DETAILED ACTION
The Examiner and Art Unit location of your application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Bridget Bunner, Group Art Unit 1647.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Application, Amendments and/or Claims
The amendment of 17 December 2025 has been entered in full. Claim 1 is amended. Claims 3, 5, 11, 12, 18, 22-27, 30-33, and 35-41 are cancelled.
Claims 1, 2, 4, 6-10, 13-17, 19-21, 28, 29, and 34 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 4, 6-10, 13-17, and 19-21, drawn to a method of treating a subject at risk of having anaphylaxis in the reply filed on 17 December 2025 is acknowledged.
Applicant’s election of an agent that inhibits RELMβ as the species of anti-anaphylaxis (therapeutic) agent is acknowledged. Applicant’s election of an antibody as the species of agent type is also acknowledged.
Claims 13, 19, 28, 29, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 December 2025.
Claims 1, 2, 4, 6-10, 14-17, 20, and 21 are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 19 August 2022 and 24 September 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
1. The drawings are objected to because in Figure 1, the text is illegible due to the gray shading in the boxes and small font. It is suggested that the Figure is updated to have (i) white boxes, rather than gray ones and (ii) larger font size. See 37 CFR 1.84(p)(3).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
2. Claims 1 and 21 are objected to because of the following informalities:
2a. In claim 1, line 4, the word “of” in the phrase “sample of obtained from the subject” is extraneous and should be deleted.
2b. Claim 21 recites the acronym “RELMβ” without first defining what it represents. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
3. Claims 1, 2, 4, 6-10, 14-17, and 20 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.
3a. Claims 1, 2, 4, 6-10, 14-17, and 20 are rejected as being indefinite because claim 1, subpart (b) recites the phrase “identifying a subject as being at risk for anaphylaxis if the level of (a) is greater…”. However, claim 1, subpart (a) is a method step (i.e., “receiving results”), not a level. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted that this issue could be overcome by amending claim 1, subpart (b) to recite, for example, “identifying a subject as being at risk for anaphylaxis if the level of RELMβ from step (a) is greater than a reference level”.
3b. Claim 9 is rejected as being indefinite because in lines 2-3, the claim recites “an expression vector encoding an inhibitory nucleic acid”. However, it is not clear how the vector encodes a nucleic acid sequence. A vector comprises a DNA (nucleic acid) sequence, just like the inhibitory nucleic acid of claim 9. A DNA sequence encodes a protein, not another nucleic acid sequence. (Please note that this issue could be overcome by amending claim 9 to recite, for example, “, comprising an inhibitory nucleic acid, or an expression vector encoding an inhibitory polypeptide”.)
3c. Claim 10 recites the limitation "antibody reagent" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. Claims 1, 2, and 9, from which claim 10 depends, do not recite an “antibody reagent”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 1, 2, 4, 6-10, 14-17, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions (abstract idea and law of nature) without significantly more.
Claim 1, for example, is directed to a method for treating a subject at risk of having anaphylaxis, the method comprising:
(a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject;
(b) identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level; and
(c) administering to the subject identified as being at risk for anaphylaxis an anti-anaphylaxis therapeutic, wherein the reference level is the RELMβ level in a healthy patient.
The claims recite a series of steps or acts, thus the claims are directed to a process, which is one of the statutory categories of invention (step 1 of the subject matter eligibility test in the 2019 Revised Patent Subject Matter Eligibility Guidance).
First, independent claim 1 recites the steps of “receiving the results of an assay that measures the level of RELMβ” and “identifying a subject as being at risk for anaphylaxis”. These limitations set forth a judicial exception (2019 Revised Eligibility Guidance, revised step 2A, Prong One: Yes) because the “receiving” and “identifying” steps can be performed using mental steps or basic thinking, representing an abstract idea (see Univ. of Utah Research Found v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014)).
Second, claim 1, subpart (b) also recites another judicial exception (revised step 2A, Prong One: yes) (“identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level”) because RELMβ expression levels in a subject at risk for anaphylaxis (and a healthy patient) are a consequence of natural processes, similar to the naturally occurring correlation found to be law of nature by the Supreme Court in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) (see also, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017);; Ariosa Diagnostics, Inc. v. Sequenom, 788 F.3d 1371, 1373, 115 USPQ2d 1152, 1153 (Fed. Cir. 2015)).
However, the claims do not recite any additional elements that integrate the judicial exceptions into a practical application (revised step 2A: Prong Two: No). It is noted that although claim 1 recites administering an anti-anaphylaxis therapeutic, this treatment step is not particular and is instead merely instructions to “apply” the judicial exception in a generic way. Thus, the treatment step does not integrate the mental analysis and naturally-occurring correlation into a practical application.
