DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group I, claims 1-13, and the species of a combination of gram-positive and gram-negative bacteria, and amine oxides, in the reply filed on 20 April 2026, is acknowledged. However, upon further search and consideration, the species of gram-negative bacteria or gram-positive bacteria (claim 1), and quaternary ammoniums (claim 1, 6-8), are rejoined and examined on the merits.
The traversal is on the ground(s) that if Group I is found to be novel and nonobvious, the claims of Groups II and IV would also necessarily be novel and nonobvious and should be rejoined. This is not found persuasive because Applicant has not shown that the indicated shared technical feature is a special technical feature.
As such, the requirement is still deemed proper and is therefore made FINAL.
Claims 14-21 have been withdrawn. Claims 1-13 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/JP2022/043413, filed 24 November 2022, which claims priority to Japanese Patent Document No. JP2021-190593, filed 24 November 2021.
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.
Claims 1-13 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.
Claim 1 recites in relevant part “at least one or more species of Gram-positive bacteria and/or Gram-negative bacteria in a sample” (emphasis added). The noted limitation is indefinite, because it is unclear if “at least one,” (which includes only one), or “more than one” (which is at least two) species of bacteria is required to be present in the method, as these limitations are contradictory. Further, as lysis is intended to be for a “group of two or more species of bacteria” (emphasis added), it is unclear if/what other unrecited bacterial species would be included if only one species of the gram-positive/negative bacteria are then required.
Claim 11 recites the limitation "the genus Staphylococcus" in line 2-3. There is insufficient antecedent basis for this limitation in the claim. No genus of Staphylococcus is previously recited in the claims.
Claim 12 recites that the solution contains “a dye selected from red, blue, and green” (emphasis added). This claim is indefinite, because it is unclear what dye(s) are intended to be utilized in the method, as red, blue, and green are colors, while a dye is a generally understood to be chemical compound (e.g. safranin, methylene blue, prodigiosin, pyocyanin).
Claim 13 recites that the method of claim 1 is used for detecting one or more species of bacteria “in a sample” by immunochromatography. This claim is indefinite, because it is unclear if “a sample” is intended to refer to the sample of claim 1, or instead to another sample that is separate from the sample of claim 1.
Claims 2-10 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Maehana et al. (IDS; US 2016/0320387; Published 2016).
With regard to claims 1-3, 6, and 11, Maehana et al. teach a method of lysing bacterial species responsible for mastitis infection, including E. coli, Klebsiella, and/or S. aureus, which are gram-negative and/or gram-positive bacteria, in a milk sample, by treating the milk sample with a solution containing a surfactant and a bacteriolytic enzyme (Abs.; Para. 60). The surfactant can include an ampholytic surfactant, such as an amine oxide (Para. 70), and/or a cationic surfactant, such as a quaternary ammonium salt (Para. 71). As Maehana et al. expressly teach that the surfactant can include an amine oxide and/or a quaternary ammonium salt, it would have been obvious to an ordinary artisan to select an expressly taught surfactant for use in the method.
With regard to claims 4, 5, 7, and 8, Maehana et al. teach that the amine oxide includes N,N-dimethyldodecylamine N-oxide (Para. 70), and the quaternary ammonium salt includes benzalkonium chloride (Para. 71). Surfactants may be present in amounts including 0.01% or higher and 0.2% or lower, and 0.005% or higher and 0.15% or lower (Para. 69). As these concentrations are taught for use with surfactants of the invention, it would have been obvious to one of ordinary skill in the art to utilize a concentration within the expressly taught ranges, which encompass 0.01-0.2 mass% and 0.005-0.08 mass%.
With regard to claims 9 and 10, Maehana et al. teach that the bacteriolysis enzyme includes lysostaphin (Para. 60). The lysostaphin is present in an amount of particularly preferably 25 mg/ml or lower (Para 63), wherein it would have been obvious to one of ordinary skill in the art from the express teachings of Maehana et al. to utilize an amount of lysostaphin that is 25 mg/ml or lower, which encompasses 0.01 µg/mL to 5.0 µg/mL.
With regard to claims 12 and 13, Maehana et al. teach that immunochromatography is used for detecting bacteria in the sample (Para 67), and colored particles that provide a detectable signal, which are deemed to be a dye, are included in the solution (Para. 90). It would have been routine for an ordinary artisan to determine the most appropriate color particle to include in the solution, based on the specific bacterial species expected to be present in the sample and the specific combination of components present in the solution, including a color known to be visible to the eye, which includes red, blue, and green.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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