Prosecution Insights
Last updated: October 04, 2026
Application No. 19/104,383

THE USE OF FATTY ALCOHOL POLYGLYCOL ETHER TO REDUCE ENDOTOXIN ACTIVITY AND/OR ENDOTOXINS IN COLLAGEN-CONTAINING AND/OR COLLAGEN-DERIVED PRODUCTS

Final Rejection §101§102§103§112
Filed
Feb 18, 2025
Priority
Apr 11, 2023 — BE 2023/5269 +2 more
Examiner
GARYU, LIANKO G
Art Unit
1654
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Rousselot B V
OA Round
4 (Final)
66%
Grant Probability
Favorable
5-6
OA Rounds
1y 2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allowance Rate
385 granted / 583 resolved
+6.0% vs TC avg
Strong +45% interview lift
Without
With
+45.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
16 currently pending
Career history
599
Total Applications
across all art units

Statute-Specific Performance

§101
5.8%
-34.2% vs TC avg
§103
31.9%
-8.1% vs TC avg
§102
17.8%
-22.2% vs TC avg
§112
32.1%
-7.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 583 resolved cases

Office Action

§101 §102 §103 §112
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 . Claim Status The claim listing filed June 23, 2026 is pending. Claims 1, 20, 23 and 24 are amended. Claims 31 and 32 are new. Claims 3-5, 8, 10-11, 14-16, 18, 19, 21, 22, 25 and 26 are canceled. Claims 1, 2, 6, 7, 9, 9, 12, 13, 17, 20, 23, 24, and 27-32 are pending and under examination. Priority This application is the national stage of international application PCT/EP2024/059850, filed April 11, 2024 and claimed priority to foreign application BE2023/5269 filed in The Kingdom of Belgium on April 11, 2023. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Rejections - 35 USC § 112(b) Response to Arguments The rejection of claim 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph has been withdrawn in view of the amendment filed June 23, 2026. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. New Rejection Necessitated by Amendment Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 2 is indefinite. Claim 2 recites the collagen containing material (interpreted as the collagen material) and the collagen derived material are selected from the finite and closed list of species, which includes extracellular matrix and native collagen. However, the scope of the claim is unclear because claim 1 requires the material to be selected from gelatin, chemically modified gelatin, collagen hydrolysate, gelatin hydrolysate and mixtures thereof. Accordingly, the scope of the claim 2 is broader than claim 1, thus creating uncertainty as to the scope of the claimed collagen and collagen-derived materials. Claim Rejections - 35 USC § 101 Response to Arguments Applicant’s arguments, see pp. 6-8, filed June 23, 2026, with respect to the rejection of claims 20, 22, 23 and 26 are rejected under 35 U.S.C. 101 have been fully considered and are persuasive. The amendment with the addition of residual polyglycol ether of a fatty alcohol is considered not a natural product. The rejection of claims 20, 22, 23 and 26 are rejected under 35 U.S.C. 101 has been withdrawn. Claim Rejections - 35 USC § 102 Response to Arguments Applicant’s arguments with respect to claims 20, 22, 23 and 26 under 35 U.S.C. 102(a)(1) as being anticipated by Olijve et al. (US 10,155,805 B2; 2018) have been considered but are moot in view of the amendments filed June 23, 2026. See Applicant’s arguments, see pp. 8-10, filed June 23, 2026. The rejection of claims 20, 22, 23 and 26 under 35 U.S.C. 102(a)(1) as being anticipated by Olijve et al. (US 10,155,805 B2; 2018) has been withdrawn. Applicant’s arguments with respect to claims 20 and 22-24 under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (WO 2022/003565A1; published 2022have been considered but are moot in view of the amendments filed June 23, 2026. See Applicant’s arguments, see pp. 8-10, filed June 23, 2026. The rejection of claims 20 and 22-24 under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al. (WO 2022/003565A1; published 2022has been withdrawn. Claim Rejections - 35 USC § 103 Response to Arguments Applicant’s arguments filed June 23, 2026 have been fully considered but are found unpersuasive for the reasons set forth below. Applicant argues that a person of ordinary skill in the art (POSITA) would not have considered purification of collagen-derivatives based on the teachings of Hunter et al. because collagen-derivatives and gelatin are not biotherapeutics, and Hunter et al. focuses on the purification of biotherapeutics from viruses rather than the removal of endotoxin. Accordingly, Applicant contends that the references, Olijve et al. and Hunter et al., are not analogous. See pages 10-11 in the remarks. Applicant’s arguments are unconvincing because Hunter et al. do not focus solely on the purification of viruses from biotherapeutics. Rather, Hunter et al. expressly teach that Laureth-9 can be used to remove endotoxins, stating that “the method includes contacting a mixture containing the biotherapeutic of interest with a solution that includes an endotoxin removing amount of Laureth-9; and incubating the mixture.”