DETAILED ACTION
Status of the claim rejections
The objections to the specification are withdrawn in view of Applicant’s filing of a substitute specification in the response filed 06/11/2026.
The rejections of record under 35 USC 103 are maintained in view of Applicant’s amendments in the response filed 06/11/2026.
This Action is FINAL.
Maintained 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 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Chandler et al (US10648010 B2; published 05/12/2020; hereinafter “Chandler”; prior art of record) 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 (see col 11, lines 1-16; see Example 3; Table 1).
Chandler does not teach using 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 (see col 10, lines 64-col 11 lines 1-6). 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).
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 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 51, Chandler teaches hydroxypropyl-β-cyclodextrin can be added as a lyoprotectant (see col 11, lines 10-25).
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 and 51 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 skill 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.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
On pg. 7-10 of the remarks, Applicant argues that the combination of cited references do not teach or suggest a spray-dried bacterial extract comprising a composition with about 50-100 g/kg of trehalose. Applicant argues Chandler teaches a trehalose concentration outside the claimed range, and that freeze-dried bacterial extracts are not stable when stored in trehalose. Applicant argues that storage for 1 day at room temperature demonstrated only 5% cell-free protein synthesis compared to controls demonstrating 70% after 175 days, citing to Table 1 and Example 7. Applicant argues Chandler is silent to testing of different concentrations and teaches away from using trehalose to preserve bacterial extracts. Applicant argues that Vaessen only discloses using 0.3 M trehalose dihydrate (calculated to be 113.5 g/kg) outside the claimed range, and Tabare also discloses concentrations outside the claimed range (calculated to be 30-45 g/kg) and that Tabare is silent on testing for trehalose concentrations outside the 30-45 g/kg range.
In response, the examiner disagrees. First, while Chandler demonstrates that 100% trehalose concentrations in Table 1/Example 7 demonstrated only 5% cell-free protein synthesis, Chandler demonstrates this for freeze-dried bacterial extracts, not spray-dried as instantly claimed. Second, Chandler also explicitly teaches that trehalose is a lyoprotectant additive that can be added to bacterial extracts (see col 11). As such, the disclosed examples and preferred embodiments of Chandler do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (see MPEP 2123(II). Third, Vaessen explicitly teaches that when using spray drying as instantly claimed, trehalose can be used to stabilize microorganisms for prolonged shelf life for advantageous industrial drying of bacteria (see above). Indeed, an obviousness rejection under 35 U.S.C 103 requires one of ordinary skill to balance each individual teaching of the prior art references with the totality of the references in combination. Applicant’s arguments do not take into account the combination of teachings of the prior art references, and do not appreciate all of the evidence as a whole.
Finally, while the references may teach varying amounts of trehalose, Chandler explicitly 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). Thus, the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bater C, Santos M, Galmarini MV, Gómez-Zavaglia A, Chirife J. Influence of different storage conditions on the performance of spray-dried yogurt used as inoculum for milk fermentation. Journal of Dairy Research. 2019;86(3):354-360: teaches commercial drinkable yogurt with and without 4% of added trehalose (as cell protectant) was spray-dried obtaining a powder with low water activity (aw). Total bacterial count in the powder was between 8.48–8.90 log cfu/g. The dried yogurt was stored: (i) at 38 °C and aw =0.33; (ii) at 38 °C in hermetically sealed flasks (aw = 0.21/0.22); (iii) in a cyclic tempera ture chamber (10–20 °C) in hermetically sealed flasks (aw = 0.21/0.22). Bater teaches that trehalose protected the lactobacilli present in the spray dried yogurt (see abstract, throughout).
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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