The claims also do not recite any additional elements/steps that do more than just describe the judicial exceptions with general instructions to apply the judicial exception. Overall, the claims do not integrate the abstract ideas and laws of nature into a practical application that impose a meaningful limit on the judicial exceptions (revised step 2A, Prong Two: No).
Lastly, each claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The instant claims do not include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exceptions (step 2B: No). For instance, claim 1 recites receiving results of an assay that measures the level of RELMβ in a biological sample. Measuring RELMβ in a sample is well-understood, routine and conventional activity for those in the field of diagnostics and is recited at a high level of generality such that it amounts to insignificant extra-solution activity. When recited at this level of generality, again, there is no meaningful limitation in these steps that distinguishes the claimed method from well-understood, routine and conventional data gathering activity engaged in by scientists prior to Applicant's invention at the time of filing. For example, the state of the art at the time of filing the instant application discloses assaying samples for RELMβ (Ahmed et al., Front Immunol 10: 445, 2019; Fang et al., Eur Respir J 39(2): 458-466, 2012; Mishra et al., Am J Physiol Lung Cell Mol Physiol 293: L305-L313, 2007; Neilson et al., Cancer Epidemiol 35: 485-489, 2011).
Therefore, the instant claims as a whole do not amount to significantly more than the exceptions themselves and do not qualify as eligible subject matter under 35 U.S.C. §101. See also Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Association for Molecular Pathology v. Myriad Genetics, 569 U.S. __, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) and www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility.
Claim Rejections - 35 USC § 112(a)
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.
5. Claims 2, 9, 10, 14, 15, 17, and 21 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 claim(s) contains 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.
Claim 1 of the instant application recites a method for treating a subject at risk of having anaphylaxis, the method comprising (a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject; (b) identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level; and (c) administering to the subject identified as being at risk for anaphylaxis an anti-anaphylaxis therapeutic, wherein the reference level is the RELMβ level in a healthy patient.
However, claim 2 recites that the anti-anaphylaxis therapeutic is an agent that inhibits RELMβ.
Instant claim 9 recites that the agent is selected from the group consisting of: a small molecule, a compound, an antibody, a peptide, and an expression vector encoding an inhibitory nucleic acid or polypeptide.
Claim 14 recites that the agent increases the population of RORγt+ regulatory T cells.
Claim 21 recites a method for treating or preventing the onset of anaphylaxis, inducing tolerance to an allergen, or reducing or eliminating a subject’s immune reaction to an allergen in the subject, the method comprising administering an agent that inhibits RELMβ to a subject.
The specification of the instant application teaches that RELMβ was initially described as a hormone that regulates responsiveness to insulin, but has subsequently found to also be involved in allergic inflammation and host defenses in the gut (page 21, [00116]). The specification discloses that methods and compositions described require that the levels and/or activity of RELMβ are inhibited (page 21, [00117]; page 23, [00124-00125]). The specification indicates that an agent that inhibits RELMβ is a small molecule, an antibody or antibody fragment, a peptide, an antisense oligonucleotide, a genome editing system, or an RNAi (page 23, [00123]; page 24, [00127-00129]; page 25, [00130-00133]; page 26, [00134-00138]; page 37, [00139-00144]; page 28, [00145-00147]). The instant specification teaches RELMβ deficient mice (pages 46-47, [00206, 00208]). However, the instant claims encompass administering an infinite number of agents that inhibit RELMβ. The general (non-specific) teachings in the specification of a small molecule, a compound, an antibody, a peptide, and an expression vector encoding an inhibitory nucleic acid or polypeptide are not adequate written description for an entire genus of compounds that agents that inhibit RELMβ.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). An adequate written description of a chemical invention "requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir. 2004); Regents of the Univ. of Cal. v. Eli Lilly & Co., Inc., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly, 119 F.3d at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. In addition, possession of a genus "may be achieved by means of a recitation of a representative number of [compounds]... falling within the scope of the genus." Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 F.3d at 927.
Thus, case law dictates that to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include actual reduction to practice, disclosure of drawings or structure chemical formulas, sufficient relevant identifying characteristics (such as, complete or partial structure, physical and/or chemical properties, and functional characteristics when coupled with a known or disclosed structure/function correlation), methods of making the claimed product, level of skill and knowledge in the art, predictability in the art, or any combination thereof. In the instant case, the only factors present in the claims for the administered agent are functional characteristics of inhibiting RELMβ and being an anti-anaphylaxis therapeutic. Although instant claim 9 recites that the agent is a small molecule, a compound, an antibody, a peptide, or an expression vector encoding an inhibitory nucleic acid or polypeptide, there is no identification of any particular sequence or structure of the agent, small molecule, compound, antibody, peptide, or expression vector that must be conserved in order to provide the required function of inhibiting RELMβ and being an anti-anaphylaxis therapeutic. Thus, the method claims are drawn to a genus of agents that inhibit RELMβ and are an anti-anaphylaxis therapeutic.
