Prosecution Insights
Last updated: October 01, 2026
Application No. 18/559,869

METHOD FOR DETERMINING PERSONALIZED OMEGA-3 DOSE

Final Rejection §101§103§112
Filed
Nov 09, 2023
Priority
May 10, 2021 — EU 21173074.2 +1 more
Examiner
FRITCHMAN, REBECCA M
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Nestlé S.A.
OA Round
2 (Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
1y 1m
Est. Remaining
81%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
303 granted / 663 resolved
-19.3% vs TC avg
Strong +35% interview lift
Without
With
+35.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
78 currently pending
Career history
753
Total Applications
across all art units

Statute-Specific Performance

§101
5.4%
-34.6% vs TC avg
§103
59.4%
+19.4% vs TC avg
§102
8.8%
-31.2% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 663 resolved cases

Office Action

§101 §103 §112
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 . Detailed Action Summary This is the Final Office Action based on application 18/559869 response filed 07/07/2026. Claims 2-3,5-7, 9 , 11 & 16-22 are pending and have been fully considered. Claims 1, 4, 8, 10, 12-22 are cancelled. Claims 16-22 are newly added. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title. The claimed invention of Claims 2-3, 5-7, 9 , 11 & 16-22 are rejected under 101 as being directed to non-statutory subject matter without significantly more. Through 101, inquiry: Inquiry: Are the claims directed to a statutory category of invention? Yes, the claims are drawn towards a statutory category of a method. Step 2A, Prong 1: Do the claims involve a Judicial Exception? Yes, independent Claim 11 and the claims depending from recite a method of providing an omega 3 dose to promote full-term birth. The amount of omega-3 level in a person correlation with full term birth (a physical condition) is a natural correlation which is a law of nature judicial exception. Further, the claimed determining seems to just be a determining by a general mental comparison which is an abstract idea--- and if instead the determining is done by a detection method, which is not claimed, the determining would then be done by measuring the level and comparing to a reference, for example of a group who has had full term birth (though this is extrapolating a little from what is claimed). Comparison of a measured level to a first and second “threshold,” or reference level is a correlation, which is a mathematical process, and a comparison is a mental process which are both abstract ideas. It is noted that though claimed method is for “providing… a dose,” there are instances in the claim where no dose, “omega-3 zero dose,” and therefore in some instances of reading the claim all that is done is the mental process and natural correlation steps. See MPEP 2106.04 (a) and 2106.04 (b). Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application? For independent Claim 11 there are no steps other than the claimed which are considered a practical application of the abstract idea and natural correlation. It is noted that though claimed method is for “providing… a dose,” there are instances in the claim where no dose, “omega-3 zero dose,” and therefore in some instances of reading the claim all that is done is the mental process and natural correlation steps and the claimed administration step= not administering anything- “zero dose.” Further, a “low dose,” and “maintenance dose,” also do not seem to practically apply since a maintenance dose would seemingly change nothing as a result of the judicial exception to apply it, and there are clarity issues with the term “low, “ in “low dose.” The claimed determining by “dried spot analysis, a home-based test kit, or blood analysis,” in Claim 11 also does not show practical application. First of all “analysis,” is claimed which through broadest reasonable interpretation can be mental or visual analysis—so this again reads on being an abstract ideas judicial exception. Futher, is some kind of detecting is actually done, especially at the level of generality claimed it does not do anything to turn the claims into a practical application. Instead, the determining to detecting step is data gathering (i.e. taking samples) and is considered and insignificant extra solution activity. Data-gathering steps which are insignificant extra-solution activity which is used to accomplish the judicial exceptions. See MPEP 2106.05(g). Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea? For Claim 11, the only steps in addition to the judicial exceptions are “determining,” the omega-3 level by blood analysis, dried spot analysis or a home-based test kit, and administering the personalized omega-3 dose. Especially as generally claimed, the determining by dried blood spot a home kit or blood analysis is well understood, routine and conventional (WURC) in the art. Also, the claims are left open to no treatment actually being administered by “zero-dose,” however even both administering a low dose and maintenance dose of omega-3 are well understood, routine and conventional (WURC) in the art. This is evidence by… Things which are WURC are not considered to add significantly more than the judicial exception. See MPEP 2106.05 (a) & MPEP 2106.05 (d). The dependent claims are reviewed for additional limitations dependent on the independent claim above. Here—none of the dependent claims are considered to practically apply at Step 2 A, 2, nor to add significantly more at step 2B. Claim 2 specifies that additional parameters are used, without saying what they are. Additional parameters do nothing to practically apply, instead they are used for data gathering which is insignificant extra-solution activity. Further- additional parameters are WURC. Claim 3 specifies what the parameters are, however these are all things which are data, and data gathering, so there is nothing that practically applies and further the claimed parameters are all WURC parameter used in the art. Claim 5-7 specify that if certain thresholds are met, then the does is determined to be a supplementation, maintenance, or low dose. However--- this is a mental determination, and not a treatment, so this is not something that practically applies nor which adds significantly more. Claim 9 specifies that the doses are “adjusted,” for additional parameters. Adjustment as broadly claimed is math which is an abstract idea and part of the judicial exception itself. Claims 16- 19 & 22 specify what the maintenance dose and low dose comprises, however this does not change the fact that they claims are left open to no dose/ zero dose being administered. Therefore, there is not practical application at step 2A/2 and this does not add significantly more at step 2B. Claim 20 specifies when the omega 3 dose is determined. The timing of a determination however does not change that the claimed determining is done for data gathering so no practical application at step 2A/2 and does not do anything to add significantly more at step 2B. Claim 21 specifies what the thresholds are determined with respect to—relative risk of early preterm birth. This does not change the fact that the threshold itself is part of the natural correlation and comparison. Adjusting for an unspecified parameter also does not change this as it is seemingly adjusting a numerical number for a mental comparison. Therefore this does not add practical application at step 2A/2 and does not do anything to add significantly more at step 2B. Claim Rejections - 35 USC § 112 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. Claim 11 and 2-3,5-7, 9 & 16-22 are 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. With respect to Claim 11, both the terms “low,” and “maintenance,” when referring to dose are relative terms and not defined in the claim so are unclear. Both these terms would mean different things to different people reading the claims and therefore are relative terms. (Claims 17-19 & 22 clear up this issue.) Further with respect to Claim 11, it is noted that the claim is drawn towards “providing a personalized omega-3 dose,” however the claim results in one option for the administration being “omega-3 zero dose,” which reads on no dose. Therefore it is unclear is the claim is really a method for providing a dose, or if instead it is for detecting levels of omega 3. Claims 2-3,5-7, 9 & 16-22 are also rejected by virtue of their dependency on Claim 11. Further with respect to Claim 7, it is unclear how a % when claimed as a percent of total fatty acids , can be a threshold. From how this is claimed, it is unclear what the threshold being compared to actually is. Claim Rejections - 35 USC § 103 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 11 and 2-3,5-7, 9 & 16- 22 are rejected under 35 U.S.C. 103 as being obvious by ELSWYK in US 20030060509 in view of SIMMONDS in “Omega-3 fatty acid supplementation in pregnancy-baseline omega-3 status and early preterm birth: exploratory analysis of a randomized controlled trial” (publication date March, 3, 2020). With respect to Claim 11, ELSWYK teaches of a method and product for improving maternal and child health through nutrition. Omega-6 fatty acid and/or omega-3 fatty acid are provided to a woman and/or child prior to, during and/or after pregnancy to improve the health of the woman and her child. The ratios of the omega-6 and omega-3 fatty acids vary during various stages, e.g., pre-pregnancy, pregnancy and post-pregnancy. The omega-6 and omega-3 fatty acids can be in a variety of forms, such as at least one of highly purified algal oil comprising 70% by weight or more of the desired HUFA, triglyceride oil combined with phospholipid, phospholipid, protein and phospholipid combination, or dried marine microalgae(abstract). ELSWYK further teaches that effective levels of omega- 3 and DHA levels during pregnancy report full term birth/pregnancy (paragraph 0047). ELSWYK teaches that the preferred range ratio of omega-6 HUFA:omega-3 HUFA during pregnancy is from about 1:10 to about 10:1 (paragraph 0034) and that “effective,” doses are used. This reads on “determining a personalized dose to be taken,” through broadest reasonable interpretation. ELSWYK teaches of providing around 300 mg of omega-3 per day/dose (paragraph 0069, 0089-0093). ELSWYK does not teach of testing/detecting/dosing a woman’s omega 3 level in comparison to threshold nor of the claimed