Prosecution Insights
Last updated: July 05, 2026
Application No. 17/830,726

METHODS FOR VIRAL INACTIVATION BY ENVIRONMENTALLY COMPATIBLE DETERGENTS

Final Rejection §103
Filed
Jun 02, 2022
Priority
Dec 12, 2019 — provisional 62/947,276 +1 more
Examiner
BRANDSEN, BENJAMIN MICHAEL
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Eli Lilly and Company
OA Round
4 (Final)
61%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
79%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
64 granted / 105 resolved
+1.0% vs TC avg
Strong +18% interview lift
Without
With
+17.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
31 currently pending
Career history
147
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
54.2%
+14.2% vs TC avg
§102
24.6%
-15.4% vs TC avg
§112
5.1%
-34.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 105 resolved cases

Office Action

§103
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 . Priority The present application, filed June 2, 2022, is a national stage application of PCT/US2020/063531, filed December 7, 2020, which claims the benefit of U.S. provisional application 62/947276, filed December 12, 2019. Status of the Application Applicant’s communications, received March 30, 2026, is acknowledged. Claims 1-6, 8-24, 26-28, and 31-33 are pending and examined on the merits herein. The following rejection is maintained from the previous Office action mailed December 29, 2025. Applicant’s arguments are addressed following this rejection. Claims 1-6, 8-24, 26-28, and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher (U.S. pre-grant publication US 20160333046 A1; cited in Office action mailed April 22, 2025) in view of Brandt (Publication no. WO 2019121846 A1; cited in IDS received June 2, 2022), as evidenced by Ghyzel (U.S. patent 8,367,756; cited in Office action mailed April 22, 2025) and Bach (Bach, J. et al. Biotechnology and Bioengineering 2015, vol. 112, pp. 743-750; cited in Office action mailed April 22, 2025). Brandt was published June 27, 2019, and thus qualifies as eligible prior art under 35 U.S.C. 102(a)(1). Claim 1 is drawn to a method of inactivating a virus in a feedstream comprising, adding to the feedstream an environmentally compatible detergent at a final concentration of about 0.05% w/w to about 1 % w/w, wherein the environmentally compatible detergent is a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides. Claim 2 requires the detergent comprises about 40% to about 60% undecyl alkyl glycoside, claim 3 requires the detergent comprises about 53% to about 57% undecyl alkyl glycoside, claim 4 requires the detergent comprises greater than about 50% undecyl alkyl glycoside, and claims 5 and 6 require the detergent comprises less than about 15% other alkyl glycosides and less than about 10% other alkyl glycosides. Claims 8 and 9 require the detergent is added to the feedstream at a concentration of about 0.1 % w/w to about 1 % w/w and of about 0.3% w/w, claims 10 and 11 require the feedstream is at a temperature of about 15°C to about 30°C or about 15°C to about 20°C when adding the detergent, claim 12 requires the feedstream is at a pH of about 5.5 to about 8.0 when adding the detergent, claim 13 requires further comprising the step of incubating the detergent in the feedstream for about 1 minute to about 180 minutes, claim 14 requires the detergent has a viral log reduction factor (LRF) in the feedstream of greater than about one, or greater than about two, and claims 15 and 16 require the virus being inactivated is recited therein. Claim 17 depends from claim 1 and further requires the step of incubating the feedstream and the detergent for about 60 minutes to about 180 minutes at a temperature of about 4°C to about 30°C and at a pH of about 5.5 to about 8.0, wherein the detergent is added to the feedstream at a final concentration of about 0.3% w/w, and wherein the detergent in the feedstream has a viral log reduction factor (LRF) of greater than about 5. Claim 18 requires the feedstream is a harvested cell culture fluid, a capture pool or a recovered product pool, claim 19 requires the capture pool or the recovered product pool is a protein A pool, a protein G pool or a protein L pool affinity chromatography pool, claim 20 requires the capture pool or recovered product pool is a mixed mode chromatography pool, claim 21 requires the further step of filtering the feedstream, claim 22 requires the feedstream is subjected to a second filtrate step, claim 23 requires subjecting the filtered feedstream to an affinity chromatography column, claim 24 requires the affinity chromatography column is a Protein A column, claim 26 requires the feedstream comprises a protein as recited therein, claim 27 requires