DETAILED ACTION
Examiner acknowledges receipt of the reply filed 12/23/2025, in response to the non-final office action mailed 9/25/2025.
Claims 1-19 are pending. Claims 16-19 are newly added. Claim 15 is withdrawn for the reasons made of record.
Claims 1-14 and 16-19 are being examined on the merits in this office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
NPL documents 1-15, 17, 19 and 21-24 in the IDS filed 12/23/2025 have been struck-through. Full citations, including references titles, must be included in the IDS.
Claim Objections- withdrawn
The objection of claims 1, 2, 7, 9, and 11 is withdrawn in view of the amendment filed 12/23/2025.
Claim Rejections - 35 USC § 112- withdrawn, in part
The rejection of claims 2-6, 8, 10, 11, and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 12/23/2025.
Response to Arguments
Applicant’s amendment and arguments, filed 12/23/2025, with respect to the above objections and rejections have been fully considered and are persuasive. The objections and rejections have been withdrawn.
Applicant's arguments filed 12/23/2025have been fully considered but they are not persuasive with the maintained rejections below.
Upon further consideration, a new ground(s) of objection and rejection is made in view of the amendment filed 12/23/2025.
An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 and 16-19 remain/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reducing the risk of developing or treating an allergic response to an allergen originating from food via administering non-denatured lactoferrin in conjunction with exposure/sensitization to correlating allergens, does not reasonably provide enablement for treating/reducing the risk without a step of allergen sensitization. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This rejection is maintained from the office action mailed 9/23/2025, but has been amended to reflect claims filed 12/23/2025.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
(1) The nature of the invention and (5) Breadth of the claims:
The claims are drawn to a method for reducing the risk of developing or treating an allergic response to an allergen originating from food in an infant or a toddler, comprising administering to the infant or toddler in need thereof a nutritional composition comprising 0.03-14 wt% non-denatured lactoferrin, calculated by weight of total protein within the nutritional composition, said nutritional composition being selected from infant formula, follow-on formula and growing-up milk.
The as-filed specification expressly states:
Consequently, the administration of a nutritional composition containing non-denatured lactoferrin has a beneficial effect on pediatric subjects in that it enhances (vaccine) specific immune response and further in that it can prevent or reduce the adverse effects of allergy, allergic rhinitis, asthma, urticaria, atopic eczema, allergic conjunctivitis, atopic dermatitis or atopic diseases.
Specification at p 3. Emphasis added.
(2) The state of the prior art:
The Merck Manual indicates that allergic (including atopic) and other hypersensitivity disorders are inappropriate or exaggerated immune reactions to foreign antigens (Overview of Allergic and Atopic Disorders, Merck Manual, Fernandez et al, accessed 9/22/2025 at URL merckmanuals.com/professional/immunology-allergic-disorders/allergic-autoimmune-and-other-hypersensitivity-disorders/overview-of-allergic-and-atopic-disorders, 21 pages- previously cited). Type I hypersensitivity are IgE-mediated and reactions develop < 1 hour after exposure to antigen (pp. 1-2). Type I reactions underlie all atopic disorders (e.g., atopic dermatitis, allergic asthma, rhinitis, conjunctivitis) and many allergic disorders (e.g., anaphylaxis, some cases of angioedema, urticaria, latex and some food allergies). The terms atopy and allergy are often used interchangeably but are different. Atopy is an exaggerated IgE-mediated immune response; all atopic disorders are type I hypersensitivity disorders. Allergy is any exaggerated immune response to a foreign antigen regardless of mechanism. Thus, all atopic disorders are considered allergic, but many allergic disorders (e.g., hypersensitivity pneumonitis) are not atopic (p. 2). Atopic disorders most commonly affect the nose, eyes, skin, and lungs. These disorders include conjunctivitis, extrinsic atopic dermatitis (the most common type of eczema), immune-mediated urticaria, some forms of angioedema, acute latex allergy, some allergic lung disorders (e.g., allergic asthma, IgE-mediated components of allergic bronchopulmonary aspergillosis), allergic rhinitis, and allergic reactions to venomous stings. Id.
