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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Priority
This application claims benefit of priority to EP Application No. EP20161528.3 filed on 03/06/2020. This application is also a 371 of PCT/EP2021/055793 filed on 03/08/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The Drawings filed on 09/01/2022 are accepted by the Examiner.
Amendment and Claim Status
In the reply filed on 12/17/2025, Applicant amended claim 15.
Claims 15 and 25-27 are currently pending and under examination.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Squirrell et al. (WO 0070082 A1, 11/23/2000) in view of Ribault et al. (FR 2955121 A1, 07/15/2011).
Regarding claims 15, 25 and 27, Squirrell et al. disclose a method for detecting the presence of the contents of lysed eukaryotic cells (See entire document, Abstract). Squirrell et al. further disclose a kit for performing the method of the invention wherein the kit comprises the essential reagents required for the method, including adenosine diphosphate, luciferase, luciferin and cell culture medium (Page 12, Lines 17-20). The kit may also contain a magnesium ion source (Page 12, Line 22), reading on nutrients, and a phosphate buffer, reading on a buffer substance (Page 12, Line 27). The kit is in the form of a single package (Page 12, Line 22-23). When the reagents are stored together, it is preferred they are kept in freeze dried form, reading on a lyophilized powder, to avoid any premature ADP conversion to ATP (Page 12, Line 25-27).
Squirrell et al. do not disclose the use of agar in the kit.
However, Ribault et al. disclose an agar culture medium for microorganisms comprising a nutrient medium wherein the medium is present in a dehydrated state and a kit for detecting microorganisms (See entire document, Abstract). Ribault et al. further disclose the kit for detecting microorganisms comprises a culture medium (Page 4, Paragraph 4). When the medium is agarose, the medium comprises about 10 grams to about 20 grams of agar (Page 3, Paragraph 6). Additionally, for the rapid preparation of the culture medium, it is advantageous that it be formulated or preserved in a dehydrated form, that is, a composition in which each of the ingredients is present in powder form (Page 3, Paragraph 7). The medium can be reconstituted by adding a certain volume of water to obtain specific proportions (Page 3, Paragraph 7).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize agar, in the form of a powder, in the kit of Squirrell et al. because Ribault et al. teach an agar culture medium in powder form in a kit. One of ordinary skill in the art would be motivated to incorporate agar, in the form of a powder, into the kit of Squirrel et al. because Ribault et al. disclose is it advantageous that the ingredients be in powder form for the rapid preparation of the culture medium.
Regarding claim 26, Squirrel et al. disclose luciferase/luciferin preparations are known in the art and commercially available, and a typical formulation comprises about 0.1 to 10 mg/litre luciferase and 15 to 1000µmol/litre D-luciferin (Page 5, Lines 28-32).
Squirrel et al. do not disclose that the composition comprises 0.01 – 0.10 wt% luciferase, 0.02 – 0.40 wt% D-luciferin, 30 – 70 wt% agar or at least one of peptone, yeast extract or meat extract.
However, as discussed above, Ribault et al. disclose the medium comprises about 10 grams to about 20 grams of agar (Page 3, Paragraph 6). Additionally, Ribault et al. disclose the culture medium comprises a nutrient support based on yeast extract (Page 3, Paragraph 5).
Generally, differences in percentage or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such percentage or amount is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II)(A). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed components (i.e., luciferase, luciferin and agar). Although the prior art does not teach the percentage or amount claimed, since the claimed components are known to have luminescent properties and are known components of culture mediums, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed components motivated by the desire to create a kit with the essential reagents (luciferase and luciferin) and the necessary culture medium components necessary to create an effective culture medium and provide luminescence.
It would have been further obvious to one of ordinary skill in the art to include yeast extract as one of the components of the culture medium in the kit of Squirrel et al. motivated by the desire to provide nutrients to the culture medium because yeast extract is a known and effect nutrient support in culture mediums as taught by Ribault et al.
Response to Arguments
Applicant’s arguments filed with the Request for Continued Examination, filed 01/15/2026, with respect to the rejection of claims 15 and 25-27 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new rejection has been set forth above.
Conclusion
Claims 15 and 25-27 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights