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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on April 16, 2026 has been entered.
Response to Amendment
The following Office action in response to communications received April 16, 2026. Without acquiescing to the merits of the rejections and solely to advance prosecution of the present application, this Response amends Claim 1 as fully supported by, at least, page 2, lines 11-15, page 4, line 12, page 9, lines 31-32, page 10, lines 20-21, page 17, lines 21-30, and page 18, lines 3-6; and amends Claim 5 for clarity only, not to avoid any prior art. Claims 10 and 18- 19 are canceled without prejudice or disclaimer. Therefore, claims 1-10 and 16-20 are pending and addressed below.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 101 rejections set forth in the previous office action dated January 16, 2026.
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.
Claims 1-9, 16-17 and 20 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. Claim 1-9, 16-17 and 20 are rejected under 35 U.S.C. §112(b) as being indefinite. The claim recites a sequence of conditional steps introduced by the term “if,” e.g., “if the DHA level of the mother's milk meets DHA requirements … a personalized DHA dose … is determined to be from 0 mg/day to 400 mg/day” and “if the DHA level of the mother's milk does not meet the DHA requirements … determining a personalized DHA supplementation dose ….” It is unclear whether the limitations following these “if” phrases are always part of the claimed method or are only performed conditionally, rendering the metes and bounds of the claim uncertain. As in MPEP §2175, where language such as “for example” or “such as” renders a claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention, the conditional “if” structure here fails to inform those skilled in the art with reasonable certainty as to the scope of the claimed method. Appropriate clarification and correction are required.
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.
Claims 1-9, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over (Randomized controlled trial of docosahexaenoic acid supplementation in midwestern U.S. human milk donors) to Valentine et al. in view of Pub. No.: US 20100267830 A1 to Gibson et al.
As per Claim 1, Valentine et al. teaches a method comprising:
-- determining a DHA level of a mother's milk using gas chromatography; if the DHA level of the mother's milk meets DHA requirements of the mother's infant or meets a DHA target threshold of at least about 0.3 g DHA per 100 g fatty acids, a personalized DHA dose for the mother is determined to be from 0 mg/day to 400 mg/day; if the DHA level of the mother's milk does not meet the DHA requirements of the mother's infant or the DHA target threshold of at least about 0.3 g DHA per 100 g fatty acids, determining a personalized DHA supplementation dose for the mother using the DHA level of the mother's milk and one or more infantile parameters to determine the personalized DHA supplementation dose (see Valentine et al. Abstract, Page 90 Col 1 || 1-7; After Institutional Review Board approval and informed consent, human milk donors to the Mother's Milk Bank of Ohio were randomized to receive 1 g of DHA (Martek(®) [now DSM Nutritional Lipids, Columbia, MD]) or placebo soy oil. Dietary intake data were collected and analyzed by a registered dietitian. Fatty acids were measured by gas chromatography/flame ionization detection. Statistical analysis used linear mixed models. FIG. 2. DHA contents in milk samples during the course of supplementation. DHA concentration was measured by gas chromatography, and concentrations expressed as mole weight percent of total fatty acid contents. Data were analyzed by mixed models. The concentration of DHA was significantly different from baseline at Days 7 and 14 in the supplemented group (p<0.01)).
Valentine et al. fails to explicitly teach:
-- administering the personalized DHA supplementation dose to the mother,
-- wherein the administering of the personalized DHA supplementation dose to the mother (i) promotes development of mental or physical characteristics of the infant comprising cognitive development, visual acuity, motor skills, language and communication skills, immune system development, and physical growth and/or (ii) improves survival and long-term well-being of the infant.
Gibson et al. teaches the present invention relates to a method of feeding an infant, the method comprising: (i) administering fatty acids including DHA to the infant's mother in an amount sufficient to provide a content of DHA in the breast milk of the infant's mother that is about 1% or more of the total fatty acids present in the breast milk, and (ii) feeding the infant with breast milk following step (i).
