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 .
Claim Status
1. Claims 1-2, 4-16, 18, and 20-22 are currently pending. Claim 19 was cancelled by the Applicant. Claims 1-2, 4-5, 7-8, 11, and 21-22 are amended. Claims 1-2, 4-16, 18, and 20-22 are under examination.
Withdrawn Rejections
2. The Office Action of 2/17/2026 rejected claims 1-2, 4-16, 18-22 under 35 U.S.C. 112(a) for written description. In response Applicant argued that the instant specification did support the inventor possessing the claimed subject matter at the time of filing, citing in particular paragraphs [006], [007], [026], [027], [032], [047], [049], [050], and [091] as providing support for the limitations of 28 days old at most, 14 days old at most, and 7 days old at most.
Applicant’s arguments, see pgs. 6-7, filed 7/16/2026, with respect to claims 1-2, 4-16, and 18-22 have been fully considered and are persuasive. The rejection under 35 U.S.C. 112(a) of claims 1-2, 4-16, 18, and 20-22 has been withdrawn.
3. The Office Action of 2/17/2026 rejected claims 2 and 4 under 35 U.S.C. 112(a) for enablement, specifically for the use of “drops” as not being in scope with formulations disclosed in the specification. In response, Applicant has amended claims 1 and 4 to recite specific formulas represented in the instant specification as comprising the drops of the claimed invention. For those reasons, the rejection is withdrawn.
4. The Office Action of 2/17/2026 rejected claims 11-13 under 35 U.S.C. 112(b) for indefiniteness. In response, Applicant properly amended claim 11. For those reasons, the rejection is withdrawn.
5. The Office Action of 2/17/2026 rejected claims 1-2, 4-5, 7-16, 18-19, and 21-22 under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Friedman (US 2016/026312 A1, pub. 9/15/2016). In response, Applicant amended claims 1 and 4 to recite subject matter not disclosed by Friedman. For this reason, the rejection is withdrawn.
6. The Office Action of 2/17/2026 rejected claim 6 under 35 U.S.C. 103 as being unpatentable over Friedman (US 2016/026312 A1, pub. 9/15/2016) in view of Caubet (J. Allergy Clin Immunol., 2016, 139(2):572-583). In response, Applicant amended claim 1 to recite subject matter not disclosed in Friedman. For this reason, the rejection is withdrawn.
7. The Office Action of 2/17/2026 rejected claim 20 under 35 U.S.C. 103 as being unpatentable over Friedman (US 2016/026312 A1, pub. 9/15/2016) in view of Devonshire (Allergy Asthma Proc., 2019, 40:450-452). In response, Applicant amended claim 1 to recite subject matter not disclosed in Friedman. For this reason, the rejection is withdrawn.
Maintained Rejection
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.
8. Claim 2 remains 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.
In claim 2 the phrase, “said subject being characterized by having…” is also indefinite. It is unclear how the claim element is related to the other claim limitations. As written, it could be interpreted to be either a criterion for selecting a subject or a new claim limitation element.
To overcome this rejection, it is suggested applicant re-write the claim to clarify the relationship between the phrase and the prior claim element. This can be accomplished by replacing “said subject being characterized” with either “and,” or “wherein the subject is further characterized.”
9. Claims 8-10 remain 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.
Specifically, claims 8-10 recite reducing the titer of IgE and reducing wheal size from skin prick tests. Claim 8 is indefinite because the use of the word “reducing” is not clear. Specifically, the claim provides no reference as to what the IgE titer or the wheal size are reduced from. Claim 9 does not overcome the indefinite rejection because the claim recites results being reduced by 5% of a control subject without further defining what is being reduced by 5%. Claim 10 does not overcome this rejection because it cites the wheal size being reduced to 1 mm at most, but has no clear reference of what it is being reduced from.
To overcome this rejection, it is suggested the applicant re-write the claims to more clearly define the test results and how they are interpreted as evidence of preventing sensitization. As they are written, the examiner is interpreting any disclosure of a reduced effect on IgE and wheal size as disclosing reading on the claim limitation.