blood testing. SIMMONDS is used to remedy this and teaches of a method studying/determining the effects of omega-3 supplementation on pregnant women on early preterm birth versus full term birth. They further teach of testing the omega-3 status (the percentage of total omega-3 in total fatty acids measured in capillary blood sample—so testing a woman’s omega-3 level) of pregnant women supplemented with either omega-3 polyunsaturated fatty acid (PUFA) enriched fish oil or isocaloric vegetable oil and its effect on early preterm birth. They conclude that, - for total omega-3, the threshold for benefit is equal to or lower than 4.1% (i.e., women with a percentage of total omega-3 equal to or lower than 4.1% of the total fatty acids are at higher risk for early preterm birth and would benefit from omega-3 supplementation) and the threshold for harm is above 4.9% (i.e., women with a percentage of total omega-3 higher than 4.9% of the total fatty acids are at lower risk for early preterm birth but omega-3 supplementation may increase risk of early preterm birth—therefore teaching of two thresholds as instantly claimed); - for the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 2.5% and the threshold for harm is above 3.4%; - for docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 1.9% and the threshold for harm is above 2.9% (so teaching of additional thresholds) (SIMMONDS, abstract; "Effect modification of supplementation by baseline status", on page 978; figure 3). SIMMONDS also teaches of administration of ≈900 mg omega‐3 PUFA (3 9 DHA enriched fish oil/day [≈800 mg DHA and ≈100 mg eicosapentaenoic acid (EPA)/day]) or isocaloric vegetable oil control capsules with trace fish oil for masking (≈15 mg DHA and ≈4 mg EPA/day). SIMMONDS also teaches that some patients are already consuming a low dose DHA supplement <_ 150 mg/day (Page 976, column 1, last paragraph). Therefore this reads on the claimed dosing of the supplementation dose being 640mg/day DHA and EPA dosing being between 80 and 120 mg/day, and also the claimed low dose of less than 100 mg of fatty acids per day (Page 976, column 1, last paragraph). SIMMONDS further specifically teaches that the omega -3 supplementation with the approximately 900 mg dose, reduced preterm birth when the omega-3 stats at baseline was < 4.5 % of total fatty acids in blood (so one threshold being the < 4.5%), and reading on the claimed comparison to threshold and supplementation dosing in Claim 11. SIMMONDS further teaches of there being an increased early term birth with omega-3 supplementation with a baseline status of omega-3s which is above 4.9%. This would make it obvious to one of ordinary skill in the art that since early term birth is not desired, then one should not dose with omega-3s (so a zero dose as claimed) to prevent pre-term birth. The examiner notes that to read on the instant claims, and contingent “if,” clauses--- the prior art must only teach one of the “if,”s to make the claims obvious. SIMMONDS further teaches of testing whole blood (page 975, column 1, methods) and of dried blood spot analysis (Page 976, column 2, last paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to measure a woman’s omega- 3 level in comparison to supplementation and determine dosing based on that as is done in SIMMONDS in the method of ELSWYK due to the advantage that this shows for determining risk or reduction of risk for early term birth (Page 978, column 1, last paragraph, lines 4-6). It would have been obvious to do blood testing/analysis as is done in SIMMONDS in the method of ELSWYK since this has the advantage of being able to give fatty acid status data (Page 976, column 2, paragraph 1 & 3). With respect to Claim 2, ELSWYK teach that the amounts of HUFA (omega 3 and omega 6) dependent on the stage of pregnancy (amount of term/duration of current pregnancy) (paragraph 0009). This is a parameter as claimed. With respect to Claim 3, ELSWYK teach that the amounts of HUFA (omega 3 and omega 6) dependent on the stage of pregnancy (amount of term/duration of current pregnancy) (paragraph 0009). This is a parameter as claimed. With respect to Claim 5-6, SIMMONDS teaches of determining early pre term birth EPTB (Page 957, column 1, main outcome measure) and the relative risk of this and further of determining which patients fall in this outcome area ( Page 975, column 2, paragraph 1). With respect to Claim 7, SIMMONDS teaches that for total omega-3, the threshold for benefit is equal to or lower than 4.1% (i.e., women with a percentage of total omega-3 equal to or lower than 4.1% of the total fatty acids are at higher risk for early preterm birth and would benefit from omega-3 supplementation) and the threshold for harm is above 4.9% (i.e., women with a percentage of total omega-3 higher than 4.9% of the total fatty acids are at lower risk for early preterm birth but omega-3 supplementation may increase risk of early preterm birth); - for the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 2.5% and the threshold for harm is above 3.4%; - for docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 1.9% and the threshold for harm is above 2.9% (SIMMONDS, abstract; "Effect modification