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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/30/2026 has been entered.
Claims 1-3, 5-7, 27, 47-53 and 57 are currently pending.
Claims 1-3, 5-7, 27, 48-53 and 57 are currently under consideration.
Claim 47 is withdrawn from consideration as being drawn to a non-elected invention.
Response to Amendment
The declaration by Benjamin John Marsland, a co-inventor of the US Patent application, under 37 CFR 1.132 filed on 6/30/2026 is insufficient to overcome the rejection of the claims as being anticipated by University of Florida Research Foundation or Roger et al. as set forth in the last Office action for the following reasons:
The Declarant provides their opinion that the use of a compound or composition in one biological or therapeutic context does not mean that the same compound would necessarily be expected to provide therapeutic benefit in a different disease context, particularly where the claimed effect involves modulation of eosinophil associated biology. For example, the Declarant opines that the Florida reference does not expressly disclose a method of treating and/or preventing an eosinophilic disease or disorder in a subject. In particular, the Declarant asserts that the Florida reference does not identify eosinophilic diseases or disorders as a therapeutic target, does not describe relevant clinical or preclinical data in such a disease, and does not explain a mechanism by which the disclosed compositions would be expected to provide the therapeutic effects now claimed. Similarly, the Declarant opines that the Rogers et al. reference does not expressly disclose a method of treating and/or preventing an eosinophilic disease or disorder in a subject. Specifically, the Declarant contends that the formulation described by Rogers is a tyrosine-adsorbed modified allergen product in which L-tyrosine is used as a depot adjuvant for an allergen. Thus, the Declarant contends that this is technically and functionally different from the claimed invention in which the amino acid is used as a free, soluble active agent in an allergen-free composition.
In response to the Declarants opinions, the Examiner recognizes that “Although factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962) (see MPEP 716.01(c)). Regarding the Declarants opinion on the Florida reference, the Examiner recognizes that Florida teaches compositions comprising tyrosine or consisting essentially of tyrosine; and further method of treating a condition comprising administering said composition, wherein the condition includes, but is not limited to, skin conditions such as dermatitis and atopic dermatitis, lung disorder such as asthma, improving mucosal barrier function, treating injury to GI mucosa, allergy and/or eosinophilic gastroenteritis. These conditions are taught within the specification and/or claimed as being eosinophilic diseases or disorders. Accordingly, the same compound appears to be administered to the same patient population or patient population encompassed by the claims. Applicants are reminded that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). (see MPEP 2112). Regarding the Declarants opinion on Rogers, the examiner would like to first point out that the instant claims are drawn to a method “comprising” administering. In the instant case, the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As such, the claims do not exclude the administration of L-tyrosine as a depot adjuvant for an allergen. Note: The instant claims do not specifically recite “free” amino acid.
Rejections Maintained:
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3, 5, 7, 27, 48 and 52-53 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by University of Florida Research Foundation, Incorporated (WO2018/067717A1, 2018-04-12, IDS) referred to herein as Florida.
Florida teaches compositions comprising tyrosine or consisting essentially of tyrosine (paragraphs 0016, 0122, 0014, 0130, claim 22). Moreover, Florida teaches a method of treating a condition comprising administering said composition, wherein the condition includes, but is not limited to, skin conditions such as dermatitis and atopic dermatitis, lung disorder such as asthma, improving mucosal barrier function, treating injury to GI mucosa, allergy and/or eosinophilic gastroenteritis (paragraphs 0023, 0026, 0030, claims 2-3, 5-7 and 9). Florida further teaches that the compositions are administered via oral, intravenous, intra-arterial, subcutaneous, intra-peritoneal, intra-muscular, intranasal, subcutaneous, topical or rectal, wherein the compositions comprise excipients, adjuvants, flavoring agents and other additives (paragraphs 0184-0185, 0191, 0203).
