DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
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finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Claims 6, 14-15, 19, and 21-29 are cancelled.
Claims 4 and 7-8 are withdrawn.
Claim 30 is newly added.
Claims 1-3, 5, 9-13, 16-18, 20, and 30 are under current examination. The claims are being examined in view of the species election in the reply filed 12/18/2024 of an IgE related disease of food allergy and the step of selecting comprises determining whether the subject was exposed to pollution.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
Claims 2-3 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “having a trans epidermal water loss (TEWL) forearm and/or forehead value greater than 7 g/m2/h”. The specification provides units of TEWL values of g/m2 (paragraphs [072], [0100], [0104], [0120], [0212]). The specification does not provide support for TEWL units of g/m2/h; accordingly, the instant claim introduces new matter.
Claim 3 is dependent on claim 2 and requires all the limitation of claim 2; thus, claim 3 also fails to comply with the written description requirement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 9, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (“The skin as a target for prevention of the atopic march” Ann. Allergy Asthma Immunol. 2018, 120, 145-151; included on IDS submitted 10/18/2022), hereafter “Lowe”, in view of Benton et al. (“Environmental Factors Contribute to the Onset of Food Allergies” J. Environ. Sci. Public Health 2017, 1(1), 27-43; of record), hereafter “Benton”.
Regarding instant claim 1, Lowe teaches that skin-barrier impairment and early-life atopic dermatitis (AD) could play a causal role in the development of sensitization and subsequent food allergies; targeting the skin barrier has potential to lower the incidence of allergic disease (see entire document, particularly pg. 145, “Objective”). There is a strong link between AD and food allergy, and evidence that regular use of prophylactic emollients can significantly decrease the expression of AD; decreased AD expression could alter the association between early-life AD and subsequent development of food allergy (pg. 145, “Results”). Neonatal emollient use could be a simple measure to lower the incidence of AD, food allergies, and allergic airways disease (pg. 146, “Conclusion”).
Lowe teaches the selection of infants (a subject) at risk of developing allergic disease, including food allergies, including selecting those with genetic polymorphisms in the FLG gene and based on family history of allergic disease (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”).
Lowe further teaches that there are several emollient products that could be used to build infant skin barrier with the aim of decreasing the incidence of AD and food allergy, and that such products are applied topically (pg. 149-150, “Choice of Emollient”; pg. 150, “Safety”; pg. 148, Table 1); as these products are used to build infant skin barrier, it is interpreted that they are capable of restoring skin barrier and are applied in a therapeutically effective amount to achieve this effect. Table 1 teaches application of such products beginning when infants are younger than one year old; for example, “from first week”, “from within 3 wk”, “from <2 wk”, etc. (pg. 148).
Lowe further teaches that there is evidence that early introduction of allergenic foods during infancy provides allergen-specific protection against food allergy; a combined strategy of early allergenic food exposure and barrier improvement strategies could be the optimal means to decrease the incidence of these conditions (pg. 150, “Alternate Strategies”). Lowe further teaches that early oral ingestion of food allergens can promote immune tolerance to foods and that regular oral exposure to peanut allergen from 4 to 11 months of age in children at high risk of peanut allergy resulted in a decrease in the cumulative incidence of food allergy (pg. 146, “Dual-Allergen Exposure Hypothesis”). Thus, a skilled artisan would be motivated to specifically use oral administration of a food allergen in the combined food exposure/barrier improvement strategy taught by Lowe in order to promote immune tolerance to such foods.
Regarding instant claim 9, Lowe teaches emollients used to build infant skin barrier which can be in the form of a cream (pg. 149-150, “Choice of Emollient”; pg. 150, “Safety”; pg. 148, Table 1).
Regarding instant claim 16, as noted above, Lowe teaches that early oral ingestion of food allergens can promote immune tolerance to foods and that regular oral exposure to peanut allergen from 4 to 11 months of age in children at high risk of peanut allergy resulted in a decrease in the cumulative incidence of food allergy (pg. 146, “Dual-Allergen Exposure Hypothesis”). Thus, a skilled artisan would be motivated to include peanut (a legume) in the combined food exposure/barrier improvement strategy taught by Lowe in order to decrease the incidence of food allergy.