Legrand (Biometals 23:365-376 (2010)- previously cited) teaches that Lactoferrin (Lf) is an essential element of innate immunity, which refers to antigen-nonspecific defense mechanisms that a host uses immediately or within hours after exposure to an antigen. Following infection, Lf is released from neutrophils (PMNs) in blood and inflamed tissues and, such as other soluble pattern-recognition receptors of the innate immunity (abstract). The multifunctionality of Lf makes the understanding of its activities very tricky (p. 366). The literature is indeed crammed of evidences for roles of Lf in the host defense but, unfortunately, most of them are not necessarily informative on the actual mechanisms of action of the host molecule in immunity. Indeed, whereas many in vivo studies reported protective effects against infections or septic shock, it is not perfectly clear whether those effects are the result of a direct anti-microbial activity or of a boost of cell mediated immunity modulation. However, recent studies undoubtly demonstrate that bovine Lf (bLf) supports immune and antioxidant status in healthy human volunteers. In addition to the evidence that Lf levels markedly increased in biological fluids of patients suffering of inflammatory diseases, the main in vivo indications of the role of Lf in the host defense came from observations on organisms suffering a lack of Lf synthesis (p. 366).
Zellweger et al. (Allergy European Journal of allergy and clinical immunology 71: 1652 – 1661 (2016)- previously cited) teach that IgE-associated allergic diseases belong to the most common inflammatory conditions. Their clinical manifestation ranges from mild symptoms to life-threatening episodes. The continuously rising number of people that are affected by an allergic condition indicates an urgent need for better diagnostics and more efficient treatment options (abstract). IgE-associated allergic diseases include, but are not limited to, allergic asthma, food allergy, skin allergy (atopic dermatitis, contact dermatitis, etc.), and allergic rhinitis. The gold standard for the diagnosis of IgE-mediated allergic disorders is the examination of the patient’s disease history in combination with in vivo provocation tests. Depending on the allergic condition and in order to demonstrate specific responses to the relevant allergens, either dermal, conjunctival, oral, nasal, or bronchial allergen challenges are routinely performed (p. 1655). Two of the most commonly used treatment options include corticosteroids and antihistamines (p. 1656). Due to the heterogeneous pathophysiology of different allergic conditions, it is hard to predict which of the tested drugs or drug candidates will be most efficient. Effective treatment might even require a combinatorial drug regimen simultaneously targeting multiple mediators. Future studies will help to design more tailored approaches to achieve maximal treatment benefit. Id. Allergen-specific IgE plays a key role in the development and the initiation of allergic responses in various disease conditions. Thus, it is clear that IgE represents an interesting drug target for intervention strategies. Anti-IgE antibodies blocking the interaction of soluble IgE with its high affinity receptor FceRI on allergic effector cells have been developed by various companies and follow-up antibodies are currently under investigation in clinical trials (p. 1658). Even though IgE is an important key player in allergic reactions, researchers are increasingly realizing that also IgE independent components contribute to disease manifestation and progression. The multifactorial etiology reflects the complexity of allergies, and the heterogeneous clinical manifestations underline the broad diversity of these diseases. The variety in pathophysiology of allergic disorders poses major challenges for the development of diagnostic tests. While in vivo testing is very time-consuming and associated with the risk of adverse events, in vitro measurements do not always correspond to the clinical picture. This lack of correlation indicates that there is an urgent need for better ex vivo diagnostics helping to identify disease-associated biomarkers and to choose appropriate therapeutic intervention strategies (p. 1659).
The Merck manual (Hyper-IgE syndrome accessed 11/20/2021 at URL merckmanuals.com/professional/immunology-allergic-disorders/immunodeficiency-disorders/hyper-ige-syndrome?query=hyper ige syndrome- previously cited) indicates that hyper-IgE syndrome is a hereditary combined B- and T-cell immunodeficiency characterized by recurrent staphylococcal abscesses of the skin, sinopulmonary infections, and severe pruritic eosinophilic dermatitis. Diagnosis is confirmed by measurement of serum IgE levels. Treatment consists of supportive measures, including lifelong prophylactic antistaphylococcal antibiotics.
