DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/09/2026 has been entered.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
3. Applicant’s amendments and remarks, filed 06/09/2026, are acknowledged. Claim 297 is cancelled. Claim 34 is amended. As such, claims 34-35, 295-296 and 298-303 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
Maintained Rejections
Claim Rejections - 35 USC § 102/103
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 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.
(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.
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.
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.
4. Claims 34-35, 295-296 and 298-303 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Sun, et al. 2006 (US 2006/0115494)
This rejection is maintained for reasons of record (pp. 4-5, Office action mailed 11 March 2026) and for the reasons discussed below. For convenience, the rejection is repeated herein, modified slightly to address the new and amended claims’ limitations:
Sun teaches therapeutic treatment methods comprising intradermal administration of compositions comprising BCG to human patients (e.g. [0071, 0077]; meeting limitations found in instant claims 34, 295, and 296). Sun teaches compositions of BCG with a pharmaceutically acceptable carrier (i.e. sole therapeutic agent; e.g. [0092]; meeting limitations found in instant claim 34) at preferable doses of 105 to 109 organisms (e.g. [0091]; meeting limitations found in instant claims 298, 299, and 300 with sufficient specificity; see MPEP 2131.03). Sun teaches the use of priming and booster doses (e.g. [0090]; meeting limitations found in instant claim 301).
With regards to the preamble of “A method of treating an allergy in a subject in need thereof…” in claim 34 and the types of allergies in claim 35; it is noted that MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated; emphasis added; see In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) "While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).
Therefore, Sun anticipates the invention as claimed.
Applicant’s Arguments
Applicant’s arguments (page 4-5, remarks received 06/09/2026) have been fully considered but are not found to be persuasive for the following reasons. Applicant argues that claim 34 is amended to recite BCG as the sole therapeutic agent administering to the subject. Applicant argues that the treatment does not explicitly teach treatment of an allergy. Applicant argues that Sun cannot inherently anticipate the claimed method, as Sun fails to mention administration of BCG to any patient with an allergy.
Response to arguments
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons. Sun expressly discloses each step recited in the body of claim 34: intradermally administering to a human patient a composition comprising BCG (paragraph 71 and 77), wherein BCG is the sole therapeutic agent administered (paragraph 92). Applicant does not dispute that Sun discloses these steps. Applicant further argues that the claims require administration of BCG to a subject known to have an allergy and in need of treatment thereof, and that this constates an express limitation rather than an intended result. The body of claim 34, as amended, recites a single manipulative step, namely intradermally administering a composition comprising BCG to the subject. The claim recites no step of diagnosing an allergy, n step of identifying or selecting an allergic subject and no step of determining that the subject is in need of allergy treatment. The phrase “in a subject in need thereof” appears in the preamble, and the phrase “for the treatment of the allergy” states the purpose for which the sole recited administration step is performed. MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated; emphasis added; see In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use.
Additionally, applicant argues that Sun is directed to a Myobacterium genetically engineered to express a non-secreted SOD and directed solely to the treatment of cancers. The phrase “comprising” is open and does not exclude additional components or modification and a genetically modified BCG strain remains a BCG strain. See. MPEP 2111.03. Accordingly, the rejects of claims 34-35, 295-296 and 298-301 under 35 U.S.C. 102(a)(1) is maintained.
5. Claims 34-35, 295-296 and 298-303 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bottomly et al. 2000 (WO 2000/61157).
This rejection is maintained for reasons of record (page 5, Office action mailed 11 March 2026) and for the reasons discussed below. For convenience, the rejection is repeated herein, modified slightly to address the new and amended claims’ limitations:
Bottomly teaches methods of treating allergies comprising intradermal administration of therapeutically effective amounts of compositions comprising BCG to human patients (e.g. see pages 6, 8, 12, and 31; and Bottomly claims 1, 2, 7, 66, 104; meeting limitations found in instant claims 34, 295, and 296). Bottomly teaches the allergies include those to pollen, food, and/or drugs (e.g. see page 12; meeting limitations found in instant claim 35). Bottomly teaches therapy takes several rounds of vaccination over 3 to 5 years or more and includes booster immunizations (e.g. see pages 12 and 26; meeting limitations found in instant claims 301, 302 and 303 with sufficient specificity). Bottomly teaches their compositions may be utilized alone or in combination and with typical doses of 1 x 106 cells per injection (e.g. see page 26; meeting limitations found in instant claims 34, 298, 299, and 300 with sufficient specificity; see MPEP 2131.03).
