DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Examiner acknowledges that, according to the Filing receipt received 10/20/2023, that the instant application 18/481,566 filed 10/05/2023 is a CON of 17/132,038 filed 12/23/2020 which is a DIV of 14/132,578 filed 12/18/2013, which claims foreign priority of European Patent Office applications 12199302.6 filed 12/21/2012 and 13190393.2 filed 10/25/2013.
Information Disclosure Statement
The Information Disclosure Statements filed on 01/31/2024, 04/18/2025, and 01/08/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full, with the exception of foreign reference WO 1997012687 A1 which was not provided with the IDS filed 01/31/2024. A signed copy of list of references cited from the IDS is included with this Office Action.
Specification
The disclosure is objected to because of the following informalities: paragraph [0023] "budesonide) as powders for inhalation)" contains two closed .
Appropriate correction is required.
The use of the terms ALVESCO®, SPIRIVA® RESPIMAT®, COMBIVENT® RESPIMAT®, BERODUAL® RESPIMAT®, RESPIMAT®, OMNARIS®/OMNIAIR®, DEXABENE®, VIANI® DISCUS®, PULMICORT® TURBOHALER®, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear 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.
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.
Claims 1-14 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.
Claim 1 recites “at 0.1 or 1.0 molar”. It is unclear what aspect of the solution is “at” 0.1 or 1.0 molar or what “at” means. Is the solution of ciclesonide, ethanol, and water “at” 0.1 or 1.0 molar? Does “at” mean that the concentration of the pharmaceutically acceptable acid is 0.1 or 1.0 molar? Clarification is requested. Claims 2-14 are rejected for requiring the limitation at issue.
Claim 2 recites “wherein a proportion of ethanol in the solvent is in a range of 85 – 100% V/V”. It is unclear how a solvent which, per claim 1, necessarily contains ethanol and water can also contain 100% ethanol. Clarification is requested.
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 (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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 14 is/are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Radau et al. (US 2008/0041369 A1; IDS filed 01/24/2024).
Radau et al. discloses a medicament formulation comprising a compound of formula 1, an active substance 2 selected from budesonide, beclomethasone, fluticasone, and ciclesonide, an active substance 3, and at least one pharmacologically acceptable acid (claim 1), further comprising ethanol or a mixture of water and ethanol as the solvent (claim 3), wherein the pH of the formulation is 2.0 to 6.5 (claim 17). Radau et al. further discloses a working example comprising active substance 2, 70% ethanol/water, and HCl with a pH of 4.0 (#2, tables corresponding to paragraphs [0219]-[0230]).
Per MPEP 2131.02, “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).” Given that ciclesonide is specifically and narrowly delineated as a species of substance 2 in the formulation disclosed by Radau et al., one of ordinary skill in the art would be able to envisage the claimed formulation comprising ciclesonide as an active substance.
Alternatively, it would be prima facie obvious for one of ordinary skill in the art to formulate the claimed invention of Radau et al. with ciclesonide as an active substance. One would be motivated to do so, with a reasonable expectation of success, as Radau et al. sets forth a finite number of predictable potential species of steroids to be pursued as active substance 2, including ciclesonide.
Examiner additionally notes that while instant claim 14 is directed toward a product made by a particular process (the method of claim 1), per MPEP 2113, the product is not limited by the particular steps recited, only the structure implied by the steps.
Double Patenting – Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 10 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,819,549. This is a statutory double patenting rejection.
Double Patenting – Non-Statutory
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,819,549. Although the claims at issue are not identical, they are not patentably distinct from each other because they are narrower in scope than, and therefore anticipate, the instant claims.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,925,964. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are narrower than, and therefore anticipate, the instant claims. Examiner additionally notes that while instant claim 14 is directed toward a product made by a particular process (the method of claim 1), per MPEP 2113, the product is not limited by the particular steps recited, only the structure implied by the steps.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/M.E.B./Examiner, Art Unit 1624 03/11/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624