Food allergy is an exaggerated immune response to dietary components, usually proteins (Food allergy, Merck Manual, Fernandez et al, accessed 9/22/2025 at URL merckmanuals.com/professional/immunology-allergic-disorders/allergic-autoimmune-and-other-hypersensitivity-disorders/food-allergy, 10 pages- previously cited). Manifestations vary widely and can include atopic dermatitis, gastrointestinal or respiratory symptoms, and anaphylaxis. Diagnosis is by history and sometimes allergen-specific serum IgE testing, skin testing, and/or elimination diets (p. 1). Food allergy should be distinguished from nonimmune reactions to food (e.g., lactose intolerance, irritable bowel syndrome, infectious gastroenteritis) and reactions to additives (e.g., monosodium glutamate, metabisulfite, tartrazine) or food contaminants (e.g., latex dust in food handled by workers wearing latex gloves). Prevalence of true food allergy ranges from < 1 to 3% and varies by geography and method of ascertainment; patients tend to confuse intolerance with allergy. Id. Almost any food or food additive can cause an allergic reaction, but the most common triggers include in infants and young children: Milk, soy, eggs, peanuts, and wheat. In older children and adults: Nuts and seafood are more common (p. 2). Cross-reactivity between food and nonfood allergens exists, and sensitization may occur nonenterally. For example, patients with oral allergies (typically, pruritus, erythema, and edema of the mouth when fruits and vegetables are eaten) may have been sensitized by exposure to pollens that are antigenically similar to food antigens. Children with peanut allergy may have been sensitized by topical creams containing peanut oil used to treat rashes. Many patients who are allergic to latex are also allergic to bananas, kiwis, avocados, or a combination. Id.
In regards to Allergic rhinitis, the Merck manual indicates that “allergic rhinitis is seasonal or perennial itching, sneezing, rhinorrhea, nasal congestion, and sometimes conjunctivitis, caused by exposure to pollens or other allergens. Diagnosis is by history and occasionally skin testing and first-line treatment is with nasal corticosteroid or with an oral antihistamine plus an oral decongestant (see Merck manual, Allergic Rhinitis, 1st paragraph- previously cited). The Merck manual indicates that patients have itching, sneezing, rhinorrhea, and nasal and sinus obstruction and diagnosis is by clinical evaluation and skin testing (see Merck manual, Allergic Rhinitis, “Symptoms and Signs” and “Diagnosis”). The Merck manual indicates that there are treatments for allergic rhinitis, including and an anti-IgE antibody (see Merck manual, Allergic Rhinitis, “Treatment”).
The Merck manual indicates that “asthma is a disease of diffuse airway inflammation caused by a variety of triggering stimuli resulting in partially or completely reversible bronchoconstriction” (see Merck manual, Asthma, 1st paragraph- previously cited). The Merck manual indicates that “development of asthma is multifactorial and depends on the interactions among multiple susceptibility genes and environmental factors, and include allergen exposure, diet and perinatal factors (see Merck manual, Asthma, “Etiology”). Specifically, there are more than 100 asthma susceptibility genes that have been reported. The Merck manual indicates that common triggers of an asthma exacerbation include environmental and occupational allergens, infections, exercise, inhaled irritants, emotion, aspirin, gastroesophageal reflux disease (GERD) (see Merck manual, Asthma, “Asthma triggers”). The Merck manual indicates that “patients with mild asthma are typically asymptomatic…patients with more severe disease and those with exacerbations experience dyspnea, chest tightness, audible wheezing, and coughing…” (see Merck manual, Asthma, “Symptoms and Signs”). The Merck manual indicates that diagnosis is by clinical evaluation and pulmonary function testing (see Merck manual, Asthma, “Diagnosis”). The Merck manual indicates that there are treatments available.
(3) The relative skill of those in the art:
The relative skill of those in the art: MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” /d. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(4) The predictability or unpredictability of the art:
Applicant’s activity is based on the determination of predicting those who are susceptible of the claimed allergic and atopic diseases, much less prevention of the diseases in their first appearance. Additionally, as indicated by the Merck manual, some IgE disorders such as hyper IgE syndrome have a genetic component thus optimization of a specific treatment regimen may be difficult.
