Prosecution Insights
Last updated: April 19, 2026
Application No. 17/416,087

METHOD AND SYSTEM FOR FORMULATING A REQUIRED COMPOSITION FROM AT LEAST ONE INGREDIENT OF VARIABLE COMPOSITION

Final Rejection §103
Filed
Jun 18, 2021
Examiner
HYUN, PAUL SANG HWA
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Sigma Alimentos S A De C V
OA Round
2 (Final)
70%
Grant Probability
Favorable
3-4
OA Rounds
3y 5m
To Grant
99%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allow Rate
582 granted / 834 resolved
+4.8% vs TC avg
Strong +36% interview lift
Without
With
+36.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
38 currently pending
Career history
872
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
38.5%
-1.5% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
31.0%
-9.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 834 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 . Response to Amendment The amendment filed on September 29, 2025 is acknowledged. Claims 1-9 remain pending wherein claims 5-9 remain withdrawn pursuant to the election made in the response filed on June 16, 2025. Applicant amended claims 1 and 2. Response to Arguments Applicant's arguments with respect to the patentability of the claims have been fully considered but they are not persuasive. In general, Applicant’s remarks are replete with references to the specification (text and figures) when alleging differences between Applicant’s invention and the inventions taught by Wynn and Onnheim. In other words, much of Applicant’s arguments directed to the patentability of the claims rely on features not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). That said, the arguments that are bolded in the remarks are hereby addressed individually, in addition to other non-bolded arguments that are deemed pertinent to the outstanding rejections. Applicant argues that the claims are patentable over the combination of Wynn and Onnheim because “Wynn does not address time-varying ingredient compositions”. Remarks 7. According to Applicant, “the system in Wynn operates under the assumption that the raw milk input has a relatively stable composition”, and hence “it does not monitor or compensate for compositional changes in the input ingredients during the process”. Id. The argument is not persuasive. Even if, arguendo, that Applicant’s assertion that “the system in Wynn operates under the assumption that the raw milk input has a relatively stable composition” is correct, the significance of this assertion as it applies to the patentability of the claims is unclear. Applicant does not identify the claim limitation(s) that is/are not taught by, or rendered obvious by, Wynn’s disclosure. As discussed above, Applicant refers to the disclosure of the specification rather than the claim language to distinguish Applicant’s invention from the prior art. Applicant also argues that “Wynn’s technical approach is separation-based, not formulation-based”. Remarks 7. According to Applicant, “Wynn uses a centrifugal separator to physically divide raw milk…into low fat milk, or skim milk, and high fat milk, or cream”, which is “fundamentally different from the present invention’s approach of formulating compositions by controlling the amounts of distinct ingredients with known but variable compositions”. Id. The argument is not persuasive because again, the significance of this alleged distinction between Applicant’s invention and the disclosure of Wynn as it applies to the patentability of the claims is unclear. Applicant does not identify the claim limitation(s) that is/are not taught by, or rendered obvious by, Wynn’s disclosure. As discussed above, Applicant refers to the disclosure of the specification rather than the claim language to distinguish Applicant’s invention from the prior art. Applicant also argues that “Wynn’s control system is unidirectional”. Remarks 8. According to Applicant, Wynn’s system “adjusts only the cream control valve to control butterfat content, whereas the present invention requires bidirectional control of multiple ingredient feeding lines based on simultaneous monitoring of compositional profiles of multiple components”. Id. The argument is not persuasive because again, the significance of this alleged distinction between Applicant’s invention and the disclosure of Wynn as it applies to the patentability of the claims is unclear. Applicant does not identify the claim limitation(s) that is/are not taught by, or rendered obvious by, Wynn’s disclosure. As discussed above, Applicant refers to the disclosure of the specification rather than the claim language to distinguish Applicant’s invention from the prior art. Regarding Applicant’s arguments regarding to Onnheim (Remarks 8-9), the arguments suffer from the same deficiency as Applicant’s arguments regarding Wynn. Specifically, Applicant does not identify the claim limitation(s) not taught by, or rendered obvious by, the combination of Wynn and Onnheim. In