Regarding instant claim 17, as noted above, Lowe teaches topical application of emollient products to build infant skin barrier with the aim of decreasing the incidence of AD and food allergy (pg. 149-150, “Choice of Emollient”; pg. 150, “Safety”; pg. 148, Table 1). Table 1 teaches daily application of such products (pg. 148).
Regarding instant claim 18, as noted above, Lowe teaches topical application of emollient products to build infant skin barrier with the aim of decreasing the incidence of AD and food allergy (pg. 149-150, “Choice of Emollient”; pg. 150, “Safety”; pg. 148, Table 1). Table 1 teaches application of such products for time periods between 2 weeks and 72 months; for example, “from first week to 32 weeks”, “from within 3 wk to 6 mo”, “for the first year of life”, etc. (pg. 148). Per MPEP 2144.05, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding instant claim 20, as noted above, Table 1 of Lowe teaches application of emollient products to build infant skin barrier beginning when infants are younger than one month old; for example, “from first week”, “from within 3 wk”, “from <2 wk”, etc. (pg. 148).
Lowe does not teach that selecting a subject at risk of developing food allergy comprises the elected species of a step of determining whether said subject is or was exposed to pollution (instant claims 1 and 5).
Benton teaches that increased urbanization contributes to the environment-food allergy nexus and that by identifying causes of food allergies, recommendations can be offered to improve the quality of life of those inflicted (pg. 27, “Conclusions”). Benton teaches that traffic pollution, smoking, and air pollution contribute to food allergies; exposure to traffic and air pollution can increase rates of asthma which therefore can increase the rates of food allergies (pg. 29, paragraph 2). Benton further teaches that identifying and investigating health threats in a timely manner is an essential service in the interface with food allergies and the environment (pg. 37, including Table 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the selection of a subject at risk of developing food allergies in the method of Lowe with a step of determining whether the subject is or was exposed to pollution, as suggested by Benton.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as Benton teaches that exposure to pollution is known to increase rates of food allergies, and that identification of causes of food allergies can be used to recommend improvements in quality of life. There is a reasonable expectation of success as Lowe similarly teaches the importance in identifying children at risk of developing allergic disease to determine the impact of skin-barrier interventions (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe in view of Benton as applied to claims 1, 5, 9, 16-18, and 20 above, and further in view of Kelleher et al. (“Skin barrier impairment at birth predicts food allergy at 2 years of age” J. Allergy Clin. Immunol. 2016, 137(4), 1111-1116; included on IDS submitted 10/18/2022), hereafter “Kelleher”, as evidenced by O’Donovan et al. (“Cohort profile: The Cork BASELINE Birth Cohort Study: Babies after SCOPE: Evaluating the Longitudinal Impact on Neurological and Nutritional Endpoints”, International Journal of Epidemiology 2015, 44(3), 764-775; of record), hereafter “O’Donovan”.
The teachings of Lowe and Benton are described above. Further, regarding instant claim 2, Lowe teaches that transepidermal water loss measurement can be useful in identifying high-risk groups that would benefit from intervention (pg. 149, column 2, paragraph 1). Lowe further teaches that a family history of allergic disease modestly increases the risk that an infant will develop AD and food allergy and recruiting infants based on family history of allergic disease is a strategy for selecting high-risk children (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”), rendering it prima facie obvious to select subjects at a risk of developing food allergy characterized by family history of food allergy. Further, regarding instant claim 3, as noted above, Benton teaches that exposure to pollution is known to increase rates of food allergies, and that identification of causes of food allergies can be used to recommend improvements in quality of life, rendering it prima facie obvious to select subjects at a risk of developing food allergy characterized by exposure to pollution.
The combination of Lowe and Benton do not teach the limitation of instant claim 2 that the subject at risk of developing food allergy is characterized by having a TEWL forearm and/or forehead value greater than 7 g/m2/h.