The invention is directed toward the treatment of disease and is therefore physiological in nature. It is well established that “scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
Example 1 discloses vaccination of mice with inactivated influenza virus vaccine or control (unvaccinated)- 2 groups. The mice groups were then further divided into 2 subgroups: +/- lactoferrin administration (4 groups total; see example 1 for details). Mice that were vaccinated + lactoferrin (LF) had an improved immune response, over mice vaccinated alone (as-filed specification at p. 16).
Example 2 discloses that raw cow’s milk “has the capacity to prevent the development of OVA-induced [ovalbumin] food allergy and a mirroring animal model” (as-filed specification at p. 17). The specification further states “this protective effect was lost once the milk was heat-treated, e.g. by pasteurization, such as in shop milk”. Id. Three week old pathogen free mice were orally treated with PBS (control), raw milk, shop milk, or shop milk with lactoferrin for 8 days. Animals were then sensitized with OVA (test allergen). Following intradermal challenge with the antigen, mice were assessed for allergic symptoms. Mice treated with raw milk or “shop milk + lactoferrin” had an improved immune skin response, over mice treated with shop milk [pasteurized /denatured milk] (as-filed specification at p. 16).
Example 3 discloses an infant formula comprising non-denatured lactoferrin. The formulation was further spray dried to create an infant formula powder.
The examples are limited to specific allergens- flu vaccine and ovalbumin.
Examiner expressly notes in each example, animal models were sensitized with a specific allergen. The examples are limited to specific allergens- flu vaccine and ovalbumin.
The skilled cannot extrapolate to all iterations of allergens originating from food based on 1 examples (ovalbumin allergen). The examples did not assess IgE levels, responses, etc. Examiner expressly notes that the animal model assays used intradermal challenges and assessed skin reactions (swelling, etc).
(8) The quantity of experimentation necessary:
Owing especially to factors 1-7 the quantity is expected to be high.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Response to Arguments
Applicant traversed the rejection at remarks pages 1-2 of the reply filed 12/23/2025. Applicant refers to example 2 of the specification for the assertion that non-denatured lactoferrin is capable of suppressing the development of allergic symptoms. Mice were sensitized with ovalbumin. Applicant refers to reference Kanagaratham which applicant asserts was attached. Applicant states “it is clear from the text in table 1 (see sensitization) of this review, ovalbumin is the main model antigen used in food allergy research” (pp. 1-2).
Examiner has reviewed and considered applicants arguments, but is not persuaded.
As noted by applicant, example 2 indicates that mice were sensitized with OVA and administered non-denatured lactoferrin. Specifically, in order to achieve the claimed result of reducing the risk of developing or treating an allergic response to a food allergen, the mouse model was sensitized to the OVA allergen, in conjunction with administration of claimed non-denatured lactoferrin.
Contrary to applicant’s assertions, the reference was not made of record/filed by Applicant. Examiner has attached the reference Kanagaratham et al (Cell Mol Gastroenterol Hapatol 6: 356-369 (2018)). As indicated by table 1, animal models required sensitization and challenge with the respective food allergen (OVA or peanut).
Applicant states that “since OVA is an adequate model antigen to re-create IgE mediated responses in laboratory context … the plausibility of the findings obtained with OVA can be extrapolated to other food allergens” (reply at p. 2). This underscores examiner’s position. In order to have an IgE mediated response, the mouse model [or patient/toddler/infant] must first have exposure/sensitization to a particular food allergen. In order for the claimed method of reducing the risk of developing or treating an allergic response to an allergen originating from food in an infant or toddler to be effective, the infant or toddler must be exposed/sensitized to a particular food allergen.
The rejection is maintained for at least these reasons and those previously made of record.
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 1-14 and 16-19 remain/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. This rejection is maintained from the office action mailed 9/23/2025, but has been amended to reflect claims filed 12/23/2025.
Claim 1 remains/is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: an infant or toddler is further exposed to a specific food allergen in conjunction with administering the nutritional composition comprising non-denatured lactoferrin. Examples 1 and 2 indicate a temporal relationship in which the mouse model was administered lactoferrin as well as exposed to/sensitized, etc to a specific allergen.