the protein is an antibody as recited therein, claim 28 requires that adding the detergent to the feedstream does not significantly alter turbidity of the feedstream, and the step of adding the detergent to the feedstream does not alter final product quality of the purified feedstream protein, claim 29 requires the detergent contains a stabilizing agent, and claim 31 requires the method of inactivating a virus in a feedstream with steps recited therein. Claims 32 and 33 depend from claims 1 and 31, respectively, and require the undecyl alkyl glycoside is undecyl glucopyranose. Fisher teaches and claims a method of inactivating virus in a product feedstream in a manufacturing process of a therapeutic polypeptide comprising the step of subjecting the feedstream to a detergent, wherein the detergent is environmentally compatible (p. 32, claim 1). Fisher claims the detergent is added to the feedstream at a final concentration of about 0.3% to about 1% (p. 32, claim 11). Fisher further teaches and claims that one of the environmentally compatible detergents has the CAS registry number 132778-08-6 (p. 33, claim 29, line 7), which Fisher teaches is detergent APG 325N (p. 31, Table 29, First entry, CAS registry number 132778-08-6). As evidenced by Ghyzel, APG 325N® is a nonionic alkyl polyglycoside in which R is a mixture of C9, C10, and C11 chains in a weight ratio, respectively, of 20:40:40 (column 8, lines 46-51). Fisher teaches additional conditions for inactivating virus in a product feedstream. Fisher teaches an example wherein APG 325N is used to inactivate Xenotropic Murine Leukemia Virus (XMuLV) at a concentration of 0.3% and 12°C for 1 and 3 hours in harvested cell culture fluid (abbreviated by Fisher as HCCF), showing viral log reduction of 5.5, 5.9, and 5.9 depending on source of the HCCF (p. 22, [0228], see Table 16). Fisher teaches an additional example wherein APG 325N is used to inactivate virus at 20 °C in concentrations of 0.5% and 1% (p. 22, [0227], Table 15). Fisher further teaches that the basal medium has a pH of between about pH 5.0 to about pH 6.9 during treatment to inactivate virus (p. 15, [0129], lines 6-8). Fisher teaches and claims wherein the feedstream comprises a capture pool or a recovered product pool (p. 33, left column, claim 34), wherein the capture pool or recovered product pool is a protein A pool, a protein G pool or a protein L pool (p. 33, left column, claim 36), and wherein the wherein the capture pool or recovered product pool is a mixed mode chromatography pool (p. 33, left column, claim 37). Fisher teaches and claims wherein the method further comprises a step of filtering the feedstream after adding the detergent (p. 33, left column, claim 47). Fisher teaches and claims wherein the feedstream is subjected to chromatography after addition of the detergent (p. 33, left column, claim 52), claims the chromatography may be affinity chromatography (p. 33, left column, claim 53), and claims wherein the affinity chromatography may be protein A chromatography (p. 33, left column, claim 54). Fisher teaches and claims the therapeutic polypeptide is an antibody, an immunoadhesin, an enzyme, a growth factor, a receptor, hormone, a regulatory factor, a cytokine, an Fc fusion polypeptide, an antigen, or a binding agent (p. 33, right column, claim 57), and further claims the antibody is a monoclonal antibody, a chimeric antibody, a humanized antibody, a human antibody, a bispecific antibody, or an antibody fragment (p. 33, right column, claim 58). Fisher teaches and claims wherein addition of the detergent to the feedstream does not increase the turbidity of the feedstream (p. 33, left column, claim 22). Fisher further teaches that the environmentally compatible detergent does not adversely affect product quality while effectively inactivating virus in the feedstream (cover page, Abstract, lines 4-6). Finally, Fisher teaches and claims wherein their method is used to inactivate a virus from a group of viruses that includes a retrovirus, a herpesvirus, a flavivirus, a poxvirus, a hepadnavirus, a hepatitis virus, an orthomyxovirus, a paramyxovirus, a rhabdovirus, or a togavirus (p. 33, claim 42). As evidenced by Bach, the XMuLV virus is a retrovirus (p. 743, Title). Fisher does not teach wherein the environmentally compatible detergent is a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides, as required by claim 1, wherein the detergent comprises about 40% to about 60% or about 53% to about 57% undecyl alkyl glycoside as recited in claims 2 and 3, wherein the detergent comprises greater than about 50% undecyl alkyl glycoside as recited in claim 4, or wherein the detergent comprises less than about 15% or about 10% other alkyl glycoside, as