Prosecution Insights
Last updated: April 19, 2026
Application No. 17/799,036

METHOD FOR PRODUCING REDUCED COENZYME Q10 FORM II CRYSTALS

Final Rejection §103§112§DP
Filed
Aug 11, 2022
Examiner
NOLAN, JASON MICHAEL
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kaneka Corporation
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
2y 11m
To Grant
37%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
235 granted / 355 resolved
+6.2% vs TC avg
Minimal -29% lift
Without
With
+-29.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
45 currently pending
Career history
400
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
22.2%
-17.8% vs TC avg
§102
22.8%
-17.2% vs TC avg
§112
32.2%
-7.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 355 resolved cases

Office Action

§103 §112 §DP
DETAILED ACTION A non-final Office action was mailed 20 June 2025 (“Office Action”). Applicant’s reply was received 22 September 2025 (“Reply”). Status of the Claims The listing of claims filed with the Reply has been examined. Claims 1, 10, and 12–20 are pending. Claims 1, 10, 12–14 are amended. Claims 2–9 and 11 are canceled. Status of Rejections and Objections The text of those sections of Title 35, U.S. Code and/or text providing the basis for double patenting rejections not included in this action can be found in the Office Action. Unless repeated herein, any objection or rejection in the Office Action is withdrawn. Claim Rejections - 35 U.S.C. § 112 and 35 U.S.C. § 132 The following is a quotation of 35 U.S.C. § 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of 35 U.S.C. § 132(a): (a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. No amendment shall introduce new matter into the disclosure of the invention. As shown above, 35 U.S.C. § 132(a) states: “no amendment shall introduce new matter into the disclosure of the invention.” Claims 1 and 12–20 are rejected under 35 U.S.C. § 132(a) because they introduce new matter into the disclosure and under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention. The subject matter that is not supported by the original disclosure is: “wherein the Ti is from 20°C to 35°C.” In other words, the disclosure does not describe a range of 20–35°C for Ti. Original claims 3 and 9 recite: “wherein the Ti is from 20° C. to 43° C.” Original claims 4 and 10 recite: “wherein the Ti is from 20° C. to lower than 32° C.” Specification, p.4, states: “wherein the Ti is from 20° C. to 43° C.” and “wherein the Ti is from 20° C. to lower than 32° C.” Specification, p.12, ¶25, states: The temperature Ti of the mixed solution when the addition of seed crystals is preferably within a range of 20° C. to 43° C. When the temperature Ti is 20° C. or higher, the difference between the saturated concentration of the Form II-type crystal and the saturated concentration of the Form I-type crystal is large and the saturated concentration of the Form I-type crystal is high, which is thus appropriate for selective precipitation of the Form II-type crystal. When the temperature Ti is 43° C. or lower, the crystal formation rate is high. When the temperature Ti is more preferably 25° C. or higher, even more preferably 30° C. or higher, further preferably 32° C. or higher, still further preferably 35° C. or higher, the difference between the saturated concentration of the Form II-type crystal and the saturated concentration of the Form I-type crystal is greater than the above, and the saturated concentration of the Form I-type crystal is high, which thus makes it easier to selectively precipitate the Form II-type crystal. The upper limit of the temperature Ti is more preferably 40° C. or lower. When the Ti is from 20° C. to lower than 32° C., it is also one preferred embodiment of the present invention. Specification, pp.13–14, ¶29, states: One preferred example of the crystal precipitation step includes maintaining the temperature Tp at a constant temperature, for example, a temperature range mentioned above as a preferred range of the temperature Ti when the addition of seed crystals, for example, at a constant temperature within a range of 20° C. to 43° C. In particular, it is more preferable that the step includes maintaining the temperature Tp for 1 hour or longer after the addition of seed crystals within the temperature range mentioned above as a preferred range of the temperature Ti when the addition of seed crystals, for example, at a constant