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 1-30 are pending as of the response and amendments filed on 7/14/26.
The nonstatutory double patenting rejections over the claims of US 11904046, US 12133914, and US 12419831 are withdrawn in consideration of the acceptance of the terminal disclaimer filed on 7/14/26.
Applicants’ arguments regarding the 103 rejection over Vega, EP 1527772, and the amendments to claim 30 have been fully considered but they are not persuasive. The arguments are summarized and addressed below.
Applicants have argued Vega fails to teach or suggest a hydrocortisone liquid composition for oral administration, as a skilled person in the art would understand “oral or nasal inhalation” in Vega to refer to oral inhalation and nasal inhalation, not oral administration for systemic delivery. Applicants have pointed to paras [0004-0005] of Vega which state it is often desirable to deliver steroids topically or by pulmonary route, as evidence Vega doesn’t teach oral administration. Applicants have further argued Vega includes propellants in pressurized formulations, which can cause gas and discomfort in the digestive system.
Applicants’ arguments are not persuasive, as claim 30 is drawn to a kit, which is a product, not a method or process. Although it is acknowledged claim 30 as amended recites “an oral solution for systemic delivery”, the terms “for systemic delivery” are directed to intended use of the product. If preamble statements drawn to intended use of a product limit the structure, as opposed to just reciting intended use, then they should be treated as a claim limitation. If, however, the statement of intended use doesn’t further limit the structure, they don’t further limit the claim. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. The statement of intended use “an oral solution for systemic delivery” doesn’t further distinguish the hydrocortisone composition from Vega, as there is no specific language in the claim that excludes for instance the propellants taught by Vega. Notably, the composition of claim 30 recites “comprising”, which is inclusive and open-ended. Additionally, it is maintained that Vega does teach the compositions to be suitable for oral administration. Therefore, the 103 rejection over claim 30 is maintained. This rejection is reiterated and updated below to address the amendments to the claim.
Claims 1-30 were examined. Claim 30 is rejected. Claims 1-29 are allowed.
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.
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) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vega et. al., EP 1527772 A1, publ. 5/4/2005 (cited in the IDS).
Vega teaches a pharmaceutical solution formulation containing glucocorticoids, water or a mixture of water and citric acid, a cosolvent to stabilize the glucocorticoid, a propellent, and optionally a surfactant (title & abstract). Vega teaches glucocorticoids having an additional hydroxyl group in carbon 17 or 20 are highly susceptible to chemical degradation in solution, however, the solution formulation as recited above stabilizes the glucocorticoid (abstract; para [0001-0002], [0016]). Specifically, the formulations comprise from 0.05-1.0% by weight of a glucocorticoid having a C-20 ketone and hydroxyl group in carbons 17 and/or 21; water or a mixture of water and organic acid in an amount between 0.1-3.0% by weight; a cosolvent; and a propellant in an amount to achieve 100% by weight of the final solution (para [0022-0023]). Vega teaches the solution in a container which consists of a metal cannister having a dosage valve (abstract; para [0001], [0034], [0043]). Hydrocortisone is included as a suitable glucocorticoid for the solution (para [0027]; p. 9, claim 4). Vega provides an exemplary formulation comprising the glucocorticoid budesonide; 10% by weight alcohol absolute; 0.22% by weight water; and 89.6078% by weight 1,1,1,2-tetrafluoroethane (HFA) 134a propellant carrier (para [0036], [0052]). Based on the small, defined list of glucocorticoids taught by Vega which includes hydrocortisone, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claim to have modified the exemplary formulation of Vega by replacing budesonide with hydrocortisone, with the reasonable expectation that hydrocortisone would have been stabilized in the solution, which is present in a container with a dosage valve. The teaching of a container with a dosage valve to enclose the formulation meets the limitation of a package enclosing the liquid pharmaceutical composition, as recited by instant claim 30.
Although it is acknowledged claim 30 as amended recites “an oral solution for systemic delivery”, the terms “for systemic delivery” are directed to intended use of the product. If preamble statements drawn to intended use of a product limit the structure, as opposed to just reciting intended use, then they should be treated as a claim limitation. However, if the statement of intended use doesn’t further limit the structure, it doesn’t further limit the claim. See MPEP 2111.02(II): If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. The statement of intended use “for systemic delivery” doesn’t further distinguish the hydrocortisone composition from Vega, as it doesn’t add further structural limitations to the composition.
Regarding the recitation “instructions to systemically delivering to a subject the liquid pharmaceutical composition wherein the systemic delivery comprises orally administering the liquid pharmaceutical composition to the subject”, although Vega doesn’t explicitly teach such instructions, see MPEP 2112.01(III): Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). As the “instructions to systemically delivering to a subject the liquid pharmaceutical composition wherein the systemic delivery comprises orally administering the liquid pharmaceutical composition to the subject” are not functionally related to the formulation, and as the formulation exists independently in Vega apart from these instructions, the instructions recited in the claim don’t distinguish the claimed formulation from the formulation of Vega.
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.
Correspondence
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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