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 .
Response to Amendment
The amendment to the claims on 3/09/2026 in response to the Non-Final Rejection of 12/12/2025 is acknowledged and 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Claim 47 is withdrawn from consideration as being drawn to a non-elected invention.
Nucleotide and/or Amino Acid Sequence Disclosures
The submission of the sequence listing on 3/09/2026 is acknowledged. However, the sequence listing has been deemed defective (see validation report of 3/09/2026) because there were errors that were identified by the USPTO during validation of the sequence listing. See reviewers comments.
Specification
The amendment to the specification is acknowledged. However, the disclosure is objected to because of the following informalities: Paragraphs 0319 and 0321 recites a nucleic acid sequence without a corresponding SEQ ID NO: which corresponds to the sequence listing filed on 3/09/2026.
Appropriate correction is required.
Rejections Withdrawn:
The rejection of Claim 55 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of cancelation of claim 55.
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 contend that while Florida discloses tyrosine compositions, Florida does not disclose that tyrosine or any of the listed compounds is an eosinophil antagonist. As such, Applicants contend that Florida does not disclose of suggest the treatment and/or prevention of an eosinophilic disease by administering a therapeutically effective amount of one or more eosinophil antagonists.
These arguments have been carefully considered, but are not found persuasive.
While the examiner acknowledges and does not disagree with Applicants contention that Florida does not specifically teach that tyrosine is a eosinophil antagonist or that 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 are eosinophil conditions, the Examiner recognizes that the specification appears to define them as such. Therefore, 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
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 that Roger uses tyrosine as an adjuvant with a modified allergen, not as a pharmaceutically active agent that antagonizes eosinophils. In particular, Applicants contend that the in the present invention the “eosinophil antagonist” is a free (soluble) amino acid administered as the active agent, not adsorbed, or conjugated to an allergen, that that the composition is allergen free.
These arguments have been carefully considered, but are found persuasive.
In the instant case, the Examiner acknowledges that Roger uses tyrosine as an adjuvant in combination with an allergen. However, the Examiner recognizes that the instant claims recite “comprising” therefore allow other agents to be administered in addition to the tyrosine. Moreover, regarding Applicants contention that the claims are limited to free (soluble) tyrosine, it is noted that the features upon which applicant relies (i.e., free (soluble) tyrosine) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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, in the interest of compact prosecution, repeats and incorporates by reference all prior remarks made concerning Florida. Additionally, Applicants assert that the Examiners reliance on the Florida reference still appears to be an exercise of impermissible “hindsight reconstruction”, which is proscribed.
These arguments have been carefully considered, but are not found persuasive.
Applicants previous remarks concerning Florida have been addressed above and incorporated herein. In response to applicant's 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).
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, in the interest of compact prosecution, repeats and incorporates by reference all prior remarks made concerning Florida. Additionally, Applicants assert that Miller whom is directed to standard asthma pharmacotherapy, is not directed to amino acid-mediated immunomodulation, and therefore, would not be considered on its own nor would it be reasonably combined with Florida.
These arguments have been carefully considered, but are not found persuasive.
Applicants previous remarks concerning Florida have been addressed above and incorporated herein. Regarding Applicants arguments directed at Miller, In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Florida teaches the use of tyrosine for treating a number of different disease including, but not limited to, asthma. Miller teaches that combination therapies for treating asthma. As such, 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. 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.
New Rejections Necessitated by Amendment:
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) 57 is 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.
Conclusion
Therefore, No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, 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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