temperature within a range of 20° C. to 43° C. Specification, pp.21–22, ¶49, states: To approximately 30 g of each hydrous ethanol, approximately 10 g of a Form I-type crystal or a Form II-type crystal was added, the mixture was stirred under a nitrogen atmosphere and maintained for approximately 1 hour at temperatures of 25° C., 30° C., 35° C., and 40° C. Sampling was performed at each temperature and each sample was filtered quickly to obtain a liquid phase sample. Each sample was analyzed under the above HPLC conditions and the solubility was calculated. Specification, p.26, ¶65, states: “At the time of the addition of seed crystals at 35° C. . . .” Nowhere in the original disclosure is temperature Ti described as a range of 20–35°C. In fact, when a temperature of 35°C is mentioned in ¶25, it is identified as the lower limit of a range (“still further preferably 35° C. or higher”). And in ¶¶49 and 65, the temperature 35°C is an example embodiment, as opposed to the endpoint of a range. Accordingly, there is no explicit or implicit support for the claimed temperature Ti range of 20–35°C. Applicant is required to cancel the new matter in the reply to this Office Action. Claim Objections Claim 1 is objected to for minor informalities. Claim 1 recites: “wherein the Ti is from 20°C to 35°C”; “wherein the Tp is from 5°C to 43°C”; and “units of the Ti and the Tp are each designated to be K.” The first two clauses define the units of Ti and Tp as Celsius (C) for the precipitating step, and the third clause defines the units of Ti and Tp as Kelvin (K). Because the third clause appears to refer to the Expressions 1–6 and not the precipitating step, the clause should be relocated after those Expressions and amended to explicitly state “units of the Ti and the Tp in the Expressions 1–6 are each designated to be K” to improve clarity and avoid confusion. Appropriate correction is required. Claim Rejections - 35 U.S.C. § 103 Claims 1, 10, and 12–20 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2014/0120073 (“Kawachi”) [IDS] in view of US 7,145,044 (“Ueda”). Kawachi is the English language equivalent and national stage application of WO2012/176842 (referred to as Patent Literature 4 in the instant specification). The Graham factors are addressed in turn below. Determining the scope and contents of the prior art Applicant acknowledges that Kawachi discloses a process of preparing a reduced coenzyme Q10 Form II-type crystal. (Spec., ¶7). Regarding claims 1, 10, 15, 17, and 19, Kawachi discloses processes of producing reduced coenzyme Q10 Form II-type crystal. (Kawachi, ¶¶86–88). One process comprises: warming a solution of 96g of ethanol and 4g of commercially available reduced coenzyme Q10 to 40°C to completely dissolve the reduced coenzyme Q10; cooling the solution to 30°C, adding 0.4g (0.1% by weight) of a reduced coenzyme Q10 Form II-type crystal as a seed crystal to the solution comprising ethanol and reduced coenzyme Q10, and maintaining the 30°C temperature constant for 24h; precipitating a reduced coenzyme Q10 Form II-type crystal from the solution after adding the seed crystal; filtering the reduced coenzyme Q10 Form II-type crystal; and drying the reduced coenzyme Q10 Form II-type crystal. (Id., ¶88). The temperature Ti of the solution while adding the seed crystal and the controlling temperature Tp while precipitating the reduced coenzyme Q10 Form II-type crystal are 30°C. Kawachi states 4g of coenzyme Q10 is completely dissolved in 96g of ethanol. (Id.). Therefore, the dissolved concentration Ci before adding the seed crystal is 4%, which is “1.5% by weight or more.” (Id.). Regarding claim 15, Kawachi uses 96g of ethanol and no other solvent, which is within the claimed range of 95% or more. (Id.). Regarding claim 17, Kawachi uses 0.4g of seed crystal compared to 4g of reduced coenzyme Q10, which is within the claimed range of 0.1–20 wt%. (Id.). Ueda states, “cooling crystallization, concentration crystallization, solvent substitution crystallization and other methods” are “conventional crystallization methods.” (Ueda, 13:23–30) (column:lines). Regarding “other methods,” Ueda states, “seed crystals are preferably added so that the state of supersaturation may be prevented from occurring and the nucleation and crystal growth may be allowed to proceed smoothly.” (Id., 14:26–29). Ascertaining the differences between the prior art and the claims at issue Regarding claim 1, Kawachi is silent with respect to the concentration of ethanol used in the method and whether the ethanol contains water. Kawachi is silent with respect to whether Cp is 1.5% by weight or more. Regarding claims 12–14, Kawachi is silent with respect to maintaining and/or lowering the temperature Tp while precipitating the reduced coenzyme Q10 Form II-type crystal. Regarding claim 16, Kawachi is silent with respect to the dissolved concentration Ci of the reduced coenzyme Q10 before adding the seed crystal. Regarding claim 18, Kawachi is silent with respect to a cooling rate of between 1–15°C per hour during the precipitating step in Example 3. In other examples, the cooling rate was 10°C per hour. (Kawachi, ¶¶86, 87, 89). Regarding claim 19, Kawachi is silent with respect to drying the reduced coenzyme Q10 Form II-type crystal at a temperature between 46–52°C. Regarding claim 20, Kawachi is silent with respect to drying for 4 hours or more. Resolving the level of ordinary skill in the pertinent art The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience. Considering objective evidence present in the application indicating obviousness or nonobviousness The instant application does not include evidence of unexpected results, such as a comparison between the process in Kawachi with the process covered by the instant claims. The comments in the background of the instant specification are not specific and do not represent evidence of nonobviousness. (Spec., ¶7). With respect to a process in Kawachi, the specification states, “it cannot be necessarily said that this method is industrially optimal.” (Id.). Thus, the instant claims are directed to an optimization of the known methods disclosed in Kawachi. The question of obviousness Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art, prior to filing the instant application, to arrive at the claimed process based on the disclosure in Kawachi. Crystallization processes, including the use of a seed crystal, are well-known in the art, as evidenced by Ueda. And the crystallization process for producing reduced coenzyme Q10 Form II-type crystal from reduced coenzyme Q10 is disclosed in Kawachi, including each of the positively recited steps in the instant claims. Although Kawachi is silent with respect to certain features in the claims related to concentration and temperature, such differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the claimed concentration or temperature parameters are critical. MPEP § 2144.05(II). There is no evidence a claimed feature not disclosed in Kawachi is critical to the crystallization process for producing reduced coenzyme Q10 Form II-type crystal. The instant specification includes a general comment that a process in Kawachi “takes a long period of time and further, the recovered amount is small.” (Spec. ¶7). But the specification does not explain which process the comment refers to. The specification also states it was discovered that Form-I-type crystals precipitate in preference to Form II-type crystals. (Id.). While the discovery of a problem may be relevant to obviousness, the claimed features that are not disclosed in Kawachi appear to be controlled and/or measured using routine laboratory equipment. The claimed method is an optimized version of the processes disclosed in Kawachi. One of ordinary skill in the art would have had a reasonable expectation of success at arriving at the optimized method because the general conditions (i.e., the positively recited steps) are disclosed in Kawachi and the specific limitations not disclosed in Kawachi, if not inherently described, are aspects that can be controlled (e.g., temperature, Ci) and/or measured (e.g., solubility, Cp), and therefore those aspects are within the knowledge and skill of an ordinary artisan. Because Kawachi discloses the claimed positively recited steps, the skill level in the art is high, and the high level of ordinary skill in the art would have had a reasonable expectation of success at improving the known process by manipulating concentration and/or temperature of one or more steps of the known process. Response to Arguments Applicant’s arguments submitted with the Reply have been considered but are not persuasive. Applicant first argues: “The claimed subject matter has these different distinguishing features from Kawachi [ ] and Ueda.” (Remarks, p.7; italics added; underlining omitted). It is unclear