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 Claims
Claims 1-3, 10, 12, and 14-18 are pending in the instant application.
Claims 4-9, 11, and 13 have been canceled.
Withdrawn Rejections/Objections
Applicant’s amendment is sufficient to overcome the rejection of Claims 11 and 14-15 under 35 U.S.C. 112(b). Applicant’s cancellation of Claim 11 renders the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 14-15 under 35 U.S.C. 101. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-10 and 12-14 under 35 U.S.C. 103. Applicant’s cancellation of Claims 4-9 and 13 renders the rejections thereof moot. These rejections are hereby withdrawn.
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10 and 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 10 and 16 depend from Claim 4, which has been canceled. A dependent claim cannot depend from a canceled claim. Claims 17-18 are drawn to a method comprising administration of the composition recited at Claim 16, which depends from canceled Claim 4, and therefore are also improperly dependent. Per MPEP 608.01(n), V., “If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lugo et. al. (WO2000051605A1; 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).
Applicant traversed the rejections under 35 U.S.C. 103 raised based on the above-cited references on the basis that the specific amount of betamethasone, 0.25 mg was not taught in the prior art and that the references do not disclose the specifically defined pharmaceutical composition comprising desloratadine and betamethasone in combination with the excipients recited in the amended Claim 1.
In view of the previously cited references, the examiner does not find this persuasive.
Regarding Claim 1, Lugo teaches a pharmaceutical composition comprising a therapeutically effective amount of an antihistamine and one or more glucocorticoid.
At Page 12, Claim 7, Lugo teaches inclusion of the antihistamine desloratadine.
At Page 13, Claim 8, Lugo teaches the glucocorticoid can be betamethasone.
At Page 4, Last paragraph, Lugo teaches the glucocorticoid is present in an amount between 0.02 mg and 0.8 mg, and that the antihistamine is present in an amount ranging from 2 to 20 milligrams.
At Page 5, First Paragraph, Lugo teaches the composition can further include a pharmaceutically acceptable carrier, which includes diluents and excipients, further to include disintegrating agents and lubricants.
At Page 6, Last Paragraph, Lugo teaches the composition can be a tablet in a solid dosage form.
At Page 9, Lines 25-26, Lugo teaches solid forms of the composition may be coated by standard aqueous or nonaqueous techniques.
At Page 10, Table I, an embodiment of such a composition is disclosed wherein betamethasone is included in an amount ranging from 0.1-0.5 mg, and loratadine is included as the antihistamine in ana mount ranging from 2-10 milligrams.
Though Applicant argues at Page 7, Sixth Paragraph, of the remarks filed February 12th, 2026 that formulation challenges exist for a composition comprising desloratadine and betamethasone in a pharmaceutical composition. This is not persuasive, as in view of Lugo, as noted above, the inclusion of desloratadine and betamethasone in a single pharmaceutical composition is directly suggested by the prior art. The excipients chosen to overcome the purported challenge thereof are obvious in view of the aforementioned references.
Further, at Page 7, Third Paragraph, Lugo teaches the inclusion of microcrystalline cellulose as a diluent.
At Page 13, Claim 12, Lugo teaches the inclusion of calcium diphosphate, reading on calcium dibasic phosphate anhydrous as a second diluent.
At Page 8, Second Paragraph, Lugo teaches the inclusion of talc as a glident.
With regard to the amount of betamethasone, the instantly recited amount falls within the range taught by Lugo. It is routine in the art to optimize concentrations of active pharmaceutical ingredients in development of a pharmaceutical composition. Per MPEP 2144.05, II., A., “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.” In the instant case, the Applicant has claimed an amount of betamethasone that falls within this range.
Applying KSR exemplary rationale B, it would have been prima facie obvious for a person having ordinary skill in the art to substitute loratadine, as taught by Lugo in the embodiment disclosed at Page 10, Table I, with desloratadine, as instantly claimed to arrive at the instantly claimed composition, as Lugo teaches compositions in which desloratadine and loratadine are both suitable, interchangeable antihistamines with a common core structure. Therefore, a person of ordinary skill in the art would practice the substitution of loratadine for desloratadine with reasonable expectation of success.
Lugo does not teach the inclusion of crospovidone as a disintegrant.
At Page 12, under “5.4.3. Crospovidone”, Zarmpi teaches crospovidone is used in solid dosage form manufacturing as a disintegrant and that it is considered an excellent excipient due to fast disintegration and in inability to form a gel.
Applying KSR exemplary rationale C, it would have been prima facie obvious to a person having ordinary skill in the art to select crospovidone as the distinegrant in the instantly claimed composition due to its status in the art as an excellent disintegrant in solid dosage formulations, motivated by the advantageous property that it provides fast disintegration without forming a gel.
Lugo does not teach the use of aluminum and magnesium silicate as an absorbent.
At Page 1391, under “Preparation of LLT”, Sander teaches magnesium aluminosilicate (MAMS) is an absorbent suitable for direct compression and contributes to increased flowability. Under “Liquid Loading Capacity of LLT Compared with Capsules”, Sander teaches MAMS can absorb 3 mL/g of an oil.
Applying KSR exemplary rationale C, it would have been prima facie obvious for a person having ordinary skill in the art to select MAMS as the absorbent in the instantly claimed composition due to its status in the art, motivated by the advantageous property that it increases flowability in solid formulations.
Lugo does not teach sodium lauryl sulphate as the surfactant used.
At the abstract, Norouz Alizadeh teaches sodium lauryl sulfate (SLS) is a common stabilizing agent in the pharmaceutical sciences. Further, at the Abstract, Norouz Alizadeh teaches that most drugs showed a considerable increase in solubility above the critical micelle concentration with the inclusion of SLS as a surfactant often increases solubility.
Applying KSR exemplary rationale C, it would have been prima facie obvious to a person having ordinary skill in the art to select sodium lauryl sulfate as the surfactant in the instantly claimed composition due to its state in the art as a commonly used surfactant, motivated by the teaching that inclusion of SLS as a surfactant often increases solubility.
Taken together, this results in the practice of Claim 1 with reasonable expectation of success, as the excipients not explicitly taught by Lugo were known in the art at the time of filing to be advantageous for immediate release solid pharmaceutical formulations, as noted above.
Regarding Claims 14-15, Lugo teaches at Page 5, Lines 22-31, that the aforementioned composition is useful in treating atopic dermatitis, angioedema, urticaria, seasonal and allergic rhinitis, food and drug allergies, allergic asthma, and allergic reaction to insect stings and bites. As the aforementioned composition comprises the same active ingredient as instantly claimed, both desloratadine and betamethasone, applying KSR exemplary rationale A, the additional components obviated by the secondary references as noted above, it would have been prima facie obvious to modify the composition taught by Lugo with excipients well-known in the art to arrive at the instantly claimed method with reasonable expectation of success.
Conclusion
Claims 1-3, 10, 12, and 14-18 are rejected.
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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624