The specification further indicates that the claimed method is in correlation with a specific allergen:
Consequently, the administration of a nutritional composition containing non-denatured lactoferrin has a beneficial effect on pediatric subjects in that it enhances (vaccine) specific immune response and further in that it can prevent or reduce the adverse effects of allergy, allergic rhinitis, asthma, urticaria, atopic eczema, allergic conjunctivitis, atopic dermatitis or atopic diseases.
As-filed specification at p 3. Emphasis added.
Claim clarification is required.
Because claims 2-14 and 16-19 depend from indefinite claim 1 and do not clarify the point of confusion, they must be rejected under 35 USC 112, second paragraph.
Claim 12 recites the limitation "the composition". There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “the nutritional composition”.
Applicant did not address this rejection in the reply filed 12/23/2025.
Response to Arguments
Applicant traversed the rejection at remarks pages 2 of the reply filed 12/23/2025. Applicant asserts that the arguments provided with respect to the enablement rejection, apply to the indefinite rejection as well. Applicant states, “results obtained with the OVA model are representative of generally reducing the risk of developing or treating an allergic response to a food allergen, without the requirement of actually administering the allergen”. Id. Applicant states “In example 2, the allergen is administered to measure the extent of the allergic response, which is not mean that tolerance towards the allergen can only be developed by administration of the allergen”.
Applicant's reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference. After full consideration of applicants arguments, the rejection is maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 and 16-19 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holt (WO 2012/077076 - previously cited), as evidenced by GRAS notification No. 669 (Drummond Food Science Adv Ltd, pp. 1-69, 2016; hereinafter referred to as “GRAS 669”- previously cited). This rejection is maintained from the office action mailed 9/23/2025, but has been amended to reflect claims filed 12/23/2025.
Holt teaches a method of decreasing a subject’s risk of developing sensitivity to one or more bovine milk allergens, comprising orally administering to the subject one or more bovine milk allergens, wherein the administration is of a composition comprising one or more milk bovine allergens present at a concentration of at least 50% greater than the concentration of the milk allergen and whole bovine milk. The bovine milk protein is a component capable of increasing IgE production or levels in the subject exposed to same, such as lactoferrin (pp. 2, 5, 8, 10, 12, claims 2,4, 22). Lactoferrin was explicitly disclosed as a therapeutically active agent for the treatment of sensitivity to bovine milk allergens, such as allergy (e.g., pp. 5-6, 10, claims 4, 20). Preferably the subject is a neonatal, an infant, or a child (e.g., pp. 4-5; claims 15, 17). The composition is suitable for use as an infant formula, follow-on formula or growing up milk (e.g., pp. 5, 12; claim 33). The composition or product comprises, consist essentially of, or consists of fresh whole milk, fractional milk, fresh skim milk, colostrum, or concentrated milk (e.g., p. 6, ll. 11-28; claim 34). Holt teaches compositions can be used to treat allergy [e.g., milk food allergy] (e.g., pp. 4-6, 10).
As evidenced by GRAS 669, lactoferrin is one of the whey proteins in cow’s [bovine] milk, accounting for 0.3% of the total milk protein, or 1.4% of the total whey protein in milk (p. 9). Examiner notes that the reference does not disclose heat or other treatment of lactoferrin, which would lead to its denaturation. It is therefore considered that the lactoferrin is non-denatured. The reference discloses fresh milk.
Accordingly, the limitations of instant claims 1-3, 7, 9, 16, 17, and 19 are satisfied. Regarding claim 4, Holt teaches that the composition is a powder (e.g., pp. 4, 6, 12-13, 17-18; claim 18, 34). Regarding claim 5, Holt teaches that the composition can be a powder form that is reconstituted for oral consumption (e.g., pp. 1, 5-6, 8, 18; claim 34). Regarding claims 6 and 18, Holt teach that the concentration of lactoferrin is approximately 0.1g/L (p. 8, ll. 3-7). Regarding claim 8, the method is for allergen sensitized infants or toddlers (e.g., claim 1). Regarding claim 9, Holt teaches that method is for IgE mediated allergies. Figures 7 and 8 indicate a reduction in IgE serum levels in treated animals (BLGIP +10x). Regarding claims 10 and 11, Holt teaches that the allergen includes other allergies- food (e.g. peanut, shellfish) and mold (e.g., p. 10). Regarding name 12, Holt does not teach or suggest that the composition is fermented.