addition, some of Applicant’s remarks (see bolded sentences, “Onnheim does not handle time-varying ingredient compositions”; “Onnheim’s process is predetermined and sequential, not adaptive”; and “Onnheim lacks the sensor arrangement and control logic of the present invention”) are directed to the alleged deficiencies of Onnheim only even though the claims are rejected based on the combination of Wynn and Onnheim. Applicant’s remarks identified above constitute piecemeal analysis of references, which is insufficient to establish nonobviousness in a situation where a rejection is based on a combination of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Regarding Applicant’s remarks that the “claimed solution requires specific technical elements absent from the prior art” (Remarks 9-10), Applicant does refer to claim limitations. Specifically, Applicant argues that the combination of Wynn and Onnheim fails to teach “simultaneous correlation of real-time profiles with pre-established target profiles as specified in amended claim 1, steps (e)-(g)”. Remarks 10. The argument is not persuasive. The rejection of claim 1 below explicitly provides citations in Wynn corresponding to steps (e)-(g). The citations explicitly disclose the steps of “providing a…reference signal corresponding to desired butterfat content“ (see claim 4), “provid[ing] an output signal which varies in accordance with the butterfat content of the product” (see claim 4), and “in accordance with the…reference signal and the output signal…to control the butterfat content” (see claim 4). Based on the disclosure, the examiner maintains that Wynn explicitly teaches “simultaneous correlation of real-time profiles with pre-established target profiles”, contrary to Applicant’s assertion. Applicant also argues that one of ordinary skill in the art would not have been motivated to combine the teachings of Wynn and Onnheim. Remarks 10. According to Applicant, “Wynn focuses on butterfat control through separation, while Onnheim addresses protein standardization through predetermined processing steps”. Id. The argument is not persuasive. Even if, arguendo, that Applicant’s characterization of Wynn and Onnheim is correct, it is unclear how the distinction undermines the motivation set forth in the rejection of claim 1. Applicant also argues that the teachings of Wynn and Onnheim are technically incompatible. Remarks 10. To support this argument, Applicant cites to alleged incompatibilities between Applicant’s invention and the inventions of Wynn and Onnheim, respectively. Id. The argument is not persuasive because the foundation of Applicant argument is not commensurate with alleged evidence posited by Applicant. Specifically, the relevance of comparing Applicant’s invention with those of Wynn and Onnheim is unclear when tenet of Applicant’s argument is that “the teachings of the applied references are technically incompatible [with each other]”. Regarding Applicant’s argument that Applicant’s invention provides unexpected technical advantages over the prior art (Remarks 10), the argument is not persuasive because the prior art teaches, or renders obvious, all of the claimed limitations. In other words, because the combination of Wynn and Onnheim teaches or renders obvious all of the claimed limitations, the alleged advantages of the claimed invention are deemed to flow naturally from following the suggestion of the prior art. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant also argues that the combination of Wynn and Onnheim fails to teach or suggest step (f) recited in claim 1. Remarks 10-11. According to Applicant’s argument, Wynn only monitors final product composition, not real-time changes in composition. Id. The argument is not persuasive because: Applicant’s argument is not commensurate with the scope of claim 1; and contrary to Applicant’s remarks, Wynn does teach continuous monitoring of composition in real-time. Firstly, contrary to Applicant’s remarks, the claims are silent regarding continuous real-time monitoring of composition changes. Instead, step (f) of claim 1 merely requires determining whether a composition “has changed” (i.e. one time determination). Secondly, contrary to Applicant’s remarks, making continuous determination of a composition in real-time is taught by Wynn (i.e. composition of milk/cream is determined continuously while the milk/cream flows past an in-line sensor, as opposed to sampling milk/cream after processing and measuring its composition using an offline analyzer) (see claim 4 of Wynn disclosing in-line sensor, and abstract of Wynn explicitly disclosing “monitored continuously”). Applicant also argues that the combination of Wynn and Onnheim fails to teach or suggest the continuous feedback loop described in steps (e) through (g) of claim 1. Remarks 11. The argument is not persuasive. As discussed above, Wynn teaches continuous monitoring of composition of a final product (standardized