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 following Office action in response to communications received October 14, 2025. Claims 1 and 3-10 have been amended. Claims 16-20 have been added. 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 § 102 rejections set forth in the previous office action dated August 14, 2025.
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 of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1 and 10 are directed to an abstract idea comprising a method for determining a personalized docosahexaenoic acid (DHA) supplementation dose to be taken by a mother to meet the DHA requirements of the mother's infant.
Independent Claim 1 recites “using a DHA level of milk of the mother and one or more infantile parameters to determine the personalized DHA supplementation dose; and 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.”
Independent Claim 10 recites “determining a DHA level of milk of the mother and determine the personalized DHA supplementation dose using the DHA level of the milk of the mother and one or more infantile parameters to determine the personalized DHA supplementation dose; and 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.”
The limitations of Claims 1 and 10, as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and/or Certain Methods Of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including fundamental economic principles, commercial or legal interactions, social activities, teaching, and following rules or instructions), but for the recitation of generic computer components. That is, other than reciting the method claim limitation, nothing in the claim element precludes the step from practically being performed in the mind and/or following rules or instructions. For example, but for the “determining” language, in the context of this claim encompasses the user merely deciding a personalized docosahexaenoic acid (DHA) supplementation dose to be taken by a mother to meet the DHA requirements of the mother's infant. Similarly, using the mother's milk DHA level and one or more infantile parameters to determine the personalized DHA supplementation dose, under its broadest reasonable interpretation, covers being performed in the mind and/or following rules or instructions, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers being performed in the mind and/or following rules or instructions, but for the recitation of generic computer components, then it falls within the “Mental Process and/or Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims do not recite additional elements to perform the “determining” steps. Accordingly, having no additional element at least fails to integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1 and 10 have no additional elements (i.e., computer system, memory, etc.). Looking to the specification, these components are described at a high level of generality (Page 22 || 18-21; In one aspect, the present invention provides a computer program comprising instructions which, when the program is executed by a computer, cause the computer to determine a personalized DHA supplementation dose to be taken by a mother to meet the DHA requirements of the mother's infant, given one or more parameters). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-9). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Process and/or Certain Methods Of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-10 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
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 1-10 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pub. No.: US 20040048926 A1 to Hoffman et al. in view of Pub. No.: US 20100267830 A1 to Gibson et al.
As per Claim 1, Hoffman et al. teaches a method for determining a personalized docosahexaenoic acid (DHA) supplementation dose to be taken by a mother to meet DHA requirements of an infant of the mother, wherein the method comprises:
-- using a DHA level of milk of the mother and one or more infantile parameters to determine the personalized DHA supplementation dose (see Hoffman et al. paragraphs 16 and 35; Postnatally, breast-fed infants receive a direct supply of DHA and ARA from the mother's milk. 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.), wherein the method comprises using the mother's milk DHA level and one or more infantile parameters to determine the personalized DHA supplementation dose (see paragraphs 36-37 and 39; In one embodiment of the invention, the combination of DHA and ARA is administered as part of an infant formula. The infant formula for use in the present invention is, typically, nutritionally complete and contains suitable types and amounts of lipids, carbohydrates, proteins, vitamins and minerals.
The form of administration of DHA and ARA in the method of the present invention is not critical, as long as a visual development enhancing amount is administered. Most conveniently, DHA and ARA are supplemented into an infant formula to be fed to the infants. Alternatively, DHA and ARA can be administered as a supplement not integral to formula feeding, for example, as oil drops, sachets or in combination with other nutrients such as vitamins.
The visual development enhancing amount of DHA for use in the present invention is typically from about 11 mg per kg of body weight per day to about 75 mg per kg of body weight per day. In one embodiment of the invention, the amount is from about 12 mg per kg of body weight per day to about 60 mg per kg of body weight per day. In another embodiment the amount is from about 13 mg per kg of body weight per day to about 50 mg per kg of body weight per day. In yet another embodiment the amount is from about 15 mg per kg of body weight per day to about 26 mg per kg of body weight per day.).
Hoffman 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 Hoffman 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.
As per Claim 2, Hoffman et al. and Gibson et al. teach 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.).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 3, Hoffman et al. and Gibson et al. teach 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.
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 4, Hoffman et al. and Gibson et al. teach 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).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 5, Hoffman et al. and Gibson et al. teach 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).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 6, Hoffman et al. and Gibson et al. teach 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).).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 7, Hoffman et al. and Gibson et al. teach 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).).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 8, Hoffman et al. and Gibson et al. teach 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.).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 9, Hoffman et al. and Gibson et al. teach 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).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 10, Claim 10 is directed to a method for determining a personalized DHA supplementation dose to be taken by a mother to meet DHA requirements of an infant of the mother. Claim 10 recites the same or substantially similar limitations as those addressed above for Claim 1 as taught by Hoffman et al. and Gibson et al. Claim 10 is therefore rejected for the same reasons as set forth above for Claim 1 respectively.