Kelleher teaches that skin barrier function in early infancy relates to the later development of food allergy (FA); infants with upper-quartile day 2 TEWL were 3.5 times more likely to have FA at 2 years than infants in the lowest quartile (see entire document, particularly title and abstract). Kelleher teaches that the study was part of the BASELINE birth cohort study (pg. 1112, “Study subjects”); as evidenced by O’Donovan, which sets forth this study, TEWL measurements were taken on the lower volar site of the right forearm (pg. 770, column 2, paragraph 3). Kelleher teaches that mean neonatal TEWL was apportioned into quartiles: 25th, 50th, and 75th at 5, 7, and 9 gwater/m2/h, respectively; infants with neonatal TEWL in the top quartile were 3.1 times more likely to have FA at age 2 years than those with lower-quartile TEWL (pg. 1113, “Prediction of FA at 2 years of age”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the selection of a subject at risk of developing food allergies in the method of Lowe in view of Benton to select subjects at a risk of developing food allergy characterized by having a TEWL forearm value greater than 7 gwater/m2/h, as suggested by Kelleher.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as Kelleher teaches that TEWL is a noninvasive measurement of skin barrier function and that TEWL greater than 9 gwater/m2/h, as measured on the forearm, was a significant predictor of food allergy (abstract; pg. 1114, “Discussion”). There is a reasonable expectation of success as Lowe teaches the importance in identifying children at risk of developing allergic disease to determine the impact of skin-barrier interventions (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”), and suggests that transepidermal water loss measurement can be useful in identifying high-risk groups that would benefit from intervention (pg. 149, column 2, paragraph 1) .
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe in view of Benton as applied to claims 1, 5, 9, 16-18, and 20 above, and further in view of Dawid-Pać (“Medicinal plants used in treatment of inflammatory skin disease” Postep. Derm. Alergol. 2013, 3, 170-177; of record) and Yates et al. (US 2016/0243164 A1, published August 25, 2016; of record), hereafter “Yates”.
The teachings of Lowe and Benton are described above.
The combination of Lowe and Benton do not teach that the composition capable of restoring skin barrier comprises an immune-stimulator (instant claim 10), a therapeutically effective amount of acemannan (instant claim 11), acemannan in an amount ranging from 0.1 to 1.0% w/w (instant claim 12), or that the composition capable of restoring skin barrier reduces TEWL by at least 20% (instant claim 13).
Dawid-Pać teaches that atopic dermatitis is a typical inflammation-based disease with symptoms of excessive skin dryness and itching, exfoliation, redness, skin irritation, exudations, swelling of the affected skin areas, etc.; further, Staphylococcus aureus is observed to colonize on the skin (pg. 170-171, “Introduction”, paragraph 6). They further teach that Aloe vera gel can reduce acute inflammation and is used for external treatment of minor wounds, inflammatory skin disorders, and minor skin irritations including burns, bruises, and abrasions; acemannan is an active ingredient in fresh Aloe vera that has been shown to reduce inflammation induced experimentally in vivo (pg. 172, “Aloe vera folium recens – aloe fresh leaf (fresh leaves of Aloe vera)”).