Therefore, Bottomly anticipates the invention as claimed.
Applicant’s Arguments
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons. Applicant argues that Bottomly describes administering an inducing agent such as BCG “concurrently with exposure to an antigen an/or a T cell” and therefore fails to teach BCG as the sole therapeutic agent.
Response to arguments
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons. The instant claim 34 is drawn to a method of treating an allergy in subject in need thereof comprising intradermally administering a composition comprising BCG as the sole therapeutic agent administered for the treatment of an allergy. Applicant argues that Bottomly does not teach BCG as the sole therapeutic, however, Bottomly expressly teaches at page 26 that the disclosed compositions may be utilized alone or in combination. Thus, Bottomly discloses administrations of the BCG composition without a second agent. Bottomly therefore discloses each and every limitation of the claim method and the rejection of claims 34-35, 295-296 and 298-303 under 35 U.S.C. 102(a)(1) is maintained.
New Objection/Rejections
Specification
6. The use of the terms such as TICE (page 21), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant should review the specification for other trademarks and correction is required.
Claims Rejections
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.
7. Claims 34-35, 295-296 and 298-303 is 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 34-35, 295-296 and 298-303 are drawn a method of treating an allergy in a subject in need thereof comprising intradermally administering a composition comprising Bacillus Calmette-Guerin (BCG) to said subject, wherein said BCG is the sole therapeutic agent administered to said subject for the treatment of the allergy.
The specification teaches "allergy" refer to consisting of food allergy, seasonal allergy, pet allergy, hives, hay fever, allergic conjunctivitis, poison ivy allergy oak allergy, mold allergy, drug allergy, dust allergy, cosmetic allergy, and chemical allergy (page 5).
The claims are drawn to treating any and allergies with BCG, however, the specification has failed to demonstrate an allergy to be treated with BCG as the specification only teaches these examples: administration of BCG promotes sustained decrease in serum lipids, administration of BCG restores healthy levels of N-acetylated amino acids and methylated metabolites, diagnosing a patient presenting with or prone to elevated cholesterol as likely to respond to BCG therapy, determining the likelihood that a patient presenting with elevated cholesterol would benefit from additional doses of BCG, administering BCG to a subject in order to treat an immunological disorder, diagnosing a subject as having a disease by assessing the level of a biomarker and treating the subject by administering BCG, case study of the effect of BCG on human serum lipid levels, administering BCG to a subject prone to the onset of hypercholesteremia in order to prevent the development of elevated serum cholesterol levels, administrations of BCG induces a shift from oxidative phosphorylation to aerobic glycolysis, and BCG therapy can treat hyperglycemia in any disease state, regardless of the underlying etiology. The specification has not demonstrated the treatment of all allergies comprising administering BCG in any of the working examples. Applicant does not have written description for treatment of any allergies and does not teach the genus of the allergies claimed.
A method of treating an allergy in a subject comprising administering BCG does not meet the written description provision of 35 U.S.C. 112, first paragraph. The claims broadly encompass treating all allergies using the aforementioned method. The claims broadly encompass the use of BCG with all allergies; however, the specification does not demonstrate that the BCG has the function of treating all allergies. Therefore, the method has no correlation with its function. The specification is not deemed sufficient to reasonably convey to one skilled in the art that the inventors, at the time the invention was made, had possession of a method of treating all allergies with the claimed method because the genus encompasses conditions which differ from those disclosed in etiologies, molecular mechanisms, diagnostic approaches, treatment modalities, and therapeutic endpoints. Furthermore, the recited genus encompasses conditions yet to be discovered and/or characterized; therefore, the skilled artisan cannot envision preventing all the contemplated diseases encompassed by the instant claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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.) 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.)