. See Hunter et al., p. 4, 2nd ¶. Further, both gelatin and derivatives of collagen fall within Hunter et al.’s definition of biotherapeutics. A POSITA would recognize collagen-derivatives and gelatin as biotherapeutics because they are polypeptides and proteins, and Hunter et al. define biotherapeutics as including polypeptides and proteins. See Hunter et al., p. 1, 2nd ¶. Applicant argues that the claimed invention is unobvious because Hunter et al. teach a higher concentration than claimed and the removal of endotoxin using Laureth-9 from biotherapeutics without the use of a cation exchange column is not taught or suggest in the prior art. Applicant further argues that surprisingly good results are achieved with low concentrations of Laureth-9, and because Hunter teaches purification before use of Laureth-9, one would only be led to use high concentrations after column purification. See pp.11-13 in Applicant’s remarks. Applicants’ arguments are found unpersuasive because the claimed invention is not limited to only contacting the composition comprising collagen or a collagen-derived material with Laureth-9. The claims use the transitional phrase “comprising” which is open-ended and inclusive; thus, the addition of purification steps, such as the use of a cation exchange column, upstream or downstream of the claimed contacting step is not precluded. The only step required is contact with an endotoxin-removing amount of Laureth-9 that results in a reduction in endotoxin activity (EU/g), which is taught by Hunter et al. Because Hunter et al. teach Laureth-9 removes endotoxin (i.e., lipopolysaccharides (LPS)), determining the smallest effective amount for a particular biotherapeutic, such as gelatin, would be a matter of routine optimization to the POSITA. 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) MPEP §2144.05 II (A). Accordingly, the rejection under 35 U.S.C. 103 as being unpatentable over Olijve et al. (US 10,155,805 B2; 2018) in view of Hunter et al. (WO 2022/003565A1; published 2022) is maintained. Please note, the rejections have been modified to address the amendments filed June 23, 2026. 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. Claims 1, 2, 4, 6, 7, 9-13, 17 and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Olijve et al. (US 10,155,805 B2; 2018) in view of Hunter et al. (WO 2022/003565A1; published 2022). The teachings of Olijve et al. are directed to the removal of lipopolysaccharides from aqueous mediums comprising gelatin utilizing TRITON X-100. See e.g., the abstract, Examples 1-14; claims 1-14. Olijve et al. teach the medium (composition) is aqueous. See e.g., claim 1. Olijve et al. teach removing lipopolysaccharide (LPS) with TRITON X-100, where the level of LPS activity is less than 100 EU/g and less than 10 EU/g. See Table 15 The difference between the instantly claimed invention and the teachings of Olijve et al is the use of 0.001-0.05 w/w% of a polyglycol ether of a fatty alcohol such as Laureth -9 for the removal of lipopolysaccharides. Hunter et al. describe methods of removing endotoxins, lipopolysaccharides, from biotherapeutics using an environmentally compatible detergent comprising Laureth-9 (polyglycol ether of a fatty alcohol). Hunter et al. teach Laureth-9 advantageously does not adversely impact product quality. See the e.g., abstract. Hunter et al. teach the endotoxins are removed from a biotherapeutic of interest by contacting the biotherapeutic with the environmentally compatible detergent comprising Laureth-9 and recovering the biotherapeutic of interest. See §Endotoxin removal. Hunter et al. teach using an amount of Laureth-9 that is effective to dissociate the endotoxin from the biotherapeutic of interest. See §Endotoxin removal. Hunter et al. refer to this amount as an endotoxin removing amount. See p.21, 1st ¶. Hunter et al. further teach obtaining purified product (eluate) with endotoxin concentrations as low as below 0.1 EU/mg. See p. 28, 1st ¶. Hunter et al. teach the use of Laureth-9 does not increase the amount of product variants in the product stream as compared to a purification process in which Triton X-100 is used as a surfactant. See p. 22, lines 17-21. Hunter et al. teach utilizing at least about 0.1 w/v% up to 10 w/v% Laureth-9. See p.27; 1st ¶, p. 29, 1st ¶; claims 19 and 32. The density of Laureth-9 is about 0.96-0.97 