what “these” refers to. The paragraph preceding Applicant’s statement is merely a recitation of amended claim 1. Applicant does not identify any specific distinguishing features. Applicant next argues the claimed process results in “superior and unexpected results compared to Kawachi and Ueda.” (Remarks, p.8). Applicant specifically refers to Experiment 2 of the instant specification and identifies a rate of 100% and a recovery rate of 97% as results for the claimed process. But Applicant does not point to any data comparing the results in Experiment 2 and the results from the process in Kawachi to support a claim that a rate of 100% and a recovery rate of 97% are actually superior and unexpected results. Attorney argument cannot take the place of factually supported objective evidence. MPEP § 2145. Accordingly, Applicant’s argument is not persuasive. Double Patenting (i) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/281,592 (reference claims). Instant Application claim 1 18/281,592 claim 1 (12 September 2023) A method for producing a reduced coenzyme Q10 Form II-type crystal, comprising: A method for producing a reduced coenzyme Q10 Form II crystal or a crystalline solid thereof, comprising: adding a reduced coenzyme Q10 Form II-type crystal as a seed crystal to a solution comprising ethanol reduced coenzyme Q10; and adding a reduced coenzyme Q10 Form II crystal as a seed crystal to a mixed solution containing an alcohol and a reduced coenzyme Q10; and precipitating a reduced coenzyme Q10 Form II-type crystal from the solution after adding the seed crystal, precipitating a reduced coenzyme Q10 Form II crystal in the mixed solution after adding the seed crystal, wherein a dissolved concentration Ci of reduced coenzyme Q10 in the solution before adding the seed crystal is equal to or more than a saturated concentration of a Form II- type crystal and less than a saturated concentration of a Form I-type crystal at a temperature Ti of the solution when adding the seed crystal, wherein the Ti is from 20°C to 35°C, and precipitating the reduced coenzyme Q10 Form II-type crystal comprises controlling a temperature Tp of the solution so that a dissolved concentration Cp of reduced coenzyme Q10 in the solution is equal to or more than the saturated concentration of the Form II-type crystal and less than the saturated concentration of the Form I-type crystal, wherein the Tp is from 5°C to 43°C, wherein a change rate of formazin turbidity (FTU) is maintained at 15 FTU/min or more for 80% or more of a period during which the formazin turbidity (FTU) shifts from 1,000 to 10,000 in the precipitation. the ethanol further contains water, an ethanol concentration based on a total volume of the water and the ethanol is Z% (v/v), the Z is from 90 to 100, units of the Ci and the Cp are each designated to be % by weight and units of the Ti and the Tp are each designated to be K, and if the Ci and the Cp are 1.5% by weight or more, all of the following conditions are satisfied: (Expression 1) AII·Ti + BII log Ci< AI·Ti + BI, (Expression 2) AII·Tp, + BII logC < AI·Tp + BI, (Expression 3) AI = 0.0089·Z - 0.6754, (Expression 4) BI = -2.3607·Z + 172.70, (Expression 5) AI = 0.0086·Z - 0.6844, and (Expression 6) BII = -2.3178·Z + 178.26. Although the independent claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are directed to a method comprising the same two—and only two—positively recited steps (i.e., adding a seed crystal to a solution of alcohol and reduced coenzyme Q10; and precipitating reduced coenzyme Q10 Form II crystal). The differences between the instant and references claims relate to specific nuances in the known process. For example, the instant claims include aspects directed to concentration and temperature, and the reference claims include aspects related to the turbidity of the solution. With respect to those differences, there is no evidence of criticality. Indeed, both processes provide the same result. Furthermore, the instant claims do not exclude the turbidity and crystal diameter claim elements; and the reference claims do not exclude the temperature and concentration claim elements. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference application may also be an infringer of the other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. (ii) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/283,863 (reference claims). Instant Application claim 1 18/283,863 claim 1 (25 September 2023) A method for producing a reduced coenzyme Q10 Form II-type crystal, comprising: A method for producing a reduced coenzyme Q10 Form II crystal or a crystalline solid thereof, comprising: providing a crystallizer, wherein the crystallizer comprises a crystallization unit, a turbidity detection unit for detecting a turbidity in the crystallization unit, and a temperature adjustment unit for adjusting a temperature in the crystallization unit; providing a mixed solution comprising an alcohol and a reduced coenzyme Q10 in the crystallization unit; adding a reduced coenzyme Q10 Form II-type crystal as a seed crystal to a solution comprising ethanol reduced coenzyme Q10; and adding a reduced coenzyme Q10 Form II crystal as a seed crystal to the mixed solution; and precipitating a reduced coenzyme Q10 Form II-type crystal from the solution after adding the seed crystal, precipitating a reduced coenzyme Q10 Form II crystal in the mixed solution after adding the seed crystal, wherein a dissolved concentration Ci of reduced coenzyme Q10 in the solution before adding the seed crystal is equal to or more than a saturated concentration of a Form II- type crystal and less than a saturated concentration of a Form I-type crystal at a temperature Ti of the solution when adding the seed crystal, wherein the Ti is from 20°C to 35°C, and precipitating the reduced coenzyme Q10 Form II-type crystal comprises controlling a temperature Tp of the solution so that a dissolved concentration Cp of reduced coenzyme Q10 in the solution is equal to or more than the saturated concentration of the Form II-type crystal and less than the saturated concentration of the Form I-type crystal, wherein the Tp is from 5°C to 43°C, wherein the precipitating comprises controlling a temperature with the temperature adjustment unit based on a turbidity change rate obtained by the turbidity detection unit. the ethanol further contains water, an ethanol concentration based on a total volume of the water and the ethanol is Z% (v/v), the Z is from 90 to 100, units of the Ci and the Cp are each designated to be % by weight and units of the Ti and the Tp are each designated to be K, and if the Ci and the Cp are 1.5% by weight or more, all of the following conditions are satisfied: (Expression 1) AII·Ti + BII log Ci< AI·Ti + BI, (Expression 2) AII·Tp, + BII logC < AI·Tp + BI, (Expression 3) AI = 0.0089·Z - 0.6754, (Expression 4) BI = -2.3607·Z + 172.70, (Expression 5) AI = 0.0086·Z - 0.6844, and (Expression 6) BII = -2.3178·Z + 178.26. Although the independent claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are directed to a method comprising the same steps (i.e., adding a seed crystal to a solution of alcohol and reduced coenzyme Q10; and precipitating reduced coenzyme Q10 Form II crystal). The differences between the instant and references claims relate to specific nuances in the known process. For example, the instant claims have aspects directed to concentration and temperature, and the reference claims refer to providing a device that controls temperature and turbidity. With respect to those differences, there is no evidence of criticality. Indeed, both processes provide the same result. Furthermore, the instant claims do not exclude using the device for controlling temperature and turbidity claim; and the reference claims do not exclude the temperature and concentration aspects. Thus, an infringer of a patent granted based on the claims of one of the instant application or the reference application would also be an infringer of the other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. (iii) Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 5 of U.S. Pat. No. 11,453,633 (reference claims). Instant Application claim 1 11,453,633 claim 1 A method for producing a reduced coenzyme Q10 Form II-type crystal, comprising: A method for producing a reduced coenzyme Q10 Form II crystal, comprising: adding a reduced coenzyme Q10 Form II-type crystal as a seed crystal to a solution comprising ethanol reduced coenzyme Q10; and adding a reduced coenzyme Q10 Form II crystal as a seed crystal to a solution with a temperature of 32 °C. to 43 °C., said solution comprising (a) at lease one organic solvent selected from the group consisting of an alcohol [claims 4 and 5 refer to ethanol], a hydrocarbon, an aliphatic acid ester and a nitrogen compound, and (b) reduced coenzyme