recited in claims 5 and 6. In addition, Fisher does not teach wherein the undecyl alkyl glycoside is undecyl glucopyranose, as recited in claims 32 and 33. Brandt teaches a method of protein purification and virus inactivation with alkyl glycosides (cover page, Title). Brandt teaches and claims a process for purifying a recombinant polypeptide comprising the steps of: i) providing a solution comprising the recombinant polypeptide; ii) adding an alkyl glycoside to the solution; and iii) purifying the recombinant polypeptide by carrying out a step of chromatography on the solution (p. 42, claim 1). In addition, Brandt teaches and claims that the detergent may be n-octyl-β-D-glucopyranoside, n-decyl-β-D-glucopyranoside, or n-dodecyl-β-D-glucopyranoside (p. 44, claim 25), which have C8, C10, and C12 alkyl groups, respectively. The detergents n-decyl-β-D-maltoside and n-dodecyl-β-D-maltoside are one methylene group shorter and longer than the presently claimed undecyl alkyl glycoside, respectively. Brandt teaches additional exemplary alkyl glycosides that may be used in their method, specifically reciting n-undecyl-β-D-maltoside as one such alkyl glycoside (p. 18, line 26) (emphasis added). Furthermore, Brandt teaches that in their method, the solution comprising the recombinant polypeptide is treated with an alkyl glycoside, and that this treatment can be conveniently achieved by mixing the solution with a stock solution of the alkyl glycoside, for example, at 10x the intended final concentration (p. 19, lines 5-8). Brandt teaches that if the solution comprising the recombinant polypeptide is the eluate from a chromatography step, then the solution may be diluted with further elution buffer prior to addition of the alkyl glycoside if desired (p. 19, lines 12-14). In this instance, the stock solution of alkyl glycoside is reasonably considered as a detergent, and thus the specific concentration of the alkyl glycoside in the detergent would vary depending on the final concentration of alkyl glycoside desired in the solution comprising the recombinant polypeptide. Finally, Brandt teaches that a step of viral filtration may be part of their workflow (p. 24, line 9). Brandt teaches that typically one or more steps of ultrafiltration or diafiltration are performed after the viral filtration step (p. 24, lines 20-21). Brandt teaches that ultrafiltration may be used to reduce the volume of the sample through permeation of the sample buffer through the filter (p. 24, lines 26-27) (emphasis added), and that diafiltration may be used to remove salts, sugars, non-aqueous solvents, and other low molecular material (p. 24, lines 29-31). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute the detergent APG 325N taught by Fisher with a solution comprising an undecyl alkyl glycoside, such as the n-undecyl-β-D-maltoside taught by Brandt, for the purposes of viral inactivation in a product feedstream. One of ordinary skill in the art would have been motivated to substitute the detergent APG 325N taught by Fisher with a solution comprising an undecyl alkyl glycoside, such as the n-undecyl-β-D-maltoside taught by Brandt, because Brandt teaches a method for viral inactivation using alkyl glycoside detergents and teaches n-undecyl-β-D-maltoside as an example alkyl glycoside that may be used for viral inactivation. In this instance, the rationale “simple substitution of one known element for another to obtain predictable results” would apply. Because Fisher teaches viral inactivation in a product feedstream using APG 325N, which is mixture of C9, C10, and C11 alkyl glycosides and comprises about 40% undecyl alkyl glycoside, and because Brandt teaches viral inactivation with alkyl glycosides, specifically teaching n-undecyl-β-D-maltoside as an exemplary alkyl glycoside, one of ordinary skill in the art would have contemplated substituting the detergent APG 325N, which comprises approximately 40% C11 alkyl glycoside, with a single undecyl alkyl glycoside, such as n-undecyl-β-D-maltoside, because such a detergent would also have been expected to be effective for viral inactivation, as taught by Brandt. Moreover, in view of Brandt teaching n-undecyl-β-D-maltoside as an exemplary alkyl glycoside, and further teaching and claiming the alkyl glycoside may be n-octyl-beta-D-glucopyranoside, n-decyl-beta-D-glucopyranoside, or n-dodecyl-beta-D-glucopyranoside, one of ordinary skill in the art would have also contemplated the n-undecyl-β-D-glucopyranoside as a potential alternative to APG 325N, as required by claims 32 and 33, absent a showing of unexpected or superior results achieved with an undecyl glucopyranoside compared with the n-decyl-beta-D-glucopyranoside or n-dodecyl-beta-D-glucopyranoside