Step (i) may comprise administering fatty acids including DHA to the infant's mother in an amount sufficient to provide a content of DHA in the breast milk of the infant's mother that is at least 1%, or at least 1.05%, or at least 1.1%, or at least 1.2%, or at least 1.3%, or at least 1.4%, or at least 1.5%, or at least 1.6%, or at least 1.7%, or at least 1.8%, or at least 1.9%, or at least 2%, or at least 2.1%, or at least 2.2%, or at least 2.3%, or at least 2.4%, or at least 2.5%, or at least 2.6%, or at least 2.7%, or at least 2.8%, or at least 2.9%, or at least 3.0% of the total fatty acids present in the breast milk.
Step (i) may comprise administering fatty acids including DHA to the infant's mother in an amount sufficient to provide a content of DHA in the breast milk of the infant's mother that is between more than 1% and about 20%, or between more than 1.05% and about 20%, or between more than 1.1% and about 20%, or between more than 1% and about 30%, or between more than 1% and about 25%, or between more than 1% and about 15%, or between more than 1% and about 10%, or between about 1.5% and about 20%, or between about 1.5% and about 15%, or between about 1.5% and about 10%, or between about 1.5% and about 5%, or between about 2% and about 20%, or between about 2% and about 15%, or between about 2% and about 10%, of the total fatty acids present in the breast milk.
Step (i) may comprise administering fatty acids including DHA to the infant's mother in an amount and over a time period sufficient to provide a constant DHA content in the breast milk of the infant's mother that is about 1% or more of the total fatty acids present in the breast milk of the infant's mother. This outcome may be achieved by administering to the infant's mother approximately 600 mg or more of DHA per day. However, in the case of a mother who consumes minimal DHA as part of her diet, the amount of DHA administered on a daily basis may be approximately 900 mg or more. In the case of a mother who consumes a diet rich in DHA, it may be possible to achieve a content of DHA in the breast milk of the infant's mother that is about 1% or more of the total fatty acids present by administering less than 600 mg of DHA per day. Those skilled in the art will be capable of determining the amount of DHA required to be administered to an infant's mother in order to achieve a desired amount of DHA as a percentage of total fatty acids in breast milk by routine trial and experimentation based on the teachings herein (see Gibson et al. paragraphs 113-119).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Gibson et al. within the systems/methods as taught by reference Valentine et al. with the motivation of determining the amount of DHA required to be administered to an infant's mother in order to achieve a desired amount of DHA as a percentage of total fatty acids in breast milk by routine trial and experimentation, thereby ensuring that the desired amount of DHA in the breast milk has been reached and is essentially constant (see Gibson et al. Paragraph 122).
Examiner notes that the "wherein" clauses merely recite the inherent, well-known biological benefits of DHA supplementation and do not impose meaningful limits on the claim's scope. The "wherein" clause, which asserts that administering the dose promotes infant development and improves survival, recites an anticipated but not guaranteed biological outcome. This language describes the intended purpose or hoped-for result of the invention, the inventor's assumption of its utility, rather than a specific, verifiable step or condition that defines the method's execution. Such statements of inherent or expected result are generally not treated as limiting claim elements, as they do not impose concrete restrictions on how the claimed process must be performed, nor do they ensure the result actually occurs in every instance of practicing the method. Consequently, this clause adds little to no patentable weight when assessing novelty, non-obviousness, or subject matter eligibility.
Claims 2-9, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Valentine et al. and Gibson et al. as applied to claim 1 above, and further in view of Pub. No.: US 20040048926 A1 to Hoffman et al.
As per Claim 2, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1, wherein the one or more infantile parameters comprise infant weight-for-age z-score and/or infant age (see Hoffman et al. paragraph 31; FIG. 6 shows growth z scores for weight, length, and head circumference of infants weaned to LCP-supplemented formula or to control formula at 6 weeks of age.).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 3, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1 or claim 2, wherein the method further comprises using maternal BMI to determine the personalized DHA supplementation dose (see Hoffman et al. paragraph 74 and 129; weight-for-length).