g/ml, evidenced by. Utilizing this conversion, 0.1 w/v% up to 10 w/v% Laureth-9 is equivalent to approximately 0.1 w/w% up to 10 w/w% Laureth-9. At the time before the effective filing date of the instant invention, it would have been prima facie obvious to a person having ordinary skill in the art to substitute Laureth-9 taught by Hunter et al. for TRITON X-100 in the process of Olijve et al. to remove the endotoxins (LPS). The artisan would have been motivated to apply Laureth-9 to the LPS-containing aqueous gelatin medium of Olijve et al. with the expectation that the product quality would not be adversely affected with a reduction in the amount of product variants produced. There would be a reasonable expectation of success because Hunter et al. demonstrated removal of endotoxin from a protein composition using Laureth-9; achieving an endotoxin concentration below 1 EU/mg. See Example 5, ¶¶ [0135-0141]. It is clear that Hunter et al. recognizes the amount of Laureth-9 is a result effective variable. Hunter et al. refers to the term “endotoxin-removing amount” as referring to an amount the is effective to dissociate endotoxin from a biotherapeutic of interest in a mixture. See Hunter et al., p. 21, 1st ¶. It is also noted that the desired resultant endotoxin concentration of Hunter et al. is encompassed by the claimed endotoxin concentration. Therefore, it would have been obvious to the artisan of ordinary skill at the time of the effective filing date of the invention to optimize the amount of Laureth-9 to have any appropriate effective amount including the amounts claimed in order to achieve the desired concentration of endotoxin in the final compositions encompassed by the claimed range. Routine optimization of an efficacious amount of Laureth-9 would have led the skilled artisan to any appropriate amount including the amounts claimed because Hunter et al. shows 1% w/v of Laureth- 9 effectively removes endotoxin from a protein containing composition and recognizes the amount is a result effective variable. Regarding claim 2, Olijve et al. teach gelatin. See e.g., claim 1. Regarding claim 6, Olijve et al. teach the composition comprise at least 2 w/w% to up to 30 w/w% or even higher gelatin. See col. 9, lines 25-45; Examples 1-14, claims 1, 8. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. Regarding claims 7, 9, 29 and 30, Hunter et al. teach Laureth-9 (polyglycol ether of laurel alcohol). See e.g., the abstract. Laureth-9 has a chain of 9 ethylene oxide units. Regarding claim 12, Olijve et al. teach contacting the composition with an adsorbent. See the e.g., abstract; Example 3. Regarding claim 13, Olijve et al. teach the adsorbent is solid or comprises activated carbon. See the e.g., abstract; col. 17, lines 14-20. Regarding claim 17, Olijve et al. teach recovering purified biotherapeutic/gelatin by filtration. See col. 6, lines 65-67; col. 7, lines 5-7; col. 8, lines 21-25; col. 17, lines 5-8. Regarding claim 27, Olijve et al. teach for medical applications (e.g., implants and devices), the endotoxin (LPS) content should be preferably ≤10 EU/g. See col. 2, lines 34-46. Although Olijve et al. do not expressly teach providing gelatin in a medical device as claimed, it would have been obvious to provide purified gelatin for such use in view of Hunter et al. which demonstrate using Laureth-9 can reduce endotoxin levels to very low concentrations (e.g., as low as 1 EU/mg). Regarding claim 28, Olijve et al. teach the recovered gelatin is in an aqueous medium. See e.g., claim 15. Regarding claims 31 and 32, both Olijve et al. and Hunter et al. teach removing residual surfactant after the contacting step with a surfactant used to remove endotoxins. See Olijve, col. 17, lines 51-55 and Hunter et al., p. 25, continuing ¶, respectively. However, neither Olijve nor Hunter et al. teach obtaining a final product containing less than 10 ppm, 2 ppm, 1 ppm, or 0.1 ppm, and greater than 0.001 ppm, of the polyglycol ether of a fatty alcohol such as Laureth-9 (surfactant) as presently claimed. Based on the teachings of Olijve and Hunter et al., it would have been obvious to a person of ordinary skill in the art to optimize the conditions to remove residual Laureth-9 in the final product containing gelatin to any desirable amount, including the amounts recited in the instant claims. The artisan would have had motivation to optimize the conditions to obtain pure gelatin. There would also have been a reasonable expectation of success because both Olijve et al. and Hunter et al. recognize that residual surfactant must be removed and provide suggested mechanisms and parameters for removing the surfactant to obtain a product equivalent to pure gelatin. Therefore, before the