taught by Brandt. Regarding the requirements in claims 2-4 that the detergent comprises about 40% to about 60%, about 53% to about 57%, or greater than 50% undecyl alkyl glycoside, in the instance of a single alkyl glycoside being used as a detergent, the limitations of claims 2, 3, and 4 effectively limit the final concentration of alkyl glycoside in the feedstream. Brandt teaches concentrations of alkyl glycosides that include, for example, 0.3% alkyl glycoside. If the single alkyl glycoside were to make up, for example, 55% of the detergent, then the detergent comprising the single alkyl glycoside would be present in the feedstream at a concentration of approximately 0.55%, which falls within the limitation of independent claim 1. Moreover, because Brandt teaches that the alkyl glycoside may be prepared as a stock concentration, and teaches that the stock may be diluted depending on the application (e.g., if the polypeptide being produced is the eluate from a chromatography step), one of ordinary skill in the art would have contemplated different concentrations of alkyl glycoside in the stock solution, depending on the application of that specific stock solution. Finally, one of ordinary skill in the art would have recognized that the final concentration of alkyl glycoside added to the feedstream would impact viral inactivation, not necessarily the amount of stock solution added to the feedstream. MPEP 2144.05 II at A states: “Generally, 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).” In this instance, because Fisher teaches varying final concentrations of alkyl glycoside detergent (APG-325N) used for viral inactivation, and because Brandt teaches additional alkyl glycosides that may be used for viral inactivation, including n-undecyl-β-D-maltoside, one of ordinary skill in the art would have recognized the alternative alkyl glycosides may be effective for viral inactivation in the method of Fisher. Furthermore, one would have tested different concentrations of these alternative alkyl glycosides to determine the most effective concentration for a specific virus and application, as demonstrated by Fisher for APG-325N (for example, see pp. 21-23, Tables 9-20). Moreover, one of ordinary skill in the art would have recognized that the final concentration of alkyl glycoside added to the feedstream would impact viral inactivation, not necessarily the amount of stock solution added to the feedstream. Regarding claims 5-6, because Brandt teaches and claims viral inactivation using specific alkyl glycoside compounds, one of ordinary skill in the art would have considered substituting APG 325N for a solution comprising a single alkyl glycoside, such as n-undecyl-β-D-maltoside or n-undecyl-β-D-glucopyranoside, as described above, which would necessarily have less than about 15% or less than about 10% other alkyl glycosides. Regarding claim 22, because Brandt teaches workflows for viral inactivation in feedstreams of therapeutic proteins using alkyl glycosides, one of ordinary skill in the art would have considered adding an addition filtration step in the method of Fisher, such as the ultrafiltration or diafiltration steps taught by Brandt, to reduce the volume of the composition or to remove low molecular weight species from the feedstream, as taught by Brandt, which would satisfy the limitations of the second filtration step required by claim 22. Regarding claim 31, Fisher teaches all limitations recited in claim 31 except wherein the environmentally compatible detergent is a solution comprising greater than about 50% undecyl alkyl glycoside and less than about 10% other alkyl glycosides, as described above. Therefore, because each step recited in claim 31 is taught by Fisher, and because Brandt teaches viral inactivation during protein purification using alkyl glycosides, including teaching n-undecyl-β-D-maltoside as an exemplary alkyl glycoside and rendering obvious n-undecyl-β-D-glucopyranoside, as described above, one of ordinary skill in the art would have reasonably contemplated substituting the APG 325N detergent taught by Fisher with as solution comprising n-undecyl-β-D-maltoside or n-undecyl-β-D-glucopyranoside, thus rendering obvious the method of claim 31 and claim 33, which depends from claim 31. Therefore the invention taken as a whole is prima facie obvious. Response to Applicant’s arguments: With respect to the rejection of claims 1-6, 8-24, 26-28, and 31-33 under 35 U.S.C. 103 as unpatentable over Fisher in view of Brandt, as evidenced by Ghyzel and Bach, Applicant presents the following arguments: 1. Applicant argues that even if a person of ordinary skill in the art would have substituted the component described in Fisher, APG 325N, into the methods described by Brandt (which Applicant does not concede), they still would not have arrived at the claimed invention. Pending claim 1 recites that the "environmentally compatible detergent is a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides." Applicant states that as conceded by the Examiner, APG 325N contains "a mixture of C9, C10, and C11 chains in a weight ratio, respectively, of 20:40:40 (column 8, lines 46-51)."3 Thus, APG 325N contains >20% alkyl glycosides that are not undecyl alkyl glycoside and is not the same as the environmentally compatible detergent recited in the pending claims. Applicant further argues that Brandt also provides no disclosure or guidance, beyond a single mention of n-undecyl-β-D-maltoside as an exemplary alkyl glycoside, that would have led a person of ordinary skill in the art to have selected an environmentally compatible detergent as a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides, as recited in the pending claims. Brandt provides no guidance at all with respect to whether n-undecyl-β-D-maltoside would be delivered as a "single" undecyl glycoside as alleged by the Examiner or in a mixture with other alkyl glycosides, and for at least these reasons, a prima facie case of obviousness has not been established with respect to the pending claims. 2. Applicant argues that the examiner has not provided the requisite evidence to make a finding that the results of substituting a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides for those described by Fisher would have been predictable. Instead, the Examiner points to generalized disclosure in both Fisher and Brandt that indicates alkyl glycosides, among other environmentally friendly detergents, could potentially be used for viral inactivation. However, neither Fisher nor Brandt provide any data or evidence that a solution comprising greater than about 40% undecyl alkyl glycoside and less than about 20% other alkyl glycosides, as recited in the pending claims, would be effective for viral inactivation. Based on the generic disclosures of Fisher and Brandt, a person of ordinary skill in the art would not have had a reasonable expectation of success that using the environmentally friendly detergent recited in the amended claims would result in viral inactivation. 3. Applicant argues the evidence provided in the instant specification highlights the unpredictability of using alkyl glycosides for viral inactivation and describes the superior viral inactivation mediated by C11 alkyl glycosides relative to C10 or C12 alkyl glycosides. Applicant states that Table 3 of the specification clearly shows that SIMULSOL™ SL 11 W (an environmentally friendly detergent comprising at least 40% undecyl alkyl glycoside and less than 20% other alkyl glycosides) showed superior viral inactivation relative to SIMULSOL™ SL10 and SL26 (e.g., C10 and C12 alkyl glycosides), and the specification teaches "[s]urprisingly, these results suggest that not all glycosides are capable of robust viral inactivation, or they require extremely high concentrations to achieve robust inactivation as was observed for SIMULSOL™ AS 48. However, Applicant argues that SIMULSOL™ SL 11 W showed complete viral inactivation of greater than an LRF of 4, within 0-5 minutes of adding it to the clarified mAb bioreactor harvest material." Applicant concludes by stating that in view of the unpredictability in the art, a person of ordinary skill in the art would have found the superior viral inactivation mediated by the environmentally friendly detergents recited in the pending claims relative to other alkyl glycoside-based detergents to be surprising and unexpected. The pending claims are not obvious over the combination of cited references. Applicant’s arguments have been fully considered but they are not found persuasive. Regarding Applicant’s first argument above, the examiner maintains that substituting the alkyl glycoside detergent taught by Fisher with an alkyl glycoside taught by Brandt, including the n-undecyl-β-D-maltoside, would have been obvious because the alkyl glycosides in each reference are taught as being used for viral inactivation. Each of Fisher and Brandt teach alkyl glycosides that may be used for glycoside activation, and thus one of ordinary skill in the art would have reasonably the alkyl glycosides taught by Brandt for viral inactivation may be used in the method Fisher. Regarding Applicant’s arguments about the n-undecyl-β-D-maltoside administered as a single detergent, Brandt claims a method that requires adding an alkyl glycoside to a solution (p. 42, claim 1), which suggests the use of a single alkyl glycoside. In addition, Brandt teaches embodiments for viral inactivation that utilize single alkyl glycosides, including n-octyl-β-D-glucopyranoside (p. 29, Example 1, see Summary section; data on p. 31, Tables 2, 3, and 4), decyl β-D-glucopyranoside, dodecyl β-D-glucopyranoside, decyl β-D-maltoside and dodecyl β-D-maltoside (p. 34, see data in Table 9). Therefore, the examiner maintains that in view of the disclosure of Brandt, one of ordinary skill in the art would have considered methods in which a single alkyl glycoside is used for viral inactivation. Regarding Applicant’s second argument above, the examiner maintains that because each of Fisher and Brandt teach methods of viral inactivation with alkyl glycosides, with Brandt teaching n-undecyl-β-D-maltoside as an exemplary alkyl glycoside, one of ordinary skill in the art would have had a reasonable expectation of success substituting the alkyl glycoside detergent taught by Fisher with the n-undecyl-β-D-maltoside suggested by Brandt. In this instance, Brandt recognizes n-undecyl-β-D-maltoside as an alkyl glycoside for viral inactivation, and thus one of ordinary skill in the art would have had a reasonable expectation of applying said alkyl glycoside acknowledged by the prior art for viral activation in the method of viral inactivation taught by Fisher. Regarding Applicant’s third argument of superior results of SIMULSOLTM SL 11W compared with other alkyl glycoside detergents, SIMULSOLTM SL 10 and SIMULSOLTM SL 26 C both appear to be approximately equally effective for viral inactivation as SIMULSOLTM SL 11W at 90 minutes and 180 minutes. From 0-5 minutes, SIMULSOLTM SL 11W shows an LRF of ≥ 4.55, whereas SIMULSOLTM SL 10 and SIMULSOLTM SL 26 C show LRF of ≥ 3.10 and ≥ 3.60, respectively. However, these values are minimum LRF values from 0-5 minutes, indicating the LRF is at least 4.55, 3.10, and 3.60. This is not persuasive evidence of superior results because these data do not show SIMULSOLTM SL 11W has an LRF from 0-5 minutes greater than SIMULSOLTM SL 10 and SIMULSOLTM SL 26 C, only a minimum LRF greater than SIMULSOLTM SL 10 and SIMULSOLTM SL 26 C. Based on the data provided for this experiment, each of SIMULSOLTM SL 11W, SIMULSOLTM SL 10, and SIMULSOLTM SL 26 C could have an LRF of for example, 4.8, from 0-5 minutes, and such data which would be consistent with the data provided in Table 3. Therefore, the evidence presented in Table 3 is not persuasive evidence of nonobviousness because it does not demonstrate that SIMULSOLTM SL 11W shows a greater LRF from 0-5 minutes than SIMULSOLTM SL 10, and SIMULSOLTM SL 26 C. Regarding viral inactivation of alkyl glycosides and unpredictability, although the examiner agrees that SIMULSOLTM AS 48 and SIMULSOLTM SL 4 are ineffective for XMuLV inactivation under the experimental conditions of Table 3, SIMULSOLTM AS 48 is a C8 alkyl glycopyranoside and SIMULSOLTM SL4 is a butyl glycoside. Neither SIMULSOLTM AS 48 and SIMULSOLTM SL 4 are reasonably considered as the closest prior art to the claimed undecyl alkyl glycosides, and thus their inactivity is also not persuasive evidence of nonobviousness. The closest prior art would be considered the decyl or dodecyl (e.g., C10 or C12) alkyl glycoside detergents disclosed by Brandt, which Brandt teaches as effective for inactivating the pseudorabies virus (abbreviated as PRV) (p. 34, Tables 9 and 10a). Thus persuasive evidence of superior activity or unexpected results should be compared to these alkyl glycosides. Therefore, for the reasons stated above, the present rejection of claims 1-6, 8-24, 26-28, and 31-33 under 35 U.S.C. § 103 as unpatentable over Fisher in view of Brandt is maintained. Conclusion No claims are 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN BRANDSEN whose telephone number is (703)756-4780. The examiner can normally be reached Monday - Friday from 9:00 am to 5:00 pm. 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, Scarlett Goon can be reached at (571)270-5241. 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. /B.M.B./ Examiner, Art Unit 1693 /ANDREA OLSON/ Primary Examiner, Art Unit 1693
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Prosecution Timeline

Show 1 earlier event
Apr 22, 2025
Non-Final Rejection mailed — §103
Jul 15, 2025
Response Filed
Oct 01, 2025
Final Rejection mailed — §103
Dec 17, 2025
Request for Continued Examination
Dec 18, 2025
Response after Non-Final Action
Dec 29, 2025
Non-Final Rejection mailed — §103
Mar 30, 2026
Response Filed
Apr 07, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
61%
Grant Probability
79%
With Interview (+17.6%)
3y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 105 resolved cases by this examiner. Grant probability derived from career allowance rate.

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