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 Amendment
The amendment filed March 5, 2026 has been entered.
Claims 1-3 and 6-20 remain pending in the application, with claims 1-3 and 6-16 being examined, and claims 17-20 deemed withdrawn. Claims 4-5 are canceled.
Applicant’s amendments to the Claims have overcome some of the claim objections and all of the 112(b) rejections previously set forth in the Non-Final Office Action mailed December 8, 2025. However, numerous claim objections are still outstanding, as detailed in the Claim Objections section of this instant Office Action.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Objections
Claims 1-3 and 10-12 are objected to because of the following informalities:
Regarding claim 1, Lns. 2, 4, and 7 recite, “cooperatively-engaged”. The hyphen in this phrase is unnecessary, and should be deleted.
Further regarding claim 1, 5th to Last Ln.-4th to Last Ln. recite, “wherein said compartmentalized assay development device adapted to sequentially introduce…”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein said compartmentalized assay development device is adapted to sequentially introduce…” to be grammatically correct.
Regarding claim 2, Ln. 2 recites, “said sample collector reservoir housing assay components...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “said sample collector reservoir houses assay components…” to be grammatically correct.
Further regarding claim 2, Ln. 3 recites, “and adapted to releasably introduce...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “and is adapted to releasably introduce...” to be grammatically correct.
Further regarding claim 2, Ln. 4 recites, “said media rehydrating compartment housing assay components...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “said media rehydrating compartment houses assay components...” to be grammatically correct.
Further regarding claim 2, Ln. 6 recites, “said phage amplification compartment housing assay components...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “said phage amplification compartment houses assay components...” to be grammatically correct.
Further regarding claim 2, Ln. 7 recites, “and adapted to releasably introduce...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “and is adapted to releasably introduce...” to be grammatically correct.
Regarding claim 3, Ln. 2 recites, “said sample collector reservoir housing assay components...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “said sample collector reservoir houses assay components...” to be grammatically correct.
Further regarding claim 3, Ln. 3 recites, “and adapted to releasably introduce...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “and is adapted to releasably introduce...” to be grammatically correct.
Further regarding claim 3, Lns. 4-5 recite, “said phage amplification compartment housing recombinant phage assay components...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “said phage amplification compartment houses recombinant phage assay components...” to be grammatically correct.
Further regarding claim 3, Ln. 5 recites, “and adapted to releasably introduce...”, which is grammatically incorrect. The above limitation needs to be amended to recite, “and is adapted to releasably introduce...” to be grammatically correct.
Regarding claim 10, Lns. 1-2 recite, “wherein said prepared sample for detection of bacteria being adapted for detection…”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein said prepared sample for detection of bacteria is adapted for detection…” to be grammatically correct.
Regarding claim 11, Lns. 1-2 recite, “wherein said recombinant luciferase enzyme being an insert into an infecting phage and being replicated as part of a virus replication”, which is grammatically incorrect. The above limitation needs to be amended to recite, “wherein said recombinant luciferase enzyme is an insert into an infecting phage and is replicated as part of a virus replication” to be grammatically correct.
Regarding claim 12, Lns. 3-4 recite, “replicate at least one specific nucleic acid sequence”. However, as this is limitation is the last item in a list, an “and” should be placed at the beginning of the limitation, and the above limitation should therefore be amended to recite, “and replicate at least one specific nucleic acid sequence” to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 6-12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wicks et al. (US Pub. No. 2004/0191892; hereinafter Wicks; already of record) .
Regarding claim 1, Wicks discloses a compartmentalized assay development device ([0025], see Fig. 1). The device comprises:
a. a sample collector reservoir cooperatively engaged with an opening and adapted to receive a sample ([0025]-[0026], see Fig. 1 at chamber 12. As the first chamber 12 receives sample, an opening adapted to receive the sample is intrinsically present in the chamber).
b. a media rehydrating compartment cooperatively engaged in communication with said sample collector reservoir and housing a media in a storage position ([0025]-[0026], see Fig. 1 at second chamber 14, which contains antiviral agent. The antiviral agent is intrinsically in a storage position when not in use).
c. a phage amplification compartment cooperatively engaged in communication with said media rehydrating compartment ([0025]-[0026], see Fig. 1 at third chamber 18).
d. a first temporary barrier positioned between said sample collector reservoir and said media rehydrating compartment ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
e. a second temporary barrier positioned between said media rehydrating compartment and said phage amplification compartment ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
Said compartmentalized assay development device is adapted to sequentially introduce said sample from said sample collector reservoir into said media rehydrating compartment and subsequently into said phase amplification compartment to expose a phage amplification enclosure and prepare said sample for detection of bacteria, when present, in said sample ([0025]-[0028], see Fig. 1, [0006]. The seals are capable of being activated to sequentially move the sample into each of the compartments as claimed).
Note: The instant Claims contain a large amount of functional language (ex: “adapted to receive a sample…”, “adapted to sequentially introduce said sample…”, “adapted to releasably introduce said assay components…”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 2, Wicks discloses the device of Claim 1, wherein
a. said sample collector reservoir houses assay components in a storage position and is adapted to releasably introduce said assay components in an admixture ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
b. said media rehydrating compartment houses assay components in a storage position ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
c. said phage amplification compartment houses assay components in a storage position and is adapted to releasably introduce said assay components in an admixture ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
Regarding claim 3, Wicks discloses the device of Claim 1, wherein
a. said sample collector reservoir houses assay components in a storage position and is adapted to releasably introduce said assay components in an admixture ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006]).
b. said phage amplification compartment houses recombinant phage assay components in a storage position and is adapted to releasably introduce said assay components in an admixture ([0025]-[0028], see Fig. 1, each chamber 12, 14, and 18 is separated from each other by a seal, [0006], [0037]).
