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 .
DETAILED ACTION
This action is in response to a request for continued examination received June 19th, 2026.
Status of Claims
Claims 1-3, 10, 12, 14-15, and 17-18 are pending in the instant application.
Claims 4-9, 11, 13, and 16 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claims 10 and 16-18 under 35 U.S.C. 112(d). Applicant’s cancellation of Claim 16 renders the rejection thereof moot. This rejection is hereby withdrawn.
Applicant has traversed the rejection of Claims 1-3, 12, and 14-15 under 35 U.S.C. 103 as being unpatentable over Lugo et. al. (WO20000051605A1; cited on Applicant’s Information Disclosure Statement filed October 6th, 2023; cited in non-final rejection mailed November 12th, 2025; hereinafter referred to as Lugo) in view of Zarmpi et. al. (“Biopharmaceutical aspects and implications of excipient variability in drug product performance”, European Journal of Pharmaceutics and Biopharmaceutics, 111, 1-15, 2017; cited in non-final rejection mailed November 12th, 2025; hereinafter referred to as Zarmpi), Sander et. al., (“Porous Magnesium Aluminosilicate Tablets as Carrier of a Cyclosporine Self-Emulsifying Formulation”, AAPS PharmSciTech, 10, 4, 2009; cited in non-final rejection mailed November 12th, 2025; hereinafter referred to as Sander), and Norouz Alizadeh et. al., (“Solubilization of drugs using sodium lauryl sulfate: Experimental data and modeling”, Journal of Molecular Liquids, 268, 410-414, 2018; cited in non-final rejection mailed November 12th, 2025; hereinafter referred to as Norouz Alizadeh).
In particular, Applicant notes in the remarks received June 19th, 2026 that Lugo’s instruction is generic, disclosing a broad range of betamethasone that would not specifically direct one of ordinary skill in the art to select the instantly claimed 0.25 mg of betamethasone in combination with desloratadine in an immediate-release solid formulation.
In view of Applicant’s remarks and the aforementioned references, the Examiner finds this argument persuasive. While Lugo does broadly teach a pharmaceutical composition comprising an antihistamine and one or more glucocorticoid, as noted in the final rejection mailed March 19th, 2026, in terms of specific embodiments, Lugo teaches at Table II at Page 11 the inclusion of betamethasone in a range of 0.1-0.5 mg and loratadine in a range of 2-10 mg. While Lugo teaches at Page 12, Claim 7 that the antihistamine can be desloratadine, no embodiments have been taught employing desloratadine as the antihistamine. As Applicant notes at Page 5, Third Paragraph of the remarks, “Furthermore, the substitution of loratadine with desloratadine cannot be considered a trivial modification, even though both compounds are structurally related, given that they exhibit relevant differences in their pharmacokinetic and pharmacodynamic profiles, which directly impact the design and behavior of the pharmaceutical formulation.”
Taken together, a person having ordinary skill in the art would not have been motivated to substitute desloratadine for loratadine, as taught by Lugo, much less arrive at the instantly recited amounts based on the general teaching of Lugo.
This rejection is hereby withdrawn.
Claim Objections
Applicant is advised that should claims 14-15 be found allowable, claim 17-18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-15 and 17-18 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 treating seasonal and perennial allergic rhinitis and urticaria, does not reasonably provide enablement for treating any allergic and inflammatory process. 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method for treating allergic and inflammatory processes comprising administering the composition as recited at instant Claim 1.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to the treatment of any allergic or inflammatory process. This includes a broad range of mutually exclusive conditions with distinct etiologies, both that are known presently, or allergic and inflammatory processes that are either presently unknown, or later discovered and classified as an allergic and/or inflammatory process. Can Applicant simply “reach through” and obtain patent protection for the treatment of processes that are either yet to be discovered, or those that are presently known, but later classified as allergic and inflammatory processes?
State of the prior art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
With respect to the administration of desloratadine, Limon et. al. (“Desloratadine: A Nonsedating Antihistamine”, Annals of Pharmacotherapy, 2003; hereinafter referred to as Limon) represents the state of the prior art.
At Page 237, First Paragraph of the Second Column, Limon teaches desloratadine is indicated “for relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR), and for relief of the symptoms of chronic idiopathic urticaria (CIU)”. This is re-iterated at Page 238, Table 1.
Taken together, the prior art is enabling for an administration of a composition comprising desloratadine for the treatment of seasonal and perennial allergic rhinitis and urticaria.
The amount of direction provided and working examples:
With respect to administering the instantly claimed composition as recited at instant Claim 1, Applicant discloses, beginning at Page 18 of the instant specification an example to determine bioavailability and pharmacokinetic parameters. In this example, compositions were administered to healthy subjects. Applicant teaches at Page 19, Paragraph 0100, the conclusion from this example is that there is no pharmacokinetic interaction when desloratadine is administered in combination with betamethasone.
No examples have been disclosed demonstrating treatment of any condition beyond those known in the prior art to be treatable by the administration of desloratadine. Therefore, the instant application is enabling for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and urticaria, as taught by the prior art, but the instant disclosure is not sufficiently enabling for the treatment of conditions other than these.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
MPEP § 2164.01 (a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F. 2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here that Applicant is not enabled for the instantly claimed method of the treatment of any allergic and inflammatory process.
Allowable Subject Matter
Claims 1-3, 10, and 12 are allowed.
Conclusion
Claims 14-15 and 17-18 are rejected.
Claims 1-3, 10, and 12 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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 Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights