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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 49-53 in the reply filed on 01/29/2026 is acknowledged.
Claims 1-5, 93-97, 117-120, and 125 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
Priority
The instant application claims benefit to US Provisional Application No. 63396143, filed on 08/08/2022 and is acknowledged. The instant claims herein are examined using the effective filing date of 08/08/2022 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 02/13/2024 and 05/21/2025 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg. 60. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
First rejection
Claims 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler et al (US10648010 B2; published 05/12/2020; hereinafter “Chandler”) in view of Vaessen et al (Pulsed electric field pre-treatment for enhanced bacterial survival after drying: Effect of carrier matrix and strain variability, Innovative Food Science & Emerging Technologies, Volume 66, 2020, 102515, ISSN 1466-8564; hereinafter “Vaessen”).
Chandler teaches a freeze dried bacterial extract for cell free protein synthesis comprising: dried, lysed bacterial components, wherein the extract is able to synthesize upon rehydration a target protein from a template nucleic acid encoding the target protein; and a carbohydrate composition in about 0.6-2.0:1.0 (w/w) ratio of carbohydrate to dried bacterial components (see claims 1 and 2). Chandler teaches the extract can include lyoprotectants that can be combined with the lysed extract, including trehalose and lactose (see col 11, lines 1-16).
Chandler does not explicitly teach that the extract is spray dried.
However, Vaessen teaches that both spray drying and freeze drying can be used to stabilize microorganisms such as probiotics and starter cultures for a prolonged shelf life. These heat sensitive microorganisms are often encapsulated in a carrier matrix consisting of carbohydrates (such as pre-treatment with trehalose or lactose) and/or proteins to provide protection during the drying process (see pg. 1, col 1; see pg. , col 2, paragraph 2-3). Vaessen also teaches both spray drying and freeze drying are relevant for industrial drying of bacteria (pg. 2, col 1, paragraph 2).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the dried lysed bacterial extract as taught by Chandler by spray drying as taught by Vaessen to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Vaessen teaches that spray drying, like freeze drying can be used to stabilize microorganisms for prolonged shelf life when treated with carbohydrates like trehalose for advantageous industrial drying of bacteria.
Regarding claim 50, both Chandler and Vaessen teach using trehalose and lactose.
Regarding claim 51-52, neither Chandler teach using 25-200 g/kg or 50-100 g/kg trehalose. However, Chandler teaches additives (e.g., trehalose) can be mixed with a liquid lysed bacterial extract by combining a concentrated stock solution of one or more of the additives to achieve the preferred formulation of the extract. As Chandler teaches additives like trehalose can be added to achieve preferred formulation of dried extract, the amount of trehalose would be a matter of routine optimization using standard laboratory techniques available at the time of filing, absent evidence to the contrary. Furthermore, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Second rejection
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Chandler and Vaessen as applied to claims 49-52 above, and further in view of Tabare et al. (A Design of Experiment Approach to Optimize Spray-Dried Powders Containing Pseudomonas aeruginosa Podoviridae and Myoviridae Bacteriophages. Viruses. 2021 Sep 24;13(10):1926; hereinafter “Tabare”).
As discussed above, the combined teachings of Chandler and Vaessen rendered the claims prima facie obvious.
None of the references explicitly teach using trehalose dihydrate.
However, Tabare (in a similar field of endeavor of spray drying extracts) teaches the effect of spray-drying formulations and operating parameters of a laboratory-scale spray-dryer on the characteristics of spray-dried powders containing two Pseudomonas aeruginosa bacteriophages (see abstract). Tabare teaches using trehalose dihydrate in formulations to spray dry the bacteriophages and that “[c]ompared to freeze-drying, spray-drying is highly advantageous for the biopharmaceutical industry in terms of cost (e.g., lower footprint and continuous process) and product quality process efficiency (e.g., almost instantaneous, without freezing). Due to the inherent benefit of using spray-drying, this technique was selected as the preservation technique for our bacteriophage products. Regarding the formulation, lactose and trehalose are generally used to protect biological materials from desiccation in spray-drying” (see pg. 7, paragraph 5).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the dried lysed bacterial extract as taught by Chandler and Vaessen by using trehalose dihydrate as taught by Tabare to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skil would have been motivated to make the modification because Tabare teaches that trehalose dihydrate can advantageously be used in spray drying techniques to protect biological materials from desiccation in spray-drying.
Accordingly the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ALLOWED.
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/G.C.R./ Examiner, Art Unit 1651
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672