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
Claims 44-61 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/18/2024, 08/27/2024, 09/17/2024 and 02/05/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a U.S. National phase application under 35 U.S.C 371 of PCT application PCT/US2021/045013, filed 08/06/2021, which claims priority under 35 U.S.C 119 (e) from provisional application serial No. 63/062812, filed 08/07/2020.
Terminal disclaimer
It is noted that in the child application 19/018,702 applicants had filed the terminal disclaimer on 03/04/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the current US patents application 18/260,778 which was reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 102
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.
Claims 44-47, 50-51, 53 and 58-29 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Ilomedin data sheet ( 2012, Citation 100 in instant IDS dated 01/18/2024 ) (referred to as Ilomedin hereinafter).
Instant claims are drawn a pharmaceutical composition, comprising:
iloprost, or a pharmaceutically acceptable salt thereof or a stereoisomer thereof;
ethanol;
sodium chloride; and
tromethamine.
Ilomedin discloses their 0.5 ml aqueous composition to comprise of 0.067 mg Iloprost trometamol (equivalent to 0.05 mg iloprost) which is 0.1 mg /ml . (page 1, paragraph 1, Page 12 under instructions for use/handling). It recites list of excipients to include trometamol, ethanol (96% v/v), sodium chloride and hydrochloric acid (for pH adjustment) and 1 N water for injection. (page 12, under list of excipients). Ilomedin discloses that their composition is administered after dilution as an intravenous infusion and it should be made fresh to ensure sterility by mixing the content of the ampule and the diluent thoroughly (page 1, under dosage and administration ). Ilomedin teaches that for Dilution of ILOMEDIN for use with an infusion pump, the contents of an ampoule of 1 mL ILOMEDIN (i.e. 100 µg) are diluted with 500 mL of a sterile physiological saline solution or a 5% glucose solution Or the contents of an ampoule of 0.5 mL ILOMEDIN (i.e. 50 μg) are diluted with 250mL of a sterile physiological saline solution or a 5% glucose solution and for Dilution of ILOMEDIN for use with a syringe driver, the contents of one ampoule ILOMEDIN of 1 mL (i.e. 100 µg) are diluted with 50 mL of sterile physiological saline solution or 5% glucose solution. Or the contents of one ampoule ILOMEDIN of 0.5 mL (i.e. 50 μg) are diluted with 25 mL of sterile physiological saline solution or 5% glucose solution (page 12, under instructions for use/handling). They recite that their composition is stored below 30C (page 12)
Therefore the composition disclosed by Ilomedin fully anticipates instant claims 44-47, 50-51, 53 and 58-29.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 44-61 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Ilomedin data sheet ( 2012, downloaded from the internet on 03/14/2025) (referred to as Ilomedin hereinafter).
Instant claims are drawn a pharmaceutical composition, comprising:
iloprost, or a pharmaceutically acceptable salt thereof or a stereoisomer thereof;
ethanol;
sodium chloride; and
tromethamine.
Ilomedin discloses their 0.5 ml aqueous composition to comprise of 0.067 mg Iloprost trometamol (equivalent to 0.05 mg iloprost) which is 0.1 mg /ml . (page 1, paragraph 1, Page 12 under instructions for use/handling). It recites list of excipients to include trometamol, ethanol (96% v/v), sodium chloride and hydrochloric acid (for pH adjustment) and 1 N water for injection. (page 12, under list of excipients). Ilomedin discloses that their composition is administered after dilution as an intravenous infusion and it should be made fresh to ensure sterility by mixing the content of the ampule and the diluent thoroughly (page 1, under dosage and administration ). Ilomedin teaches that for Dilution of ILOMEDIN for use with an infusion pump, the contents of an ampoule of 1 mL ILOMEDIN (i.e. 100 µg) are diluted with 500 mL of a sterile physiological saline solution or a 5% glucose solution Or the contents of an ampoule of 0.5 mL ILOMEDIN (i.e. 50 μg) are diluted with 250mL of a sterile physiological saline solution or a 5% glucose solution and for Dilution of ILOMEDIN for use with a syringe driver, the contents of one ampoule ILOMEDIN of 1 mL (i.e. 100 µg) are diluted with 50 mL of sterile physiological saline solution or 5% glucose solution. Or the contents of one ampoule ILOMEDIN of 0.5 mL (i.e. 50 μg) are diluted with 25 mL of sterile physiological saline solution or 5% glucose solution (page 12, under instructions for use/handling). They recite that their composition is stored below 30C (page 12).
With regards to instant claim 48, 49 and 52 , Ilomedin discloses that the composition comprises trometamol which is the same as instantly claimed tromethamine. They do not however recite the exact concentration of the trometamol used and also fail to disclose the pH of the solution. However, it would have been obvious to a person of ordinary skill in the art to optimize the concentrations of both iloprost and trometamol and to adjust the pH of the solution to achieve the required concentration and to obtain the desired bioavailability. These are routine optimization procedures in the development of a composition. It is also noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regards to claims 56-57, Ilomedin recites storage below 30C but does not mention the duration of stability. Absence of evidence to the contrary, since the instantly claimed composition is the similar to the one taught by Ilomedin, the stability of the solution will also be same.
With regards to instant claim 60-61, Ilomedin clearly recites that the contents of their 100 µg/ml Ilomedin ampule should be diluted to 200 ml with sterile physiological saline solution before use (under instructions for use/handling). Accordingly, putting together a kit with the predilution formulation as recited in Ilomedin with 0.9% sodium chloride injection IV bag would have been obvious to one of ordinary skill in the art at the time of invention, Since Ilomedin clearly instructs that their composition should be diluted before use. Further IV bags made of PVC is standard in the arts and would be obvious to an ordinary skilled artisan to use that in the kit.
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the teachings in Ilomedin.
As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in arriving at the instantly claimed composition , absence of evidence to the contrary.
Conclusion
Claims 44-61 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691