Examiner notes that the specification does not clearly teach how the limitation is done. While a standard BMI calculation (weight/height²) is used for older children and adults, it's not directly applicable to infants. Instead, weight-for-length charts or BMI-for-age percentiles are used for infants under 2 years old as taught by Hoffman et al.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 4, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1, wherein the method further comprises using one or more additional parameters to determine the personalized DHA supplementation dose (see Hoffman et al. paragraph 35; The present invention relates to a method of enhancing the visual development of term infants who are breast-fed up to an age of from about one and one-half months to about six and one-half months and, then, weaned to formula. The method comprises administering to those infants a combination of DHA and ARA from the time they are weaned to formula. The length of time to administer the DHA/ARA combination to the infants is from at least one month to about one year. It is desirable that the combination of DHA and ARA be administered to the infants up to at least the age of one year).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 5, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1, wherein the method comprises: (i) using the DHA level of the milk of the mother and the one or more infantile parameters to determine a current DHA intake of the mother and/or target DHA intake of the mother; and (ii) using the current DHA intake of the mother and the target DHA intake of the mother to determine the personalized DHA supplementation dose (see Hoffman et al. paragraph 78; Plotted in FIG. 2 are relative percent levels (mean.+-.SE) of DHA in RBCs of infants in the 4- and 6-month sub-groups as a function of time on the study. Pre-weaning levels of RBC-DHA in breast-fed infants in the two diet groups were equivalent at both 4 and 6 months. By 12 months of age, the blood lipid level of DHA in infants receiving commercial formula dropped about 50% over the 6-to-8-month period while DHA levels in infants on the LCP-supplemented formula increased by 25 to 40%. In infants weaned at either 4 or 6 months of age, the mean DHA levels in RBC lipids of LCP-supplemented infants were 2.6- and 2.4-fold higher than in the commercial formula-fed group, respectively).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 6, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 5, wherein the current DHA intake of the mother and/or the target DHA intake of the mother are determined using a regression equation (see Hoffman et al. paragraph 84; The relationship between sweep VEP acuity and the relative percent levels of DHA in RBCs was examined in 12-month-old infants by linear regression analysis (FIG. 5).).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 7, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 6, wherein the regression equation is: log (the current DHA intake of the mother or target DHA intake of the mother) = a + b 1 *log (the DHA level of the milk of the mother or target milk DHA level of the mother) + b2*log(maternal BMI) + b3*infant weight-for-age z-score + b4*infant age, wherein a, bl, b2, b3, b4 are determined by multiple linear regression (see Hoffman et al. paragraph 84; The relationship between sweep VEP acuity and the relative percent levels of DHA in RBCs was examined in 12-month-old infants by linear regression analysis (FIG. 5).).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 8, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 5, wherein the personalized DHA supplementation dose is determined using a difference between the target DHA intake of the mother and the current DHA intake of the mother (see Hoffman et al. paragraphs 12 and 17; Breast-fed infants are ensured a source of DHA and ARA until they are weaned from human milk. However, the need for a continued supply of preformed LCPs beyond weaning from breast-feeding is undetermined. The issue is further complicated by considerable variations in the duration of breast-feeding and levels of the LCPs in breast milk, which vary considerably, largely dependent on the maternal dietary intake.).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 9, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1, wherein the personalized DHA supplementation dose is a daily dose; and/or wherein the personalized DHA supplementation dose is rounded up to the nearest 200 mg (see Hoffman et al. paragraph 11).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 16, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 1, wherein the personalized DHA supplementation dose is determined using the DHA level of the milk of the mother, a maternal BMI, and the one or more infantile parameters, wherein the one or more infantile parameters comprise infant weight-for-age z-score and infant age (see Hoffman et al. paragraphs 16, 31 and 35).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 17, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 4, wherein the one or more additional parameters are selected from the group consisting of country or region, genetic data, maternal age, dietary data, lifestyle data and combinations thereof (see Hoffman et al. paragraphs 16, 31 and 35).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
As per Claim 20, Hoffman et al. teaches what Valentine et al. and Gibson et al. failed to explicitly teach within the method according to claim 6, wherein the regression equation is a multiple linear regression equation (see Hoffman et al. paragraph 84; The relationship between sweep VEP acuity and the relative percent levels of DHA in RBCs was examined in 12-month-old infants by linear regression analysis (FIG. 5).).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the method features taught by Hoffman et al. with the method taught by Valentine and Gibson with the motivation of optimizing maternal DHA supplementation to efficiently achieve breast milk DHA levels known to support improved infant neurodevelopment, vision, and growth using established DHA containing compositions and clinically supported dose ranges.