Thus, while the prior art does not specifically teach that the results as described in claim 7, the burden is on applicant to show that administration of the composition taught by Florida. which comprises L-tyrosine to the same patient population would not also produce the results as claimed in claim 7. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01
Lastly, regarding claim 48, the specification teaches that L-tyrosine is converted to L-DOPA (paragraph 0118). As such, the limitation of claim 48 appears to be met.
In response to this rejection, Applicants refer to and incorporates by reference the opinions of the Declarant which have been carefully considered, but are not found persuasive for the reasons set forth above.
Claim(s) 1-3, 5-7, 27 and 48-53 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roger et al. (Immunity, Inflammation and Disease 2014; 2(2): 92-98).
Roger et al. teach a method of treating perennial mite allergy comprising in a patient with persistent allergic rhinitis comprising administering under a conventional and clustered dosing schedule a tyrosine-absorbed, modified allergen product referred to as Acarovac Plus (Abstract). With regards to Acarovac Plus, Roger et al. teach that Acarovac Plus comprises extracts of Dermatophagoides pteronyssinus modified through treatment with glutaraldehyde and combined with L-tyrosine (page 93, 1st column, 2nd full paragraph). With regards to the conventional regimen, Roger et al. teach that the conventional regimen consists of administration of the vaccine in increasing doses at an interval of 1 week with a total duration of 3 weeks (page 94, 1st column, 1st full paragraph). With regards to the cluster regimen, Roger et al. teach that cluster regimen administers the vaccine more than one dose a day starting with a 1st injection followed 30 mins later with a second dose once per week for 4 weeks (page 94, 1st column, 2nd full paragraph). Thus, while the prior art does not specifically teach that the results as described in claim 7, the burden is on applicant to show that administration of the composition taught by Roger et al. which comprises L-tyrosine to the same patient population would not also produce the results as claimed in claim 7. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Regarding the limitation of claim 51, administration of the allergen is considered to be the additional therapy for treating the allergy.
Lastly, regarding claim 48, the specification teaches that L-tyrosine is converted to L-DOPA (paragraph 0118). As such, the limitation of claim 48 appears to be met.
In response to this rejection, Applicants refer to and incorporates by reference the opinions of the Declarant which have been carefully considered, but are not found persuasive for the reasons set forth above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 49-50 remain rejected under 35 U.S.C. 103 as being unpatentable over University of Florida Research Foundation, Incorporated (WO2018/067717A1, 2018-04-12, IDS), as applied above to claims 1-3, 5, 7, 27, 48 and 52-53.
As set forth above, Florida teaches compositions comprising tyrosine or consisting essentially of tyrosine (paragraphs 0016, 0122, 0014, 0130, claim 22). Moreover, Florida teaches a method of treating a condition comprising administering said composition, wherein the condition includes, but is not limited to, skin conditions such as dermatitis and atopic dermatitis, lung disorder such as asthma, improving mucosal barrier function, treating injury to GI mucosa, allergy and/or eosinophilic gastroenteritis (paragraphs 0023, 0026, 0030, claims 2-3, 5-7 and 9). Florida further teaches that the compositions are administered via oral, intravenous, intra-arterial, subcutaneous, intra-peritoneal, intra-muscular, intranasal, subcutaneous, topical or rectal, wherein the compositions comprise excipients, adjuvants, flavoring agents and other additives (paragraphs 0184-0185, 0191, 0203).
Florida does not specifically teach that the composition was administered in two or more doses or that the composition is administered daily, weekly, biweekly, bimonthly, or quarterly.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the number of doses and timing of the administration of the composition taught by Florida. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Please note: The specification does not appear to set forth a criticality in number of doses and/or the timing of administration of the composition.
In response to this rejection, Applicants refer to and incorporates by reference the opinions of the Declarant which have been carefully considered, but are not found persuasive for the reasons set forth above.
Claim(s) 51 remains rejected under 35 U.S.C. 103 as being unpatentable over University of Florida Research Foundation, Incorporated (WO2018/067717A1, 2018-04-12, IDS), as applied above to claims 1-3, 5, 7, 27, 48 and 52-53, in view of Miller-Larsson A, Selroos O (Curr Pharm Des 2006; 12(25):3261-79) referred to herein as Miller.