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 16, Hoffman et al. and Gibson et al. teach 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).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 17, Hoffman et al. and Gibson et al. teach 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).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 18, Hoffman et al. and Gibson et al. teach the method according to claim 1, wherein the DHA requirements of the infant comprise a DHA level of the milk of the mother of at least 0.3 g per 100 g fatty acids (see Gibson et al. paragraphs 113-119).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 19, Hoffman et al. and Gibson et al. teach the method according to claim 1, wherein the DHA requirements of the infant comprise a DHA level of the milk of the mother of about 0.7 g per 100 g fatty acids (see Gibson et al. paragraphs 113-119).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 20, Hoffman et al. and Gibson et al. teach 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).).
The obviousness of combining the teachings of Hoffman et al. and Gibson et al. are discussed in the rejection of claim 1, and incorporated herein.
Response to Arguments
Applicant’s arguments filed October 14, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues (1) In the Office Action, claims 1-10 are rejected under 35 U.S.C. §101 as allegedly being directed to patent ineligible subject matter.1 Specifically, the Patent Office asserts that the present claims are directed to a mental process without significantly more. Applicant has amended the claims to include the step of administering the personalized DHA supplementation dose to the mother. Because the claims recite the particular treatment by administering to the mother, Applicant respectfully submits that the claims as presently amended recite additional features that integrate the alleged exception into a practical application.
In this regard, Applicant notes that on May 4, 2016 the Patent Office issued examples to be used in conjunction with the 2014 Interim Guidance on Subject Matter Eligibility (2014 IEG). Example 29 is directed to "Diagnosing and Treating Julitis." In this example, Claim 6 recites "A method of diagnosing and treating julitis in a patient, said method comprising: a. obtaining a plasma sample from a human patient; b. detecting whether JUL-1 is present in the plasma sample; c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected; and d. administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the diagnosed patient."
Analysis of this claim states that the claim is directed to a judicial exception. Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. This example claim further recites an additional element of administering an effective amount of anti-TNF antibodies to the diagnosed patient (step d).
Similarly, here, independent Claims 1 and 10 recite the specific administering step such that the claim as whole adds meaningful limits on the alleged judicial exception recited therein. The totality of the steps recited in the independent claims integrate the alleged judicial exception into a diagnostic and treatment process.
Accordingly, Applicant respectfully submits that the present claims are patent eligible. Therefore, Applicant respectfully requests the rejection under 35 U.S.C. § 101 be reconsidered and withdrawn.
In the Office Action, claims 1-10 are rejected under 35 U.S.C. §102 as anticipated by U.S. Patent Publication No. 2004/0048926 to Hoffman et al. ("Hoffman").2 Applicant respectfully submits that Hoffman is deficient with respect to the present claims.
Amended independent Claims 1 and 10 each recite, in part, 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. Hoffman fails to disclose or suggest at least the above recited claim elements.
In this regard, the Patent Office asserts that Hoffman "teaches a method for determining a personalized docosahexaenoic acid (DHA) supplementation dose to be taken by a mother to meet the DHA of the mother's infant." Specifically, Hoffman is directed to "a method of enhancing the visual development of term infants."
However, Hoffman fails to disclose or suggest that the administering of the personalized DHA supplementation dose promotes development of mental or physical characteristics of the infant and/or improves survival and long-term wellbeing of the infant as required by the present claims.
Applicant respectfully submits that Hoffman fails to disclose or suggest each and every element of the present claims. Anticipation is a factual determination that "requires the presence in a single prior art disclosure of each and every element of a claimed invention." Federal Circuit decisions have repeatedly emphasized the notion that anticipation cannot be found where less than all elements of a claimed invention are set forth in a reference. Accordingly, Hoffman fails to anticipate the present claims.
In response to argument (1), Examiner respectfully disagrees. The Examiner has considered Applicant's arguments in response to the rejections under 35 U.S.C. §§ 101 and 102. Regarding the § 101 rejection, the position is maintained. The amended claims, while now including the administering step, remain directed to a judicial exception. The core of independent claims 1 and 10 is the abstract mental process of determining a personalized dosage, a classic optimization step based on biological inputs that could be performed mentally. The subsequent addition of administering that determined dose does not integrate this exception into a specific, inventive practical application sufficient to confer eligibility. Unlike the causally linked diagnostic and treatment steps in the cited USPTO Example 29, the relationship here is generic: determining a supplement dose naturally leads to the routine, conventional step of administering that supplement. 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. Thus, the claims lack an inventive concept that transforms the abstract idea into a patent-eligible application. However, concerning the § 102 rejection over Hoffman, the Examiner concurs with Applicant's analysis. As anticipation requires a single reference to disclose every element of the invention, the rejection under § 102 is withdrawn. Applicant is advised that overcoming the sustained § 101 rejection would require amending the claims to either recast their focus away from the judicial exception or to incorporate significantly more inventive, integrating steps that go beyond the conventional application of a determined nutritional dose.
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.
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 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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/E.B.W/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683