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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/5/2026 has been entered.
Claim Status
A request for continued examination (RCE) was filed on 05/05/2026. Claims 1, 3, 6, 20, and 22-30 are pending and under examination. Claims 2, 4-5, 7-19, and 21 are cancelled.
Withdrawal of Objections/Rejections
The 35 U.S.C 112(b) rejection of the claims 1,22, 24, 25, 26, 28, 27 and 29 has been withdrawn. Applicant has provided compliance with the requirements.
Applicant’s arguments regarding 35 USC § 102 and 35 USC § 103 are deemed moot, in view of current rejection, regarding claims 1, 3, 6, 20, and 22-30.
New Rejection: 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(s) 1, 3, 6, 21, 23,25,26,27,28,29, and 30, are rejected under 35 U.S.C. 103 as being unpatentable over Luk, M.C.J. et al., Rapid and sensitive detection of Salmonella (O: 6,7) by immunomagnetic monoclonal antibody-based assays. Journal of Immunological Methods. 1991; (137:1); pp 1-8 and further in view of Matsumoto, M. et al., Lipopolysaccaride-binding peptides obtained by phage display method. Journal of Microbial Methods. 2010; 82(1); pp.54-58.
Regarding Claims 1, 3, 6, 21, 23,25,26,27,28,29, and 30 Luk et al., teaches a test method, from a sample, for the presence of a Gram-negative microorganism, (page 2, paragraph 1 “Reagent antibodies”) comprising steps of: combining the sample with viability-preserving medium, and thereafter undertaking a selection process for a Gram-negative microorganism which includes:
A separation step of the organism from the medium using lipopolysaccharide antigens, targeted to Salmonella species lipopolysaccharide O antigens and C1 (MC1 and MC9) as capture agents to separate the magnetic beads, using a magnetic field, bound with Salmonella, from blood and/or stool (page 2, Section titled “(b) Immunomagnetic detection procedure”; paragraph 2).
The bead bound bacteria were incubated and washed with PBS and further examined through enzyme immunoassay (EIA) (page 2, Section titled “(b” Immunomagnetic detection procedure”; paragraph 3).
Samples of blood with clinical isolates of Salmonella strains were tested with enrichment media of brain heart infusion (BHI) broth, and stool cultures were enriched in tetrathionate (TT) broth, samples were incubated at 37°C (page 2, Section: “Enrichment culture of blood and stool artificially-inoculated with Salmonella strains”) for serial incubation periods from 0.5h to 18h; samples were tested from binding of bacteria to MC1 and MC9 mAbs that illustrate a lag, log, and stationary phase of growth, (page 3, Figure 1).
Regarding claims 1, 22, and 24, Luk et al., does not teach a media with an antibiotic or endotoxin testing, using a limulus amoebocyte lysate (LAL) assay and/or comparable detection method for LPS.
However, regarding claims 1,22, and 24 Matsumoto M., et al., teaches a bead-based method for LPS testing, where a buffered solution containing the antibiotic polymyxin B, along with silica beads with immobilized peptide(s), bind LPS. LPS bound to said beads are detected using an LAL assay; binding detection assays demonstrated peptide Li5-001 is able to bind LPS and/or Lipid A of LPS within 30 minutes ( Section Titled “3.3. LPS-binding assessment in a batch system”).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date to combine the teachings of Luk et al. with Matsumoto et al. The combination teaches isolation of Gram-negative bacteria using antibody-bound magnetic beads with magnetic fields harboring specificity to polysaccharide/LPS-specific antigens (exemplified by O-antigen and/or MC1 or MC9) to isolate bacteria from environmental/clinical samples.
The motivation to combine the teaching of Luk et al., with Matsumoto et al., is to simply merge biphasic assays into a singular platform, for assessing LPS concentrations from isolated Gram-negative bacteria. The use of magnetic beads to isolate microorganisms is well-known in the art, including for pathogenic Gram-negative isolates, as illustrated through Luk et al., and the detection of endotoxin using LAL assay methods, exemplified through the well-recognized standard test method(s) <USP 85> by the U.S. FDA. Therefore, an artisan would have expected success with the combination of mAbs-bound magnetic beads directed to LPS-specific antigens to (1) isolate viable Gram-negative bacteria for (2) enrichment/growth and further assessment(s) at the incubation conditions specified, to then also perform (3) a LAL assay, using the bead-based LPS-peptide-binding methods of Matsumoto et al. Since the prior art prescribes the same methods as the instant application, the combined prior art is able to produce the same outcome.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e. methods for detecting the presence of a Gram-negative bacterium, comprising the use of antibody-bound magnetic beads and magnetic separation; and methods for detecting the presence of a Gram-negative bacterium, and/or endotoxins thereof, comprising the use of LAL) were known in the art. In addition, combining these elements yields a method wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Regarding claim 24, Neither Matsumoto et al., or Luk et al., explicitly teach modified tryptic soy broth (mTSB). Luk et al., teaches BHI media, which PHOSITA would recognize as interchangeable and/or comparable to mTSB, as both are used as recovery/enrichment media, are highly versatile and were commonly used for culturing microorganisms from environmental/clinical samples at the time of the effective filing date.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date to substitute modified mTSB for the BHI broth disclosed by Luk et al. in view of Matsumoto. Both were well-known enrichment media used to recover and propagate microorganisms prior to detection. One of ordinary skill in the art would have recognized these media as functionally equivalent alternatives, and would have expected either medium to successfully enrich the target organism- effectively substituting one known media for another to obtain the predictable result of microbial growth and enrichment.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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