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Regarding the vast genus of allergies encompassed by the claims, while the state of the art is relatively high with regard to the treatment of specific allergy types, the state of the art with regards to treating all allergies with a single treatment is underdeveloped. In particular, there is no known combination of allergy agent that is effective against all allergy types. The allergy treatment art involves a very high level of unpredictability. Akdis 2012 (Akdis, C. Therapies for allergic inflammation: refining strategies to induce tolerance. Nat Med 18, 736–749 (2012). https://doi.org/10.1038/nm.2754) teach that current therapies of asthma and allergic disease are relatively safe and effective at controlling symptoms but do not alter the chronic course of the disease. Akdis further teaches that no established method of prevent asthma and allergy existed as of publication and the control of severe forms of these conditions and the development of curative therapies remained major unmet clinical needs. Akdis identifies allergy specific immunotherapy and biological immune modifies as two distinct therapeutic strategies under development, each addressing different aspects of allergic disease, and contemplates their combination to address needs that neither approach satisfies alone.
Akdis 2014 (Akdis M, Akdis C; Mechanisms of allergen-specific immunotherapy: Multiple suppressor factors at work in immune tolerance to allergens Journal of Allergy and Clinical Immunology, 133, 621-631) teach that allergic disease are complex disordered comprising several disease variant caused by different underlying cellular and molecular mechanisms, and that the clinically relevant phenotypes of rhinitis, asthma, atopic dermatitis, and urticaria do not necessarily provide insight into the pathomechanisms that underpin those diseases. Akdis further teaches that the physiology of allergic disease is influenced by many factors, including genetic susceptibility, route of exposure, allergen dose, time of exposure, the structural characteristics of the allergen and exposure with stimulators of the innate immune response. Akdis teaches that multiple distinct mechanisms of immune regulation operate depending on the type, place, intensity, and chronicity of the immune response, and that the identification of biomarkers predictive of clinical response remains an unmet need.
Arnoldussen (Arnoldussen DL, Linehan M, Sheikh A. BCG vaccination and allergy: a systematic review and meta-analysis. J Allergy Clin Immunol. 2011 Jan;127(1):246-53, 253.e1-21. doi: 10.1016/j.jaci.2010.07.039. Epub 2010 Oct 8. PMID: 20933258.) teaches that conflicting evidence existed in the art as to whether BCG vaccination represents an effective strategy against allergic sensitization and disease. Arnoldussen reports metanalyses across 17 studies showing no protective effect of BCG vaccination against the risk of sensitization as judged by IgE testing or by skin prick testing, no protective effect against atopic eczema or dermatitis, and no protective effect against allergic rhinoconjuctivitis. Arnoldussen teaches that the single apparent associated with reduced asthma ick may be explained by publication bias and concluded that BCG vaccination is unlikely to be associated with protection against allergic sensitization and disease, and that any real asthma effect is unlikely to be related to atopic mechanisms.
Linehan (Linehan MF, Nurmatov U, Frank TL, Niven RM, Baxter DN, Sheikh A. Does BCG vaccination protect against childhood asthma? Final results from the Manchester Community Asthma Study retrospective cohort study and updated systematic review and meta-analysis. J Allergy Clin Immunol. 2014 Mar;133(3):688-95.e14. doi: 10.1016/j.jaci.2013.08.007. Epub 2013 Sep 29. PMID: 24084077.) teaches that the potential of BCG vaccination to protect against atopy, asthma or both had been investigated in numerous studies with conflicting results. Linehan further teaches that its updated systematic review and metanalyses found that BCG vaccination did not protect against allergies sensitization, and that any protective effect of BCG vaccination on childhood asthma is likely to be transient. Linehan additionally teaches that asthma is a chronic disease with many different phenotypes, of which atopic asthma is one.
The prior art does not teach any treatment of BCG with all allergies, and therefore, it is unclear if the claimed method would have the claimed function. Accordingly, one of skill in the art would conclude that the claimed invention encompasses a broad genus of allergies that may not respond to treatment with the claimed method. It should be noted that the specification has not demonstrated treating all allergies with the claimed method. Based on the teaching of the instant specification and the prior art one of skill in the art would not conclude that Applicant was in possession of the claimed method of treating the genus of allergies.
Consequently, the method of administering BCG to treat all allergies does not meet the written description provision of 5 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The applicant has not disclosed any species representative of the genus, which is highly variant. Applicant is reminded that Vas- Cath makes clear that the written description provision of 5 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is severable from its enablement provision. (See page 1115).
Conclusion
8. No claims are allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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