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 .
DETAILED ACTION
The instant claims are entitled to an effective filing date of 12/21/2022.
Claims 2-3, and 6 are canceled. Claims 1, 4-5, and 7-15 are pending. Claims 8-9, and 11-15 are withdrawn. Claims 1, 4-5, 7, and 10 are under consideration in this action.
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, 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jelinek (US 2006/0172371) in view of Lu (US 2019/0240356).
Regarding claim 1, Jelinek teaches a calorimetric and/or fluorescent detector comprising one or more polydiacetylenes. See claim 1 of Jelinek. The calorimetric and/or fluorescent detector is in the form of a gel-like solid. See claim 2. Jelinek teaches a porous, gel-like solid organic matrix, which may be used for the detection of a microorganism. See [0012]. The calorimetric and/or fluorescent comprises nutrients required for the growth of microorganism. See claim 7 of Jelinek. The gel-like solid selected from a group that includes agarose (i.e. hydrogel polymer), or other natural or synthetic gelatinous polymers. See claim 6 of Jelinek. For the growth of a microorganism, Jelinek teaches preparing a blue Luria-Bertani (LB)-agar (i.e. a microbial nutrient source that is LB agar). See [0113]. Furthermore, Jelinek suggests that a blue agar matrix can comprise polydiacetylene. See [0098]. Jelinek teaches that the growth (i.e. proliferation) of Salmonella typhimurium wild type, kanamycin-resistant Salmonella typhimurium and E. coli MC4100 strain in an agar matrix containing polydiacetylene and liquids induces a visible color change from blue to red, or the characteristic fluorescence emission. See [0061].
Jelinek does not teach a microbial nutrient source that is encapsulated inside the porous hydrogel structure.
Lu teaches a hydrogel-alginate capsule comprising a hydrogel shell and alginate core. See claim 86 of Lu. The hydrogel shell is comprised of polyacrylamide (i.e. a hydrogel polymer) and alginate. See claim 88 of Lu. The hydrogel shell comprises pores. See claim 90 of Lu. The alginate core is infused with nutrients to support cell growth. This can be achieved, for example, by combining the alginate with cell culture media. See [0060]. Lu suggests that the alginate core supports growth by supplying nutrients to bacteria and the hydrogel shell provides mechanical protection for the entire bead. See [0130].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the polydiacetylene and microbial nutrient source of Jelinek with the porous hydrogel shell of Lu for encapulation. One of ordinary skill in the art would have been motivated to do so because Jelinek suggests that the calorimetric and/or fluorescent detector should be capable of supporting the growth of microorganisms (see [0016] of Jelinek), and Lu teaches a hydrogel-alginate capsule in which the alginate core supports bacterial growth (see [0130] of Lu). There would have been a reasonable expectation of success because Jelinek teaches incorporating polydiacetylene into solid frameworks of polysaccharides and polyacrylamides, and Lu demonstrates a hydrogel shell structure comprising an alginate polysaccharide and polyacrylamide.
Regarding claim 4, Jelinek teaches a gel-like solid selected from a group that includes agarose. See claim 6 of Jelinek. Furthermore, Jelinek teaches a polymer from which the matrix is made selected from a group that includes polyacrylamides. See claim 4 of Jelinek.
Lu teaches a hydrogel shell is comprised of polyacrylamide (i.e. a hydrogel polymer) and alginate. See claim 88 of Lu.
Regarding claim 5, Jelinek teaches that suitable nutrients include broth needed for the growth of said microorganisms are included in liquid precursor. See [0036]. In example 18, Jelinek teaches preparing E. coli in 20 ml of LB medium (i.e. liquid LB). See [0092].
Although Jelinek does not explicitly teach LB broth, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the Jelinek’s LB medium is necessarily a broth, because Jelinek teaches a liquid volume of the LB medium.
Regarding claim 7, Jelinek teaches a calorimetric and/or fluorescent detector for detecting the presence of bacteria. See claim 27 of Jelinek.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jelinek (US 2006/0172371) and Lu (US 2019/0240356), as applied to claims 1, 4-5 and 7 above, and further in view of Super (US 2015/0064703).
Regarding claim 10, Jelinek teaches a calorimetric and/or fluorescence detector that further comprises one or more antibiotic. See claim 8 of Jelinek. Jelinek teaches using a calorimetric and/or fluorescent detector for determining the antibiotic resistance of a bacterial strain. See claim 28 of Jelinek.
Jelinek and Lu do not teach a kit.
Super teaches kits for rapid determination of antibiotic susceptibility of a microbe. See [0003]. Super teaches a kit for determining antibiotic susceptibility of a microbe in a sample comprising an antibiotic. See claim 88 of Super. The kit can comprise a gel matrix for forming a detection substrate. See [0315].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to organize Jelinek and Lu’s colorimetric biosensor with Jelinek’s antibiotic in a kit based Super’s suggestion. One of ordinary skill in the art would have been motivated to do so because Super suggests using kits for rapid determinations of antibiotic susceptibility. There would have been a reasonable expectation of success because Jelinek teaches a gel-like calorimetric and/or fluorescent detector (see claim 2 of Jelinek) comprising an antibiotic (see claim 8 of Jelinek), and Super teaches kits comprising a gel matrix (see [0135]) and an antibiotic (see claim 88 of Super).
Response to Arguments
Applicant's arguments filed 07/14/2026 have been fully considered to the extent that they might apply to the new grounds of rejection set forth above, but they do not apply to the new grounds of rejection set forth above.
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 KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE HUMPHREY can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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