 15, section 6).
Setoguchi does not specifically teach POE alkyl ether comprises a POE (7) alkyl (sec-C11-15) ether.
Although Setoguchi reference does not teach the specific nonionic surfactant called POE (7) alkyl (sec-C11-15) ether, Setoguchi does teaches that the nonionic surfactant could include various polyoxyethylenes such as POE (n) dodecyl ether and POE (7) decyl ether (pg 15, section 6) for the hemolysis reagents because it doesn’t affect the bacteria in the blood (pg 29, para 0057). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Setoguchi with POE (7) alkyl (sec-C11-15) ether as the nonionic surfactant for the benefit of not effecting the bacteria in the blood (pg 29, para 0057).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Setoguchi (JP 2003207497 A) as applied to claims 1 and 4 in view of non-patent literature “Lipid emulsions as a novel system to reduce the hemolytic activity of lytic agents: mechanism of the protective effect” by Jumaa et al.
Regarding claim 5, Setoguchi teaches the hemolysis agent further comprising a dispersing agent (pg 14 , section 1). Setoguchi further teaches that salts can be combined with nonionic surfactants to be the hemolyzing reagent (pg 13-15).
Setoguchi does not teach the dispersing agent comprises a long-chain saturated fatty acid salt or a long-chain unsaturated fatty acid salt.
However, Jumaa teaches the micellular formation and hemolytic activity to understand drug delivery systems (pg, 285, Introduction). Jumaa teaches hemolytic activity of sodium oleate in various surfactants (pg, 285, Abstract) because sodium oleate lead to complete hemolysis (pg 286, Results). Sodium oleate is a long chain unsaturated fatty acid salt. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Setoguchi with sodium oleate as taught by Jumaa because sodium oleate lead to complete hemolysis (pg 286, Results).
Regarding claim 6, Setoguchi teaches the hemolysis agent further comprising a dispersing agent (pg 14 , section 1). Setoguchi further teaches that salts can be combined with nonionic surfactants to be the hemolyzing reagent (pg 13-15).
Setoguchi does not teach the long-chain unsaturated fatty acid salt comprises an oleate salt.
However, Jumaa teaches hemolytic activity of sodium oleate in various surfactants (pg, 285, Abstract) because sodium oleate lead to complete hemolysis (pg 286, Results). Sodium oleate is an oleate salt. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Setoguchi with sodium oleate as taught by Jumaa because sodium oleate lead to complete hemolysis (pg 286, Results).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Setoguchi (JP 2003207497 A) as applied to claims 1 and 8 in view of Kaminagayoshi (JP 59196084 A). The examiner has obtained a machine translation of the JP document above from J-Plat Pat. The rejection below is based off the machine translation.
Regarding claim 10, Setoguchi teaches a pretreatment method for a clinical microbiological test, comprising a step of mixing a culture of a blood sample collected from a subject and the hemolysis reagent to obtain a hemolyzed sample (pg 23, para 0048).
Setoguchi does not teach introducing the hemolyzed sample into a bacterial identification testing system and/or a drug susceptibility testing system.
However, Kaminagayoshi teaches introducing the hemolyzed sample into a bacterial identification testing system and/or a drug susceptibility testing system for the benefit of determining the efficacy of an antibacterial agent (pg 2, Section: Technical Field). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings in Setoguchi with the bacterial identification testing system or a drug susceptibility testing system as taught by Kaminagayoshi for the benefit determining the efficacy of an antibacterial agent (pg 2, Section: Technical Field).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Setoguchi (JP 2003207497 A) as applied to claims 1, 11, and 12 in view of Kaminagayoshi (JP 59196084 A). The examiner has obtained a machine translation of the JP document above from J-Plat Pat. The rejection below is based off the machine translation.
Regarding claim 13, Setoguchi teaches a pretreatment method for a clinical microbiological test, comprising a step of mixing a culture of a blood sample collected from a subject and the hemolysis reagent to obtain a hemolyzed sample (pg 23, para 0048).
Setoguchi does not teach introducing the hemolyzed sample into a bacterial identification testing system and/or a drug susceptibility testing system.
However, Kaminagayoshi teaches introducing the hemolyzed sample into a bacterial identification testing system and/or a drug susceptibility testing system for the benefit of determining the efficacy of an antibacterial agent (pg 2, Section: Technical Field). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings in Setoguchi with the bacterial identification testing system or a drug susceptibility testing system as taught by Kaminagayoshi for the benefit determining the efficacy of an antibacterial agent (pg 2, Section: Technical Field).
Conclusion
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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