milk), and Wynn uses this information for “controlling delivery of…high fat milk [i.e. cream]” used to make the final product (see claim 4; see also lines 13-29, col. 4 disclosing a process of adjusting input of ingredient based on sensor output of final product). Contrary to Applicant’s assertion, the examiner maintains that Wynn teaches a continuous feedback loop recited in steps (e) through (g) of claim 1. Lastly, Applicant argues that the combination of Wynn and Onnheim fails to teach the specific sensor arrangements recited in the claims, including “a first chemical composition sensor in the first feeding line and a second chemical composition sensor in the second feeding line” that transmit “transduction information…to the controller in real time”. Remarks 11. The basis of Applicant’s argument is that sensor 19 taught by Wynn monitors the product stream (as opposed to ingredient streams), and Onnheim does not disclose continuous real-time monitoring sensors. Id. The argument is not persuasive because Applicant’s argument amounts to piecemeal analysis of the references. As discussed above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In this instance, the rejection of claim 1 acknowledges Wynn does not disclose the claimed first chemical composition sensor, and thus relies on Onnheim to remedy the deficiency. Consequently, Applicant’s argument that the claims are patentable because Wynn fails to disclose the first chemical composition sensor is not persuasive. As for Applicant’s remarks directed to Onnheim, again it is the combination of Wynn and Onnheim that teaches real-time monitoring of the ingredients. Moreover, Applicant again refers to differences between the prior art and disclosure in Applicant’s specification to argue for the patentability of the claimed invention. As discussed above, limitations from the specification are not read into the claims. Consequently, Applicant’s argument that the claims are allowable because Onnheim fails to teach real-time monitoring disclosed in the specification is not persuasive. For the foregoing reasons, the outstanding rejections are maintained, albeit they have been updated to address the amendment. Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wynn (US 5,137,738) in view of Önnheim et al. (“Onnheim”) (US 2020/0375141 A1). With respect to claim 1, Wynn discloses a method for formulating a predetermined composition of dairy product (see abstract), the method comprising the steps of: (a) pre-establishing, in a memory, a final profile (reference signal representing desired butterfat content, see lines 63-67, col. 3; see also line 47, col. 5 disclosing “desired value”) of components of the predetermined composition; (b) providing, by a first feeding line 43 and a second feeding line 44, a first ingredient (skim milk) and a second ingredient (cream), respectively (see Fig. 3), wherein at least one of said first and second ingredient (cream) has a time-varying composition (milk and cream both have time-varying composition), wherein the first ingredient and the second ingredient are selected from a group consisting of liquid ingredients, solid ingredients, powdered ingredients, and combinations thereof (see above); (c) determining, in a controller, an initial profile of components of the second ingredient by correlating transduction information of the second ingredient, wherein the transduction information is transmitted to the controller in real time (see line 41, col. 6) by a second chemical composition sensor 51 in the second feeding line (see lines 54-64, col. 4 and Fig. 3); d) estimating, using the controller, an amount of the second ingredient to be supplied to a storage tank 48 by the second feeding line 44 (see Fig. 3 and claim 4), to form a composition close to the predetermined composition (see claim 4 disclosing “controlling delivery of the high fat milk to an output line in accordance with the second reference signal and the butterfat content signal for the high fat milk”), wherein the amount is estimated by correlating the initial profile of components of the second ingredient with the pre-established final profile of components (see claim 4 and lines 45-50, col. 5); (e) supplying, by the second feeding line under an order of the controller (see line 10, col. 6 disclosing “automatic mode”, meaning all of the steps are controlled by the controller), the estimated amount of the second ingredient to the storage tank (see claim 4), and simultaneously, generating, using the controller, a real-time profile of components of the second ingredient being supplied, through real-time transduction that the second chemical composition sensor performs on the amount of the second ingredient being supplied (see Fig. 1 illustrating use of sensor 51; see also lines 54-64, col. 4); (f) determining in real-time, using the controller, whether the second ingredient has changed its composition, wherein the change of composition is determined by simultaneously