In this case, the specification fails to disclose and there is no art-recognized correlation between the structure of the genus of agents and the functions of inhibiting RELMβ and being an anti-anaphylaxis therapeutic. In other words, the specification does not teach the structure which results in an agent with the claimed required characteristics. The lack of description agents that inhibit RELMβ (including a small molecule, a compound, an antibody, a peptide, or an expression vector encoding an inhibitory nucleic acid or polypeptide) in the instant specification and the prior art indicates that instant claims 2, 9, 10, 14, 15, 17, and 21 contain subject matter which was not described in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Applicant is reminded that generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus (Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). A patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017) at page 1358). An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (See page 1117). See also, Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (See Vas-Cath at page 1116). A “mere wish or plan” to obtain the claimed invention is not sufficient (Centocor Orth Biotech, Inc. v. Abbott Labs, 636 F.3d 1341 (Fed. Cir. 2011); Regents of the Univ. of California, 119 F.3d at 1566). In the instant application, the skilled artisan cannot envision the detailed chemical structure of the genus of agents that inhibit RELMβ of the encompassed method claims, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The specific agent is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). See also Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010).
6. Claims 1, 2, 4, 6-10, 14-17, 20, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for (A) a method for treating a subject having anaphylaxis associated with a food allergy comprising (a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject; (b) identifying a subject as having anaphylaxis associated with a food allergy if the level of RELMβ is greater than a reference level; and (c) administering to the subject an anti-anaphylaxis therapeutic, wherein the reference level is the RELMβ level in a healthy patient, does not reasonably provide enablement for a method for treating a subject at risk of having anaphylaxis, the method comprising (a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject; (b) identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level; and (c) administering to the subject identified as being at risk for anaphylaxis an anti-anaphylaxis therapeutic.
The specification, while being enabling for (B) a method of reducing a subject’s immune response to an allergen in a subject comprising administering an inhibitor of RELMβ, does not reasonably provide enablement for a method for treating or preventing the onset of anaphylaxis, inducing tolerance to an allergen, or eliminating a subject’s immune reaction to an allergen comprising administering an inhibitor of RELMβ.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 1 of the instant application recites a method for treating a subject at risk of having anaphylaxis, the method comprising (a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject; (b) identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level; and (c) administering to the subject identified as being at risk for anaphylaxis an anti-anaphylaxis therapeutic, wherein the reference level is the RELMβ level in a healthy patient. Claim 21 recites a method for treating or preventing the onset of anaphylaxis, inducing tolerance to an allergen, or reducing or eliminating a subject’s immune reaction to an allergen in the subject, the method comprising administering an agent that inhibits RELMβ to a subject.
The specification of the instant application teaches that the invention is based on the finding that subjects having a food allergy (FA), but not asthmatics or non-allergic controls, have increased concentrations of RELMβ in their sera (page 2, [0006]). The specification discloses that RELMβ is increased in the sera and gut tissues of FA-prone IL4raF709 mice as compared to non FA-protein wild-type mice (page 2, [0006]). The instant specification also teaches that RELMβ-deficient IL4raF709 mice are protected from anaphylaxis when sensitized and orally challenged with food allergens (page 2, [0006]). The prior art of Rothenberg, M.E. (US 2004/0198686 or WO 2004/067026) discloses that the expression of RELMβ is induced in lungs of mice challenged with OVA and Aspergillus (page 5, [0056-0057]; Figures 1-2). Rothenberg teaches a method to mitigate an allergic response in a patient comprising administering a pharmaceutically acceptable formulation of a composition comprising an inhibitor of RELMβ, (page 8, claim 1; page 1, [0010]). The teachings of Rothenberg support one of the alternative methods of instant claim 21 of reducing a subject’s immune response to an allergen in a subject comprising administering an inhibitor of RELMβ.
Additionally, at page 6, the instant specification teaches that the terms “preventing” or “prevention” refers to any methodology where the disease state or disorder (e.g., an allergen, such as a food allergy or anaphylaxis) does not occur due to the actions of the methodology (such as, for example, administration of an anti-anaphylaxis agent, such as a RELMβ inhibitor) ([0037]). Thus, one interpretation of the term “preventing” by the Examiner is that an activity will not occur, i.e. onset of anaphylaxis will not occur. However, there are no methods or working examples in the specification that indicate prevention of onset of anaphylaxis by administration a RELMβ inhibitor, as required by instant claim 21.
Furthermore, there are no methods or working examples in the instant specification or prior art that treat a subject at risk of having any type of anaphylaxis, the method comprising (a) receiving the results of an assay that measures the level of Resistin-like beta (RELMβ) in a biological sample of obtained from the subject; (b) identifying a subject as being at risk for anaphylaxis if the level of (a) is greater than a reference level; and (c) administering to the subject identified as being at risk for anaphylaxis an anti-anaphylaxis therapeutic. There are also no methods or working examples in the instant specification or prior art that that indicate administration of an inhibitor of RELMβ treats or prevents the onset of anaphylaxis; induces tolerance to an allergen; or eliminates a subject’s immune reaction to an allergen.