Yates teaches an antimicrobial hydrogel comprising a soluble silver salt and acemannan, wherein the acemannan has a concentration of 0.01 to 1.0 w/w% (claim 1). The hydrogel is taught to have properties of pain relief and optimal and accelerated wound healing (paragraph [0002]) and aids in maintaining an appropriate wound environment by either receiving or donating moisture, thereby enhancing immune function thus accelerating healing (paragraph [0014]); it is interpreted that the amount of acemannan taught by Yates is a therapeutically effective amount to achieve these effects. The composition can also contain components such as moisturizers, humectants, and skin protectants for their varied wound healing properties (paragraph [0020]). Yates teaches that the hydrogels exhibit a broad antimicrobial range, including inhibiting the growth of Staphylococcus aureus (paragraph [0049]). Yates further teaches that the most predominant property attributed to acemannan is immunomodulation function, including the ability to stimulate release of primary growth factors necessary to optimal and accelerated wound healing (paragraph [0022]); it is therefore interpreted that acemannan is an immuno-stimulator. Acemannan may interfere with adherence of bacteria to epithelial cells and has been shown to have anti-inflammatory properties and aid in the control of pain (paragraph [0022]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition topically applied in the method Lowe in view of Benton with a composition comprising a therapeutically effective amount of the immuno-stimulator acemannan, as suggested by Dawid-Pać and Yates. The effective amount of acemannan taught by Yates overlaps the range of instant claim 12; per MPEP 2144.05, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate an active agent known from Dawid-Pać for use in inflammatory skin disorder which is known to reduce inflammation (Dawid-Pać, pg. 172, “Aloe vera folium recens – aloe fresh leaf (fresh leaves of Aloe vera)”) and which has immunomodulation and pain relief properties (Yates, paragraph [0022]). Further, Yates teaches acemannan may interfere with adherence of bacteria to epithelial cells and can be used in compositions for inhibiting the growth of Staphylococcus aureus, taught by Dawid-Pać to be observed on the skin as a symptom of atopic dermatitis, and that acemannan can be used in compositions that supply moisture and heal wounds. There is a reasonable expectation of success as Lowe teaches sensitization to allergens can occur through damaged skin associated with AD, which then increases the risk of food allergy and other forms of allergic disease (pg. 146, “Can the Skin be the Site of Initiation of Sensitization and Subsequent Allergic Disease?”), and that intervention may include management of AD with topical anti-inflammatory medications (Table 1, pg. 148).
The limitation of instant claim 13 “wherein topically administering said composition capable of restoring skin barrier reduces TEWL by at least 20%” characterizes the natural result of applying the composition. The instant specification notes that reduction of TEWL by 22% occurred following topical administration of acemannan (Example 2, pg. 41) and that in some embodiments, acemannan is present in an amount ranging from 0.1 to 1.0% (w/w) (paragraph [018]). Given that Lowe in view of Benson, Dawid-Pać, and Yates renders obvious the claimed method steps and the topical administration of a composition comprising an overlapping amount of acemannan, the property of reducing TEWL by at least 20% must necessarily follow, absent evidence to the contrary.
Independent claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (“The skin as a target for prevention of the atopic march” Ann. Allergy Asthma Immunol. 2018, 120, 145-151; included on IDS submitted 10/18/2022), hereafter “Lowe”, in view of Benton et al. (“Environmental Factors Contribute to the Onset of Food Allergies” J. Environ. Sci. Public Health 2017, 1(1), 27-43; of record), hereafter “Benton”, Dawid-Pać (“Medicinal plants used in treatment of inflammatory skin disease” Postep. Derm. Alergol. 2013, 3, 170-177; of record), and Yates et al. (US 2016/0243164 A1, published August 25, 2016; of record), hereafter “Yates”.
Lowe teaches that skin-barrier impairment and early-life atopic dermatitis (AD) could play a causal role in the development of sensitization and subsequent food allergies; targeting the skin barrier has potential to lower the incidence of allergic disease (see entire document, particularly pg. 145, “Objective”). There is a strong link between AD and food allergy, and evidence that regular use of prophylactic emollients can significantly decrease the expression of AD; decreased AD expression could alter the association between early-life AD and subsequent development of food allergy (pg. 145, “Results”). Neonatal emollient use could be a simple measure to lower the incidence of AD, food allergies, and allergic airways disease (pg. 146, “Conclusion”).
Lowe teaches the selection of infants (a subject) at risk of developing allergic disease, including food allergies, including selecting those with genetic polymorphisms in the FLG gene and based on family history of allergic disease (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”).