correlating the real-time profile of components of the second ingredient being supplied with the pre-established final profile of components (see claim 4 and lines 45-50, col. 5); (g) adjusting, using the controller, the estimate of the amount of the second ingredient being supplied, under the determination that the second ingredient has varied its composition (see claim 4); and (h) repeating steps (e) to (g) until the close composition reaches the predetermined composition (see abstract that the method is performed continuously, meaning it is infinitely repeated). The method taught by Wynn differs from the claimed invention in that Wynn does not determine an initial profile of components of the first ingredient using a first chemical composition sensor in the first feeding line. However, it is well-known in the art to determine the properties of skim milk when producing standardized milk (i.e. the process taught by Wynn). For example, Onnheim discloses a method of producing standardized milk by mixing skim milk and cream (see abstract) wherein the fat contents of the skim milk and the cream are independently determined using sensors prior to mixing (see [0038]), and subsequently adjusting the flow rates (i.e. amount) of the skim milk and the cream to obtain the standardized milk (see [0038]). In light of the disclosure of Onnheim, it would have been obvious to one of ordinary skill in the art to measure the fat content of the skim milk in the method taught by Wynn. The modification would provide quality control over the skim milk as well. If the modification is made, then the modified Wynn method would comprise the steps of: (c) determining, using the controller, an initial profile of components of the first ingredient by correlating transduction information of the first ingredient, wherein the transduction information is transmitted to the controller in real time by a first chemical composition sensor in the first feeding line 43; d) estimating, using the controller, an amount of the first ingredient to be supplied to the storage tank 48 by the first feeding line 43 to form the close composition, wherein the amount is estimated by correlating the initial profile of components of the first ingredient with the pre-established final profile of components; (e) supplying, by the first feeding line, under an order of the controller, the estimated amount of the first ingredient to the storage tank, and simultaneously, generating, using the controller, a real-time profile of components of the first ingredient being supplied, through real-time transduction that the first chemical composition sensor performs on the amount of the first ingredient being supplied; (f) determining in real-time, using the controller, whether the first ingredient has changed its composition, wherein the change of composition is determined by simultaneously correlating the real-time profile of components of the first ingredient being supplied with the pre-established final profile of components; and (g) adjusting, using the controller, the estimate of the amount of the first ingredient being supplied, under the determination that the first ingredient has varied its composition. With respect to claim 2, as discussed above, the ingredients are cream and skim milk. With respect to claim 3, the initial profile of components and the real-time profile of components are determined by measuring optical density (see line 44, col. 2 of Wynn). Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wynn in view of Onnheim as applied to claims 1-3 above, and further in view of Crudge et al. (“Crudge”) (US 2004/0060365 A1). With respect to claim 4, while Wynn discloses examples of sensors that can be used to measure optical density (see lines 45-55, col. 2), Wynn does not explicitly disclose the means by which the optical density is determined. That said, it would have been obvious to one of ordinary skill in the art to measure optical density using any conventional means, including optical transmission as taught by Crudge (see [0075] disclosing that the optical density of milk, which corresponds to the fat content of milk, can be measured using optical transmission). Conclusion 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 PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00. 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 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, Elizabeth Robinson can be reached at 571-272-7129. 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. /PAUL S HYUN/Primary Examiner, Art Unit 1796
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Prosecution Timeline

Jun 18, 2021
Application Filed
Jun 25, 2025
Non-Final Rejection — §103
Sep 29, 2025
Response Filed
Oct 29, 2025
Final Rejection — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
70%
Grant Probability
99%
With Interview (+36.0%)
3y 5m
Median Time to Grant
Moderate
PTA Risk
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