Accordingly, claims 1-12 and 16-19 are rejected.
Pursuant to MPEP 2121(I), when the reference relied on expressly anticipates or makes obvious all the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Moreover, MPEP 2121(III) states that a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). MPEP 716.07 states that since in a patent it is presumed that a process if used by one skilled in the art will produce the product or result described therein, such presumption is not overcome by a mere showing that it is possible to operate within the disclosure without obtaining the alleged product. In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA 1969).
Response to Arguments
Applicant traversed the rejection at remarks pages 2-4 of the reply filed 12/23/2025. Applicant asserts that Holt relates to lactoferrin and other milk proteins used at “huge amounts to decrease the sensitivity of a subject to this very same milk proteins” (p. 3). Applicant alleges that Holt does not disclose the use of non-denatured lactoferrin. Applicant states “the fact that Holt does not mention the state of the protein used does not imply that it is non-denatured” (further referring to milk processing). Id.
Applicant asserts unexpected results, referring to Example 2 for the indication that denatured lactoferrin does not provide the claimed effect in comparison to non-denatured lactoferrin. Id.
Examiner has considered and reviewed applicants arguments, but is not persuaded.
Patents and applications are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
Holt teaches decreasing a subject’s risk of developing sensitivity to one or more bovine milk allergens. Lactoferrin was explicitly disclosed as a therapeutically active agent for the treatment of sensitivity to bovine milk allergens. The compositions of Holt include “fresh whole milk” or colostrum [each reads on non-denatured proteins]. Holt teaches that the subject is a neonatal, an infant, or a child. The composition is suitable for use as an infant formula, follow-on formula or growing up milk (e.g., pp. 5, 12; claim 33). As evidenced by GRAS 669, lactoferrin is one of the whey proteins in cow’s [bovine] milk, accounting for 0.3% of the total milk protein, or 1.4% of the total whey protein in milk (p. 9).
Accordingly, Holt anticipates the instant claims.
Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See M.P.E.P. § 2131.04.
The rejection is maintained for at least these reasons, and those previously made of record.
New Objection/Rejections
Claim Objections- New Objection
Claims 10, 12, and 14 are objected to because of the following informalities:
Claim 10 should be amended to recite “originating from
Claim 12 should be amended to recite “the nutritional composition”.
Claim 14 should be amended to recite “a)[[.]] ..; b)[[.]] .. 70° C[[,]]..; c)[[.]] ..; and d)[[.]] ..”. While there is no set statutory form for claims, the present Office practice is to insist that each claim begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). See M.P.E.P. § 608.01(m).
Appropriate correction is required.
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 1-14 and 16-19 remain/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. This rejection is a new rejection necessitated by the claims filed 12/23/2025.
Claim 11 does not have antecedent basis from claim 1. Claim 1 recites “a method for reducing the risk of developing or treating an allergic response to an allergen originating from food”. Claim 11 recites “peanut, tree nut, shell fish,… pollen, mold or dust mite”. Examiner acknowledges that mold can originate from food. Pollen and dust mite are not deemed to be encompassed within the scope of food allergies.
To overcome this rejection, examiner recommends removing reference to pollen and dust mite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This rejection is a new rejection necessitated by the claims filed 12/23/2025.
Claim 11 does not properly depend from claim 1. Claim 1 recites “a method for reducing the risk of developing or treating an allergic response to an allergen originating from food”. Claim 11 recites “peanut, tree nut, shell fish,… pollen, mold or dust mite”. Examiner acknowledges that mold can originate from food.
Pollen and dust mite are not deemed to be encompassed within the scope of food allergies. Claim 11 is construed as being broader in scope than claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
To overcome this rejection, examiner recommends removing reference to pollen and dust mite.
Conclusion
No claims are allowed.
Claims 1-19 are pending. Claim 15 is withdrawn.
Claims 1-14 and 16-19 are rejected.
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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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, LIANKO GARYU can be reached at 571-270-7367. 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.
/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654