Lowe further teaches that there are several emollient products that could be used to build infant skin barrier with the aim of decreasing the incidence of AD and food allergy, and that such products are applied topically (pg. 149-150, “Choice of Emollient”; pg. 150, “Safety”; pg. 148, Table 1); as these products are used to build infant skin barrier, it is interpreted that they are capable of restoring skin barrier and are applied in a therapeutically effective amount to achieve this effect. Table 1 teaches application of such products beginning when infants are younger than one year old; for example, “from first week”, “from within 3 wk”, “from <2 wk”, etc. (pg. 148).
Lowe further teaches that there is evidence that early introduction of allergenic foods during infancy provides allergen-specific protection against food allergy; a combined strategy of early allergenic food exposure and barrier improvement strategies could be the optimal means to decrease the incidence of these conditions (pg. 150, “Alternate Strategies”). Lowe further teaches that early oral ingestion of food allergens can promote immune tolerance to foods and that regular oral exposure to peanut allergen from 4 to 11 months of age in children at high risk of peanut allergy resulted in a decrease in the cumulative incidence of food allergy (pg. 146, “Dual-Allergen Exposure Hypothesis”). Thus, a skilled artisan would be motivated to specifically use oral administration of a food allergen in the combined food exposure/barrier improvement strategy taught by Lowe in order to promote immune tolerance to such foods.
Lowe does not teach that selecting a subject at risk of developing food allergy comprises the elected species of a step of determining whether said subject is or was exposed to pollution. Lowe does not teach that the composition capable of restoring skin barrier comprises acemannan in an amount ranging from 0.1 to 1.0% w/w.
Benton teaches that increased urbanization contributes to the environment-food allergy nexus and that by identifying causes of food allergies, recommendations can be offered to improve the quality of life of those inflicted (pg. 27, “Conclusions”). Benton teaches that traffic pollution, smoking, and air pollution contribute to food allergies; exposure to traffic and air pollution can increase rates of asthma which therefore can increase the rates of food allergies (pg. 29, paragraph 2). Benton further teaches that identifying and investigating health threats in a timely manner is an essential service in the interface with food allergies and the environment (pg. 37, including Table 3).
Dawid-Pać teaches that atopic dermatitis is a typical inflammation-based disease with symptoms of excessive skin dryness and itching, exfoliation, redness, skin irritation, exudations, swelling of the affected skin areas, etc.; further, Staphylococcus aureus is observed to colonize on the skin (pg. 170-171, “Introduction”, paragraph 6). They further teach that Aloe vera gel can reduce acute inflammation and is used for external treatment of minor wounds, inflammatory skin disorders, and minor skin irritations including burns, bruises, and abrasions; acemannan is an active ingredient in fresh Aloe vera that has been shown to reduce inflammation induced experimentally in vivo (pg. 172, “Aloe vera folium recens – aloe fresh leaf (fresh leaves of Aloe vera)”).
Yates teaches an antimicrobial hydrogel comprising a soluble silver salt and acemannan, wherein the acemannan has a concentration of 0.01 to 1.0 w/w% (claim 1). The hydrogel is taught to have properties of pain relief and optimal and accelerated wound healing (paragraph [0002]) and aids in maintaining an appropriate wound environment by either receiving or donating moisture, thereby enhancing immune function thus accelerating healing (paragraph [0014]); it is interpreted that the amount of acemannan taught by Yates is a therapeutically effective amount to achieve these effects. The composition can also contain components such as moisturizers, humectants, and skin protectants for their varied wound healing properties (paragraph [0020]). Yates teaches that the hydrogels exhibit a broad antimicrobial range, including inhibiting the growth of Staphylococcus aureus (paragraph [0049]). Yates further teaches that the most predominant property attributed to acemannan is immunomodulation function, including the ability to stimulate release of primary growth factors necessary to optimal and accelerated wound healing (paragraph [0022]). Acemannan may interfere with adherence of bacteria to epithelial cells and has been shown to have anti-inflammatory properties and aid in the control of pain (paragraph [0022]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the selection of a subject at risk of developing food allergies in the method of Lowe with a step of determining whether the subject is or was exposed to pollution, as suggested by Benton.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as Benton teaches that exposure to pollution is known to increase rates of food allergies, and that identification of causes of food allergies can be used to recommend improvements in quality of life. There is a reasonable expectation of success as Lowe similarly teaches the importance in identifying children at risk of developing allergic disease to determine the impact of skin-barrier interventions (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”).