As set forth above, Florida teaches compositions comprising tyrosine or consisting essentially of tyrosine (paragraphs 0016, 0122, 0014, 0130, claim 22). Moreover, Florida teaches a method of treating a condition comprising administering said composition, wherein the condition includes, but is not limited to, skin conditions such as dermatitis and atopic dermatitis, lung disorder such as asthma, improving mucosal barrier function, treating injury to GI mucosa, allergy and/or eosinophilic gastroenteritis (paragraphs 0023, 0026, 0030, claims 2-3, 5-7 and 9). Florida further teaches that the compositions are administered via oral, intravenous, intra-arterial, subcutaneous, intra-peritoneal, intra-muscular, intranasal, subcutaneous, topical or rectal, wherein the compositions comprise excipients, adjuvants, flavoring agents and other additives (paragraphs 0184-0185, 0191, 0203).
Florida does not specifically teach that the composition is administered in combination with another therapeutic agent.
Miller teaches that asthma treatment guidelines advocate the use of long-acting beta2 agonist in addition to inhaled corticosteroids in patients whose asthma is uncontrolled by ICS alone, wherein clinical studies suggest additive and potentially synergistic effects when the agents are used in combination (abstract)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Florida to include another therapeutic agent for treating, for example, asthma in view of the teachings of Miller. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Miller teaches that clinical trials suggests an additive or potentially a synergistic effect when two agents are used in combination for treating asthma.
Moreover, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) see MPEP 2144.06.
In response to this rejection, Applicants refer to and incorporates by reference the opinions of the Declarant which have been carefully considered, but are not found persuasive for the reasons set forth above.
Claim(s) 57 remains rejected under 35 U.S.C. 103 as being unpatentable over University of Florida Research Foundation, Incorporated (WO2018/067717A1, 2018-04-12, IDS), as applied above to claims 1-3, 5, 7, 27, 48 and 52-53, in view of Dwight, Matthews (Journal of Nutrition 2007; 137(6): 1549S-1555S).
As set forth above, Florida teaches compositions comprising tyrosine or consisting essentially of tyrosine (paragraphs 0016, 0122, 0014, 0130, claim 22). Moreover, Florida teaches a method of treating a condition comprising administering said composition, wherein the condition includes, but is not limited to, skin conditions such as dermatitis and atopic dermatitis, lung disorder such as asthma, improving mucosal barrier function, treating injury to GI mucosa, allergy and/or eosinophilic gastroenteritis (paragraphs 0023, 0026, 0030, claims 2-3, 5-7 and 9). Florida further teaches that the compositions are administered via oral, intravenous, intra-arterial, subcutaneous, intra-peritoneal, intra-muscular, intranasal, subcutaneous, topical or rectal, wherein the compositions comprise excipients, adjuvants, flavoring agents and other additives (paragraphs 0184-0185, 0191, 0203).
Florida does not specifically teach that the composition comprises L-phenylalanine instead of tyrosine.
Dwight, Matthews teach that prior to the 1940’s, there was only circumstantial evidence that tyrosine was produced from phenylalanine. However, Dwight, Matthews teach that a study in 1940 provided the evidence demonstrating that phenylalanine was metabolized to tyrosine and that phenylalanine can substitute for tyrosine in the diet (page 1550S, 1st column, paragraph bridging page 1549S).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Florida to substitute tyrosine with phenylalanine in view of the teachings of Miller. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Dwight, Matthews teach that phenylalanine is metabolized to tyrosine and that phenylalanine can substitute for tyrosine in the diet.
In response to this rejection, Applicants refer to and incorporates by reference the opinions of the Declarant which have been carefully considered, but are not found persuasive for the reasons set forth above.
Conclusion
Therefore, No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baldrick et al. (J. Applied Toxicology 2002; 22 (5): 333-344).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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