Regarding claim 6, Wicks discloses the device of Claim 1, including a phage amplification enclosure housed in said media rehydrating compartment ([0025]-[0028], [0032], see Fig. 1, the antiviral agent in the second chamber 14 is used as part of the process to amplify the bacteriophage and/or generate a bacteriophage dependent signal).
Regarding claim 7, Wicks discloses the device of Claim 1, including a phage amplification enclosure housed in said phage amplification compartment ([0025]-[0028], [0032], see Fig. 1, the bacterial helper cells in the third chamber 18 amplify the bacteriophage and/or generate a bacteriophage dependent signal).
Regarding claim 8, Wicks discloses the device of Claim 1, wherein said opening comprises a recloseable proximate opening having a closure assembly adapted to seal said opening after said sample is introduced into said sample collector reservoir ([0025]-[0028], [0032], the removable plastic stoppers close recloseable proximate openings, and one is located at the top of the device in chamber 12, see Fig. 1).
Regarding claim 9, Wicks discloses the device of Claim 1, wherein said assay components include a disinfectant neutralizer ([0016], [0018], [0025], the antiviral agents act as disinfectant, and are neutralized with a buffer).
Regarding claim 10, Wicks discloses the device of Claim 1, wherein said prepared sample for detection of bacteria is adapted for detection of a recombinant luciferase enzyme (as the device of Wicks is identical to the instantly claimed device, the device of Wicks is capable of preparing a sample for detection of bacteria adapted for detection of a recombinant luciferase enzyme, absent evidence to the contrary. See also [0019]-[0020] which demonstrate that the device of Wicks can be used to detect enzymes).
Regarding claim 11, Wicks discloses the device of Claim 10, wherein said recombinant luciferase enzyme is an insert into an infecting phage and is replicated as part of a virus replication (the recombinant luciferase enzyme is not positively recited, and as device of Wicks is identical to the instantly claimed device, the device of Wicks is capable of detecting the claimed recombinant luciferase enzyme. See also [0019]-[0020] which demonstrate that the device of Wicks can be used to detect enzymes).
Regarding claim 12, Wicks discloses the device of Claim 1, wherein said phage amplification enclosure includes a bacteriophage adapted to target at least one specific bacterial receptor, insert into an enzyme operon, and replicate at least one specific nucleic acid sequence (the phage amplification enclosure is not positively recited. Nevertheless, Wicks teaches a phage amplification enclosure that can amplify a bacteriophage in [0025]-[0028], [0032]).
Regarding claim 15, Wicks discloses the device of Claim 12, wherein said phage amplification enclosure includes a nanoluciferase (the phage amplification enclosure is not positively recited).
Regarding claim 16, Wicks discloses the device of Claim 15, wherein said nanoluciferase comprises an indicator gene and a bacteriophage late promoter adapted to control transcription of said indicator gene (the phage amplification enclosure, and nanoluciferase therein, is not positively recited).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wicks as applied to claims 1-3, 6-12 and 15-16 above, in view of Nguyen et al. (US Pub. No. 2019/0218590; hereinafter Nguyen; already of record).
Regarding claim 13, Wicks discloses the device of Claim 1. Wicks further discloses wherein said prepared sample produces a luminescent signal indicative of bacterial presence ([0025]-[0028]).
Wicks fails to explicitly disclose a luciferase assay substrate.
Nguyen is in the analogous field of bacterial detection (Nguyen [0007]-[0008]). Nguyen teaches a luciferase assay substrate (Nguyen [0099]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Wicks with the teachings of Nguyen to include a luciferase assay substrate, in order to provide a luminescent activity detectable by a luminometer for the presence of specific bacterial cells (Nguyen; [0099], [0023]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Wicks as applied to claims 1-3, 6-12 and 15-16 above, further in view of Chen et al. (US Pub. No. 2004/0161788; hereinafter Chen; already of record).
Regarding claim 14, Wicks discloses the device of Claim 1, and all limitations recited therein.
Wicks fails to explicitly disclose that at least one of said first temporary barrier or second temporary barrier comprises a burst liner.
Chen is in the analogous field of devices for sample processing (Chen [0004]). Chen teaches a burst liner (Chen [0102]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Wicks with the teachings of Chen so that at least one of said first temporary barrier or second temporary barrier comprises a burst liner, as a burst liner can be used to controllably mix the contents of one compartment with the contents of another compartment within the device as desired (Chen [0102]), particularly as Wicks teaches that the temporary barriers may be activated to allow chambers to communicate by crushing the seal between the chambers (Wicks [0006]).
Response to Arguments
Applicant's arguments filed March 5, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on Pg. 6 of their Remarks do not provide any evidence to support Applicant’s assertion that the claims are now patentably distinguished over the cited references, and the arguments are merely conclusory in nature. Therefore, the Examiner considers the arguments made by the Applicant to be moot, and has examined the instant claim set according to its merits. The Examiner has determined the instant claim set to remain unpatentable over the cited prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JOHN MCGUIRK/Examiner, Art Unit 1798