Response to Arguments
Applicant's arguments, filed on April 16, 2026 with respect to argument (1) in the remarks, have been considered but are moot in view of the new ground(s) of rejection necessitated by the new limitations added to Claim 1.
Examiner notes that once Valentine et al. teaches, “determining a DHA level of a mother's milk using gas chromatography,” the remaining “if … then” dosage-selection steps in claim 1 would have been an obvious application of known therapeutic rules, not a patentable invention.
Obviousness rationale for the conditional dosage steps: Valentine et al. teaches that lactating women with low dietary DHA who take 1 g/day of preformed DHA have significantly increased milk DHA levels and that “infants fed donor milk from supplemented women receive dietary DHA levels that closely mimic normal intrauterine accretion during the third trimester,” with “no adverse outcomes” at that dose. Other clinical and practice-tool references explain that “pregnant and lactating women should consume at least 200 mg DHA per day” and that supplemental DHA in the range of 200–1000 mg/day for lactating mothers is recommended to achieve milk DHA contents of at least about 0.3% of total fatty acids, which are associated with improved infant neurodevelopment and growth.
Once this art teaches determining a DHA level of a mother's milk using gas chromatography, it would have been an obvious matter of routine medical practice for a skilled clinician to apply simple conditional rules of the form:
-- if the measured milk DHA level meets or exceeds the known target threshold (e.g., ≥0.3–0.35% of total fatty acids), then prescribe either no additional DHA (0 mg/day) or a small maintenance dose within the known safe/recommended range (e.g., 200–400 mg/day); and
-- if the measured milk DHA level is below the target threshold, then prescribe a higher supplementation dose, again within the same known therapeutic range, until the mother’s milk DHA reaches the desired target level.
This is directly analogous to standard pediatric-dose tables (for example, “if the patient is 6–12 years old, administer 1 capsule; if the patient is over 12, administer 2 capsules”), where the underlying age and weight ranges and dose sizes are already established in the art, and the practitioner simply follows a straightforward decision tree to pick the correct dose for a given patient. Under MPEP §2143 and §2144, once the prior art provides the known result-effective variables (milk DHA level, infant developmental targets) and their associated safe dose ranges, implementing such “if … then” dosing logic is nothing more than routine optimization and design choice, not a non-obvious invention.
Thus, for claim 1, after Valentine et al. references teach “determining a DHA level of a mother's milk using gas chromatography,” the recited conditional steps:
-- “if the DHA level of the mother's milk meets DHA requirements of the mother's infant or meets a DHA target threshold of at least about 0.3 g DHA per 100 g fatty acids, a personalized DHA dose for the mother is determined to be from 0 mg/day to 400 mg/day;” and “if the DHA level of the mother's milk does not meet the DHA requirements … determining a personalized DHA supplementation dose for the mother using the DHA level of the mother's milk …” would have been obvious to one of ordinary skill as predictable, routine clinical decision-making that merely implements known dose-response relationships using conditional rules, without any unexpected result or non-obvious dosing algorithm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
AU 2006331645 B2; The present invention provides highly purified omega-3 fatty acid formulations. Certain formulations provided herein have contain greater than 85% omega-3 fatty acids by weight. Certain other formulations provided herein contain EPA and DHA in a ratio of from about 4.01: 1 to about 5:1. The invention also provides methods of using the dosage forms to treat a variety of cardiovascular, autoimmune, inflammatory, and central nervous system disorders by administering a formulation of the invention to a patient in need thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683
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