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the composition topically applied in the method of Lowe with a composition comprising a therapeutically effective amount of the immuno-stimulator acemannan, as suggested by Dawid-Pać and Yates. The effective amount of acemannan taught by Yates overlaps the range of instant claim 30; per MPEP 2144.05, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate an active agent known from Dawid-Pać for use in inflammatory skin disorder which is known to reduce inflammation (Dawid-Pać, pg. 172, “Aloe vera folium recens – aloe fresh leaf (fresh leaves of Aloe vera)”) and which has immunomodulation and pain relief properties (Yates, paragraph [0022]). Further, Yates teaches acemannan may interfere with adherence of bacteria to epithelial cells and can be used in compositions for inhibiting the growth of Staphylococcus aureus, taught by Dawid-Pać to be observed on the skin as a symptom of atopic dermatitis, and that acemannan can be used in compositions that supply moisture and heal wounds. There is a reasonable expectation of success as Lowe teaches sensitization to allergens can occur through damaged skin associated with AD, which then increases the risk of food allergy and other forms of allergic disease (pg. 146, “Can the Skin be the Site of Initiation of Sensitization and Subsequent Allergic Disease?”), and that intervention may include management of AD with topical anti-inflammatory medications (Table 1, pg. 148).
Response to Arguments
Applicant’s arguments filed 12/17/2025 have been fully considered, but they are not persuasive.
Regarding the claim rejections under 35 U.S.C. 112(a), Applicant argues that a person of ordinary skill in the art would understand that TEWL inherently measures water loss per unit time (and area) making the clarification of "gwater/m2/h" versus "g/m2/h" or g/m2 a matter of nomenclature rather than substantive new matter, and the specification’s disclosure provides adequate written description as the underlying measurement and its application remain unchanged.
In response, the Examiner notes that while it is understood in the art that TEWL measures water loss per unit time and area, the specification does not support the unit time of “h” recited in instant claim 2. The specification provides units of TEWL values of g/m2 (paragraphs [072], [0100], [0104], [0120], [0212]), but does not provide a unit of time associated with these TEWL values, and thus does not provide adequate written support for the claimed TEWL values.
Regarding the claim rejections under 35 U.S.C. 103, Applicant argues that the rejection is based on an improper combination of prior art references that fails to teach or suggest the specific claimed method as a whole. Specifically, Applicant argues that Lowe discusses emollient use and early food introduction as separate strategies and does not suggest the specific combination claimed; Lowe’s discussion of a combined strategy is in a separate section titled “Alternate Strategies” and merely suggests that such a combination “could be” optimal without provided specific guidance on implementation, time, or patient selection criteria. Applicant argues that this does not constitute a teaching or suggestion of the specific method which requires both topical administration of a skin barrier restoring composition and oral administration of an allergen composition to the same subject according to specific timing parameters. Applicant further argues that Benton does not teach or suggest using pollution exposure as a selection criterion for identifying subjects who would benefit from the specific combined treatment approach claimed, and the combination improperly relies on hindsight reconstruction to arrive at the claimed method.
These arguments are unpersuasive. The Examiner first notes that, per MPEP 2123, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. As set forth in the above rejection, Lowe provides clear teachings to one of ordinary skill in the art that early oral exposure to peanut allergen can result in a decrease in the incidence of food allergy (pg. 146, “Dual-Allergen Exposure Hypothesis”) and that neonatal emollient use can be used to lower the incidence of atopic dermatitis and subsequent development of food allergies (see particularly pg. 146, “Conclusion”). Lowe further explicitly envisions a combined strategy of early allergenic food exposure and barrier improvement strategies as a means of decreasing the incidence of food allergy (pg. 150, “Alternate Strategies”). The fact that this combined strategy is presented under a separate heading does not negate the conclusions one of ordinary skill in the art would draw from the teachings of Lowe as a whole.