Response to Arguments
10. Regarding the rejection of claim 2, Applicant’s response was incomplete. In their response, Applicant indicated they amended claim 2 to remove “optionally” and “being characterized by” to overcome the rejection. However, Applicant only deleted the phrase “optionally”. The other phrase still exists within the claims as filed on 7/16/2026 with the response. Thus, the rejection is maintained.
11. Regarding the rejection of claims 8-10, Applicant amended claims to recite the reducing of said subject is “each compared to a control subject”. Applicant argues this overcomes the rejection and makes the claims definite.
Applicant's arguments have been fully considered but they are not persuasive. As the original rejection stated above, the use of the word “reducing” is not clear. While reducing is not defined in the present specification, page 10 [067] provides context for what “reducing” is defined as:
PNG
media_image1.png
89
599
media_image1.png
Greyscale
The instant specification uses “reducing” the susceptibility of a subject administered with the composition within the context of preventing allergy susceptibility. It is unclear how one of ordinary skill in the art would understand the limitation of “reducing” the titer of IgE targeting said milk protein, “reducing” the wheal size of a subject in SPR, “reducing” said titer of IgE by at least 5%, or “reducing” said wheal size to 1 mm at most to be compared to a control subject. One of ordinary skill in the art may understand a result being “decreased” as compared to a control subject but this would not be the same as “reducing” especially when you are discussing preventative therapy. One of ordinary skill in the art would understand a control subject in a test as a way to verify that results are accurate and reliable, but not as a comparison for whether a treatment is effective at preventing susceptibility in a subject as the present claimed invention is implying. The use of the word “reducing” implies two results with a connection between the two, for example a result prior to therapy is administered and one after therapy is administered, or two results after therapy is administered with an established time between the two tests being given establishing a pattern of results initiated by the treatment. The addition of “compared to a control subject” fails to make the claim limitations clear and definite.
Thus, claims 8-10 remain rejected under 35 U.S.C. 112(b) as being indefinite and failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
New Objections
(In response to amendments)
Claim Objections
12. Claim 5 is objected to because of the following informalities: in lines 1-2 should recite “wherein said milk protein is a non-human milk protein (hMP),”. Appropriate correction is required.
New Rejections
(necessitated by amendments)
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.
13. Claims 1-2, 4-5, 7-16, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 2016/0263212 A1, pub. 9/15/2016) in view of Belli et al. (EP94810352.8, pub. 12/21/1994) and Kong et al. (International Dairy Journal, 2020, 111:104841).
Friedman discloses a method for preventing sensitization to a food allergen in a subject in need thereof, the method comprising (See Friedman, pg. 5 [0179]): a. selecting a subject at a risk of developing sensitization to a milk protein (See Friedman pg. 5 [0181]); and b. orally administering to said subject a therapeutically effective amount of a composition comprising said milk protein (See Friedman, pg. 5 [0182]), wherein said administering commences when said subject being 28 days old at most (See Friedman pg. 13 [0393]), thereby preventing sensitization to a food allergen in the subject (See Friedman, pg. 5 [0189]).
Regarding claim 2, Friedman discloses wherein said composition is formulated in the form of drops (See Friedman pg. 12 [0386] lines 5-6) and wherein said selecting is based on said subject having familial history of anyone of: atopic dermatitis, food allergy, allergic rhinitis. (See Friedman pg. 1 [0005]).
Regarding claim 7, Friedman discloses said preventing comprises reducing the severity of sensitization to said food allergen in the subject (See Friedman pg. 1 [0002]).
Regarding claims 8-10, Friedman discloses said preventing comprises reducing the titer of IgE targeting said food allergen in said subject, reducing wheal size developed by said subject in a skin prick test (SPR), or both. (See Friedman pg. 2 [0016]).
Regarding claims 11-13, Friedman discloses said administering is multiple administering of the composition to the subject more than once including daily and once a week. (See Friedman, pg. 7 [0293] line 15- pg. 8 [0293] line 3).
Regarding claims 14-16 and 18, Friedman discloses said composition is a pharmaceutical composition (See Friedman, pg. 10 [0369]) or a nutraceutical composition including an additional biomedical active agent, which could be vitamin D (See Friedman pg. 2 [0015]).