of supplementation by baseline status", on page 978; figure 3). This reads on the claimed from 3.5 % to less than 4.5 %. With respect to Claim 9, ELSWYK teach that the amounts of HUFA (omega 3 and omega 6) dependent on the stage of pregnancy (amount of term/duration of current pregnancy) (paragraph 0009). This is a parameter as claimed. With respect to Claim 16, ELSWYK teaches of the claims as shown above, but dose not teach of the claimed dose. SIMMONDS is used to remedy this and teaches of administration of ≈900 mg omega‐3 PUFA (3 9 DHA enriched fish oil/day [≈800 mg DHA and ≈100 mg eicosapentaenoic acid (EPA)/day]) or isocaloric vegetable oil control capsules with trace fish oil for masking (≈15 mg DHA and ≈4 mg EPA/day). SIMMONDS also teaches that some patients are already consuming a low dose DHA supplement <_ 150 mg/day (Page 976, column 1, last paragraph). Therefore this reads on the claimed dosing of the supplementation dose being 640mg/day DHA and EPA dosing being between 80 and 120 mg/day, and also the claimed low dose of less than 100 mg of fatty acids per day (Page 976, column 1, last paragraph). SIMMONDS further specifically teaches that the omega -3 supplementation with the approximately 900 mg dose, reduced preterm birth when the omega-3 stats at baseline was < 4.5 % of total fatty acids in blood (so one threshold being the < 4.5%), and reading on the claimed comparison to threshold and supplementation dosing in Claim 11. SIMMONDS further teaches of there being an increased early term birth with omega-3 supplementation with a baseline status of omega-3s which is above 4.9%. See reason for combination from Claim 11. With respect to Claim 17, ELSWYK teaches of providing around 300 mg of omega-3 per day/dose (paragraph 0069, 0089-0093). ELSWYK does not teach of the claimed administration level of EPA. SIMMONDS teaches of dosing with approximately 4 mg EPA or approximately 100 mg EPA per day(Page 976, column 1, last paragraph). Therefore, SIMMONDS makes the claimed 20-30 mg dosing obvious since all of the claimed dosing includes this range since they teach dosing 4mg and 100 mg, so making the range of 4-100 mg including the claimed range obvious. See reason for combination from Claim 11. Further it is noted that since the *if clauses in Claim 11 still apply, what is claimed in Claim 17, does not require that the claim maintenance does is actually administered. Further- it would have been obvious to adjust the concentration of the claimed dose through routine optimization. See MPEP 2144.05. With respect to Claim 18, ELSWYK teaches of providing around 300 mg of omega-3 per day/dose or about 150mg DHA or about 25-200 mg DHA (paragraph 0069, 0089-0093). ELSWYK does not teach of the claimed administration level of EPA. SIMMONDS teaches of dosing with approximately 4 mg EPA or approximately 100 mg EPA per day (Page 976, column 1, last paragraph). This reads on “about 25 mg,” through broadest reasonable interpretation. See reason for combination from Claim 11. Further it is noted that since the *if clauses in Claim 11 still apply, what is claimed in Claim 18, does not require that the claim maintenance does is actually administered. With respect to Claim 19, ELSWYK teaches of the claims as shown above, but dose not teach of the claimed dose. SIMMONDS also teaches of administration of isocaloric vegetable oil control capsules with trace fish oil for masking (≈15 mg DHA and ≈4 mg EPA/day). SIMMONDS also teaches that some patients are already consuming a low dose DHA supplement <_ 150 mg/day (Page 976, column 1, last paragraph). Therefore this reads on the claimed dosing of the supplementation dose being 640mg/day DHA and EPA dosing being between 80 and 120 mg/day, and also the claimed low dose of less than 100 mg of fatty acids per day (Page 976, column 1, last paragraph). See reason for combination from Claim 11. With respect to Claim 20, ELSWYK teaches of the claims as shown above, but do not teach of the claimed gestational age of 12 to 16 weeks. SIMMONDS is used to remedy this and teaches of detecting and then dosing at 14 gestational weeks (Page 975, column 1, methods, and Page 976, column 1, last paragraph). It would have been obvious to one of ordinary skill in the art prior to the effective filing of the instant application to monitor/start dosing around 12-16 weeks as is done in SIMMONDS in the method of ELSWYK due to the advantage this offers for monitoring until close to birth time at 34 week(Page 976, column 1, last paragraph). With respect to Claim 21, ELSWYK teaches of the claims as shown above, but does not teach of relative risk of preterm birth. SIMMONDS teaches that for total omega-3, the threshold for benefit is equal to or lower than 4.1% (i.e., women with a percentage of total omega-3 equal to or lower than 4.1% of the total fatty acids are at higher risk for early preterm birth and would benefit from omega-3 supplementation) and the threshold for harm is above 4.9% (i.e., women with a percentage of total omega-3 higher than 4.9% of the total fatty acids are at lower risk for early preterm birth but omega-3 supplementation may increase risk of early preterm birth); - for the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 