DETAILED ACTION
Claims 1-2, 4-16, and 18-22 are currently pending and under examination in this 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 .
Priority
The present application claims benefit from PCT/IL2022/050143 and provisional applications 63/144,592. The prior application were reviewed and claimed subject matter was determined to be properly supported by the above applications. Therefore, priority and the effective filing date of 2/2/2021 have been granted to the present application.
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 1-2, 4-16, 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the specification does not support the claimed subject matter of the “subject being 28 days old at most.
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. (MPEP 2163(I)(A)). Claims 1 and 4 recite that the subject is 28 days old at most, with claim 21 further limiting that to 14 days old at most, and claim 22 limiting it to 7 days old at most. The specification describes subject for the study as being recruited at 4-11 months old (See pg. 17 [0139]). Further, the specification indicates results of the study indicated that introduction of allergens prior to 3 months of age resulted in significant prevention. (See pg. 17 [0139]). The specification fails to support the claimed limitation of the subject being 28 days at most at the time of administration or any time prior to that. Therefore, claims 1, 4, 21-22 lack adequate written description.
Claims 2, 5-16, 18-20 are rejected on the basis of dependency of above claims and their failure to provide subject matter that would overcome the written description rejection.
Claims 2 and 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Specifically, the subject matter that is not enabled is the composition is formulated in the form of drops. Without undue experimentation a person of ordinary skill in the art would not be enabled to formulate “drops” for preventing sensitization as claimed in the present invention.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to the rejection of the present claims are the breadth of the claims, the nature of the invention, the state of the prior art, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In regards to the breadth of the claims and the nature of the invention, the claims are too broad to enable one of ordinary skill in the art to make or use the invention without undue experimentation. Applying the broadest reasonable interpretation, the claim limitation, “composition is formulated in the form of drops” could be interpreted as any liquid preparation of known food allergens intended to be administered in small doses as being able to prevent sensitization. The nature of the art would indicate that there needs to be a specific formulation given to a subject to elicit the desired response but not enough to cause a hypersensitive reaction. As claimed “drops” fails to adequately enable a person of ordinary skill in the art to successfully prevent sensitization of food allergens.
Regarding the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of the experimentation needed to make or use the invention based on the content of the disclosure, the specification provides evidence that the formulation requires more than a liquid preparation or “drops” to enable a person of ordinary skill in the art to make or use the claimed invention. The specification provides 13 different formulations of working examples to make the claimed invention. (See Table 1 pg. 17-19). Additionally, the specification cites the inventors as finding formulations 5A and 5G to be satisfactory. (See pg. 19, [0143]). This implies that the other formulations are not satisfactory and that there are specific requirements to make a “drop” satisfactory and successful at preventing sensitization. Therefore, one of ordinary skill in the art would not be enabled to make or use the claimed invention based off the limitation of a “drop.”
To overcome this rejection, it is suggested the applicant re-write claims 2 and 4 incorporating a formula using the formulations disclosed in the specification.
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.
Claim 2 is 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, claim 2 recites, “wherein said composition is formulated in the form of drops, and optionally wherein said selecting…” The phrase “and optionally wherein” is indefinite because it is ambiguous as to whether the limitation is an alternative or required.
Additionally, the use of the word “optionally” makes the criteria for selecting a subject for treatment indefinite. Claim 1, which claim 2 is dependent on, lists the limitation of “selecting a subject at a risk for developing sensitization to a food allergen;” The criteria further defines the subjects at risk. However, if left as an option it fails to further define which subjects are at risk making the limitation in claim 1 indefinite.
To overcome this rejection, it is suggested applicant re-write “and optionally wherein” to “and wherein.”
Further 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.”
Claims 8-10 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.
Specifically, claims 8-10 recite reducing the titer of IgE and reducing wheal size from skin prick tests. Claims 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.
Claims 11-13 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.
Specifically, the phrase “multiple administering” is indefinite. This phrase is indefinite because it is not clear whether applicant is referring to multiple administrations of the same formula, multiple administrations of different formulas at the same time, or multiple administration of different formulas at different times.
To overcome this rejection, it is suggested that applicant re-write claims 11-13 to clearly define what is meant by “multiple administering.” As it is written, the examiner has interpreted “multiple administering” to mean multiple administrations of the same formula at different times.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7-16, 18-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Friedman (U.S. Patent Publication 2016/0263212 A1).
In regards to claims 1, Friedman discloses a method for preventing sensitization to a food allergen in a subject in need thereof, the method comprising (See Friedman, claim 153): a. selecting a subject at a risk of developing sensitization to a food allergen (See Friedman claim 153(a)); and b. orally administering to said subject a therapeutically effective amount of a composition comprising said food allergen (See Friedman claim 153(b)), 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 claim 153(c)).