effective filing date of the claimed invention, the instantly claimed invention was prima facie obvious to the artisan of ordinary skill. New Rejection Necessitated by Amendment Claims 20, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Olijve et al. (US 10,155,805 B2; 2018) in view of Hunter et al. (WO 2022/003565A1; published 2022). Regarding claims 20, 23 and 24, Olijve et al. gelatin comprising residual surfactant, namely TRITON X-100, after being contacted with TRITON X-100 to remove endotoxins, LPS, where the level of LPS activity is less than 100 EU/g and less than 10 EU/g. Olijve et al. do not teach the residual surfactant polyglycol ether of a fatty alcohol such as Laureth -9. Hunter et al. describe methods of removing endotoxins, lipopolysaccharides, from biotherapeutics using an environmentally compatible detergent comprising Laureth-9 (polyglycol ether of a fatty alcohol). Hunter et al. teach Laureth-9 advantageously does not adversely impact product quality. See the e.g., abstract. Hunter et al. teach the endotoxins are removed from a biotherapeutic of interest by contacting the biotherapeutic with the environmentally compatible detergent comprising Laureth-9 and recovering the biotherapeutic of interest. See §Endotoxin removal. Hunter et al. teach using an amount of Laureth-9 that is effective to dissociate the endotoxin from the biotherapeutic of interest. See §Endotoxin removal. Hunter et al. refer to this amount as an endotoxin removing amount. See p.21, 1st ¶. Hunter et al. further teach obtaining purified product (eluate) with endotoxin concentrations as low as below 0.1 EU/mg. See p. 28, 1st ¶. Hunter et al. teach the use of Laureth-9 does not increase the amount of product variants in the product stream as compared to a purification process in which Triton X-100 is used as a surfactant. See p. 22, lines 17-21. It would have been obvious to one of ordinary sill in the art to substitute Laureth-9 for TRITON X-100 in the method of removing LPS from gelatin taught by Olijve et al. in order to obtain gelatin with reduced endotoxin activity. The artisan would have been motivated to apply Laureth-9 to the LPS-containing aqueous gelatin medium of Olijve et al. with the expectation that the product quality would not be adversely affected with a reduction in the amount of product variants produced. There would be a reasonable expectation of success because Hunter et al. demonstrated removal of endotoxin from a protein composition using Laureth-9; achieving an endotoxin concentration below 1 EU/mg. See Example 5, ¶¶ [0135-0141]. There would have been a reasonable expectation of success that there would be remaining Lauerth-9 because both Olijve et al. and Hunter et al. teach residual surfactant, such as Laureth-9, remains after being contacted to remove endotoxins. Regarding claim 23, both Olijve et al. and Hunter et al. teach removing residual surfactant after the contacting step with a surfactant used to remove endotoxins. See Olijve, col. 17, lines 51-55 and Hunter et al., p. 25, continuing ¶, respectively. However, neither Olijve nor Hunter et al. teach obtaining a final product containing less than 10 ppm, 2 ppm, 1 ppm, or 0.1 ppm, and greater than 0.001 ppm, of the polyglycol ether of a fatty alcohol such as Laureth-9 (surfactant) as presently claimed. Based on the teachings of Olijve and Hunter et al., it would have been obvious to a person of ordinary skill in the art to optimize the conditions to remove residual Laureth-9 in the final product containing gelatin to any desirable amount, including the amounts recited in the instant claims. The artisan would have had motivation to optimize the conditions to obtain pure gelatin. There would also have been a reasonable expectation of success because both Olijve et al. and Hunter et al. recognize that residual surfactant must be removed and provide suggested mechanisms and parameters for removing the surfactant to obtain a product equivalent to pure gelatin. Regarding claims 20, 23, and 24, Olijve et al. teach gelatin comprising residual surfactant, namely Triton X-100, after being contacted with Triton X-100 to remove endotoxins (LPS), where the level of LPS activity is less than 100 EU/g and less than 10 EU/g. See e.g., the abstract, Examples 1-14; claims 1-14, Table 15. However, Olijve et al. do not teach that the residual surfactant is a polyglycol ether of a fatty alcohol, such as Laureth-9. Hunter et al. describe methods of removing endotoxins, i.e., lipopolysaccharides, from biotherapeutics using an environmentally compatible detergent comprising Laureth-9 (a polyglycol ether of a fatty alcohol). Hunter et al. teach that Laureth-9 advantageously does not adversely impact product