Q10, to prepare a mixture, and precipitating a reduced coenzyme Q10 Form II-type crystal from the solution after adding the seed crystal, precipitating the reduced coenzyme Q10 from the mixture, in the form of the coenzyme Q10 Form II crystal; wherein a dissolved concentration Ci of reduced coenzyme Q10 in the solution before adding the seed crystal is equal to or more than a saturated concentration of a Form II- type crystal and less than a saturated concentration of a Form I-type crystal at a temperature Ti of the solution when adding the seed crystal, wherein the Ti is from 20°C to 35°C, and precipitating the reduced coenzyme Q10 Form II-type crystal comprises controlling a temperature Tp of the solution so that a dissolved concentration Cp of reduced coenzyme Q10 in the solution is equal to or more than the saturated concentration of the Form II-type crystal and less than the saturated concentration of the Form I-type crystal, wherein the Tp is from 5°C to 43°C, wherein the reduced coenzyme Q10 Form II crystal is obtained with a Form II rate of 70-100%; or wherein the reduced coenzyme Q10 Form II crystal is obtained with a recovery rate of 78-99%. the ethanol further contains water, an ethanol concentration based on a total volume of the water and the ethanol is Z% (v/v), the Z is from 90 to 100, units of the Ci and the Cp are each designated to be % by weight and units of the Ti and the Tp are each designated to be K, and if the Ci and the Cp are 1.5% by weight or more, all of the following conditions are satisfied: (Expression 1) AII·Ti + BII log Ci< AI·Ti + BI, (Expression 2) AII·Tp, + BII logC < AI·Tp + BI, (Expression 3) AI = 0.0089·Z - 0.6754, (Expression 4) BI = -2.3607·Z + 172.70, (Expression 5) AI = 0.0086·Z - 0.6844, and (Expression 6) BII = -2.3178·Z + 178.26. Although the independent claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are directed to a method comprising the same two—and only two—positively recited steps (i.e., adding a seed crystal to a solution of alcohol and reduced coenzyme Q10; and precipitating reduced coenzyme Q10 Form II crystal). The differences between the instant and references claims relate to specific nuances in the known process. For example, the instant claims include aspects directed to concentration and temperature, and the reference claims has features related to rate or recovery rate. With respect to those differences, there is no evidence of criticality. Indeed, both processes provide the same result. Furthermore, the instant claims do not exclude the rate or recovery rate claim aspects; and the reference claims do not exclude the temperature and concentration claim aspects. Thus, an infringer of a patent granted based on the instant claims or the reference claims would also be an infringer of the other. Response to Arguments Applicant’s arguments submitted with the Reply have been considered but are not persuasive. Applicant argues the amendment to instant claim 1 to incorporate the subject matter of claim 2, which was not rejected, overcomes the rejection. Examiner disagrees. As established in the rejections, the conflicting claims are directed to methods with identical steps. The additional claim elements are directed to desired/intended results (e.g., obtained with a Form II rate of 70-100%; with a recovery rate of 78-99%) or optimizable parameters (e.g., turbidity, concentration, temperature) that are within the skill level of one or ordinary skill in the art and which do not distinguish the otherwise same process. Conclusion THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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. Communication Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00. 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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674. 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. /JASON M. NOLAN/Patent Examiner, Art Unit 1623 /ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Read full office action

Prosecution Timeline

Aug 11, 2022
Application Filed
Jun 13, 2025
Non-Final Rejection — §103, §112, §DP
Sep 22, 2025
Response Filed
Nov 11, 2025
Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
37%
With Interview (-29.1%)
2y 11m
Median Time to Grant
Moderate
PTA Risk
Based on 355 resolved cases by this examiner. Grant probability derived from career allow rate.

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