Regarding claims 21-22, Friedman discloses said administering commences when said subject being 14 days old at most and 7 days old at most. (See Friedman, pg. 13 [0393]).
Friedman does not disclose the milk protein composition as comprising: (i) casein protein and whey protein in a weight per weight ratio (w/w) ranging from 55:45 (w/w) to 85:15 (w/w); and (ii) a polyol at a volume of at least 40% by volume of said composition. Friedman does not disclose the milk protein as being a non-human milk protein and more specifically, a cow’s milk protein or a cow’s milk formula.
Friedman does teach that the compositions for inducing tolerance can include the allergenic substance in a concentration of 0.05% to 99% w/w and can include a second active ingredient in a concentration of 0.05% to 99% w/w (See Friedman, pg. 11 [0370]) and can include a carrier, including polyethylene glycol (See Friedman, pg. 11 [0372]).
Belli teaches the use of cow’s milk protein in a cow’s milk formula to induce milk protein tolerance in children susceptible to milk allergy. (See Belli, abstract). Specifically, Belli teaches a composition comprising casein protein and whey protein in a 50:50 to 70:30 weight ratio, preferably 60:40. (See Belli, pg. 4 lines 20-23). Belli teaches that the milk protein formula can be administered in a nutritionally acceptable form. (See belli, pg. 6 lines 30-31.)
Belli does not teach the composition further comprises 40% polyol by volume.
Kong teaches the use of xylitol, a polyol or sugar alcohol, with cow casein and whey proteins are successful at stabilizing the proteins and increase solubility and emulsification. (See Kong, abstract). Kong also teaches making the formula in increasing concentrations including 33.3% and 50% by volume of the formula. (See Kong, pg. 2 Section 2.2). Kong also teaches that sugar alcohols, or polyols, are known to improve, stabilize, and protect the functional properties of proteins. (See Kong, pg. 2 column 1, paragraph 2).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective date to use the disclosed casein and whey protein formula of Belli with the teachings of Kong to produce the disclosed formula of the present claimed invention. It would have been obvious because Belli teaches a formula of cow casein and whey proteins and Kong teaches that polyols including in the concentration of 33.3% and 50% are able to improve, stabilize and protect the functional properties of cow milk proteins. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to develop a formula of casein to whey protein with 40% polyol as claimed using Belli and Kong with a reasonable expectation of success at producing a functional composition of milk allergens.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the method of Friedman with the cow milk protein composition of Belli and Kong to develop the method of the claimed invention. It would have been obvious because Belli discloses a composition for preventing milk allergy in susceptible children and Friedman teaches that the compositions for their method can be in similar concentrations and can include a polyol as its carrier. Therefore, it would have been obvious to a person of ordinary skill in the art to use the formula disclosed in Belli and Kong in the method of Friedman with a reasonable expectation of success at preventing milk allergy sensitization in an infant.
14. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 2016/026312 A1, pub. 9/15/2016) in view of Belli et al. (EP94810352.8, pub. 12/21/1994) and Kong et al. (International Dairy Journal, 2020, 111:104841) as applied to claims 1-2, 4-5, 7-16, 18, and 21-22 from above and in further view of Caubet (J. Allergy Clin Immunol., 2016, 139(2):572-583).
The limitations of claims 1-2, 4-5, 7-16, 18, and 21-22 are disclosed by Friedman, Belli, and Kong as discussed above.
Friedman, Belli, and Kong do not disclose the sensitization comprising food protein-induced enterocolitis syndrome (FPIES), immunoglobulin E (IgE)-mediated, Type 2, or both.
Caubet teaches that food protein-induced enterocolitis syndrome (FPIES) is an allergic disease caused by food proteins. Caubet also teaches that a common cause of FPIES is exposure to cow’s milk and soy proteins which can result in failure to thrive in young infants with chronic exposure. (See Caubet, pg. 573 column 1, paragraphs 1-2).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date to use the method of Friedman, Belli, and Kong to prevent the development of FPIES in a young infant deemed susceptible to the disorder. It would have been obvious because Caubet teaches that FPIES is an allergic disease caused by exposure to cow’s milk and the present claimed invention is a method of preventing milk protein allergies. Therefore, it would have been obvious to one of ordinary skill in the art to prevent sensitization to food allergens known to cause allergic disorders in young infants, such as FPIES, to prevent the development of further allergies later in life using the present claimed invention with a reasonable expectation of success.
15. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US 2016/026312 A1, pub. 9/15/2016) in view of Belli et al. (EP94810352.8, pub. 12/21/1994) and Kong et al. (International Dairy Journal, 2020, 111:104841) as applied to claims 1-2, 4-5, 7-16, 18, and 21-22 from above and in further view of Devonshire (Allergy Asthma Proc., 2019, 40:450-452).
The limitations of claims 1-2, 4-5, 7-16, 18, and 21-22 are disclosed by Friedman, Belli, and Kong as discussed above.
Friedman, Belli, and Kong do not disclose a method for preventing sensitization where the subject is fed strictly on human breast milk.
Devonshire teaches that exclusive breast-feeding of infants below six months is beneficial but still exposes them to food allergens through the mother’s diet. (See Devonshire pg. 1 “Maternal Diet, Breast-Feeding, and Prevention). Devonshire further teaches that infants exclusively breast fed are still susceptible to developing food allergens and should be introduced early to food allergens when indicated. (See Devonshire, pg. 1 “Early Allergenic Food Introduction”).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to apply the methods of Friedman, Belli, and Kong to exclusively breastfed infants because of the teachings of Devonshire for the present claimed invention. It would have been obvious because the development of food allergies early in life can lead to the development of more complex allergies and Devonshire teaches breast-feeding is beneficial but not completely protective against food allergies for the infant. Therefore, a person of ordinary skill in the art would have been motivated prior to the effective filing date to use the methodology of Friedman to prevent sensitization in infants fed strictly on human breast milk according to the teachings in Devonshire with a reasonable expectation of success.
Response to Arguments
16. Applicant argues that Friedman does not disclose the limitation of claim 1, “wherein said administration commences at 28 days old at most” or further in claim 21 “14 days old at most” or in claim 22 “7 days old at most”. Specifically, Applicant recites in Friedman paragraph [0393] the use of “a treatment regimen as described herein can begin when the infant is about 1, 2, 4, 6, 8, 10, 12, or 15 months old” and indicates that Friedman’s teachings are directed to infants several months old. (Response pg. 10).
17. Applicant’s arguments have been fully considered but they are not persuasive. Friedman teaches in [0393] that while there are preferred regimen treatments, any subject who has not been exposed to an allergen can begin treatment, even a newborn baby. This suggests that it would have been obvious to treat a newborn baby at 7 days old, at 14 days old, and at 28 days old at most.
First, Applicant incorrectly states that Friedman only generically references a newborn baby in [0016] (Response pg. 7 line 2) and commences with the youngest age being “about 1 month” in [0393] (Response pg. 7 line 9). However, Friedman in [0393] specifically states:
“Similarly, while the compositions of the invention are intended to be administered to very young individuals, individuals of any age can be treated as described herein, particularly if they have not be previously exposed to the allergen. For example, one can administer an allergen from insect venom ( e.g., bee venom) to an adult who has never been stung or bitten by the insect in question. Thus, in various embodiments, the individual can be a newborn baby, an infant up to 18 months old ( e.g., a treatment regimen as described herein can begin when the infant is about 1, 2, 4, 6, 8, 10, 12, or 15 months old), a child, adolescent, or adult (i.e., a person over 18 years old).”
As demonstrated by the second underlined passage [0393] clearly indicates treatment can commence with a newborn baby, meaning Friedman discloses the use of the treatment when the subject is 28 days old at most, 14 days old at most, and 7 days old at most.
Additionally, Applicant argues that “about 1 month” and 28 days are distinctly different times. This is not persuasive because about 1 month could be construed by those of ordinary skill in the art to be about 28 days. For example, in a typical year February comprise 28 days and is considered one month.
18. Conclusion: All Claims are rejected.
Conclusion
19. THIS ACTION IS MADE FINAL. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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, Samira Jean-Louis can be reached at 571-270-3503. 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.
/LINDSAY DUNN/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642
Prosecution Insights