2.5% and the threshold for harm is above 3.4%; - for docosahexaenoic acid (DHA), the threshold for benefit is equal to or lower than 1.9% and the threshold for harm is above 2.9% (SIMMONDS, abstract; "Effect modification of supplementation by baseline status", on page 978; figure 3). This reads on the claimed from 3.5 % to less than 4.5 %. SIMMONDS teaches that all of these thresholds are with respect to risk and relatively reducing or increasing the risk of early preterm birth- which reads on the instant claims (Page 978, column 1, last paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to monitor with respect to risk as is done in SIMMONDS in the method of ELSWYK due to the advantage that this shows for potential reduction of risk for early term birth (Page 978, column 1, last paragraph, lines 4-6). With respect to Claim 22, ELSWYK teaches of the claims as shown above, but dose not teach of the claimed dose. SIMMONDS also teaches of administration of isocaloric vegetable oil control capsules with trace fish oil for masking (≈15 mg DHA and ≈4 mg EPA/day). SIMMONDS also teaches that some patients are already consuming a low dose DHA supplement <_ 150 mg/day (Page 976, column 1, last paragraph). Therefore this reads on the claimed dosing of the supplementation dose being 640mg/day DHA and EPA dosing being between 80 and 120 mg/day, and also the claimed low dose of less than 100 mg of fatty acids per day (Page 976, column 1, last paragraph). See reason for combination from Claim 11. It is noted that due to the if clauses in Claim 1, the instant claim only needs to meet one of the claimed doses. Response to Arguments Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive. With respect to the prior 112 b rejection, the prior issue was overcoming however a new issue was introduced with amendments dated 07/07/2026, so a 112b rejection remains on the record as shown above. With respect to the 101 rejection it is maintained. The claims were significantly amended 07/07/2026, so the reasons for this are shown in the above rejection. It is noted that with respect to the 101 rejection, applicant argues that section MPEP § 2106.04(a) states: “ The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular and instead merely instructions to “apply,” the exception.” With respect to this, the examiner notes that the instant claims are not like those in the example given in the MPEP. Most notably, but not only, because the instant claims leave open the possibility for no treatment to occur within the boundaries of the claim as shown in the rejection above. Therefore, when there is no treatment, there is no applying of the judicial exception. Further, as claimed, the administration of the maintenance dose also reads instantly in Claim 11 as just instructions to just apply the judicial exception. The 101 rejection is maintained for all pending claims. With respect to the 103 rejection, applicant argues that the prior art does not teach of the claimed dosing as amended 07/07/2026. The examiner disagrees. Please see the 103 rejection as shown above since this subject matter was newly amended. All claims remain rejected under 103. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. GIORDANO in US 20100260836. GIORDANO teaches of methods of co-administration of various vitamin and mineral compositions, and in a specific embodiment, said methods comprise co-administering one composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D.sub.3, vitamin E, iron, magnesium and zinc, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states; and kits provided for co-administration of various vitamin and mineral compositions, and in a specific embodiment, said kits comprise one composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D.sub.3, vitamin E, iron, magnesium and zinc, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states(abstract). GIORDANO teaches that one of the stressful states can be pregnancy (paragraph 0002-0003), and that supplementation with omega-three can help pregnancies carry to full term (paragraph 0003, 0091-0092). BEST in Effect of omega-3 lcpufa supplemenatation on maternal fatty acid and oxylipin concentrations during pregnancy (as cited on IDS dated 11/09/2023). BEST teaches of identifying a polyunsaturated fatty acid (PUFA) biomarker able to detect which women with singleton pregnancies are most likely to benefit from omega‐3 supplementation to reduce their risk of early preterm birth(abstract section, objective). 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 REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday. 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, Maris Kessel can be reached on 571-270-7698. 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. /REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Read full office action

Prosecution Timeline

Nov 09, 2023
Application Filed
Apr 07, 2026
Non-Final Rejection mailed — §101, §103, §112
Jul 07, 2026
Response Filed
Sep 14, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
46%
Grant Probability
81%
With Interview (+35.3%)
4y 0m (~1y 1m remaining)
Median Time to Grant
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