quality. See, e.g., the abstract. Hunter et al. further teach that endotoxins are removed from a biotherapeutic of interest by contacting the biotherapeutic with the environmentally compatible detergent comprising Laureth-9 and recovering the biotherapeutic of interest. See § Endotoxin Removal. Hunter et al. teach using an amount of Laureth-9 effective to dissociate the endotoxin from the biotherapeutic of interest, which Hunter et al. refer to as an “endotoxin removing amount.” See p. 21, first paragraph. Hunter et al. further teach obtaining purified product (eluate) with endotoxin concentrations as low as below 0.1 EU/mg. See p. 28, first paragraph. Hunter et al. also teach that use of Laureth-9 does not increase the amount of product variants in the product stream as compared to a purification process in which Triton X-100 is used as the surfactant. See p. 22, lines 17–21. Both Olijve et al. and Hunter et al. teach removing residual surfactant after the contacting step with a surfactant used to remove endotoxins. See Olijve, col. 17, lines 51-55 and Hunter et al., p. 25, continuing ¶, respectively. It would have been obvious to one of ordinary skill in the art to substitute Laureth-9 for Triton X-100 in the method of removing LPS from gelatin taught by Olijve et al. in order to obtain gelatin with reduced endotoxin activity. The artisan would have been motivated to apply Laureth-9 to the LPS-containing aqueous gelatin medium of Olijve et al. with the expectation that product quality would not be adversely affected and that the amount of product variants would be reduced. There would also have been a reasonable expectation of success because Hunter et al. demonstrated removal of endotoxin from a protein composition using Laureth-9, achieving an endotoxin concentration below 1 EU/mg. See Example 5, ¶¶ [0135–0141]. Further, there would have been a reasonable expectation that residual Laureth-9 would remain, because both Olijve et al. and Hunter et al. teach that residual surfactant remains after contacting the composition to remove endotoxins. Regarding claim 23, both Olijve et al. and Hunter et al. teach removing residual surfactant after the contacting step with a surfactant used to remove endotoxins. See Olijve, col. 17, lines 51–55, and Hunter et al., p. 25, continuing paragraph. However, neither Olijve nor Hunter et al. teaches obtaining a final product containing less than 10 ppm, 2 ppm, 1 ppm, or 0.1 ppm, and greater than 0.001 ppm, of the polyglycol ether of a fatty alcohol, such as Laureth-9, as presently claimed. Based on the teachings of Olijve and Hunter et al., it would have been obvious to a person of ordinary skill in the art to optimize the conditions to remove residual Laureth-9 in the final gelatin product to any desirable amount, including the amounts recited in the instant claims. The artisan would have had motivation to optimize the conditions to obtain pure gelatin. There also would have been a reasonable expectation of success because both Olijve et al. and Hunter et al. recognize that residual surfactant must be removed and provide suggested mechanisms and parameters for removing the surfactant to obtain a product equivalent to pure gelatin. Therefore, before the effective filing date of the claimed invention, the instantly claimed invention was prima facie obvious to the artisan of ordinary skill. Summary No claim is allowed. Claim 24 is rejected under 35 U.S.C. 112(b). Claims 1, 2, 6, 7, 9, 12, 13, 17, 20, 23, 24 and 27-32 are rejected under 35 U.S.C. 103. Correspondence Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Lianko G Garyu whose telephone number is (571)270-7367. The examiner can normally be reached Monday through Friday 8:30 AM - 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, Jennifer Michener can be reached at 571-272-1424. 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. /LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654 Lianko G. Garyu, Ph.D. Supervisory Patent Examiner Art Unit 1654
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Prosecution Timeline

Show 2 earlier events
Jun 13, 2025
Examiner Interview (Telephonic)
Jun 18, 2025
Non-Final Rejection mailed — §101, §102, §103
Sep 10, 2025
Response Filed
Oct 22, 2025
Final Rejection mailed — §101, §102, §103
Feb 11, 2026
Interview Requested
Mar 24, 2026
Non-Final Rejection mailed — §101, §102, §103
Jun 23, 2026
Response Filed
Sep 22, 2026
Final Rejection mailed — §101, §102, §103 (current)

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Prosecution Projections

5-6
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+45.4%)
2y 9m (~1y 2m remaining)
Median Time to Grant
High
PTA Risk
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