In regards to claim 2, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses wherein said composition is formulated in the form of drops (See Friedman pg. 12 [0386] lines 5-6) and optionally wherein said selecting is based on at least one criterion selected from the group consisting of: parent of said subject planning to exclusively breastfeed said subject, said subject having familial history of anyone of: atopic dermatitis, food allergy, allergic rhinitis, asthma, eosinophilic esophagitis, and any combination thereof, said subject being characterized by having an above-average/over a predetermined threshold of transepidermal water loss (TEWL) value, and any combination thereof (See Friedman pg. 1 [0005]).
In regards to claim 4, Friedman discloses a method for preventing sensitization to a food allergen in a subject in need thereof (See Friedman claim 153), the method comprising orally administering to said subject a therapeutically effective amount of a composition comprising said food allergen (See Friedman claim 153(b)), wherein said composition is formulated in the form of drops (See Friedman pg. 2 [0012]), and 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 claim 153(c)).
In regards to claim 5, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses wherein said food allergen is selected from the group consisting of: non-human milk protein (hMP), egg protein, peanut, sesame, shellfish, fish, soy, grains, a tree nut, and any combination thereof, and optionally wherein any one of: said non-hMP comprises a cow milk protein (CMP), and said non-hMP comprises cow milk formula (CMF) (See Friedman claim 146).
In regards to claim 7, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses said preventing comprises reducing the severity of sensitization to said food allergen in the subject (See Friedman pg. 1 [0002]).
In regards to claim 8, the limitations of claim 1 are disclosed as discussed above. Friedman further 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]).
In regards to claim 9, the limitations of claim 1 and 8 are disclosed as discussed above. Friedman further discloses said reducing comprises reducing said titer of IgE by at least 5% compared to a control subject (See Friedman pg. 2 [0016] lines 22-24).
In regards to claim 10, the limitations of claim 1 and 8 are disclosed as discussed above. Friedman further discloses said reducing comprises reducing said wheal size to 1 mm at most (See Friedman pg. 2 [0016]).
In regards to claim 11, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses said administering is multiple administering (See Friedman, pg. 2 [0016]).
In regards to claim 12, the limitations of claims 1 and 11 are disclosed as discussed above. Friedman further discloses said multiple administering comprises daily administering (See Friedman, pg. 8 [0293]).
In regards to claim 13, the limitations of claims 1 and 11 are disclosed as discussed above. Friedman further discloses said multiple administering comprises at least once a week administering (See Friedman, pg. 7 [0293]).
In regards to claim 14, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses said composition is a pharmaceutical composition (See Friedman, pg. 10 [0369]) or a nutraceutical composition (See Friedman pg. 2 [0015]).
In regards to claim 15, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses said composition further comprises an additional biomedical active agent (See Friedman, pg.2 [0009]).
In regards to claim 16, the limitations of claims 1 and 15 are disclosed as discussed above. Friedman further discloses said additional biomedical active agent is selected from the group consisting of: a mineral, a vitamin, probiotics, and any combination thereof, and optionally wherein said mineral comprises iron (See Friedman, pg. 2 [0009]).
In regards to claim 18, the limitations of claims 1 and 16 are disclosed as discussed above. Friedman further discloses said vitamin comprises vitamin D, vitamin B 12, or any combination thereof (See Friedman, pg. 2 [0009]).
In regards to claim 19, the limitations of claim 1 are disclosed as discussed above. Friedman further discloses said food allergen is a non-hMP (See Friedman, claim 146(A)(vi)).
In regards to claim 21, the limitations of claims 1 and 19 are disclosed as discussed above. Friedman further discloses said administering commences when said subject being 14 days old at most (See Friedman, pg. 13 [0393]).
In regards to claim 22, the limitations of claims 1 and 19 are disclosed as discussed above. Friedman further discloses said administering commences when said subject being 7 days old at most (See Friedman, pg. 13 [0393]).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman (U.S. Patent Publication 2016/0263212 A1) in view of Caubet (J. Allergy Clin Immunol., 2016, 139(2):572-583).
The limitations of claim 1 are disclosed as discussed above. Freidman does 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).
A person of ordinary skill in the art would have been motivated prior to the effective filing date to use the method of Friedman to prevent the development of FPIES in a young infant deemed susceptible to the disorder. Allergies that develop early in life can lead to more complex allergies later in life (See pg. 1, [003]). 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. Therefore, it would be obvious to a person of ordinary skill in the art to combine the teachings of Caubet with a reasonable expectation of success to use the method of Friedman to prevent FPIES allergic reactions in young infants as disclosed in the current invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman (U.S. Patent Publication 2016/0263212 A1) in view of Devonshire (Allergy Asthma Proc., 2019, 40:450-452).
The limitations of claim 1 are disclosed as discussed above. Freidman does not disclose 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 obvious for a person of ordinary skill in the art prior to the effective filing date to use the methos of Friedman to breastfed infants because of the teachings of Devonshire. The development of food allergies early in life can lead to the development of more complex allergies. (See pg. 1, [003]). As discussed in Devonshire, 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.
Conclusion
In Summary, claims 1-2. 4-16, and 18-22 are all rejected.
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.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642