The Examiner respectfully maintains that the teachings of Lowe reasonably suggest to an ordinary skilled artisan a combination of oral administration of a food allergen and skin barrier improvement as a strategy or lowering the incidence of food allergies. Lowe further provides guidance on selecting children at risk for developing food allergy and the limitation of step “b” that topically administering, orally administering or both starts when the subject is one year old, at most and the further timing parameters of the dependent claims, as set forth in the above rejections (see particularly pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”; pg. 148, Table 1; and pg. 146, “Dual-Allergen Exposure Hypothesis”).
The argument that Benton does not teach or suggest using pollution exposure as a selection criterion for identifying subjects who would benefit from the specific combined treatment approach claimed, and that the combination improperly relies on hindsight reconstruction to arrive at the claimed method is unpersuasive. The Examiner first notes that the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Further, regarding the argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Here, Benton reasonably suggests to one of ordinary skill in the art that pollution contributes to food allergies (pg. 29, paragraph 2), that identifying health threats in a timely manner is essential in the interface with food allergies and the environment (pg. 37, including Table 3), and that identification of the causes of food allergies can be used to recommend improvements in quality of life (pg. 27, “Conclusions”). Lowe similarly teaches the importance of identifying children at risk of developing allergic disease to determine the impact of skin-barrier interventions (pg. 149, “Key Issues in Studies of Trials that Evaluate the Impact of Emollients on Incidence of Food Allergy and Allergic Airways Disease”). Thus, the combined teachings of the prior art as a whole render obvious the use of exposure to pollution as an identifying factor for a subject at risk of developing food allergies that could benefit from the interventions of Lowe. Such knowledge was within the level of ordinary skill before the effective filing date of the instant invention.
Applicants further argue that the claimed method provides unexpected benefits by combining topical skin barrier restoration with oral allergen exposure in at-risk subjects; this specific combination produces unexpected therapeutic effects required for reducing the susceptibility, delaying, suppressing, or treating an IgE -related disease that would not have been predicted based on the cited art which discuss these approaches only as separate or theoretical strategies without the specific implementation details claimed. Applicant cites to Example 3, Figure 3 showing synergistic reduction in Th2 response as evidence of unexpected results from the combined approach to overcome the prima facie case of obviousness. Applicant argues that new claim 30 is not taught or suggested by the cited references and provides unexpected synergistic benefits when combined with oral allergen administration as demonstrated in Example 3.
Regarding the allegation of unexpected results, per MPEP 716.02(b), applicants have the burden of explaining proffered data and “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. From the evidence cited (Example 3 and Figure 3), it cannot be concluded that the combination treatment produces differences that are of statistical and practical significance from the results of barrier restoration only. Figures 3A, 3B, and 3D show results that the combined (“both”) treatments are within experimental error of “Barrier Restoration” alone, and it is unclear from Figure 3C that an improvement in TGF-β from “both” treatments is of statistical and practical significance over that from barrier restoration alone, absent a further explanation from Applicant.
The Examiner further notes that the evidence does not establish that the combination of oral tolerance with barrier restoration has specifically achieved a synergistic effect that goes beyond what would be expected from the combination of two known strategies for reducing the incidence of food allergies. As noted above, the prior art of Lowe teaches that a combined strategy of early allergenic food exposure and barrier improvement strategies could be the optimal means to decrease the incidence of allergic conditions, and per MPEP 716.02(c), “"Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”.
Further, per MPEP 716.02(d), evidence of unexpected results must commensurate in scope with the claims which the evidence is offered to support. Here, Example 3 of the specification exemplifies only oral introduction of peanuts and only a single lotion for skin barrier restoration (see particularly paragraphs [0225] and [0229] of the instant specification). However, the method of independent claim 1 does not limit the composition capable of restoring skin barrier and neither independent claims 1 nor 30 limit the oral composition comprising an allergen. Thus, the evidence of record is not commensurate in scope with the claimed methods.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611