Relevant literature teaches that anaphylaxis can occur as a consequence of immunological and non-immunological mechanisms (Arias-Cruz, A., Medicina Univers 17(68): 188-191, 2015; page 188, column 1, 3rd paragraph). Arias-Cruz also states that the common causes of anaphylaxis include medications, drugs, hymenoptera venoms, allergen immunotherapy, latex, occupational allergens, seminal fluid, aeroallergens, monoclonal antibodies, exercise, physical factors (cold, heat, radiation), ethanol, opioid medications, and contrast media (page 188, column 2). Arias-Cruz discloses that anaphylaxis is characterized by a varied clinical presentation and its manifestations include skin, respiratory, ocular, cardiovascular, and gastrointestinal symptoms (page 188, column 2). The examples in the instant specification only provide a nexus between increased levels of RELMβ and anaphylaxis associated with a food allergy. Undue experimentation would be required of the skilled artisan to determine the role and levels of RELMβ in anaphylaxis that occur as a consequence of other mechanisms, besides food allergy. A large quantity of experimentation would also be required of the skilled artisan to identify and administer an inhibitor of RELMβ to treat or prevent the onset of anaphylaxis; induce tolerance to an allergen; or eliminate a subject’s immune reaction to an allergen. Such experimentation is considered undue.
The skilled artisan would also not be able to predict that the RELMβ findings of the instant specification would extend to (i) anaphylaxis that occurs as a consequence of all possible mechanisms in all possible subjects at risk (other than those with food allergy) or (ii) treatment or prevention of the onset of anaphylaxis; inducement of tolerance to an allergen; or elimination a subject’s immune reaction to an allergen comprising administration of a RELMβ inhibitor. Specifically, the present invention is unpredictable and complex because allergic disorders are complex disorders that result from the interaction of multiple, genetic, epigenetic, and environmental influences (instant specification, page 43, [00197]). The instant specification continues to state that “though allergic disorders are defined by their shared IgE mediated mechanisms, their markedly diverse clinical manifestations suggest that additional and unique factors are involved in shaping their heterogeneous phenotypical expression” (page 43, [00197]). The courts have stated that patent protection is granted in return for an enabling disclosure, not for vague intimations of general ideas that may or may not be patentable. Tossing out the mere germ of an idea does not constitute an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genentech v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 (1997). Furthermore, Applicant is reminded that a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. See In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971); In re Soll, 97 F.2d 623, 634, 38 USPQ 189, 191 (CCPA 1938; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
Due to the large quantity of experimentation necessary to (i) determine the role and levels of RELMβ in anaphylaxis that occur as a consequence of other mechanisms, besides food allergy and (ii) identify and administer an inhibitor of RELMβ to treat or prevent the onset of anaphylaxis; induce tolerance to an allergen; or eliminate a subject’s immune reaction to an allergen;; the lack of direction/guidance presented in the specification regarding the same;; the absence of working examples directed to the same; the complex nature of the invention; the state of the art (see Arias-Cruz);; the unpredictability of (i) a nexus between RELMβ and anaphylaxis that occurs as a consequence of all possible mechanisms in all possible subjects at risk (other than those with food allergy) and (ii) treating or preventing of the onset of anaphylaxis; inducing tolerance to an allergen; or eliminating a subject’s immune reaction to an allergen comprising administration of a RELMβ inhibitor;; and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
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.
7. Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothenberg, M.E. (US 2004/0198686 or WO 2004/067026 (cited on the IDS of 24 September 2024)). It is noted that both disclosures of Rothenberg are identical, so for the sake of brevity, the disclosure of US 2004/0198686 is referenced in the rejection set forth below.
Rothenberg teaches a method of reducing an allergic response in patient by regulating expression of RELMβ (page 1, [0010]). Rothenberg discloses that the expression of RELMβ is induced in lungs of mice challenged with OVA and Aspergillus (page 5, [0056-0057]; Figures 1-2). Rothenberg teaches a method to mitigate an allergic response in a patient comprising administering a pharmaceutically acceptable formulation of a composition comprising an inhibitor of RELMβ (page 8, claim 1), meeting the limitations of instant claim 21.
Conclusion
No claims are allowable.
The art made of record and not relied upon is considered pertinent to applicant's disclosure:
LoVerde et al. Chest 153(2): 528-543, 2018 (review of anaphylaxis)
Pine et al. Cytokine 110: 442-451, 2018 (review of RELMs)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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BEB
Art Unit 1647
10 April 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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